Patent Publication Number: US-2023158226-A1

Title: Perfusion system

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. Nonprovisional Application No. 16,075,791 filed Aug. 6, 2018, which is a nationals stage of International Patent Application No. PCT/IN2017/050055 filed Feb. 9, 2017, which claims the benefit of India Application No. 
     201621004576 filed Feb. 9, 2016. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a perfusion system for directly administering to patients in need thereof a dose of an antineoplastic drug calculated according to a patient parameter. 
     BACKGROUND OF THE INVENTION 
     There are certain drawbacks associated with most of the commercially available parenteral dosage forms of antineoplastic drugs. For instance, the commercially available parenteral dosage forms are available as vial products having either lyophilized powder of drug or concentrated solutions which cannot be directly administered to a patient; rather they require manipulation. 
     Particularly, in case of lyophilized compositions, in addition to the requirement of reconstitution of the freeze dried powder, its manufacturing process is itself very complicated and expensive. Further, when the composition is in the form of a concentrated solution, there is an additional step of dilution prior to administration. These difficulties only multiply, when the dose of the drug is to be delivered in terms of the patient parameter, such as body surface area, renal clearance, in which cases the dose needs to be accurately calculated and dilution and/or reconstitutions need to be done taking care of the precision aspect of the dose of the drug. While attempting to deliver the accurate dose of the drug, surplus volume of reconstituted or diluted solution may be required or withdrawal of the volume may be required. These additional steps may provide a threat or risk of contamination or loss of sterility etc. or exposure of the cytotoxic drug to the involved personnel (workers, pharmacists, medical personnel, nurses). Since the patient parameter can vary over a very wide range, it becomes practically very difficult to cater to the precise dose of the drug. 
     Thus, given many potential hazards and errors associated with the use of the prior known products, there is therefore a need to provide a perfusion system for enabling hospitals or clinics to directly administer to patients in need thereof, a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population. The present invention fulfills this need. The present invention provides a perfusion system comprising plurality of perfusion containers in different sets, each filled with an aqueous, ready-to-infuse perfusion solution of the antineoplastic drug and which enables hospitals or clinics to administer a dose of an antineoplastic drug calculated according to at least one patient parameter, to patients in need thereof, while avoiding any of the steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a schematic illustration of a perfusion container in accordance with various aspects of the disclosure; and 
         FIG.  2    is a schematic illustration of a perfusion system in accordance with various aspects of the disclosure. 
     
    
    
     SUMMARY OF THE INVENTION 
     The present invention provides a perfusion system for enabling hospitals or clinics to directly administer to patients in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, said system comprising:
         plurality of perfusion containers, each container comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug, wherein said plurality of perfusion containers comprise a first set of perfusion container (s) comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug and a second set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug and optionally a third set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug, and   instructions for selecting one or more perfusion container(s) from the first set and if required one or more top-up perfusion container(s) from the second and/or third set for directly administering the calculated dose of the antineoplastic drug from the selected perfusion containers       

     The present invention further provides a method for directly administering to a patient in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, the method comprising the steps of:
         providing the perfusion system of the present invention;   calculating the dose according to a patient parameter,   selecting one or more perfusion container(s) from the first set of perfusion container(s) and if necessary from the second and/or third set of top-up perfusion container(s) required for directly administering the calculated dose and   directly administering to the patient in need thereof the perfusion solution in the selected containers.       

     DETAILED DESCRIPTION OF THE PRESENT INVENTION 
     The term “ready-to-infuse’ or ‘directly administer’ or ‘directly administering’ or ‘direct intravenous infusion’ as used herein refers to direct intravenous infusion of the aqueous solution of antineoplastic drug to the patient without involving any intermediate steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous parenteral administration of the drug solution to the patient. The aqueous drug solution can be directly administered parenterally from the perfusion container. Suitably, the perfusion system and the method according to the present invention avoids any manipulation, any step of reconstituting or dilution such as those involved in conventional lyophilized or concentrated products. It further does not involve any step of transfer of infusion solution from one container to another before administration or any volume adjustment, i.e. addition or withdrawal of the aqueous solution from the perfusion container, before administration. The term “ready-to-infuse’ or ‘directly administer’ or ‘directly administering’ or ‘direct intravenous infusion’ also includes within its meaning administering the perfusion solution present in the perfusion container without the need to monitor the volume perfused. This eliminates the risk of any potential calculation or dilution error as well as risk of microbiological contamination prior to administration. This also eliminates or minimizes contact of the drugs by hospital personnel, thus avoiding any potential side effects associated with the cytotoxic antineoplastic drugs. The terms “ready-to-infuse’ or ‘directly administer’ or ‘directly administering’ or ‘direct intravenous infusion’ also means that the perfusion containers are filled with the aqueous perfusion solution of the antineoplastic drug and subjected to sterilization process in the pharmaceutical manufacturing facility. This is different from hospital compounding, which involves intermediate steps of dispensing or mixing of the aqueous solution which has been manufactured separately in a manufacturing plant or site and supplied in bulk volumes to the hospital or pharmacy. The term ‘directly administer’ excludes any transfer of the solution from a bulk container such as used in a pharmacy into the perfusion container from where the solution is intravenously administered. 
     Hereinafter, the terms “ready-to-infuse’ or ‘directly administer’ or ‘directly administering’ or ‘direct intravenous infusion’ as used in the specification should be understood to refer to the meaning as defined herein. 
     The term ‘perfusion’ as used herein in the present invention, refers to the intravenous infusion or administration of a solution of a drug to a patient. 
     The term ‘calculated dose’ or ‘dose calculated according to at least one patient parameter’ as used herein means the dose of the antineoplastic drug that is to be administered to the patient depending upon the disease condition or indication and the patient parameters such as body surface area, body weight, renal clearance or hepatic function and other factors, that may affect the dose calculation. 
     The term “administering the calculated dose” as used herein means administering the calculated dose with precision. For example as shown in illustrative tables (a) to (m), as the body surface area increases by increments of 0.1 mg/m 2  there is or are available perfusion containers in the set, for delivery of a precise dose. The tables illustrate that the precise dose is within ±5% of the calculated dose. 
     The term ‘instructions’ as used herein refers to the instructions accompanying the perfusion system of the present invention, which may be in the form of a written or electronic communication. The instructions may be provided with one or more perfusion container(s) of the perfusion system or a single set of instructions with the perfusion system or may be made available electronically. The instructions involve directions for arriving at the dose desired for a patient based on patient parameter and for appropriately selecting perfusion containers from the first or second or third set of perfusion containers and for directly administering the drug from the perfusion containers to deliver the desired dose within ±5% variance. The electronic instructions may be in the form of a chip or barcode which correspond to the instructions that can be read with the help of an electronic device. 
     The present invention provides a perfusion system for enabling hospitals or clinics to directly administer a dose of an antineoplastic drug calculated according to at least one patient parameter, to patients in need thereof, wherein the parameter varies over a range in the patient population. The direct administration avoids any of the steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration. 
     The antineoplastic drugs that may be used according to the present invention includes, but are not limited to cisplatin, carboplatin, oxaliplatin, vincristine, vinblastine, vinorelbine, vindesine, pemetrexed, gemcitabine, irinotecan, topotecan, methotrexate, docetaxel, paclitaxel, doxorubicin, daunonibicin, epirubicin, idarubicin, streptozocin, mitomycin, gentamicin, tenoposide, 5-fluorouracil, ifosfamide, cyclophosphamide, mechlorethamine, carmustine, dacarbazine, cladribine, clofarabine, fulvestrant, pegfilgrastim, pamidronate, zoledronic acid, mitoxantrone, leukovorin, etoposide, triplatin, picoplatin, satraplatin, lobaplatin or pharmaceutically acceptable salts thereof. According to some preferred embodiments, the antineoplastic drugs include platinum complex compounds such as cisplatin, carboplatin and oxaliplatin;  vinca  alkaloid drugs such as vincristine, vinblastine, vinorelbine, vindesine, antifolates such as pemetrexed; nucleoside metabolic inhibitor such as gemcitabine, topoisomerase inhibitor such as irinotecan or pharmaceutically acceptable salts thereof. The amount or concentration of the antineoplastic drugs in the perfusion system of the present invention is expressed in terms of the acid or base of the antineoplastic agent. The amount of antineoplastic drug is expressed in terms of the base used and when a salt is used, the amount may be converted into equivalent weight. 
     The perfusion system can be configured for a particular dosing regimen by using a specific concentration that can cater to a relatively wider range of patient population, such as for example patient population having body surface area varying from 1.4 to 2.6, preferable 1.6 to 2.1. For example for an antineoplastic drug irinotecan, such a specific concentration was found to be 0.7 mg/ml for a dosing regimen requiring 125 mg/m 2  or 180 mg/m 2  dose to be administered or a specific concentration was found to be 1.2 mg/ml for a dosing regimen requiring 350 mg/m 2  dose to be administered. For example for another antineoplastic drug carboplatin, such a specific concentration was found to be 2.0 mg/ml for a dosing regimen requiring 200 mg/m 2  dose to be administered. For example for another anti-neoplastic drug docetaxel, such a specific concentration was found to be 0.3 mg/ml for a dosing regimen requiring 55 mg/m 2  dose to be administered. For example for another anti-neoplastic drug oxaliplatin, such a specific concentration was found to be 0.7 mg/ml for a dosing regimen requiring 85 mg/m 2  dose to be administered. For example for another anti-neoplastic drug gemcitabine, such a specific concentration was found to be 10.0 mg/ml for a dosing regimen requiring 1000 mg/m 2  or 1250 mg/m 2  dose to be administered. For certain antineoplastic drugs, it was found that a combination of two different such specific concentrations could also be used to cater to a relatively wider range of patient population, such as for example patient population having body surface area varying from 1.4 to 2.6, preferable 1.6 to 2.1. Such drugs include cisplatin, topotecan, irinotecan, carboplatin, oxaliplatin, vincristine, vinblastine, vinorelbine, azacitidine, pemetrexed, gemcitabine, paclitaxel, cyclophosphamide, docetaxel, arsenic trioxide, fluorouracil and the like. For example, for an anti-neoplastic drug paclitaxel at a dose of 50 mg/m 2 , the concentration of solution was found to be 0.5 mg/ml in first perfusion container and 0.4 mg/ml in the second set of top-up perfusion container. For example, for an anti-neoplastic drug irinotecan at a dose of 180 mg/m 2 , the concentration of solution was found to be 1.5 mg/ml in first perfusion container and 0.2 mg/ml in the second set of top-up perfusion container. 
     In some embodiments the perfusion system comprises a kit with perfusion containers of two or more antineoplastic drugs so as to cater to the desired doses as per combination regimens. For example in case of colorectal cancer combination regimen, a combination of irinotecan, leucovorin and 5-fluorouracil needs to be administered and the combination regimen involves administering 180 mg/m2 irinotecan as intravenous infusion over 90 minutes on days 1, 15 and 29 with leucovorin 200 mg/m 2  intravenous infusion over two hours on days 1,2, 15, 16, 29 and 30 followed by 5-fluorouracil 400 mg/m 2  intravenous bolus infusion on days 1, 2, 15, 16, 29 and 30 and 5-fluorouracil 600 mg/m 2  intravenous infusion over 22 hours on days 1, 2, 15, 16, 29 and 30. 
     In some embodiments, the perfusion system according to the present invention comprises plurality of perfusion containers prepared in large scale manufacturing unit, each container comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug. The plurality of perfusion containers according to the present invention includes a first set of perfusion container(s) comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug and a second set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug and optionally a third set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug. The number of containers per set may range from one to fifteen containers. For instance, each set of containers may include 1 to 10 containers having varying amount of the antineoplastic drug per container. The perfusion system further includes instructions to the user such as pharmacist or hospital staff to select appropriate number of containers from one or more set of the perfusion containers so as to administer the calculated dose with precision. Suitably the precise dose delivered is equal to or within ±5%, preferably within ±3% of a dose calculated according to at least one patient parameter. 
     Whereas in some embodiments, the number of containers in each set may be selected such that for almost the entire patient population with varying patient parameter such as body surface area or weight, a combination of containers to deliver the calculated dose can be found. There are provided other embodiments that target a smaller population with a narrower range of patient parameter. In such embodiments, the number of containers per set is 1,2, 3,4,5,6,7 and not more than 10. In preferred embodiments, the number of first perfusion containers may be 5 and the number of second top-up containers may be 1,2,3,4,5,6,7,8,9 or 10, preferably, 1 or 2 or 3. 
     In a more preferred example there is provided one container from the first set and a second container from the second set. For example, for an antineoplastic drug with a dose of 180 mg/m 2 , the first set has only one container having a concentration of antineoplastic drug at 1.5 mg/ml and a volume of 200 ml, and second set has only two containers each having a concentration of antineoplastic drug at 0.2 mg/ml and a volume of 150 ml. The set can be used for accurate dosing of patients with body surface area in the range 1.6 to 2.1 mg/m 2  as illustrated below: 
                                            First Perfusion   Top-up perfusion               container, 200 ml   container, 150 ml               (blue band)   (red band)               Antineoplastic drug   Antineoplastic drug               at concentration   at concentration               of 1.5 mg/ml   of 0.3 mg/ml:                                                     Total Target   Volume of   Dose delivered   Volume of   Dose delivered       % Variation**           Dose to be   perfusion   from perfusion   top up   from top up   Total dose   from delivered       BSA   delivered   container   container   container   container   delivered   dose Vs calculated       (m 2 )   (mg) D   (ml)   (a) (mg)   (ml)   (b) (mg)   (mg) (a + b)   dose                                                     1.6   288   200   300   0   0   300   4.2       1.7   306   200   300   0   0   300   −2.0       1.8   324   200   300   100   30   330   1.9       1.9   342   200   300   100   30   330   −3.5       2.0   360   200   300   100 × 2   60   360   0.0       2.1   378   200   300   100 × 2   60   360   −4.8               **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100            
The perfusion system of above Table is accompanied by suitable instructions for example as below:
 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.6 and 1.7 
                 Infuse the full volume from one 200 ml container with 
               
               
                   
                 blue band 
               
               
                 1.8 and 1.9 
                 Infuse the full volume from one 200 ml container with 
               
               
                   
                 blue band and full volume from one 100 ml top-up 
               
               
                   
                 container with red band 
               
               
                 2.0 and 2.1 
                 Infuse the full volume from one 200 ml container with 
               
               
                   
                 blue band and full volume from two 100 ml top-up 
               
               
                   
                 containers with red band 
               
               
                   
               
            
           
         
       
     
     Thus accordingly the present invention provides a perfusion container for directly administering to patients a dose of an antineoplastic drug calculated according to a patient&#39;s parameter, wherein the first perfusion container comprises a solution of antineoplastic drug at a concentration and volume such that the amount of antineoplastic drug in the container is equal to the calculated dose for one patient but less than the calculated dose for a second patient, the calculated dose is provided to first patient within 5% variance by directly administering the full volume of the solution of antineoplastic drug from the first perfusion container, further the first perfusion container is accompanied by a second top-up perfusion container comprising a solution of antineoplastic drug at a concentration and volume such that the calculated dose is provided within 5% variance by directly administering the full volume of the solution of antineoplastic drug from the first perfusion container and the second top-up container to the second patient. 
     According to one embodiment, the concentrations the concentration in the first perfusion container and the concentration in the second top-up perfusion container is same. According to one preferred embodiment, the concentration in the first perfusion container is higher than the concentration in the second top-up perfusion container. 
     According to one embodiment, the volume in the first perfusion container and the volume in the second top-up perfusion container is same. According to one preferred embodiment, the volume in the perfusion container is higher than the volume in the second top-up perfusion container. 
     Alternatively, the present invention also provides a perfusion container for directly administering to a patient a dose of an antineoplastic drug calculated according to the patient&#39;s parameter, wherein the perfusion container comprises a solution of antineoplastic drug at a concentration and volume such that the amount of antineoplastic drug in the container is less than the calculated dose, further wherein the perfusion container is accompanied by a second top-up perfusion container comprising a solution of antineoplastic drug at a concentration and volume such that the calculated dose is provided within 5% variance by directly administering the full volume of the solution of antineoplastic drug from the first perfusion container and the second top-up container. 
     According to one embodiment, the concentrations and volumes of perfusion solution in the selected set of containers are such that for each dose calculated according to a parameter for any given patient in the patient population, a first container and if necessary top-up perfusion container(s) can be selected to deliver the dose by administering the full volume in the selected containers without the need to monitor the volume of perfusion solution administered and the dose is delivered with precision. The dose can be delivered with precision, i.e. within ±5% variance, preferably within ±3% variance from the calculated dose. 
     According to one embodiment of the present invention, there is provided a perfusion container configured to be one of perfusion containers, in the perfusion system of the present invention, wherein the perfusion container comprises a ready to infuse perfusion solution of a partial dose of an antineoplastic drug for some patients in the patient population, wherein the dose is calculated according to a patient parameter. 
     According to the present there is further provided a method for directly administering to a patient in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, the method comprising the steps of: providing the perfusion system of the present invention; calculating the dose according to a patient parameter, selecting one or more perfusion container(s) from the first set of perfusion container(s) and if necessary from the second and/or third set of top-up perfusion container(s) required for directly administering the calculated dose and directly administering to the patient in need thereof the perfusion solution in the selected containers. 
     The perfusion system and method of the present invention advantageously thus covers a range of patient population having wide range of patient parameter. For instance, when the patient parameter is body surface area (BSA), it is generally known to vary over a range of 1.2 to 2.8 mg/m 2  in a patient population. The perfusion system and method of the present invention advantageously covers the whole range of such a patient population and is suitable to directly administer the calculated dose with precision, which is achieved because of the unique configuration of the perfusion system of the present invention. 
     According to the present invention, there is provided instructions for arriving at the dose of antineoplastic drug desired for a patient in need thereof, based on one of patient parameter and for appropriately selecting one or more perfusion container(s) from the first set and if required one or more top-up perfusion container(s) from the second and/or third set perfusion containers and for directly administering the antineoplastic drug from the selected perfusion containers to deliver the desired calculated dose with precision. The instructions may be in the form of written instructions or electronic instruction or any other suitable form accompanying the perfusion system and/or with one or more perfusion container of the perfusion system. The written instructions may be in the form of a package insert or labeling. The electronic instructions may be in the form of a chip or barcode which correspond to the instructions that can be read with the help of an electronic device. Preferably the instructions are written instructions accompanying the perfusion system and/or with one or more perfusion container of the perfusion system. 
     The perfusion system and method according to the present invention comprises a first set of perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug at a first concentration, a second set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a second concentration and optionally a third set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a third concentration. 
     According to one embodiment of the present invention, the first, second and/or third concentrations may be same or different. Preferably, according to one embodiment, the first, second and/or third concentrations are different. According to one embodiment, the first, second and/or third concentrations are same. 
     According to one embodiment of the present invention, the volume of solution in the individual containers may be same or different. Preferably, according to one embodiment, the volume of solution in the individual containers is different. According to one embodiment, the volume of solution in the individual containers is same. 
     According to one preferred embodiment of the present invention, the first concentration, the second concentration and/or third concentration are different. According to this embodiment, the volume of solution in the first set, second set and/or third set of containers may be same or different. In one preferred embodiment, the first, second and/or third concentrations are different and the volume of solution in the first set is different from the volume of solution in the second set and/or third set of containers. In another embodiment, the first, second and/or third concentrations are different and the volume of solution in the first set and in the second set and/or third set of containers is same. 
     According to one embodiment of the present invention, the first, second and/or third concentrations are same. According to this embodiment, the volume of solution in the first set, second set and/or third set of containers are different. 
     According to one embodiment of the present invention, the first set of perfusion containers and the second set of top-up perfusion containers, and/or the third set of top-up perfusion containers each comprise a plurality of containers containing different volumes of ready-to-infuse, aqueous perfusion solution of an antineoplastic drug. 
     According to another preferred embodiment, the first, second and/or third concentrations are different and the first concentration is higher than the second and/or third concentration, further wherein the volume of solution in the first set is higher than the volume of solution in the second set and/or third set of containers. According to another embodiment, the first, second and/or third concentrations are different, further wherein the first concentration is higher than the second and/or third concentration, further wherein the volume of solution in the first set is lower than the volume of solution in the second set and/or third set of containers. 
     In one preferred embodiment, the perfusion system comprises the first set, the second set as well as the third set of perfusion containers. In one embodiment, the first concentration is higher than the second concentration and the second concentration is higher than the third concentration. In another embodiment, the first concentration is higher than the second concentration and the second concentration is same as the third concentration. 
     In one embodiment for antineoplastic drugs such as vincristine, vinblastine, vinorelbine, oxaliplatin, cisplatin, and the like whose dose based on the body surface area (mg/m 2 ) is low, the concentration of drug in the solution of the first set may be lower than the concentration of drug in the solution of second set and/or third set, and the volume of solution in the first set is higher than the volume of solution in the second set and/or third set of containers. 
     In another embodiment, for antineoplastic drugs such as gemcitabine, pemetrexed, carboplatin or irinotecan whose dose based on the body surface area (mg/m 2 ) is high, the concentration of drug in the solution of the first set is preferably higher than the concentration of drug in the solution of second set and/or third set, and the volume of solution in the first set may be higher or lower, preferably higher, than the volume of solution in the second set and/or third set of containers. 
     According to the present invention, the set of containers of the perfusion system may range in volume from a lower to a higher volume. The volume of the aqueous solution of drug contained in different perfusion containers may vary from about 10 ml to about 5000 ml, preferably from about 20 ml to about 2000 ml, more preferably from about 25 ml to about 1000 ml. In preferred embodiments, the different set of perfusion containers having different volumes may be distinguished. In particular, the different sets of perfusion containers may be visually distinguished, for example through the use of different patterns or colors on some or all of the containers. In particular different colors may be used for labeling. 
     According to the present invention, the aqueous perfusion solution may comprise parenterally acceptable, pharmaceutically acceptable excipients or adjuvants. The excipients that may be used are selected from but not limited to pH adjusting and/or buffering agents, tonicity adjusting agents, chelating agents, solvents etc. 
     In preferred embodiments, the perfusion container according to the present invention may be a perfusion bag, infusion bag, flexible pouch, infusion bottle. The container is made up of a suitable material such as plastic or other polymeric material or glass. The container may be single or multiple layered. In one embodiment, the perfusion containers have a single outlet for withdrawal of the aqueous solution from the container while being administered intravenously. This design avoids any manipulation, such as volume adjustment (addition or removal of aqueous solution) prior to intravenous infusion. 
     The perfusion container according to the present invention does not include devices such as syringes or autoinjectors, pen or any container that has a needle attached to it, through which the solution would be delivered, and that has low volume capacity such as 1-20 ml. Such containers are known to be used in the prior art to adjust the calculated dose of the drug in the main infusion container by transferring the drug solution from another container to the infusion container or withdrawing a volume of drug solution from the infusion container before administering to the patient. 
     The perfusion system of the present invention allows the hospital staff to select perfusion containers like infusion bags according to the calculated dose from a set and directly without any manipulation infuse the full volume from each infusion bag to the patient. This does not involve any manipulation or handling in hospital pharmacy and avoids any adjustment of contents and therefore any errors in dose or exposure of the formulation or exposure of the staff to the cytotoxic formulation. 
     In one embodiment, the perfusion containers may be packaged in a secondary packaging that surrounds the perfusion container. The secondary packaging may comprise a second container such as a pouch or overwrap or carton. The secondary packaging may comprise a suitable pouch, such as an aluminum pouch covering the perfusion container. The overwrap pouch may have a layer of oxygen absorbing material. The secondary packaging may further comprise an oxygen scavenger that may be placed in between the perfusion container and overwrap/pouch. In one preferred embodiment, the secondary packaging comprises both an aluminum pouch and an oxygen scavenger. 
     The perfusion system comprising containers filled with aqueous solution of anti-neoplastic drug according to the present invention are useful in the treatment of cancer or neoplastic disorders. In one preferred embodiment, wherein the drug is Irinotecan hydrochloride, the perfusion system is useful for the treatment of metastatic colorectal cancer wherein the target dose of irinotecan to be delivered is based on body surface area (BSA). It may be used as a Colorectal Combination Regimens, wherein 125 mg/m 2  intravenous (i. v.) infusion is administered over 90 minutes on Days 1, 8, 15, 22 in 6-week cycles with 5-fluorouracil and leucovorin. It may alternatively be used at 180 mg/m 2  as an i.v. infusion over 90 minutes on Days 1, 15, 29 in 6-week cycles with 5-fluorouracil and leucovorin. It may also be used as a Colorectal Single-Agent Regimens wherein 125 mg/m 2  i.v. infusion is administered over 90 minutes on Days 1, 8, 15, 22 followed by a 2-week rest or it may alternatively be used as 350 mg/m 2  i.v. infusion over 90 minutes once every 3 weeks. 
     Suitably, the perfusion system of the present invention is sterile. The term “sterile” as used in the context of the invention, means that the aqueous solution has been brought to a state of sterility and the solution complies with the sterility requirements of the standard Pharmacopoeias like United States Pharmacopoeias (USP). Sterilization may be achieved by suitable techniques such as filtration sterilization, radiation sterilization and the like. 
       FIG.  1    is a schematic illustration of a perfusion container  100  containing an antineoplastic drug in accordance with various aspects of the disclosure. As shown, the perfusion container  100  includes an outlet  120  and a label  140 . Label  140  may include information regarding the contents of the perfusion container  100  including the name of the antineoplastic drug solution, the antineoplastic drug concentration within the solution, the volume of the antineoplastic drug solution within the perfusion container  100  and dosage information for treatment of a patient with the antineoplastic drug solution. 
       FIG.  2    is a schematic illustration of a perfusion system  200  in accordance with various aspects of the disclosure. As shown, the perfusion system  200  includes a first set of perfusion containers  220 , a second set of top-up perfusion containers  240 , and a third set of top-up perfusion containers  260 . In  FIG.  2   , the first set of perfusion containers  220  includes three perfusion containers  222 , the second set of top-up perfusion containers  240  includes three perfusion containers  242 , and the third set of top-up perfusion containers  260  includes three perfusion containers  262 . As described herein, the sets of perfusion containers  220 ,  240 ,  260  may include 1 to 10 containers having varying concentrations and/or volumes of a particular antineoplastic drug solution and/or different antineoplastic drug solutions with different antineoplastic drugs, solution concentrations and/or solution volumes. The perfusion system further includes instructions  280  for selecting one or more perfusion containers from the first set of perfusion containers  220 , the second set of top-up perfusion containers  240 , and the third set of top-up perfusion containers  260  for directly administering to a patient the calculated dose of the antineoplastic drug from the selected perfusion containers. 
     ILLUSTRATIONS 
     According to one embodiment, there is provided a perfusion system for administration of irinotecan or its pharmaceutical acceptable salts and or hydrates thereof. Table 1 below provide details of the perfusion system having containers of first and second set with the ranges of concentration and volume of the solution or irinotecan per set. 
     
       
         
           
               
             
               
                 TABLE 1 
               
             
            
               
                   
               
               
                 Perfusion system of Irinotecan: 
               
            
           
           
               
               
               
            
               
                   
                 First set of 
                 Second set of top up 
               
               
                   
                 Perfusion container 
                 perfusion container 
               
               
                   
               
               
                 Concentration range (mg/ml) 
                 1.0-3.0 
                 0.1-0.8 
               
               
                 Preferred concentration range 
                 1.5-2.0 
                 0.2-0.4 
               
               
                 (mg/ml) 
                   
                   
               
               
                 Volume range (ml) 
                  80-500 
                  50-350 
               
               
                 Preferred volume range (ml) 
                  90-300 
                  75-150 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second set. In some embodiments, the first set of perfusion containers contain solution having higher irinotecan concentration then the solution in second set of top-up perfusion containers. In some embodiments, the first set of perfusion container and second set of top-up perfusion containers contain solution having same irinotecan concentration, but different volume. Preferably the volume of solution in the first set of perfusion containers is higher than that in the second set of top-up containers. 
     In one preferred embodiment, the first set of infusion containers comprise perfusion solution having irinotecan or its pharmaceutical acceptable salts at a concentration ranging from about 1.0 mg/ml to 3.0 mg/ml and volume of solution ranging from about 80 ml to about 500 ml, further wherein the second or third set of infusion containers comprise perfusion solution having irinotecan at a concentration ranging from about 0.1 to 0.8 mg/ml and volume of solution ranging from about 50 ml to about 350 ml. The amount of irinotecan mentioned herein in the examples refers to the concentration of irinotecan base. When the solution contain a pharmaceutical acceptable salt or hydrate of irinotecan, the amount in mg/ml of the salt or hydrate will be higher depending upon the type of salt or hydrate and the said salt or hydrate will have an equivalent amount of irinotecan depending upon the molecular weight. For instance, if irinotecan hydrochloride trihydrate is used in amounts of 1.5 mg/ml, the equivalent amount of irinotecan that it will contain will be 1.3 mg/ml. 
     In one embodiment, irinotecan is used for the treatment of colorectal cancer and it may be either administered as a combination regimen having irinotecan, leucovorin and 5-fluorouracil or as a single agent regimen. Combination regimen 1 involves administering 125 mg/m 2  irinotecan as intravenous infusion over 90 minutes on days 1, 8, 15 and 22 with leucovorin 20 mg/m 2  intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-fluorouracil 500 mg/m 2  intravenous bolus infusion on days 1, 8, 15, and 22 every 6-weeks. Combination regimen 2 involves administering 180 mg/m 2  irinotecan as intravenous infusion over 90 minutes on days 1, 15 and 29 with leucovorin 200 mg/m 2  intravenous infusion over two hours on days 1,2, 15, 16, 29 and 30 followed by 5-fluorouracil 400 mg/m 2  intravenous bolus infusion on days 1, 2, 15, 16, 29 and 30 and 5-fluorouracil 600 mg/m 2  intravenous infusion over 22 hours on days 1, 2, 15, 16, 29 and 30. Single-Agent Regimen 1 involves 125 mg/m 2  i.v. infusion, administered over 90 minutes on Days 1, 8, 15, 22 followed by a 2-week rest. Single-Agent Regimen 2 involves 350 mg/m 2  i.v. infusion over 90 minutes once every 3 weeks. 
     The perfusion system of the present invention is so configured that it provides the desired target dose of irinotecan (within ±5% of variation) as per the regimens illustrated above and can cater to a relatively wider range of patient population, such as for example patient population having body surface area varying from 1.4 to 2.6, preferable 1.6 to 2.1 using limited number of perfusion containers. 
     As illustrated below in Table 2, for combination regimen 1 and single-agent regimen 1, (having irinotecan dose of 125 mg/m 2 ), it is possible to have the following kit with 5 containers and with following instructions to cater to the desired target dose of irinotecan for patient population having body surface area varying from 1.3 to 2.6: 
     
       
         
           
               
             
               
                 TABLE 2 
               
             
            
               
                   
               
               
                 Description of perfusion system of Irinotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Top-up perfusion 
                   
               
               
                   
                 First set of Perfusion 
                 containers- 
                   
               
               
                   
                 container Drug 
                 Second set Drug 
                   
               
               
                   
                 concentration—0.7 mg/ml: 
                 concentration—0.7 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume delivered 
                 Dose delivered 
                 Volume delivered 
                   
                   
                   
               
               
                   
                 Dose at 
                 from first 
                 from first 
                 from second 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 125 mg/m2 to 
                 perfusion 
                 perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 be delivered 
                 container 
                 container 
                 perfusion 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 container (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 162.5 
                 240 
                 168 
                 0 
                 0 
                 168 
                 3.4 
               
               
                 1.4 
                 175 
                 240 
                 168 
                 0 
                 0 
                 168 
                 −4.0 
               
               
                 1.5 
                 187.5 
                 270 
                 189 
                 0 
                 0 
                 189 
                 0.8 
               
               
                 1.6 
                 200 
                 240 
                 168 
                 50 
                 35 
                 203 
                 1.5 
               
               
                 1.7 
                 212.5 
                 240 
                 168 
                 50 
                 35 
                 203 
                 −4.5 
               
               
                 1.8 
                 225 
                 270 
                 189 
                 50 
                 35 
                 224 
                 −0.4 
               
               
                 1.9 
                 237.5 
                 240 
                 168 
                 100 
                 70 
                 238 
                 0.2 
               
               
                 2.0 
                 250 
                 270 
                 189 
                 100 
                 70 
                 259 
                 3.6 
               
               
                 2.1 
                 262.5 
                 270 
                 189 
                 100 
                 70 
                 259 
                 −1.3 
               
               
                 2.2 
                 275 
                 400 
                 280 
                 0 
                 0 
                 280 
                 1.8 
               
               
                 2.3 
                 287.5 
                 400 
                 280 
                 0 
                 0 
                 280 
                 −2.6 
               
               
                 2.4 
                 300.0 
                 400 
                 280 
                 50 
                 35 
                 315 
                 5.0 
               
               
                 2.6 
                 325.0 
                 400 
                 280 
                 50 
                 35 
                 315 
                 −3.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The abbreviation BSA as used in the illustrations stands for patient&#39;s Body Surface Area. 
     The containers of the perfusion system of Table (2) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers Irinotecan 
                 containers; Irinotecan 
               
               
                 concentration 0.7 mg/ml 
                 concentration 0.7 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 Code 
                 container (ml) 
                 Code 
               
               
                   
               
            
           
           
               
               
               
               
            
               
                 240 
                 A 
                 50 
                 D 
               
               
                 270 
                 B 
                 100 
                 E 
               
               
                 400 
                 C 
               
               
                   
               
            
           
         
       
     
     The perfusion system of above Table (2) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 and 1.4 
                 Infuse the full volume from one 240 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.5 
                 Infuse the full volume from one 270 ml container having 
               
               
                   
                 an alphabetical code B 
               
               
                 1.6 and 1.7 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 A to one 50 ml container having an alphabetical code D 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Connect one 270 ml container having an alphabetical code 
               
               
                   
                 B to one 50 ml container having an alphabetical code D 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 A to one 100 ml container having an alphabetical code E 
               
               
                   
                 and Infuse the full volume 
               
               
                 2.0 and 2.1 
                 Connect one 270 ml container having an alphabetical code 
               
               
                   
                 B to one 100 ml container having an alphabetical code E 
               
               
                   
                 and Infuse the full volume 
               
               
                 2.2 and 2.3 
                 Infuse the full volume from one 400 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 2.4 and 2.6 
                 Connect one 400 ml container having an alphabetical code 
               
               
                   
                 C to one 50 ml container having an alphabetical code D 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     As illustrated below in Table 3, for combination regimen 2, (having irinotecan dose of 180 mg/m 2 ), it is possible to have the following kit with 5 containers and with following instructions to cater to the desired target dose of irinotecan for patient population having body surface area varying from 1.3 to 2.6: 
     
       
         
           
               
             
               
                 TABLE 3 
               
             
            
               
                   
               
               
                 Description of perfusion system of Irinotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of top-up perfusion 
                   
               
               
                   
                 containers Irinotecan 
                 containers; Irinotecan 
                   
               
               
                   
                 concentration 0.7 mg/ml 
                 concentration 0.7 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 234 
                 350 
                 245 
                 0 
                 0 
                 245 
                 3.8 
               
               
                 1.4 
                 252 
                 350 
                 245 
                 0 
                 0 
                 245 
                 −2.8 
               
               
                 1.5 
                 270 
                 350 
                 245 
                 50 
                 35 
                 280 
                 3.7 
               
               
                 1.6 
                 288 
                 350 
                 245 
                 50 
                 35 
                 280 
                 −2.8 
               
               
                 1.7 
                 306 
                 450 
                 315 
                 0 
                 0 
                 315 
                 2.9 
               
               
                 1.8 
                 324 
                 450 
                 315 
                 0 
                 0 
                 315 
                 −2.8 
               
               
                 1.9 
                 342 
                 450 
                 315 
                 50 
                 35 
                 350 
                 2.3 
               
               
                 2 
                 360 
                 450 
                 315 
                 50 
                 35 
                 350 
                 −2.8 
               
               
                 2.1 
                 378 
                 550 
                 385 
                 0 
                 0 
                 385 
                 1.9] 
               
               
                 2.2 
                 396 
                 550 
                 385 
                 0 
                 0 
                 385 
                 −2.8 
               
               
                 2.3 
                 414 
                 550 
                 385 
                 50 
                 35 
                 420 
                 1.4 
               
               
                 2.4 
                 432 
                 550 
                 385 
                 50 
                 35 
                 420 
                 −2.8 
               
               
                 2.5 
                 450 
                 550 
                 455 
                 100 
                 70 
                 455 
                 1.1 
               
               
                 2.6 
                 468 
                 550 
                 455 
                 100 
                 70 
                 455 
                 −2.8 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (3) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers Irinotecan 
                 containers; Irinotecan 
               
               
                 concentration 0.7 mg/ml 
                 concentration 0.7 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
            
           
           
               
               
               
               
            
               
                 350 
                 F 
                 50 
                 D 
               
               
                 450 
                 G 
                 100 
                 E 
               
               
                 550 
                 H 
               
               
                   
               
            
           
         
       
     
     The perfusion system of above Table (3) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 and 1.4 
                 Infuse the full volume from one 350 ml container having 
               
               
                   
                 an alphabetical code F 
               
               
                 1.5 and 1.6 
                 Connect one 350 ml container having an alphabetical code 
               
               
                   
                 F to one 50 ml container having an alphabetical code D 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 and 1.8 
                 Infuse the full volume from one 450 ml container having 
               
               
                   
                 an alphabetical code G 
               
               
                 1.9 and 2.0 
                 Connect one 450 ml container having an alphabetical code 
               
               
                   
                 G to one 50 ml container having an alphabetical code D 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 and 2.2 
                 Connect one 550 ml container having an alphabetical code 
               
               
                   
                 H and Infuse the full volume 
               
               
                 2.3 and 2.4 
                 Connect one 550 ml container having an alphabetical code 
               
               
                   
                 H to one 50 ml container having an alphabetical code D 
               
               
                   
                 and Infuse the full volume 
               
               
                 2.5 and 2.6 
                 Connect one 550 ml container having an alphabetical code 
               
               
                   
                 H to one 100 ml container having an alphabetical code E 
               
               
                   
                 and Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     As illustrated below in Table 4, for combination regimen 4, (having irinotecan dose of 350 mg/m 2 ), it is possible to have the following kit with 5 containers and with following instructions to cater to the desired target dose of irinotecan for patient population having body surface area varying from 1.3 to 2.4: 
     
       
         
           
               
             
               
                 TABLE 4 
               
             
            
               
                   
               
               
                 Description of perfusion system of Irinotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Top-up perfusion 
                   
               
               
                   
                 First set of Perfusion 
                 containers - 
                   
               
               
                   
                 container Drug 
                 Second set Drug 
                   
               
               
                   
                 concentration—1.2 mg/ml: 
                 concentration—1.2 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                   
                 Volume delivered 
                 Dose delivered 
                 Volume delivered 
                   
                   
                   
               
               
                   
                 Total Target 
                 from first 
                 from first 
                 from second 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 perfusion 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 container (ml) 
                 (b) (mg) 
                 (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 455 mg 
                 370 
                 444 
                 0 
                 0 
                 444 
                 −2.4 
               
               
                 1.4 
                 490 mg 
                 370 
                 444 
                 50 
                 60 
                 504 
                 2.9 
               
               
                 1.5 
                 525 mg 
                 450 
                 540 
                 0 
                 0 
                 540 
                 2.8 
               
               
                 1.6 
                 560 mg 
                 450 
                 540 
                 0 
                 0 
                 540 
                 −3.6 
               
               
                 1.7 
                 595 mg 
                 450 
                 540 
                 50 
                 60 
                 600 
                 0.8 
               
               
                 1.8 
                 630 mg 
                 450 
                 540 
                 50 
                 60 
                 600 
                 −4.8 
               
               
                 1.9 
                 665 mg 
                 570 
                 684 
                 0 
                 0 
                 684 
                 2.9 
               
               
                 2.0 
                 700 mg 
                 570 
                 684 
                 0 
                 0 
                 684 
                 −2.9 
               
               
                 2.1 
                 735 mg 
                 570 
                 684 
                 50 
                 60 
                 744 
                 1.5 
               
               
                 2.2 
                 770 mg 
                 650 
                 780 
                 0 
                 0 
                 780 
                 1.3 
               
               
                 2.3 
                 805 mg 
                 650 
                 780 
                 0 
                 0 
                 780 
                 −3.1 
               
               
                 2.4 
                 840 mg 
                 650 
                 780 
                 50 
                 60 
                 840 
                 0 
               
               
                   
               
            
           
         
       
     
     The containers of the perfusion system of Table (4) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers Irinotecan 
                 containers; Irinotecan 
               
               
                 concentration 1.2 mg/ml 
                 concentration 1.2 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 370 
                 I 
                 50 
                 M 
               
               
                 450 
                 J 
                   
                   
               
               
                 570 
                 K 
                   
                   
               
               
                 650 
                 L 
               
               
                   
               
            
           
         
       
     
     The perfusion system of above Table (4) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 
                 Infuse the full volume from one 370 ml container 
               
               
                   
                 having an alphabetical code I 
               
               
                 1.4 
                 Connect one 370 ml container having an alphabetical 
               
               
                   
                 code I to one 50 ml container having an alphabetical 
               
               
                   
                 code M and infuse the full volume 
               
               
                 1.5 and 1.6 
                 Infuse the full volume from one 450 ml container 
               
               
                   
                 having an alphabetical code J 
               
               
                 1.7and 1.8 
                 Connect one 450 ml container having an alphabetical 
               
               
                   
                 code J to one 50 ml container having an alphabetical 
               
               
                   
                 code M and infuse the full volume 
               
               
                 1.9 and 2.0 
                 Infuse the full volume from one 570 ml container 
               
               
                   
                 having an alphabetical code K 
               
               
                 2.1 
                 Connect one 570 ml container having an alphabetical 
               
               
                   
                 code K to one 50 ml container having an alphabetical 
               
               
                   
                 code M and infuse the full volume 
               
               
                 2.2 and 2.3 
                 Infuse the full volume from one 650 ml container 
               
               
                   
                 having an alphabetical code L 
               
               
                 2.4 
                 Connect one 650 ml container having an alphabetical 
               
               
                   
                 code L to one 50 ml container having an alphabetical 
               
               
                   
                 code M and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     For meeting all the dosage requirements (covering all approved dosage regimens for irinotecan and covering wide range of patient population, such as for example patient population having body surface area varying from 1.4 to 2.6), 13 containers coded A to M are required but for each patient only one or 2 containers are used at any one time. In case when two perfusion containers are to be infused to a patient then they may be connected with a Y connector. The perfusion containers have a single outlet for withdrawal of the aqueous solution from the container while being administered intravenously. This design avoids any manipulation, such as volume adjustment (addition or removal of aqueous solution) prior to intravenous infusion. 
     In another embodiment, there are provided perfusion containers in the first set having drug solution at higher concentration and top-up perfusion containers having drug solution at lower concentration. The dose of Irinotecan for a particular indication is 180 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one container from the first set and one container from the top-up perfusion container to deliver the calculated dose within ±5% variance. This is presented in table 5 below: 
     
       
         
           
               
             
               
                 TABLE 5 
               
             
            
               
                   
               
               
                 Description of perfusion system of Irinotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of top-up perfusion 
                   
               
               
                   
                 containers Irinotecan 
                 containers; Irinotecan 
                   
               
               
                   
                 concentration 1.5 mg/ml 
                 concentration 0.2 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 234 
                 160 
                 240 
                 0 
                 0 
                 240 
                 2.6 
               
               
                 1.4 
                 252 
                 160 
                 240 
                 0 
                 0 
                 240 
                 −4.8 
               
               
                 1.5 
                 270 
                 160 
                 240 
                 150 
                 30 
                 270 
                 0.0 
               
               
                 1.6 
                 288 
                 200 
                 300 
                 0 
                 0 
                 300 
                 4.2 
               
               
                 1.7 
                 306 
                 200 
                 300 
                 0 
                 0 
                 300 
                 −2.0 
               
               
                 1.8 
                 324 
                 200 
                 300 
                 150 
                 30 
                 330 
                 1.9 
               
               
                 1.9 
                 342 
                 200 
                 300 
                 150 
                 30 
                 330 
                 −3.5 
               
               
                 2 
                 360 
                 240 
                 360 
                 0 
                 0 
                 360 
                 0.0 
               
               
                 2.1 
                 378 
                 240 
                 360 
                 150 
                 30 
                 390 
                 3.2 
               
               
                 2.2 
                 396 
                 240 
                 360 
                 150 
                 30 
                 390 
                 −1.5 
               
               
                 2.3 
                 414 
                 280 
                 420 
                 0 
                 0 
                 420 
                 1.4 
               
               
                 2.4 
                 432 
                 280 
                 420 
                 0 
                 0 
                 420 
                 −2.8 
               
               
                 2.5 
                 450 
                 280 
                 420 
                 150 
                 30 
                 450 
                 0.0 
               
               
                 2.6 
                 468 
                 280 
                 420 
                 150 
                 30 
                 450 
                 −3.8 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (5) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers Irinotecan 
                 containers; Irinotecan 
               
               
                 concentration 1.5 mg/ml 
                 concentration 0.2 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 160 
                 O 
                 150 
                 S 
               
               
                 200 
                 P 
                   
                   
               
               
                 240 
                 Q 
                   
                   
               
               
                 280 
                 R 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (5) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 and 1.4 
                 Infuse the full volume from one 160 ml container 
               
               
                   
                 having an alphabetical code O 
               
               
                 1.5 
                 Connect one 160 ml container having an alphabetical 
               
               
                   
                 code O to one 150 ml container having an alphabetical 
               
               
                   
                 code S and Infuse the full volume 
               
               
                 1.6 and 1.7 
                 Connect one 200 ml container having an alphabetical 
               
               
                   
                 code P and one 150 ml container having an alphabetical 
               
               
                   
                 code S and and Infuse the full volume 
               
               
                 1.8 and 1.9 
                 Connect one 200 ml container having an alphabetical 
               
               
                   
                 code P to one 150 ml container having an alphabetical 
               
               
                   
                 code S and Infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 240 ml container 
               
               
                   
                 having an alphabetical code Q 
               
               
                 2.1 and 2.2 
                 Connect one 240 ml container having an alphabetical 
               
               
                   
                 code Q to one 150 ml container having an alphabetical 
               
               
                   
                 code S and Infuse the full volume 
               
               
                 2.3 and 2.4 
                 Infuse the full volume from one 280 ml container 
               
               
                   
                 having an alphabetical code R 
               
               
                 2.5 and 2.6 
                 Connect one 280 ml container having an alphabetical 
               
               
                   
                 code R and one 150 ml container having an alphabetical 
               
               
                   
                 code S and Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     As described above, the target dose of Irinotecan for a person having a specific body surface area can be delivered (within ±5% variance), by the perfusion system of the present invention, by infusing the full volume of solution from the selected perfusion containers of the first set and top-up perfusion containers from the second set. 
     In another embodiment, wherein the dose of Irinotecan for a particular indication is 180 mg/m 2  based on patient&#39;s body surface area, there is provided following instructions (Table 6) to calculate the total dose to be delivered to a patient based on the body surface area and to select one or more perfusion containers from different sets, to deliver the calculated dose within ±5% variance. 
     
       
         
           
               
             
               
                 TABLE 6 
               
             
            
               
                   
               
               
                 Description of perfusion system of Irinotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                 First Set of Perfusion 
                 Second Set of Top-up perfusion 
                   
               
               
                   
                 container (200 ml) (code P) 
                 containers (150 ml) (Code S) 
                   
               
               
                   
                 Irinotecan at 
                 Irinotecan at 
                   
               
               
                   
                 concentration of 1.5 mg/ml 
                 concentration of 0.2 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                 Patient 
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.6 
                 288 
                 200 
                 300 
                 0 
                 0 
                 300 
                 4.2 
               
               
                 1.7 
                 306 
                 200 
                 300 
                 0 
                 0 
                 300 
                 −2.0 
               
               
                 1.8 
                 324 
                 200 
                 300 
                 150 
                 30 
                 330 
                 1.9 
               
               
                 1.9 
                 342 
                 200 
                 300 
                 150 
                 30 
                 330 
                 −3.5 
               
               
                 2.0 
                 360 
                 200 
                 300 
                 150 × 2 
                 60 
                 360 
                 0.0 
               
               
                 2.1 
                 378 
                 200 
                 300 
                 150 × 2 
                 60 
                 360 
                 −4.8 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The perfusion system of above Table (6) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.6 and 1.7 
                 Infuse the full volume from one 200 ml container 
               
               
                   
                 having an alphabetical code P 
               
               
                 1.8 and 1.9 
                 Infuse the full volume from one 200 ml container 
               
               
                   
                 having an alphabetical code P and full volume from 
               
               
                   
                 one 150 ml top-up container having an alphabetical code S 
               
               
                 2.0 and 2.1 
                 Infuse the full volume from one 200 ml container 
               
               
                   
                 having an alphabetical code P and full volume from 
               
               
                   
                 two 150 ml top-up containers having an alphabetical code S 
               
               
                   
               
            
           
         
       
     
     In the above illustration, wherever solution of two bags have to be delivered for the desired dose, the two bags can be connected together via a suitable connector such as a Y connector/joint and the full volume of solution from the two bags can be then infused. In one embodiment, the outlet of the Y joint can be connected to an infusion pump to control the rate of infusion. In this embodiment, only two or three bags are sufficient for delivering the desired calculated dose of irinotecan (within ±5% variance) for a wide range of patient population. 
     According to one embodiment, there is provided a perfusion system for administration of carboplatin. The Table 7 below provide details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 7 
               
             
            
               
                   
               
               
                 Perfusion system of Carboplatin: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of the 
                 of Perfusion 
                 perfusion 
                 perfusion 
               
               
                 perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.4-5.0 
                 0.01-3.0 
                 0.01-3.0 
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 1.0-3.0 
                 0.01-2.0 
                 0.01-2.0 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  50-1000 
                  30-200 
                  30-200 
               
               
                 Preferred volume range 
                  50-500 
                  30-100 
                  30-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 8-10. 
     
       
         
           
               
             
               
                 TABLE 8 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having carboplatin: 
               
            
           
           
               
               
            
               
                 Volume of solution in bag 
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
            
               
                 (ml) 
                 180 
                 200 
                 250 
                 300 
                 350 
                 400 
               
               
                   
               
               
                 Carboplatin amount per bag 
                 360 
                 400 
                 500 
                 600 
                 700 
                 800 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
                   
               
               
                 2 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 9 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having carboplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 40 
                 60 
               
               
                   
               
               
                 Carboplatin amount per bag 
                 30 
                 24 
                 36 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.6 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 10 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having carboplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 40 
                 60 
               
               
                   
               
               
                 Carboplatin amount per bag 
                 20 
                 16 
                 24 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.4 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In preferred embodiments, the first set of infusion containers comprise perfusion solution having carboplatin at a concentration ranging from about 0.4 mg/ml to 5.0 mg/ml and volume of solution ranging from about 50 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having carboplatin at a second and/or third concentration ranging from about 0.01 mg/ml to 2.5 mg/ml and volume of solution ranging from about 30 ml to about 100 ml; further wherein the perfusion solution has a pH ranging from about 3.0 to 7.0. 
     In one specific embodiment, the dose of carboplatin for a particular indication is 360 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one container from the first set and one or more container from the top-up perfusion container to deliver the calculated dose within ±5% variance and is presented in table (11) below: 
     
       
         
           
               
             
               
                 TABLE 11 
               
             
            
               
                   
               
               
                 Description of perfusion system of carboplatin according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container having 
                 containers having 
                   
               
               
                   
                 carboplatin at 2.0 mg/ml 
                 carboplatin at 0.8 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 D (mg) 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.5 
                 540.0 
                 270 
                 540 
                 0 
                 0 
                 0 
                 0 
               
               
                 1.6 
                 576.0 
                 270 
                 540 
                 65 
                 52 
                 592 
                 2.7 
               
               
                 1.7 
                 612.0 
                 270 
                 540 
                 65 
                 52 
                 592 
                 −3.3 
               
               
                 1.8 
                 648.0 
                 330 
                 660 
                 0 
                 0 
                 660 
                 1.9 
               
               
                 1.9 
                 684.0 
                 330 
                 660 
                 0 
                 0 
                 660 
                 −3.5 
               
               
                 2.0 
                 720.0 
                 330 
                 660 
                 65 
                 52 
                 712 
                 −1.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (11) may be color coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers carboplatin 
                 containers; carboplatin 
               
               
                 concentration 2.0 mg/ml 
                 concentration 0.8 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 270 
                 A 
                 65 
                 C 
               
               
                 330 
                 B 
               
               
                   
               
            
           
         
       
     
     The perfusion system of above Table (11) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.5 
                 Infuse the full volume from one 270 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.6 and 1.7 
                 Connect one 270 ml container having an alphabetical 
               
               
                   
                 code A to one 65 ml top-up container having an 
               
               
                   
                 alphabetical code C and infuse the full volume 
               
               
                 1.8 and 1.9 
                 Infuse the full volume from one 330 ml container having 
               
               
                   
                 an alphabetical code B 
               
               
                 2.0 
                 Connect one 330 ml container having an alphabetical code 
               
               
                   
                 B to one 65 ml top-up container having an alphabetical 
               
               
                   
                 code C and Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     In one specific embodiment, the dose of carboplatin for a particular indication is 300 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one or more perfusion containers of carboplatin from different sets, to deliver the calculated dose within ±5% variance and is presented in table (12) below: 
     
       
         
           
               
             
               
                 TABLE 12 
               
             
            
               
                   
               
               
                 Description of perfusion system of carboplatin according to one embodiment: 
               
            
           
           
               
               
               
               
               
            
               
                   
                   
                 Second Set of Top-up 
                 Third Set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 perfusion containers; 
                 perfusion containers— 
                   
               
               
                   
                 container; Carboplatin 
                 Carboplatin 
                 Carboplatin 
                   
               
               
                   
                 concentration—2.0 mg/ml 
                 concentration—0.6 mg/ml: 
                 concentration—0.4 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 390 
                 180 
                 360 
                 50 
                 30 
                 0 
                 0 
                 390 
                 0.00 
               
               
                 1.4 
                 420 
                 180 
                 360 
                 50 
                 30 
                 50 
                 20 
                 410 
                 −2.38 
               
               
                 1.5 
                 450 
                 200 
                 400 
                 50 
                 30 
                 50 
                 20 
                 450 
                 0.00 
               
               
                 1.6 
                 480 
                 250 
                 500 
                 0 
                 0 
                 0 
                 0 
                 500 
                 4.2 
               
               
                 1.7 
                 510 
                 250 
                 500 
                 0 
                 0 
                 0 
                 0 
                 500 
                 −2.0 
               
               
                 1.8 
                 540 
                 250 
                 500 
                 50 
                 30 
                 50 
                 20 
                 550 
                 1.9 
               
               
                 1.9 
                 570 
                 250 
                 500 
                 50 × 2 
                 60 
                 0 
                 0 
                 560 
                 −1.8 
               
               
                 2.0 
                 600 
                 300 
                 600 
                 0 
                 0 
                 0 
                 0 
                 600 
                 0.00 
               
               
                 2.1 
                 630 
                 300 
                 600 
                 50 
                 30 
                 0 
                 0 
                 630 
                 0.00 
               
               
                 2.2 
                 660 
                 300 
                 600 
                 50 
                 30 
                 50 
                 20 
                 650 
                 −1.5 
               
               
                 2.3 
                 690 
                 350 
                 700 
                 0 
                 0 
                 0 
                 0 
                 0 
                 1.4 
               
               
                 2.4 
                 720 
                 350 
                 700 
                 0 
                 0 
                 50 
                 20 
                 720 
                 0.00 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (12) may be color coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 Carboplatin concen- 
                 Carboplatin concen- 
                 Carboplatin concen- 
               
               
                 tration 2.0 mg/ml 
                 tration 0.8 mg/ml: 
                 tration 0.4 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 180 
                 D 
                 50 
                 I 
                 50 
                 J 
               
               
                 200 
                 E 
                   
                   
                   
                   
               
               
                 250 
                 F 
                   
                   
                   
                   
               
               
                 300 
                 G 
                   
                   
                   
                   
               
               
                 350 
                 H 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (12) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 D to one 50 ml container having an alphabetical code 
               
               
                   
                 I and infuse the full volume 
               
               
                 1.4 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 D + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 50 ml container having an alphabetical code 
               
               
                   
                 J and infuse the full volume 
               
               
                 1.5 
                 Connect one 200 ml container having an alphabetical code 
               
               
                   
                 E + one 50 ml container having an alphabetical code I 
               
               
                   
                 band and one 50 ml container having an alphabetical code 
               
               
                   
                 J and infuse the full volume 
               
               
                 1.6 and 1.7 
                 Infuse the full volume from one 250 ml container having 
               
               
                   
                 an alphabetical code F 
               
               
                 1.8 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 F + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 50 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 F to two 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 300 ml container having 
               
               
                   
                 an alphabetical code G 
               
               
                 2.1 
                 Connect one 300 ml container having an alphabetical code 
               
               
                   
                 G and one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 2.2 
                 Connect one 300 ml container having an alphabetical code 
               
               
                   
                 G + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 50 ml container having an alphabetical code 
               
               
                   
                 J and infuse the full volume 
               
               
                 2.3 
                 Infuse the full volume from one 350 ml container having 
               
               
                   
                 an alphabetical code H 
               
               
                 2.4 
                 Connect one 350 ml container having an alphabetical code 
               
               
                   
                 H to one 50 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     In another specific embodiment, the dose of carboplatin for a particular indication is 360 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one or more perfusion containers of carboplatin from different sets, to deliver the calculated dose within ±5% variance and is presented in table (13) below: 
     
       
         
           
               
             
               
                 TABLE 13 
               
             
            
               
                   
               
               
                 Description of perfusion system of carboplatin according to one embodiment: 
               
            
           
           
               
               
               
               
               
            
               
                   
                   
                 Second set of Top-up 
                 Third set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 perfusion containers— 
                 perfusion containers— 
                   
               
               
                   
                 container Carboplatin 
                 Carboplatin 
                 Carboplatin 
                   
               
               
                   
                 concentration—2.2 mg/ml: 
                 concentration—0.6 mg/ml: 
                 concentration—0.4 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 432 
                 180.0 
                 396 
                 0 
                 0 
                 50 
                 20 
                 416 
                 −3.7 
               
               
                 1.3 
                 468 
                 180 
                 396 
                 100 
                 60 
                 0 
                 0 
                 456 
                 −2.6 
               
               
                 1.4 
                 504 
                 200 
                 440 
                 100 
                 60 
                 0 
                 0 
                 500 
                 −0.8 
               
               
                 1.5 
                 540 
                 250 
                 550 
                 0 
                 0 
                 0 
                 0 
                 550 
                 1.9 
               
               
                 1.6 
                 576 
                 250 
                 550 
                 0 
                 0 
                 50 
                 20 
                 570 
                 −1.0 
               
               
                 1.7 
                 612 
                 250 
                 550 
                 100 
                 60 
                 0 
                 0 
                 610 
                 −0.3 
               
               
                 1.8 
                 648 
                 300 
                 660 
                 0 
                 0 
                 0 
                 0 
                 660 
                 1.9 
               
               
                 1.9 
                 684 
                 300 
                 660 
                 0 
                 0 
                 50 
                 20 
                 680 
                 −0.6 
               
               
                 2.0 
                 720 
                 300 
                 660 
                 100 
                 60 
                 0 
                 0 
                 720 
                 0 
               
               
                 2.1 
                 756 
                 350 
                 770 
                 0 
                 0 
                 0 
                 0 
                 770 
                 1.9 
               
               
                 2.2 
                 792 
                 350 
                 770 
                 0 
                 0 
                 50 
                 20 
                 790 
                 −0.3 
               
               
                 2.3 
                 828 
                 350 
                 770 
                 100 
                 60 
                 0 
                 0 
                 830 
                 0.2 
               
               
                 2.4 
                 864 
                 350 
                 770 
                 100 
                 60 
                 50 
                 20 
                 850 
                 −1.6 
               
               
                 2.6 
                 936 
                 400 
                 880 
                 100 
                 60 
                 0 
                 0 
                 940 
                 0.4 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (13) may be color coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 Carboplatin concen- 
                 Carboplatin concen- 
                 Carboplatin concen- 
               
               
                 tration 2.2 mg/ml 
                 tration 0.6 mg/ml: 
                 tration 0.4 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                   
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 Alphabetical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 180 
                 K 
                 100 
                 Q 
                 50 
                 R 
               
               
                 200 
                 L 
                   
                   
                   
                   
               
               
                 250 
                 M 
                   
                   
                   
                   
               
               
                 300 
                 N 
                   
                   
                   
                   
               
               
                 350 
                 O 
                   
                   
                   
                   
               
               
                 400 
                 P 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (13) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 K to one 50 ml container having an alphabetical code R 
               
               
                   
                 and infuse the full volume 
               
               
                 1.3 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 K to one 100 ml container having an alphabetical code Q 
               
               
                   
                 and infuse the full volume 
               
               
                 1.4 
                 Connect one 200 ml container having an alphabetical code 
               
               
                   
                 L to one 100 ml container having an alphabetical code Q 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 250 ml container having 
               
               
                   
                 an alphabetical code M 
               
               
                 1.6 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 M to one 50 ml container having an alphabetical code R 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 M to one 100 ml container having an alphabetical code Q 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Infuse the full volume from one 300 ml container having 
               
               
                   
                 an alphabetical code N 
               
               
                 1.9 
                 Connect one 300 ml container having an alphabetical code 
               
               
                   
                 N to one 50 ml container having an alphabetical code R 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 300 ml container having an alphabetical code 
               
               
                   
                 N to one 100 ml container having an alphabetical code Q 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 350 ml container having 
               
               
                   
                 an alphabetical code O 
               
               
                 2.2 
                 Connect one 350 ml container having an alphabetical code 
               
               
                   
                 O to one 50 ml container having an alphabetical code R 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Connect one 350 ml container having an alphabetical code 
               
               
                   
                 O to one 100 ml container having an alphabetical code Q 
               
               
                   
                 and infuse the full volume 
               
               
                 2.4 
                 Connect one 350 ml container having an alphabetical code 
               
               
                   
                 O + one 100 ml container having an alphabetical code 
               
               
                   
                 Q + one 50 ml container having an alphabetical code R 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Connect one 400 ml container with having an alphabetical 
               
               
                   
                 code P to one 100 ml container having an alphabetical code 
               
               
                   
                 Q and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     In one specific embodiment, the dose of carboplatin for a particular indication is 200 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one or more perfusion containers from different sets, to deliver the calculated dose within ±5% variance and is presented in table (14) below: 
     
       
         
           
               
             
               
                 TABLE 14 
               
             
            
               
                   
               
               
                 Description of perfusion system of carboplatin according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set of Top-up perfusion 
                   
               
               
                   
                 First set of Perfusion 
                 containers; Carboplatin 
                   
               
               
                   
                 container; Carboplatin 
                 concentration 2.0 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
            
               
                   
                 concentration—2.0 mg/ml: 
                 Volume of 
                 Dose delivered 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 top up 
                 from top-up 
                   
                 % Variation 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 perfusion 
                 perfusion 
                 Total dose 
                 from delivered 
               
               
                 BSA * 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 D (mg) 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.6 
                 320.0 
                 160 
                 320.0 
                 0 
                 0 
                 320.0 
                 0.0 
               
               
                 1.7 
                 340.0 
                 125 
                 250.0 
                 50 
                 100 
                 350.0 
                 2.9 
               
               
                 1.8 
                 360.0 
                 125 
                 250.0 
                 50 
                 100 
                 350.0 
                 −2.8 
               
               
                 1.9 
                 380.0 
                 190 
                 380.0 
                 0 
                 0 
                 380.0 
                 0.0 
               
               
                 2.0 
                 400.0 
                 125 
                 250.0 
                 80 
                 160 
                 410.0 
                 2.5 
               
               
                 2.1 
                 420.0 
                 125 
                 250.0 
                 80 
                 160 
                 410.0 
                 −2.4 
               
               
                 2.2 
                 440.0 
                 145 
                 290.0 
                 80 
                 160 
                 450.0 
                 2.3 
               
               
                 2.3 
                 460.0 
                 145 
                 290.0 
                 80 
                 160 
                 450.0 
                 −2.2 
               
               
                 2.4 
                 480.0 
                 245 
                 490.0 
                 0 
                 0 
                 490.0 
                 2.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
               
                 * BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (14) may be color coded as follows: 
     
       
         
           
               
               
               
            
               
                   
                   
               
               
                   
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                   
                 containers Carboplatin 
                 containers; Carboplatin 
               
               
                   
                 concentration 2.0 mg/ml 
                 concentration 2.0 mg/ml: 
               
            
           
           
               
               
               
               
               
            
               
                   
                 Volume of perfusion 
                 Color 
                 Volume of top up 
                 Color 
               
               
                   
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
                   
               
               
                   
                 125 
                 S 
                 50 
                 X 
               
               
                   
                 160 
                 T 
                 80 
                 Y 
               
               
                   
                 190 
                 U 
                   
                   
               
               
                   
                 145 
                 V 
                   
                   
               
               
                   
                 245 
                 W 
               
               
                   
                   
               
            
           
         
       
     
     The perfusion system of Table (14) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.6 
                 Infuse the full volume from one 160 ml container 
               
               
                   
                 having an alphabetical code T 
               
               
                 1.7 and 1.8 
                 Connect one 125 ml container having an alphabetical 
               
               
                   
                 code S to one 50 ml container having an alphabetical 
               
               
                   
                 code X and infuse the full volume 
               
               
                 1.9 
                 Infuse the full volume from one 190 ml container 
               
               
                   
                 having an alphabetical code U 
               
               
                 2.0 and 2.1 
                 Connect one 125 ml container having an alphabetical 
               
               
                   
                 code S and one 80 ml container having an alphabetical 
               
               
                   
                 code Y and infuse the full volume 
               
               
                 2.2 and 2.3 
                 Connect one 145 ml container having an alphabetical 
               
               
                   
                 code V to one 80 ml container having an alphabetical 
               
               
                   
                 code Y and infuse the full volume 
               
               
                 2.4 
                 Infuse the full volume from one 245 ml container 
               
               
                   
                 having an alphabetical code W 
               
               
                   
               
            
           
         
       
     
     As described above, the target dose of carboplatin for a person having a specific body surface area can be delivered (within ±5% variance), by the perfusion system of the present invention, by infusing the full volume of solution from the selected perfusion containers of the first set and top-up perfusion containers from the second and/or third set. 
     According to one embodiment, there is provided a perfusion system for administration of topotecan or its pharmaceutically acceptable salt. Table 15 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 15 
               
             
            
               
                   
               
               
                 Perfusion system of topotecan: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 the perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.001 to 0.072 
                 0.0005-0.003  
                 0.003-0.005  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.01 
                 0.002 
                 0.004 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 50-500 
                 30-200 
                 30-200 
               
               
                 Preferred volume range 
                 50-340 
                 50-100 
                 50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 16-18. 
     
       
         
           
               
             
               
                 TABLE 16 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having topotecan: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 100 
                 160 
                 250 
                 340 
                 400 
                 450 
                 500 
               
               
                   
               
               
                 Topotecan amount per bag 
                 0.5 
                 1.0 
                 1.6 
                 2.5 
                 3.4 
                 4.0 
                 4.5 
                 5.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                 0.01 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 17 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having topotecan: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
                 200 
               
               
                   
               
               
                 Topotecan amount per bag (mg) 
                 0.1 
                 0.15 
                 0.2 
                 0.4 
               
               
                 (at a concentration of 0.002 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 18 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having topotecan: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
               
               
                   
               
               
                 Topotecan amount per bag (mg) 
                 0.2 
                 0.3 
                 0.4 
               
               
                 (at a concentration of 0.004 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is topotecan, the first set of infusion containers comprise perfusion solution having topotecan at a concentration ranging from about 0.001 mg/ml to 0.072 mg/ml and volume of solution ranging from about 50 ml to about 500 ml, further wherein the second or third set of infusion containers comprise perfusion solution having topotecan at a concentration ranging from about 0.0005-0.005 mg/ml and volume of solution ranging from about 30 ml to about 100 ml. 
     In one specific embodiment, the dose of topotecan for a particular indication is 1.5 mg/m 2  based on patient&#39;s body surface area. There is provided instructions for calculating the total dose to be delivered to a patient based on the body surface area and instructions for selecting one container from the first set and one container from the top-up perfusion container to deliver the calculated dose within ±5% variance and is presented in table (19) below. 
     
       
         
           
               
             
               
                 TABLE 19 
               
             
            
               
                   
               
               
                 Description of perfusion system of Topotecan according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 containers; (250 ml, 
                 containers (50 ml, code B; 
                   
               
               
                   
                 code A) topotecan 
                 200 ml code C); topotecan 
                   
               
               
                   
                 concentration 0.01 mg/ml 
                 concentration 0.002 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 D (mg) 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.6 
                 2.4 
                 250 
                 2.5 
                 0 
                 0 
                 2.5 
                 −4.3 
               
               
                 1.7 
                 2.55 
                 250 
                 2.5 
                 50 
                 0.1 
                 2.6 
                 −2.0 
               
               
                 1.8 
                 2.7 
                 250 
                 2.5 
                 50 
                 0.1 
                 2.6 
                 −3.7 
               
               
                 1.9 
                 2.85 
                 250 
                 2.5 
                 200 
                 0.4 
                 2.9 
                 1.8 
               
               
                 2.0 
                 3 
                 250 
                 2.5 
                 200 
                 0.4 
                 2.9 
                 −3.3 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The perfusion system of above Table (19) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.6 
                 Infuse the full volume from one 250 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 1.7 and 1.8 
                 Infuse the full volume from one 250 ml container having an 
               
               
                   
                 alphabetical code A and full volume from one 50 ml top- 
               
               
                   
                 up container having an alphabetical code B 
               
               
                 1.9 and 2.0 
                 Infuse the full volume from one 250 ml container having an 
               
               
                   
                 alphabetical code A and full volume from one 200 ml top- 
               
               
                   
                 up containers having an alphabetical code C 
               
               
                   
               
            
           
         
       
     
     In one specific embodiment, the dose of topotecan for a particular indication is 1.5 mg/m 2  based on patient&#39;s body surface area. There is provided instructions for calculating the total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of topotecan from first set and one or more top-up perfusion container from the second and/or third set of top-up perfusion containers, to deliver the calculated dose within ±5% variance and is presented below in table (20): 
     
       
         
           
               
             
               
                 TABLE 20 
               
             
            
               
                   
               
               
                 Description of perfusion system of topotecan according to one embodiment: 
               
            
           
           
               
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 Third set of Top-up 
                   
               
               
                   
                 container topotecan 
                 perfusion containers; 
                 perfusion containers; 
                   
               
               
                   
                 concentration 
                 topotecan concentration 
                 topotecan concentration 
                   
               
               
                   
                 0.01 mg/ml 
                 0.002 mg/ml: 
                 0.004 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.4 
                 2.1 
                 160 
                 1.6 
                 0 
                 0 
                 100 
                 0.4 
                 2.0 
                 −4.8 
               
               
                 1.5 
                 2.25 
                 160 
                 1.6 
                 100 
                 0.2 
                 100 
                 0.4 
                 2.2 
                 −2.2 
               
               
                 1.6 
                 2.4 
                 250 
                 2.5 
                 0 
                 0 
                 0 
                 0 
                 2.5 
                 4.2 
               
               
                 1.7 
                 2.55 
                 250 
                 2.5 
                 0 
                 0 
                 0 
                 0 
                 2.5 
                 −2.0 
               
               
                 1.8 
                 2.7 
                 250 
                 2.5 
                 100 
                 0.2 
                 0 
                 0 
                 2.7 
                 0.0 
               
               
                 1.9 
                 2.85 
                 250 
                 2.5 
                 0 
                 0 
                 100 
                 0.4 
                 2.9 
                 1.8 
               
               
                 2 
                 3 
                 250 
                 2.5 
                 0 
                 0 
                 100 
                 0.4 
                 2.9 
                 −3.3 
               
               
                 2.1 
                 3.15 
                 250 
                 2.5 
                 100 
                 0.2 
                 100 
                 0.4 
                 3.1 
                 −1.6 
               
               
                 2.2 
                 3.3 
                 340 
                 3.4 
                 0 
                 0 
                 0 
                 0 
                 3.4 
                 3.0 
               
               
                 2.3 
                 3.45 
                 340 
                 3.4 
                 0 
                 0 
                 0 
                 0 
                 3.4 
                 −1.4 
               
               
                 2.4 
                 3.6 
                 340 
                 3.4 
                 100 
                 0.2 
                 0 
                 0 
                 3.6 
                 0.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (20) may be color coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 topotecan concen- 
                 topotecan concen- 
                 topotecan concen- 
               
               
                 tration 0.01 mg/ml 
                 tration 0.002 mg/ml: 
                 tration 0.004 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 160 
                 D 
                   
                   
                   
                   
               
               
                 250 
                 A 
                 100 
                 F 
                 100 
                 G 
               
               
                 340 
                 E 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (20) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.4 
                 Connect one 160 ml container having an alphabetical code 
               
               
                   
                 D to one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 160 ml container having 
               
               
                   
                 an alphabetical code D+; one 100 ml container having 
               
               
                   
                 an alphabetical code F + one 100 ml container having 
               
               
                   
                 an alphabetical code G 
               
               
                 1.6 and 1.7 
                 Infuse the full volume from one 250 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.8 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 A and one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 and 2.0 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 A and one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 A + one 100 ml container having an alphabetical code 
               
               
                   
                 G + one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.2 and 2.3 
                 Infuse the full volume from one 340 ml container having 
               
               
                   
                 an alphabetical code E 
               
               
                 2.4 
                 Connect one 340 ml container having an alphabetical code 
               
               
                   
                 E and one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     As described above, the target dose of topotecan for a person having a specific body surface area can be delivered (within ±5% variance), by the perfusion system of the present invention, by infusing the full volume of solution from the selected perfusion containers of the first set and top-up perfusion containers from the second and/or third set. 
     According to the present invention, the below embodiment provides perfusion system for administration of docetaxel or its pharmaceutically acceptable salt. Table 21 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 21 
               
             
            
               
                   
               
               
                 Perfusion system of docetaxel 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 the perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.1 to 2   
                 0.1 to 2   
                 0.1 to 2   
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.3 to 0.74 
                 0.3 to 0.74 
                 0.3 to 0.74 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 50-800 
                 25-150 
                 25-100 
               
               
                 Preferred volume range 
                 50-500 
                 50-100 
                 50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 22-24. 
     
       
         
           
               
             
               
                 TABLE 22 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having docetaxel: 
               
            
           
           
               
               
            
               
                 Volume of solution  
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 in bag (ml) 
                 185 
                 200 
                 215 
                 230 
                 290 
                 315 
                 395 
                 430 
                 465 
               
               
                   
               
               
                 Docetaxel amount  
                 92.5 
                 100 
                 107.5 
                 115 
                 135 
                 157.5 
                 197.5 
                 215 
                 232.5 
               
               
                 per bag (mg) (at a  
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                 concentration of 
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                 0.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 23 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having docetaxel: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
                 150 
               
               
                   
               
            
           
           
               
               
               
               
               
            
               
                 Docetaxel amount per bag (mg) 
                 15 
                 22.5 
                 30 
                 45 
               
               
                 (at a concentration of 0.3 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 24 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having docetaxel: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
                 150 
               
               
                   
               
            
           
           
               
               
               
               
               
            
               
                 Docetaxel amount per bag (mg) 
                 7.5 
                 11.25 
                 15.0 
                 22.5 
               
               
                 (at a concentration of 0.15 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is docetaxel, the first set of infusion containers comprise perfusion solution having docetaxel at a concentration ranging from about 0.1 mg/ml to 2.0 mg/ml and volume of solution ranging from about 50 ml to about 800 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Docetaxel at a concentration ranging from about 0.1-2.0 mg/ml and volume of solution ranging from about 25 ml to about 150 ml. 
     In one specific embodiment, the dose of docetaxel for a particular indication is 100 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one or more perfusion containers from different sets to deliver the calculated dose within ±5% variance and is presented in table (25) below. 
     
       
         
           
               
             
               
                 TABLE 25 
               
             
            
               
                   
               
               
                 Description of perfusion system of Docetaxel according to one embodiment: 
               
            
           
           
               
               
               
               
               
            
               
                   
                   
                 Second set of Top-up 
                 Third set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 perfusion containers; 
                 perfusion containers; 
                   
               
               
                   
                 container; Docetaxel 
                 Docetaxel concentration 
                 Docetaxel concentration 
                   
               
               
                   
                 concentration 0.6 mg/ml 
                 0.3 mg/ml: 
                 0.15 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 of top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA * 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.6 
                 160.0 
                 270 
                 162 
                 0 
                 0 
                 0 
                 0 
                 162.00 
                 1.3 
               
               
                 1.7 
                 170.0 
                 270 
                 162 
                 0 
                 0 
                 50 
                 7.5 
                 169.50 
                 −0.3 
               
               
                 1.8 
                 180.0 
                 290 
                 174 
                 50 
                 15 
                 0 
                 0 
                 189.00 
                 5.0 
               
               
                 1.9 
                 190.0 
                 290 
                 174 
                 50 
                 15 
                 0 
                 0 
                 189.00 
                 −0.5 
               
               
                 2 
                 200.0 
                 340 
                 204 
                 0 
                 0 
                 0 
                 0 
                 204.00 
                 2.0 
               
               
                 2.1 
                 210.0 
                 340 
                 204 
                 50 
                 15 
                 0 
                 0 
                 219.00 
                 4.3 
               
               
                 2.2 
                 220.0 
                 340 
                 204 
                 50 
                 15 
                 0 
                 0 
                 219.00 
                 −0.5 
               
               
                 2.3 
                 230.0 
                 340 
                 204 
                 50 
                 15 
                 50 
                 7.5 
                 226.50 
                 −1.5 
               
               
                 2.4 
                 240.0 
                 395 
                 237 
                 0 
                 0 
                 0 
                 0 
                 237.0) 
                 −1.3 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (25) may be alphabetically coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 docetaxel concen- 
                 docetaxel concen- 
                 docetaxel concen- 
               
               
                 tration 0.6 mg/ml 
                 tration 0.3 mg/ml: 
                 tration 0.15 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 270 
                 A 
                   
                   
                   
                   
               
               
                 290 
                 B 
                 50 
                   
                   
                   
               
               
                 340 
                 C 
                   
                 E 
                 50 
                 F 
               
               
                 395 
                 D 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (25) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.6 
                 Infuse the full volume from one 270 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.7 
                 Connect one 270 ml container having an alphabetical code 
               
               
                   
                 A to one 50 ml container having an alphabetical code E 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 and 1.9 
                 Connect one 290 ml container having an alphabetical code 
               
               
                   
                 B to one 50 ml container having an alphabetical code E 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 340 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 2.1 and 2.2 
                 Connect one 340 ml container having an alphabetical code 
               
               
                   
                 C and one 50 ml container having an alphabetical code E 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Connect one 340 ml container having an alphabetical code 
               
               
                   
                 C + one 50 ml container having an alphabetical code 
               
               
                   
                 E + one 50 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.4 
                 Infuse the full volume from one 395 ml container having 
               
               
                   
                 an alphabetical code D 
               
               
                   
               
            
           
         
       
     
     In one specific embodiment, the dose of docetaxel for a particular indication is 55 mg/m 2  based on patient&#39;s body surface area. There is provided instructions to calculate the total dose to be delivered to a patient based on the body surface area and select one container from the first set and one or more container from the top-up perfusion container to deliver the calculated dose within ±5% variance and is presented in table (26) below. 
     
       
         
           
               
             
               
                 TABLE 26 
               
             
            
               
                   
               
               
                 Description of perfusion system of Docetaxel according to one embodiment: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 perfusion containers; 
                   
               
               
                   
                 container: Docetaxel 
                 Docetaxel concentration 
                   
               
               
                   
                 concentration 0.3 mg/ml 
                 0.3 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 71.5 
                 200 
                 60 
                 50 
                 15 
                 75.00 
                 4.9 
               
               
                 1.4 
                 77.0 
                 200 
                 60 
                 50 
                 15 
                 75.00 
                 −2.6 
               
               
                 1.5 
                 82.5 
                 270 
                 81.00 
                 0 
                 0 
                 81.00 
                 −1.8 
               
               
                 1.6 
                 88.0 
                 290 
                 87.00 
                 0 
                 0 
                 87.00 
                 −1.1 
               
               
                 1.7 
                 93.5 
                 315 
                 94.50 
                 0 
                 0 
                 94.50 
                 1.1 
               
               
                 1.8 
                 99.0 
                 290 
                 87.00 
                 50 
                 15 
                 102.00 
                 3.0 
               
               
                 1.9 
                 104.5 
                 290 
                 87.00 
                 50 
                 15 
                 102.00 
                 −2.4 
               
               
                 2 
                 110.0 
                 365 
                 109.50 
                 0 
                 0 
                 109.50 
                 −0.5 
               
               
                 2.1 
                 115.5 
                 395 
                 118.50 
                 0 
                 0 
                 118.50 
                 2.6 
               
               
                 2.2 
                 121.0 
                 395 
                 118.50 
                 0 
                 0 
                 118.50 
                 −2.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (26) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; docetaxel 
                 containers; docetaxel 
               
               
                 concentration 0.3 mg/ml 
                 concentration 0.3 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 200 
                 G 
                   
                   
               
               
                 270 
                 A 
                   
                   
               
               
                 290 
                 B 
                   
                   
               
               
                 315 
                 H 
                 50 
                 E 
               
               
                 365 
                 I 
                   
                   
               
               
                 395 
                 J 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (26) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 and 1.4 
                 Connect one 200 ml container having an alphabetical code 
               
               
                   
                 G to one 50 ml container having an alphabetical code pink 
               
               
                   
                 band and infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 270 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 1.6 
                 Infuse the full volume from one 290 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 1.7 
                 Infuse the full volume from one 315 ml container having an 
               
               
                   
                 alphabetical code H 
               
               
                 1.8 and 1.9 
                 Connect one 290 ml container having an alphabetical code 
               
               
                   
                 B and one 50 ml container having an alphabetical code and 
               
               
                   
                 infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 365 ml container having an 
               
               
                   
                 alphabetical code I 
               
               
                 2.1 and 2.2 
                 Infuse the full volume from one 395 ml container having an 
               
               
                   
                 alphabetical code J 
               
               
                   
               
            
           
         
       
     
     As described above, the target dose of docetaxel for a person having a specific body surface area can be delivered (within ±5% variance), by the perfusion system of the present invention, by infusing the full volume of solution from the selected perfusion containers of the first set and top-up perfusion containers from the second and/or third set. 
     According to the present invention, the below embodiment provides perfusion system for administration of cisplatin. Table 27 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 27 
               
             
            
               
                   
               
               
                 Perfusion system of Cisplatin: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 the perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.03-0.8  
                 0.005-0.5  
                 0.005-0.5  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.1-0.8 
                 0.005 0.08 
                 0.005-0.08 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 50-1000 
                 10-500 
                 10-500 
               
               
                 Preferred volume range 
                 50-900  
                 20-100 
                 20-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 28-30. 
     
       
         
           
               
             
               
                 TABLE 28 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having cisplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 500 
                 600 
                 700 
                 800 
                 900 
               
               
                   
               
               
                 Cisplatin amount per bag (mg) 
                 65 
                 78 
                 91 
                 104 
                 117 
               
               
                 (at a concentration of 0.13 mg/ml) 
                   
                   
                   
                   
                   
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 29 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having cisplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 60 
                 100 
               
               
                   
               
               
                 Cisplatin amount per bag 
                 2.5 
                 3.0 
                 5.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.05 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 30 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having cisplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 40 
                 50 
                 60 
               
               
                   
               
               
                 Cisplatin amount per bag 
                 1.2 
                 1.5 
                 1.8 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.03 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particular embodiment of the present invention wherein the antineoplastic drug is cisplatin, the first set of infusion containers comprise perfusion solution having cisplatin at a concentration ranging from about 0.03 mg/ml to 0.8 mg/ml and volume of solution ranging from about 50 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having cisplatin at a concentration ranging from about 0.005 mg/ml to 0.08 mg/ml and volume of solution ranging from about 20 ml to about 100 ml; further wherein the perfusion solution has a pH ranging from about 3.0 to 7.0. 
     According to one embodiment, the dose for a particular indication is 50 mg/m 2  based on body surface area as the patient parameter. There is provided instructions to calculate the dose based on the body surface area and select one or more perfusion containers of cisplatin from different sets, to deliver the calculated dose within ±5% variance and is presented in table (31) below: 
     
       
         
           
               
             
               
                 TABLE 31 
               
             
            
               
                   
               
               
                 Description of perfusion system of cisplatin: 
               
            
           
           
               
               
               
               
               
            
               
                   
                   
                   
                 Third set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 perfusion container; 
                   
               
               
                   
                 container; Cisplatin 
                 perfusion containers; 
                 Cisplatin concentration 
                   
               
               
                   
                 concentration 
                 Cisplatin concentration 
                 0.03 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
            
               
                   
                 0.13 mg/ml: 
                 0.05 mg/ml: 
                 Volume of 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 top up 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 perfusion 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 65 
                 500 
                 65 
                 0 
                 0 
                 0 
                 0 
                 65 
                 0 
               
               
                 1.4 
                 70 
                 500 
                 65 
                 100 
                 5 
                 0 
                 0 
                 70 
                 0 
               
               
                 1.5 
                 75 
                 600 
                 78 
                 0 
                 0 
                 0 
                 0 
                 78 
                 3.8 
               
               
                 1.6 
                 80 
                 600 
                 78 
                 0 
                 0 
                 0 
                 0 
                 78 
                 −2.5 
               
               
                 1.7 
                 85 
                 600 
                 78 
                 100 
                 5 
                 0 
                 0 
                 83 
                 −2.4 
               
               
                 1.8 
                 90 
                 700 
                 91 
                 0 
                 0 
                 0 
                 0 
                 91 
                 1.1 
               
               
                 1.9 
                 95 
                 700 
                 91 
                 100 
                 5 
                 0 
                 0 
                 96 
                 1.0 
               
               
                 2.0 
                 100 
                 700 
                 91 
                 100 
                 5 
                 50 
                 1.5 
                 97.5 
                 −2.6 
               
               
                 2.1 
                 105 
                 800 
                 104 
                 0 
                 0 
                 0 
                 0 
                 104 
                 −0.9 
               
               
                 2.2 
                 110 
                 800 
                 104 
                 100 
                 5 
                 0 
                 0 
                 109 
                 −0.9 
               
               
                 2.3 
                 115 
                 900 
                 117 
                 0 
                 0 
                 0 
                 0 
                 117 
                 1.7 
               
               
                 2.4 
                 120 
                 900 
                 117 
                 0 
                 0 
                 50 
                 1.5 
                 118.5 
                 −1.3 
               
               
                 2.6 
                 130 
                 500 × 2 
                 130 
                 0 
                 0 
                 0 
                 0 
                 130 
                 0.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (31) may be alphabetical coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 cisplatin concen- 
                 cisplatin concen- 
                 cisplatin concen- 
               
               
                 tration 0.13 mg/ml 
                 tration 0.05 mg/ml: 
                 tration 0.03 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 500 
                 A 
                 100 
                 F 
                 50 
                 G 
               
               
                 600 
                 B 
                   
                   
                   
                   
               
               
                 700 
                 C 
                   
                   
                   
                   
               
               
                 800 
                 D 
                   
                   
                   
                   
               
               
                 900 
                 E 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (31) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 
                 Infuse the full volume from one 500 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.4 
                 Connect one 500 ml container having an alphabetical 
               
               
                   
                 code A to one 100 ml container having an 
               
               
                   
                 alphabetical code F and infuse the full volume 
               
               
                 1.5 and 1.6 
                 Infuse the full volume from one 600 ml container 
               
               
                   
                 having an alphabetical code B 
               
               
                 1.7 
                 Connect one 600 ml container having an alphabetical 
               
               
                   
                 code B toone 100 ml container having an alphabetical 
               
               
                   
                 code F and infuse the full volume 
               
               
                 1.8 
                 Infuse the full volume from one 700 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 1.9 
                 Connect one 700 ml container having an alphabetical code 
               
               
                   
                 C to one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 700 ml container having an alphabetical code 
               
               
                   
                 C + one 100 ml container having an alphabetical code 
               
               
                   
                 F + one 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 800 ml container having 
               
               
                   
                 an alphabetical code D 
               
               
                 2.2 
                 Connect one 800 ml container having an alphabetical code 
               
               
                   
                 D to one 100 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Infuse the full volume from one 900 ml container having 
               
               
                   
                 an alphabetical code E 
               
               
                 2.4 
                 Connect one 900 ml container having an alphabetical code 
               
               
                   
                 E to one 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Infuse the full volume from two 500 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                   
               
            
           
         
       
     
     According to another embodiment, the table (32) below gives instructions for calculation of the dose and instructions for selecting one or more perfusion containers of cisplatin from different sets, at a dose of 100 mg/m 2 , in accordance with body surface area as the patient parameter, to deliver the calculated dose within ±5% variance: 
     
       
         
           
               
             
               
                 TABLE 32 
               
             
            
               
                   
               
               
                 Description of perfusion system of cisplatin: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                   
               
               
                   
                 container; Cisplatin 
                 perfusion containers; 
                   
               
               
                   
                 concentration— 
                 Cisplatin concentration— 
                   
               
               
                   
                 0.26 mg/ml: 
                 0.10 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.3 
                 130 
                 500 
                 130 
                 0 
                 0 
                 130 
                 0.0 
               
               
                 1.4 
                 140 
                 500 
                 130 
                 100 
                 10 
                 140 
                 0.0 
               
               
                 1.5 
                 150 
                 600 
                 156 
                 0 
                 0 
                 156 
                 4.0 
               
               
                 1.6 
                 160 
                 600 
                 156 
                 50 
                 5 
                 161 
                 0.6 
               
               
                 1.7 
                 170 
                 600 
                 156 
                 100 
                 10 
                 166 
                 −2.4 
               
               
                 1.8 
                 180 
                 700 
                 182 
                 0 
                 0 
                 182 
                 1.1 
               
               
                 1.9 
                 190 
                 700 
                 182 
                 100 
                 10 
                 192 
                 1.1 
               
               
                 2 
                 200 
                 700 
                 182 
                 100 
                 10 
                 192 
                 −4.0 
               
               
                 2.1 
                 210 
                 800 
                 208 
                 0 
                 0 
                 208 
                 −0.9 
               
               
                 2.2 
                 220 
                 800 
                 208 
                 100 
                 10 
                 218 
                 −0.9 
               
               
                 2.3 
                 230 
                 900 
                 234 
                 0 
                 0 
                 234 
                 1.7 
               
               
                 2.4 
                 240 
                 900 
                 234 
                 50 
                 5 
                 239 
                 −0.4 
               
               
                 2.6 
                 260 
                 1000.0 
                 260 
                 0 
                 0 
                 260 
                 0.00 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (32) may be alphabetical coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; cisplatin 
                 containers; cisplatin 
               
               
                 concentration 0.13 mg/ml 
                 concentration 0.05 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
            
           
           
               
               
               
               
            
               
                 500 
                 H 
                 50 
                 N 
               
               
                 600 
                 I 
                 100 
                 O 
               
               
                 700 
                 J 
                   
                   
               
               
                 800 
                 K 
                   
                   
               
               
                 900 
                 L 
                   
                   
               
               
                 1000 
                 M 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (32) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.3 
                 Infuse the full volume from one 500 ml container having 
               
               
                   
                 an alphabetical code H 
               
               
                 1.4 
                 Connect one 500 ml container having an alphabetical code 
               
               
                   
                 H to one 100 ml container having an alphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 600 ml container having 
               
               
                   
                 an alphabetical code I 
               
               
                 1.6 
                 Connect one 600 ml container having an alphabetical code 
               
               
                   
                 I to one 50 ml container having an alphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Connect one 600 ml container having an alphabetical code 
               
               
                   
                 I to one 100 ml container having an alphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Infuse the full volume from one 700 ml container having 
               
               
                   
                 an alphabetical code J 
               
               
                 1.9 and 2.0 
                 Connect one 700 ml container having an alphabetical code 
               
               
                   
                 J to one 100 ml container having an alphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 800 ml container having 
               
               
                   
                 an alphabetical code K 
               
               
                 2.2 
                 Connect one 800 ml container having an alphabetical code 
               
               
                   
                 K to one 100 ml container having an alphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Infuse the full volume from one 900 ml container having 
               
               
                   
                 an alphabetical code L 
               
               
                 2.4 
                 Connect one 900 ml container having an alphabetical code 
               
               
                   
                 L to one 50 ml container having an alphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Infuse the full volume from one 1000 ml container having 
               
               
                   
                 an alphabetical code M 
               
               
                   
               
            
           
         
       
     
     As described above, the target dose of docetaxel for a person having a specific body surface area can be delivered (within ±5% variance), by the perfusion system of the present invention, by infusing the full volume of solution from the selected perfusion containers of the first set and top-up perfusion containers from the second and/or third set. 
     According to the present invention, the below embodiment provides perfusion system for administration of oxaliplatin. Table 33 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 33 
               
             
            
               
                   
               
               
                 Perfusion system of Oxaliplatin: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of the 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.4-2.0 
                 0.05-1.25 
                 0.05-1.25 
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.6-1.0 
                 0.1-0.5 
                 0.1-0.5 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  50-1000 
                  25-500 
                  25-500 
               
               
                 Preferred volume range 
                  70-500 
                  25-100 
                  25-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Table 34-36: 
     
       
         
           
               
             
               
                 TABLE 34 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having oxaliplatin: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 150 
                 180 
                 220 
                 260 
                 300 
               
               
                   
               
               
                 Oxaliplatin amount per bag 
                 105 
                 126 
                 154 
                 182 
                 210 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
               
               
                 0.7 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 35 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having oxaliplatin 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 40 
                 60 
               
               
                   
               
               
                 Oxaliplatin amount per bag 
                 7.5 
                 6.0 
                 9.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.15 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 36 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having oxaliplatin 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 40 
                 60 
               
               
                   
               
               
                 Oxaliplatin amount per bag 
                 5.0 
                 4.0 
                 6.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.10 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particular embodiment of the present invention wherein the antineoplastic drug is oxaliplatin, the first set of infusion containers comprise perfusion solution having oxaliplatin at a concentration ranging from about 0.4 mg/ml to 2.0 mg/ml and volume of solution ranging from about 50 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having oxaliplatin at a concentration ranging from about 0.05 mg/ml to 0.25 mg/ml and volume of solution ranging from about 20 ml to about 100 ml; further wherein the perfusion solution has a pH ranging from about 3.0 to 7.0. 
     According to one embodiment, the antineoplastic drug is oxaliplatin and the dose for a particular indication is 85 mg/m 2  based on body surface area as the patient parameter. There is provided instructions to calculate the dose based on the body surface area of the patient and select appropriately one or more perfusion containers of oxaliplatin from different sets, to deliver the calculated dose within ±5% variance and is presented in table (37) below: 
     
       
         
           
               
             
               
                 TABLE 37 
               
             
            
               
                   
               
               
                 Description of perfusion system of oxaliplatin: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container Oxaliplatin 
                 containers; Oxaliplatin 
                   
               
               
                   
                 concentration— 
                 concentration— 
                   
               
               
                   
                 0.7 mg/ml: 
                 0.15 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA* 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 102 
                 150 
                 105 
                 0 
                 0 
                 105 
                 2.9 
               
               
                 1.4 
                 119 
                 150 
                 105 
                 100 
                 15 
                 120 
                 0.8 
               
               
                 1.5 
                 127.5 
                 180 
                 126 
                 0 
                 0 
                 126 
                 −1.2 
               
               
                 1.6 
                 136 
                 180 
                 126 
                 50 
                 7.5 
                 133.5 
                 −1.8 
               
               
                 1.7 
                 144.5 
                 180 
                 126 
                 100 
                 15 
                 141 
                 −2.4 
               
               
                 1.8 
                 153 
                 220 
                 154 
                 0 
                 0 
                 154 
                 0.7 
               
               
                 1.9 
                 161.5 
                 220 
                 154 
                 50 
                 7.5 
                 161.5 
                 0.0 
               
               
                 2.0 
                 170 
                 220 
                 154 
                 100 
                 15 
                 169 
                 −0.6 
               
               
                 2.1 
                 178.5 
                 260 
                 182 
                 0 
                 0 
                 182 
                 1.96 
               
               
                 2.2 
                 187 
                 260 
                 182 
                 50 
                 7.5 
                 189.5 
                 1.3 
               
               
                 2.3 
                 195.5 
                 260 
                 182 
                 100 
                 15 
                 197 
                 0.8 
               
               
                 2.4 
                 204 
                 260 
                 182 
                 100 
                 15 
                 19 
                 −3.4 
               
               
                 2.6 
                 221 
                 300 
                 210 
                 100 
                 15 
                 225 
                 1.8 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
               
                 *BSA—Body Surface Area 
               
            
           
         
       
     
     The containers of the perfusion system of Table (37) may be alphabetical coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; oxaliplatin 
                 containers; oxaliplatin 
               
               
                 concentration 0.7 mg/ml 
                 concentration 0.15 mg/ml: 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
            
           
           
               
               
               
               
            
               
                 150 
                 A 
                 50 
                 F 
               
               
                 180 
                 B 
                 100 
                 G 
               
               
                 220 
                 C 
                   
                   
               
               
                 260 
                 D 
                   
                   
               
               
                 300 
                 E 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (37) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Infuse the full volume from one 150 ml container having 
               
               
                   
                 an alphabetical code A 
               
               
                 1.4 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 A to one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 180 ml container having 
               
               
                   
                 an alphabetical code B 
               
               
                 1.6 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 B to one 50 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 B to one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Infuse the full volume from one 220 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 1.  
                 Connect one 220 ml container having an alphabetical code 
               
               
                   
                 C to one 50 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 220 ml container having an alphabetical code 
               
               
                   
                 C to one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 260 ml container having 
               
               
                   
                 an alphabetical code D 
               
               
                 2.2 
                 Connect one 260 ml container having an alphabetical code 
               
               
                   
                 D to one 50 ml container having an alphabetical code F 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 and 2.4 
                 Connect one 260 ml container having an alphabetical code 
               
               
                   
                 D to one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Connect one 300 ml container having an alphabetical code 
               
               
                   
                 E to one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to another embodiment, the table (38) below gives instructions for calculating the dose and instructions for selecting one or more perfusion containers of oxaliplatin from different sets, at a dose of 85 mg/m 2 , in accordance with body surface area as the patient parameter, to deliver the calculated dose within ±5% variance: 
     
       
         
           
               
             
               
                 TABLE 38 
               
             
            
               
                   
               
               
                 Description of perfusion system of oxaliplatin: 
               
            
           
           
               
               
               
               
               
            
               
                   
                   
                   
                 Third set of Top-up 
                   
               
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 perfusion containers; 
                   
               
               
                   
                 container oxaliplatin 
                 perfusion containers; 
                 oxaliplatin concentration 
                   
               
               
                   
                 concentration— 
                 oxaliplatin concentration 
                 0.7 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
            
               
                   
                 0.7 mg/ml: 
                 0.7 mg/ml: 
                 Volume of 
                 Dose  
                   
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 top up 
                 delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 perfusion 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 102 
                 100 
                 70 
                 50 
                 35 
                 0 
                 0 
                 105 
                 2.9 
               
               
                 1.3 
                 110.5 
                 100 
                 70 
                 50 
                 35 
                 0 
                 0 
                 105 
                 −4.97 
               
               
                 1.4 
                 119 
                 120 
                 84 
                 50 
                 35 
                 0 
                 0 
                 119 
                 0.0 
               
               
                 1.5 
                 127.5 
                 130 
                 91 
                 50 
                 35 
                 0 
                 0 
                 126 
                 −1.2 
               
               
                 1.6 
                 136 
                 145 
                 102 
                 50 
                 35 
                 0 
                 0 
                 137 
                 0.4 
               
               
                 1.7 
                 144.5 
                 160 
                 112 
                 50 
                 35 
                 0 
                 0 
                 147 
                 1.7 
               
               
                 1.8 
                 153 
                 160 
                 112 
                 50 
                 35 
                 0 
                 0 
                 147 
                 −3.9 
               
               
                 1.9 
                 161.5 
                 170 
                 119 
                 50 
                 35 
                 0 
                 0 
                 154 
                 −4.6 
               
               
                 2 
                 170 
                 145 
                 102 
                 0 
                 0 
                 100 
                 70 
                 172 
                 1.2 
               
               
                 2.1 
                 178.5 
                 160 
                 112 
                 0 
                 0 
                 100 
                 70 
                 182 
                 2.0 
               
               
                 2.2 
                 187 
                 160 
                 112 
                 0 
                 0 
                 100 
                 70 
                 182 
                 −2.7 
               
               
                 2.3 
                 195.5 
                 180 
                 126 
                 0 
                 0 
                 100 
                 70 
                 196 
                 0.3 
               
               
                 2.4 
                 204 
                 180 
                 126 
                 0 
                 0 
                 100 
                 70 
                 196 
                 −3.9 
               
               
                 2.5 
                 212.5 
                 160 
                 112 
                 50 
                 35 
                 100 
                 70 
                 217 
                 2.1 
               
               
                 2.6 
                 221 
                 180 
                 126 
                 50 
                 35 
                 100 
                 70 
                 231 
                 4.5 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (38) may be alphabetical coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 oxaliplatin concen- 
                 oxaliplatin concen- 
                 oxaliplatin concen- 
               
               
                 tration 0.7 mg/ml 
                 tration 0.7 mg/ml: 
                 tration 0.7 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 100 
                 H 
                 50 
                 N 
                 100 
                 O 
               
               
                 120 
                 I 
                   
                   
                   
                   
               
               
                 130 
                 J 
                   
                   
                   
                   
               
               
                 145 
                 K 
                   
                   
                   
                   
               
               
                 160 
                 L 
                   
                   
                   
                   
               
               
                 170 
                 M 
                   
                   
                   
                   
               
               
                 180 
                 B 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (38) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 and 1.3 
                 Connect one 100 ml container having an alphabetical code 
               
               
                   
                 H and one 50 ml container having an alphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 1.4 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 I and one 50 ml container having an alphabetical code pink 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Connect one 130 ml container having an alphabetical code 
               
               
                   
                 J and one 50 ml container having an alphabetical code 
               
               
                   
                 J and infuse the full volume 
               
               
                 1.6 
                 Connect one 145 ml container having an alphabetical code 
               
               
                   
                 K and one 50 ml container having analphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 and 1.8 
                 Connect one 160 ml container having an alphabetical code 
               
               
                   
                 L and one 50 ml container having an alphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 170 ml container having an alphabetical code 
               
               
                   
                 M and one 50 ml container having an alphabetical code N 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 145 ml container having an alphabetical code 
               
               
                   
                 K and one 100 ml container having an alphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 and 2.2 
                 Connect one 160 ml container having an alphabetical code 
               
               
                   
                 L and one 100 ml container having analphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 and 2.4 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 B and one 100 ml container having analphabetical code O 
               
               
                   
                 and infuse the full volume 
               
               
                 2.5 
                 Connect one 160 ml container having an alphabetical code 
               
               
                   
                 L + one 50 ml container having analphabetical code N + 
               
               
                   
                 one 100 ml container having an alphabetical code O and 
               
               
                   
                 infuse the full volume 
               
               
                 2.6 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 B + one 50 ml container having analphabetical code N + 
               
               
                   
                 one 100 ml container having an alphabetical code O and 
               
               
                   
                 infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of vinorelbine or its pharmaceutically acceptable salt such as vinorelbine tartrate. Table 39 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 39 
               
             
            
               
                   
               
               
                 Perfusion system of Vinorelbine: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of the 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.2-2.5 
                 0.01-1.25  
                 0.01-1.25  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.5-1.5 
                 0.01-0.8  
                 0.01-0.8  
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  25-1000 
                 20-500 
                 20-500 
               
               
                 Preferred volume range 
                  60-600 
                 20-100 
                 20-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 40-42. 
     
       
         
           
               
             
               
                 TABLE 40 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having vinorelbine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 70 
                 80 
                 100 
                 120 
                 140 
                 160 
               
               
                   
               
               
                 Vinorelbine amount per bag 
                 35 
                 40 
                 50 
                 60 
                 70 
                 80 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
                   
               
               
                 0.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 41 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having vinorelbine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 40 
                 50 
                 60 
               
               
                   
               
               
                 Vinorelbine amount per bag 
                 2 
                 2.5 
                 3 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.05 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 42 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having vinorelbine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 40 
                 50 
               
               
                   
               
               
                 Vinorelbine amount per bag 
                 1 
                 1.25 
               
               
                 (mg) (at a concentration of 
                   
                   
               
               
                 0.025 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particular embodiment of the present invention wherein the antineoplastic drug is vinorelbine, the first set of infusion containers comprise perfusion solution having vinorelbine at a concentration ranging from about 0.2 mg/ml to 2.5 mg/ml and volume of solution ranging from about 50 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having vinorelbine at a concentration ranging from about 0.01 mg/ml to 1.25 mg/ml and volume of solution ranging from about 20 ml to about 100 ml; further wherein the perfusion solution has a pH ranging from about 3.8 to 5.0. 
     According to one embodiment, the dose of vinorelbine for a particular indication is 30 mg/m 2  based on body surface area as the patient parameter. There is provided instructions to calculate the dose based on the body surface area of the patient and select one or more perfusion containers of vinorelbine from different sets, to deliver the calculated dose within ±5% variance and is presented in table (43) below: 
     
       
         
           
               
             
               
                 TABLE 43 
               
             
            
               
                   
               
               
                 Description of perfusion system of vinorelbine: 
               
            
           
           
               
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 Third set of Top-up 
                   
               
               
                   
                 container Vinorelbine 
                 perfusion containers; 
                 perfusion containers; 
                   
               
               
                   
                 concentration— 
                 Vinorelbine concentration— 
                 Vinorelbine concentration— 
                   
               
               
                   
                 0.5 mg/ml 
                 0.05 mg/ml 
                 0.025 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.4 
                 42 
                 80 
                 40 
                 40 
                 2 
                 0 
                 0 
                 42 
                 0 
               
               
                 1.5 
                 45 
                 90 
                 45 
                  0 
                 0 
                 0 
                 0 
                 45 
                 0 
               
               
                 1.6 
                 48 
                 90 
                 45 
                 40 
                 2 
                 40 
                 1 
                 48 
                 0 
               
               
                 1.7 
                 51 
                 100 
                 50 
                  0 
                 0 
                 40 
                 1 
                 51 
                 0 
               
               
                 1.8 
                 54 
                 100 
                 50 
                 40 × 2 
                 4 
                 0 
                 0 
                 54 
                 0 
               
               
                 1.9 
                 57 
                 110 
                 55 
                 40 
                 2 
                 0 
                 0 
                 57 
                 0 
               
               
                 2.0 
                 60 
                 120 
                 60 
                  0 
                 0 
                 0 
                 0 
                 60 
                 0 
               
               
                 2.1 
                 63 
                 120 
                 60 
                 40 
                 2 
                 40 
                 1 
                 63 
                 0 
               
               
                 2.2 
                 66 
                 130 
                 65 
                  0 
                 0 
                 40 
                 1 
                 66 
                 0 
               
               
                 2.3 
                 69 
                 130 
                 65 
                 40 × 2 
                 4 
                 0 
                 0 
                 69 
                 0 
               
               
                 2.4 
                 72 
                 140 
                 70 
                 40 
                 2 
                 0 
                 0 
                 72 
                 0 
               
               
                 2.5 
                 75 
                 150 
                 75 
                  0 
                 0 
                 0 
                 0 
                 75 
                 0 
               
               
                 2.6 
                 78 
                 150 
                 75 
                 40 
                 2 
                 40 
                 1 
                 78 
                 0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (43) may be alphabetical coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 vinorelbine 
                 vinorelbine 
                 vinorelbine 
               
               
                 concentration  
                 concentration  
                 concentration  
               
               
                 0.5 mg/ml 
                 0.05 mg/ml: 
                 0.025 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                 80 
                 A 
                 40 
                 I 
                 40 
                 J 
               
               
                 90 
                 B 
                   
                   
                   
                   
               
               
                 100 
                 C 
                   
                   
                   
                   
               
               
                 110 
                 D 
                   
                   
                   
                   
               
               
                 120 
                 E 
                   
                   
                   
                   
               
               
                 130 
                 F 
                   
                   
                   
                   
               
               
                 140 
                 G 
                   
                   
                   
                   
               
               
                 150 
                 H 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (43) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.4 
                 Connect one 80 ml container having an alphabetical code A 
               
               
                   
                 and one 40 ml container having an alphabetical code I and 
               
               
                   
                 infuse the full volume 
               
               
                 1.5 
                 Infuse the full volume from one 90 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 1.6 
                 Connect one 90 ml container having an alphabetical code  
               
               
                   
                 B + one 40 ml container having an alphabetical code I +  
               
               
                   
                 one 40 ml container having an alphabetical code J and  
               
               
                   
                 infuse the full volume 
               
               
                 1.7 
                 Connect one 100 ml container having an alphabetical code  
               
               
                   
                 C and one 40 ml container having an alphabetical code J  
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Connect one 100 ml container having an alphabetical code  
               
               
                   
                 C and two 40 ml container having an alphabetical code I  
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 110 ml container having an alphabetical code  
               
               
                   
                 D and one 40 ml container having an alphabetical code I  
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 120 ml container having an 
               
               
                   
                 alphabetical code E 
               
               
                 2.1 
                 Connect one 120 ml container having an alphabetical code  
               
               
                   
                 E + one 40 ml container having an alphabetical code I +  
               
               
                   
                 one 40 ml container having an alphabetical code J and  
               
               
                   
                 infuse the full volume 
               
               
                 2.2 
                 Connect one 130 ml container having an alphabetical code F 
               
               
                   
                 and one 40 ml container having an alphabetical code J and 
               
               
                   
                 infuse the full volume 
               
               
                 2.3 
                 Connect one 130 ml container having an alphabetical code F 
               
               
                   
                 and two 40 ml container having an alphabetical code I and 
               
               
                   
                 infuse the full volume 
               
               
                 2.4 
                 Connect one 140 ml container having an alphabetical code  
               
               
                   
                 G and one 40 ml container having an alphabetical code I  
               
               
                   
                 and infuse the full volume 
               
               
                 2.5 
                 Infuse the full volume from one 150 ml container having an 
               
               
                   
                 alphabetical code H 
               
               
                 2.6 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 H + one 40 ml container having an alphabetical code I and 
               
               
                   
                 one 40 ml container having an alphabetical code J and  
               
               
                   
                 infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of pemetrexed or its pharmaceutically acceptable salt such as pemetrexed disodium heptahydrate. Table 44 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 44 
               
             
            
               
                   
               
               
                 Perfusion system of pemetrexed: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 the perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.2-20.0 
                 0.01-10.0  
                 0.01-10.0  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration range 
                 1.0-11.0 
                 0.02-5.0  
                 0.01-5.0  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  25-1000 
                 20-500 
                 20-500 
               
               
                 Preferred volume range 
                 50-600 
                 20-100 
                 20-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 45-47. 
     
       
         
           
               
             
               
                 TABLE 45 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having Pemetrexed: 
               
            
           
           
               
               
            
               
                 Volume of solution in bag 
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
            
               
                 (ml) 
                 100 
                 120 
                 140 
                 170 
                 200 
                 250 
               
               
                   
               
               
                 Pemetrexed amount per bag 
                 500 
                 600 
                 700 
                 850 
                 1000 
                 1250 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
                   
               
               
                 5.0 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 46 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having Pemetrexed: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 25 
                 40 
                 50 
                 60 
               
               
                   
               
               
                 Pemetrexed amount per bag 
                 25 
                 40 
                 50 
                 60 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 1.0 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 47 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having Pemetrexed: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 20 
                 25 
                 40 
                 50 
               
               
                   
               
               
                 Pemetrexed amount per bag 
                 10 
                 12.5 
                 20 
                 25 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 0.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is pemetrexed, the first set of infusion containers comprise perfusion solution having pemetrexed at a concentration ranging from about 0.2 mg/ml to 20.0 mg/ml and volume of solution ranging from about 25 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having pemetrexed at a concentration ranging from about 0.01 mg/ml to 10.0 mg/ml and volume of solution ranging from about 20 ml to about 100 ml, further wherein the perfusion solution has a pH ranging from about 6.0 to 8.0. 
     In one embodiment, the dose of pemetrexed for a particular indication is 500 mg/m 2  based on patient&#39;s body surface area. There is provided instructions for calculating the dose based on the body surface area and instructions for selecting one or more perfusion containers of pemetrexed from different sets, to deliver the calculated dose within ±5% variance and is presented in table (48): 
     
       
         
           
               
             
               
                 TABLE 48 
               
             
            
               
                   
               
               
                 Description of perfusion system of pemetrexed: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container Pemetrexed 
                 containers; Pemetrexed 
                   
               
               
                   
                 concentration—5.0 mg/ml 
                 concentration 1.0 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 600 
                 100 
                 500 
                 50 × 2 
                 100 
                 600 
                 0.0 
               
               
                 1.3 
                 650 
                 120 
                 600 
                 50 
                 50 
                 650 
                 0.0 
               
               
                 1.4 
                 700 
                 140 
                 700 
                  0 
                 0 
                 700 
                 0.0 
               
               
                 1.5 
                 750 
                 140 
                 700 
                 50 
                 50 
                 750 
                 0.0 
               
               
                 1.6 
                 800 
                 140 
                 700 
                 50 × 2 
                 100 
                 800 
                 0.0 
               
               
                 1.7 
                 850 
                 170 
                 850 
                  0 
                 0 
                 850 
                 0.0 
               
               
                 1.8 
                 900 
                 170 
                 850 
                 50 
                 50 
                 900 
                 0.0 
               
               
                 1.9 
                 950 
                 170 
                 850 
                 50 × 2 
                 100 
                 950 
                 0.0 
               
               
                 2.0 
                 1000 
                 200 
                 1000 
                  0 
                 0 
                 1000 
                 0.0 
               
               
                 2.1 
                 1050 
                 200 
                 1000 
                 50 
                 50 
                 1050 
                 0.0 
               
               
                 2.2 
                 1100 
                 200 
                 1000 
                 50 × 2 
                 100 
                 1100 
                 0.0 
               
               
                 2.3 
                 1150 
                 200 
                 1000 
                 50 × 2 
                 100 
                 1100 
                 −4.3 
               
               
                 2.4 
                 1200 
                 250 
                 1250 
                  0 
                 0 
                 1250 
                 4.2 
               
               
                 2.5 
                 1250 
                 250 
                 1250 
                  0 
                 0 
                 1250 
                 0.0 
               
               
                 2.6 
                 1300 
                 250 
                 1250 
                 50 
                 50 
                 1300 
                 0.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (48) may be alphabetical coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; pemetrexed 
                 containers; pemetrexed 
               
               
                 concentration 5.0 mg/ml 
                 concentration 1.0 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 100 
                 A 
                 50 
                 G 
               
               
                 120 
                 B 
                   
                   
               
               
                 140 
                 C 
                   
                   
               
               
                 170 
                 D 
                   
                   
               
               
                 200 
                 E 
                   
                   
               
               
                 250 
                 F 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (48) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Connect one 100 ml container having an alphabetical code 
               
               
                   
                 A and two 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.3 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B and one 50 ml container having an alphabetical code G 
               
               
                 1.4 
                 Infuse the full volume from one 140 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 1.5 
                 Connect from one 140 ml container having an alphabetical 
               
               
                   
                 code C and one 50 ml container having an alphabetical code 
               
               
                   
                 G and infuse the full volume 
               
               
                 1.6 
                 Connect one 140 ml container having an alphabetical code 
               
               
                   
                 C and two 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Infuse the full volume from one 170 ml container having 
               
               
                   
                 an alphabetical code D 
               
               
                 1.8 
                 Connect one 170 ml container having an alphabetical code 
               
               
                   
                 D and one 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 170 ml container having an alphabetical code 
               
               
                   
                 D and two 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Infuse the full volume from one 200 ml container having 
               
               
                   
                 an alphabetical code E 
               
               
                 2.1 
                 Connect one 200 ml container having an alphabetical code 
               
               
                   
                 E and one 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.2 and 2.3 
                 Connect one 200 ml container having an alphabetical code 
               
               
                   
                 E and two 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 2.4 and 2.5 
                 Infuse the full volume from one 250 ml container having 
               
               
                   
                 an alphabetical code F 
               
               
                 2.6 
                 Connect one 250 ml container having an alphabetical code 
               
               
                   
                 F and one 50 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of gemcitabine or its pharmaceutically acceptable salt such as gemcitabine hydrochloride. Table 49 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 49 
               
             
            
               
                   
               
               
                 Perfusion system of gemcitabine: 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                 From set of 
                 First set 
                 of top up 
                 of top up 
               
               
                 container of 
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                 the perfusion system 
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.1-15.0 
                 0.005-7.5   
                 0.005-7.5   
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 1.0-10.0 
                 0.01-5.0  
                 0.01-5.0  
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  80-2000 
                 20-800 
                 20-800 
               
               
                 Preferred volume range 
                 100-1000 
                 50-200 
                 50-200 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 50-52. 
     
       
         
           
               
             
               
                 TABLE 50 
               
             
            
               
                   
               
               
                 Perfusion containers of first set having gemcitabine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 100 
                 120 
                 150 
                 180 
                 210 
                 240 
               
               
                   
               
               
                 Gemcitabine amount per bag  
                 1000 
                 1200 
                 1500 
                 1800 
                 2100 
                 2400 
               
               
                 (mg) (at a concentration of 10  
                   
                   
                   
                   
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 51 
               
             
            
               
                   
               
               
                 Perfusion containers of second set having gemcitabine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 25 
                 50 
                 80 
                 100 
               
               
                   
               
               
                 Gemcitabine amount per bag 
                 50 
                 100 
                 160 
                 200 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 2.0 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 52 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having gemcitabine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 20 
                 25 
                 50 
                 100 
               
               
                   
               
               
                 Gemcitabine amount per bag 
                 20 
                 25 
                 50 
                 100 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 1.0 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is gemcitabine, the first set of infusion containers comprise perfusion solution having gemcitabine at a concentration ranging from about 0.1 mg/ml to 15.0 mg/ml and volume of solution ranging from about 25 ml to about 2000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having gemcitabine at a concentration ranging from about 0.005 mg/ml to 7.5 mg/ml and volume of solution ranging from about 20 ml to about 100 ml, further wherein the perfusion solution has a pH ranging from about 6.0 to 8.0. 
     According to one embodiment, the dose of gemcitabine for a particular indication is 1000 mg/m 2  based on body surface area. There is provided instructions for calculating the dose and instructions for selecting one or more perfusion containers of gemcitabine from different sets, to deliver the calculated dose within ±5% variance and is presented in table (53) below: 
     
       
         
           
               
             
               
                 TABLE 53 
               
             
            
               
                   
               
               
                 Description of perfusion system of gemcitabine: 
               
            
           
           
               
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 Third Set of Top-up 
                   
               
               
                   
                 container Gemcitabine 
                 perfusion containers; 
                 perfusion containers; 
                   
               
               
                   
                 concentration 
                 Gemcitabine concentration 
                 Gemcitabine concentration 
                   
               
               
                   
                 10 mg/ml 
                 2 mg/ml: 
                 1 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 1200 
                 100 
                 1000 
                 100 
                 200 
                 0 
                 0 
                 1200 
                 0.0 
               
               
                 1.3 
                 1300 
                 120 
                 1200 
                 0 
                 0 
                 100 
                 100 
                 1300 
                 0.0 
               
               
                 1.4 
                 1400 
                 120 
                 1200 
                 100 
                 200 
                 0 
                 0 
                 1400 
                 0.0 
               
               
                 1.5 
                 1500 
                 120 
                 1200 
                 100 
                 200 
                 100 
                 100 
                 1500 
                 0.0 
               
               
                 1.6 
                 1600 
                 150 
                 1500 
                 0 
                 0 
                 100 
                 100 
                 1600 
                 0.0 
               
               
                 1.7 
                 1700 
                 150 
                 1500 
                 100 
                 200 
                 0 
                 0 
                 1700 
                 0.0 
               
               
                 1.8 
                 1800 
                 150 
                 1500 
                 100 
                 200 
                 100 
                 100 
                 1800 
                 0.0 
               
               
                 1.9 
                 1900 
                 180 
                 1800 
                 0 
                 0 
                 100 
                 100 
                 1900 
                 0.0 
               
               
                 2.0 
                 2000 
                 180 
                 1800 
                 100 
                 200 
                 0 
                 0 
                 2000 
                 0.0 
               
               
                 2.1 
                 2100 
                 210 
                 2100 
                 0 
                 0 
                 0 
                 0 
                 2100 
                 0.0 
               
               
                 2.2 
                 2200 
                 210 
                 2100 
                 0 
                 0 
                 100 
                 100 
                 2200 
                 0.0 
               
               
                 2.3 
                 2300 
                 210 
                 2100 
                 100 
                 200 
                 0 
                 0 
                 2300 
                 0.0 
               
               
                 2.4 
                 2400 
                 210 
                 2100 
                 100 
                 200 
                 100 
                 100 
                 2400 
                 0.0 
               
               
                 2.5 
                 2500 
                 240 
                 2400 
                 0 
                 0 
                 100 
                 100 
                 2500 
                 0.0 
               
               
                 2.6 
                 2600 
                 240 
                 2400 
                 100 
                 200 
                 0 
                 0 
                 2600 
                 0.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (53) may be alphabetically coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 gemcitabine 
                 gemcitabine 
                 gemcitabine 
               
               
                 concentration  
                 concentration  
                 concentration  
               
               
                 10 mg/ml 
                 2 mg/ml 
                 1 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 100 
                 A 
                 100 
                 G 
                 100 
                 H 
               
               
                 120 
                 B 
                   
                   
                   
                   
               
               
                 150 
                 C 
                   
                   
                   
                   
               
               
                 180 
                 D 
                   
                   
                   
                   
               
               
                 210 
                 E 
                   
                   
                   
                   
               
               
                 240 
                 F 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (53) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Connect one 100 ml container having an alphabetical code 
               
               
                   
                 A and one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.3 
                 Connect one 100 ml container having an alphabetical code 
               
               
                   
                 A and one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 1.4 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B and one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B + one 100 ml container having an alphabetical code 
               
               
                   
                 G + one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 1.6 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C and one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C and one 100 ml container having an alphabetical code 
               
               
                   
                 G and infuse the full volume 
               
               
                 1.8 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C + one 100 ml container having an alphabetical code 
               
               
                   
                 G + one 100 ml container having an alphabetical code 
               
               
                   
                 H and infuse the full volume 
               
               
                 1.9 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 D + one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 180 ml container having an alphabetical code  
               
               
                   
                 D and one 100 ml container having an alphabetical code G  
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 210 ml container having an 
               
               
                   
                 alphabetical code E 
               
               
                 2.2 
                 Connect one 210 ml container having an alphabetical code  
               
               
                   
                 E and one 100 ml container having an alphabetical code H  
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Connect one 210 ml container having an alphabetical code  
               
               
                   
                 E and one 100 ml container having an alphabetical code G  
               
               
                   
                 and infuse the full volume 
               
               
                 2.4 
                 Connect one 210 ml container having an alphabetical code 
               
               
                   
                 E + one 100 ml container having an alphabetical code 
               
               
                   
                 G + one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 2.5 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 F + one 100 ml container having an alphabetical code H 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 F + one 100 ml container having an alphabetical code G 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to yet another embodiment for gemcitabine at a dose is 1000 mg/m 2  in accordance with body surface area as the patient parameter, the table (54) below provides instructions for calculation of the dose and instructions for selecting one or more perfusion containers of gemcitabine from different sets, to deliver the calculated dose within ±5% variance: 
     (54): Description of perfusion system of gemcitabine: 
     
       
         
           
               
               
               
               
               
            
               
                   
               
               
                   
                 First set of Perfusion 
                 Second set of Top-up 
                 Third Set of Top-up 
                   
               
               
                   
                 container Gemcitabine 
                 perfusion containers; 
                 perfusion containers; 
                   
               
               
                   
                 concentration 
                 Gemcitabine concentration 
                 Gemcitabine concentration 
                   
               
               
                   
                 10 mg/ml 
                 4 mg/ml: 
                 4 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (ml) 
                 (c) (mg) 
                 (mg) (a + b + c) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 1200 
                 100 
                 1000 
                 50 
                 200 
                 0 
                 0 
                 1200 
                 0.0 
               
               
                 1.3 
                 1300 
                 120 
                 1200 
                 0 
                 0 
                 25 
                 100 
                 1300 
                 0.0 
               
               
                 1.4 
                 1400 
                 120 
                 1200 
                 50 
                 200 
                 0 
                 0 
                 1400 
                 0.0 
               
               
                 1.5 
                 1500 
                 120 
                 1200 
                 50 
                 200 
                 25 
                 100 
                 1500 
                 0.0 
               
               
                 1.6 
                 1600 
                 150 
                 1500 
                 0 
                 0 
                 25 
                 100 
                 1600 
                 0.0 
               
               
                 1.7 
                 1700 
                 150 
                 1500 
                 50 
                 200 
                 0 
                 0 
                 1700 
                 0.0 
               
               
                 1.8 
                 1800 
                 150 
                 1500 
                 50 
                 200 
                 25 
                 100 
                 1800 
                 0.0 
               
               
                 1.9 
                 1900 
                 180 
                 1800 
                 0 
                 0 
                 25 
                 100 
                 1900 
                 0.0 
               
               
                 2.0 
                 2000 
                 180 
                 1800 
                 50 
                 200 
                 0 
                 0 
                 2000 
                 0.0 
               
               
                 2.1 
                 2100 
                 210 
                 2100 
                 0 
                 0 
                 0 
                 0 
                 2100 
                 0.0 
               
               
                 2.2 
                 2200 
                 210 
                 2100 
                 0 
                 0 
                 25 
                 100 
                 2200 
                 0.0 
               
               
                 2.3 
                 2300 
                 210 
                 2100 
                 50 
                 200 
                 0 
                 0 
                 2300 
                 0.0 
               
               
                 2.4 
                 2400 
                 210 
                 2100 
                 50 
                 200 
                 25 
                 100 
                 2400 
                 0.0 
               
               
                 2.5 
                 2500 
                 240 
                 2400 
                 0 
                 0 
                 25 
                 100 
                 2500 
                 0.0 
               
               
                 2.6 
                 2600 
                 240 
                 2400 
                 50 
                 200 
                 0 
                 0 
                 2600 
                 0.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (54) may be alphabetical coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 gemcitabine 
                 vinblastine 
                 vinblastine 
               
               
                 concentration  
                 concentration  
                 concentration  
               
               
                 10 mg/ml 
                 4 mg/ml 
                 4 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 100 
                 A 
                 50 
                 I 
                 25 
                 J 
               
               
                 120 
                 B 
                   
                   
                   
                   
               
               
                 150 
                 C 
                   
                   
                   
                   
               
               
                 180 
                 D 
                   
                   
                   
                   
               
               
                 210 
                 E 
                   
                   
                   
                   
               
               
                 240 
                 F 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (54) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Connect one 100 ml container having an alphabetical code  
               
               
                   
                 A and one 50 ml container having an alphabetical code I  
               
               
                   
                 and infuse the full volume 
               
               
                 1.3 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 1.4 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B + one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 1.5 
                 Connect one 120 ml container having an alphabetical code 
               
               
                   
                 B + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 1.6 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 1.7 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C + one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 1.8 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 1.9 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 D + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 2.0 
                 Connect one 180 ml container having an alphabetical code 
               
               
                   
                 D + one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 210 ml container having an 
               
               
                   
                 alphabetical code E 
               
               
                 2.2 
                 Connect one 210 ml container having an alphabetical code 
               
               
                   
                 E + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Connect one 210 ml container having an alphabetical code 
               
               
                   
                 E + one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                 2.4 
                 Connect one 210 ml container having an alphabetical code 
               
               
                   
                 E + one 50 ml container having an alphabetical code 
               
               
                   
                 I + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 2.5 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 F + one 25 ml container having an alphabetical code J 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Connect one 240 ml container having an alphabetical code 
               
               
                   
                 F + one 50 ml container having an alphabetical code I 
               
               
                   
                 and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to yet another embodiment for gemcitabine, the dose for a particular indication is 1000 mg/m 2  in accordance with body surface area as the patient parameter. The table (55) below provides instruction for calculation of total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of gemcitabine from different sets, to deliver the calculated dose within ±5% variance: 
     
       
         
           
               
             
               
                 TABLE 55 
               
             
            
               
                   
               
               
                 Description of perfusion system of gemcitabine: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container Gemcitabine 
                 containers; Gemcitabine 
                   
               
               
                   
                 concentration 10 mg/ml 
                 concentration 10 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 1200 
                 120 
                 1200 
                 0 
                 0 
                 1200.00 
                 0.00 
               
               
                 1.3 
                 1300 
                 130 
                 1300 
                 0 
                 0 
                 1300.00 
                 0.00 
               
               
                 1.4 
                 1400 
                 140 
                 1400 
                 0 
                 0 
                 1400.00 
                 0.00 
               
               
                 1.5 
                 1500 
                 150 
                 1500 
                 0 
                 0 
                 1500.00 
                 0.00 
               
               
                 1.6 
                 1600 
                 160 
                 1600 
                 0 
                 0 
                 1600.00 
                 0.00 
               
               
                 1.7 
                 1700 
                 170 
                 1700 
                 0 
                 0 
                 1700.00 
                 0.00 
               
               
                 1.8 
                 1800 
                 180 
                 1800 
                 0 
                 0 
                 1800.00 
                 0.00 
               
               
                 1.9 
                 1900 
                 190 
                 1900 
                 0 
                 0 
                 1900.00 
                 0.00 
               
               
                 2 
                 2000 
                 200 
                 2000 
                 0 
                 0 
                 2000.00 
                 0.00 
               
               
                 2.1 
                 2100 
                 200 
                 2000 
                 0 
                 0 
                 2000.00 
                 −4.76 
               
               
                 2.2 
                 2200 
                 220 
                 2200 
                 0 
                 0 
                 2200.00 
                 0.00 
               
               
                 2.3 
                 2300 
                 220 
                 2200 
                 0 
                 0 
                 2200.00 
                 −4.35 
               
               
                 2.4 
                 2400 
                 120 
                 1200 
                 120 
                 1200 
                 2400.00 
                 0.00 
               
               
                 2.5 
                 2500 
                 130 
                 1300 
                 120 
                 1200 
                 2500.00 
                 0.00 
               
               
                 2.6 
                 2600 
                 130 
                 1300 
                 130 
                 1300 
                 2600.00 
                 0.00 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b + c) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (55) may be alphabetical coded as follows: 
     
       
         
           
               
               
               
            
               
                   
               
               
                 First set of 
                 Second set of top-up 
                 Third set of top-up 
               
               
                 Perfusion containers; 
                 perfusion containers; 
                 perfusion containers; 
               
               
                 gemcitabine 
                 vinblastine 
                 vinblastine 
               
               
                 concentration  
                 concentration  
                 concentration  
               
               
                 10 mg/ml 
                 4 mg/ml 
                 4 mg/ml: 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of 
                   
                 Volume of 
                   
                 Volume of 
                   
               
               
                 perfusion 
                 Alpha- 
                 top up 
                 Alpha- 
                 top up 
                 Alpha- 
               
               
                 container 
                 betical 
                 container 
                 betical 
                 container 
                 betical 
               
               
                 (ml) 
                 code 
                 (ml) 
                 code 
                 (ml) 
                 code 
               
               
                   
               
               
                 120 
                 B 
                 120 
                 B 
                 130 
                 K 
               
               
                 130 
                 K 
                   
                   
                   
                   
               
               
                 140 
                 L 
                   
                   
                   
                   
               
               
                 150 
                 C 
                   
                   
                   
                   
               
               
                 160 
                 M 
                   
                   
                   
                   
               
               
                 170 
                 N 
                   
                   
                   
                   
               
               
                 180 
                 D 
                   
                   
                   
                   
               
               
                 190 
                 O 
                   
                   
                   
                   
               
               
                 200 
                 P 
                   
                   
                   
                   
               
               
                 220 
                 Q 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (55) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Infuse the full volume from one 120 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 1.3 
                 Infuse the full volume from one 130 ml container having an 
               
               
                   
                 alphabetical code K 
               
               
                 1.4 
                 Infuse the full volume from one 140 ml container having an 
               
               
                   
                 alphabetical code L 
               
               
                 1.5 
                 Infuse the full volume from one 150 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 1.6 
                 Infuse the full volume from one 160 ml container having an 
               
               
                   
                 alphabetical code M 
               
               
                 1.7 
                 Infuse the full volume from one 170 ml container having an 
               
               
                   
                 alphabetical code N 
               
               
                 1.8 
                 Infuse the full volume from one 180 ml container having an 
               
               
                   
                 alphabetical code D 
               
               
                 1.9 
                 Infuse the full volume from one 190 ml container having an 
               
               
                   
                 alphabetical code O 
               
               
                 2.0 and 2.1 
                 Infuse the full volume from one 200 ml container having an 
               
               
                   
                 alphabetical code P 
               
               
                 2.2 and 2.3 
                 Infuse the full volume from one 220 ml container having an 
               
               
                   
                 alphabetical code Q 
               
               
                 2.4 
                 Connect two 120 ml container having an alphabetical code 
               
               
                   
                 B and infuse the full volume 
               
               
                 2.5 
                 Connect one 130 ml container having an alphabetical code 
               
               
                   
                 K + one 120 ml container having an alphabetical code 
               
               
                   
                 B and infuse the full volume 
               
               
                 2.6 
                 Connect two 130 ml container having an alphabetical code 
               
               
                   
                 K and infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to yet another embodiment for gemcitabine, the dose for a particular indication is 1250 mg/m 2  in accordance with body surface area as the patient parameter. The table (56) below provides instruction for calculation of total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of gemcitabine from different sets, to deliver the calculated dose within ±5% variance: 
     
       
         
           
               
             
               
                 TABLE 56 
               
             
            
               
                   
               
               
                 Description of perfusion system of gemcitabine: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container Gemcitabine 
                 containers; Gemcitabine 
                   
               
               
                   
                 concentration 10 mg/ml 
                 concentration 10 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.2 
                 1500 
                 150 
                 1500 
                 0 
                 0 
                 1500.00 
                 0.00 
               
               
                 1.3 
                 1625 
                 160 
                 1600 
                 0 
                 0 
                 1600.00 
                 −1.54 
               
               
                 1.4 
                 1750 
                 170 
                 1700 
                 0 
                 0 
                 1700.00 
                 −2.86 
               
               
                 1.5 
                 1875 
                 190 
                 1900 
                 0 
                 0 
                 1900.00 
                 1.33 
               
               
                 1.6 
                 2000 
                 200 
                 2000 
                 0 
                 0 
                 2000.00 
                 0.00 
               
               
                 1.7 
                 2125 
                 220 
                 2200 
                 0 
                 0 
                 2200.00 
                 3.53 
               
               
                 1.8 
                 2250 
                 220 
                 2200 
                 0 
                 0 
                 2200.00 
                 −2.22 
               
               
                 1.9 
                 2375 
                 120 
                 1200 
                 120 
                 1200 
                 2400.00 
                 1.05 
               
               
                 2 
                 2500 
                 130 
                 1300 
                 120 
                 1200 
                 2500.00 
                 0.00 
               
               
                 2.1 
                 2625 
                 130 
                 1300 
                 130 
                 1300 
                 2600.00 
                 −0.95 
               
               
                 2.2 
                 2750 
                 150 
                 1500 
                 120 
                 1200 
                 2700.00 
                 −1.82 
               
               
                 2.3 
                 2875 
                 140 
                 1400 
                 140 
                 1400 
                 2800.00 
                 −2.61 
               
               
                 2.4 
                 3000 
                 150 
                 1500 
                 150 
                 1500 
                 3000.00 
                 0.00 
               
               
                 2.5 
                 3125 
                 190 
                 1900 
                 120 
                 1200 
                 3100.00 
                 −0.80 
               
               
                 2.6 
                 3250 
                 160 
                 1600 
                 160 
                 1600 
                 3200.00 
                 −1.54 
               
               
                   
               
            
           
         
       
     
     The containers of the perfusion system of Table (56) may be alphabetically coded as follows: 
     
       
         
           
               
            
               
                   
               
               
                 First set of Perfusion containers; 
               
               
                 gemcitabine concentration 10 mg/ml 
               
            
           
           
               
               
               
            
               
                   
                 Volume of perfusion 
                   
               
               
                   
                 container (ml) 
                 Alphabetical code 
               
               
                   
                   
               
               
                   
                 120 
                 B 
               
               
                   
                 130 
                 K 
               
               
                   
                 140 
                 L 
               
               
                   
                 150 
                 C 
               
               
                   
                 160 
                 M 
               
               
                   
                 170 
                 N 
               
               
                   
                 190 
                 O 
               
               
                   
                 200 
                 P 
               
               
                   
                 220 
                 Q 
               
               
                   
                   
               
            
           
         
       
     
     The perfusion system of Table (56) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.2 
                 Infuse the full volume from one 150 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 1.3 
                 Infuse the full volume from one 160 ml container having an 
               
               
                   
                 alphabetical code M 
               
               
                 1.4 
                 Infuse the full volume from one 170 ml container having an 
               
               
                   
                 alphabetical code N 
               
               
                 1.5 
                 Infuse the full volume from one 190 ml container having an 
               
               
                   
                 alphabetical code O 
               
               
                 1.6 
                 Infuse the full volume from one 200 ml container having an 
               
               
                   
                 alphabetical code P 
               
               
                 1.7 and 1.8 
                 Infuse the full volume from one 220 ml container having an 
               
               
                   
                 alphabetical code Q 
               
               
                 1.9 
                 Infuse the full volume from two 120 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 2.0 
                 Connect one 130 ml container having an alphabetical code 
               
               
                   
                 K + one 120 ml container having an alphabetical code B 
               
               
                   
                 and infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from two 130 ml container having an 
               
               
                   
                 alphabetical code K 
               
               
                 2.2 
                 Connect one 150 ml container having an alphabetical code 
               
               
                   
                 C + one 120 ml container having an alphabetical code B 
               
               
                   
                 and infuse the full volume 
               
               
                 2.3 
                 Infuse the full volume from two 140 ml container having an 
               
               
                   
                 alphabetical code L 
               
               
                 2.4 
                 Infuse the full volume from two 150 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 2.5 
                 Connect one 190 ml container having an alphabetical code 
               
               
                   
                 O + one 120 ml container having an alphabetical code B 
               
               
                   
                 and infuse the full volume 
               
               
                 2.6 
                 Infuse the full volume from two 160 ml container having 
               
               
                   
                 an alphabetical code M 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of azacitidine or its pharmaceutically acceptable salt. Table 57 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 57 
               
             
            
               
                   
               
               
                 Perfusion system of azacitidine: 
               
            
           
           
               
               
            
               
                   
                 From set of container of the perfusion system 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                   
                 First set 
                 of top up 
                 of top up 
               
               
                   
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                   
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.07-5.0  
                 0.05-0.5  
                 0.05-0.5  
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.5-2.5  
                 0.1-0.2  
                 0.05-0.07  
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 50-500 
                 50-250 
                 50-100 
               
               
                 Preferred volume range 
                 50-100 
                 50-100 
                 50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 58-60 
     
       
         
           
               
             
               
                 TABLE 58 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having Azacitidine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 60 
                 70 
                 80 
                 90 
                 100 
                 120 
                 200 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 AZACITIDINE amount per bag (mg) 
                 30 
                 35 
                 40 
                 45 
                 50 
                 60 
                 100 
               
               
                 (at a concentration of 0.5 mg/ml) 
                   
                   
                   
                   
                   
                   
                   
               
               
                 AZACITIDINE amount per bag (mg) 
                 60 
                 70 
                 80 
                 90 
                 100 
                 120 
                 200 
               
               
                 (at a concentration of 1.0 mg/ml) 
                   
                   
                   
                   
                   
                   
                   
               
               
                 AZACITIDINE amount per bag (mg) 
                 90 
                 105 
                 120 
                 135 
                 150 
                 180 
                 300 
               
               
                 (at a concentration of 1.5 mg/ml) 
                   
                   
                   
                   
                   
                   
                   
               
               
                 AZACITIDINE amount per bag (mg) 
                 150 
                 175 
                 200 
                 225 
                 250 
                 300 
                 500 
               
               
                 (at a concentration of 2.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 59 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having Azacitidine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 25 
                 40 
                 50 
                 60 
                 100 
               
               
                   
               
               
                 Azacitidine amount per bag 
                 5.0 
                 8.0 
                 10.0 
                 12.0 
                 20.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
                   
               
               
                 0.2 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 60 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having Azacitidine: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 20 
                 25 
                 40 
               
               
                   
               
               
                 Azacitidine amount per bag 
                 1.0 
                 1.25 
                 2.0 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
               
               
                 0.05 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is Azacitidine, the first set of infusion containers comprise perfusion solution having Azacitidine at a concentration ranging from about 0.07 mg/ml to 5.0 mg/ml and volume of solution ranging from about 40 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Azacitidine at a concentration ranging from about 0.05 mg/ml to 0.5 mg/ml and volume of solution ranging from about 20 ml to about 100 ml. 
     According to one embodiment, the dose of Azacitidine for a particular indication is 100 mg/m 2  based on body surface area as the patient parameter. There is provided instructions for calculating the total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of Azacitidine from different sets, to deliver the calculated dose within ±5% variance and is presented in table (61) 
     
       
         
           
               
             
               
                 TABLE 61 
               
             
            
               
                   
               
               
                 Description of perfusion system of Azacitidine: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container; Azacitidine 
                 containers—Azacitidine 
                   
               
               
                   
                 concentration—2.5 mg/ml 
                 concentration—0.2 mg/ml 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                 Total dose 
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 delivered 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 (mg) 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 D (mg) 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (a + b) 
                 dose % 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.4 
                 140 
                 55 
                 137.5 
                 0 
                 0 
                 137.5 
                 −1.8 
               
               
                 1.5 
                 150 
                 55 
                 137.5 
                 50 
                 10 
                 147.5 
                 −1.7 
               
               
                 1.6 
                 160 
                 65 
                 162.5 
                 0 
                 0 
                 162.5 
                 1.6 
               
               
                 1.7 
                 170 
                 65 
                 162.5 
                 50 
                 10 
                 172.5 
                 1.5 
               
               
                 1.8 
                 180 
                 65 
                 162.5 
                 50 
                 10 
                 172.5 
                 −4.2 
               
               
                 1.9 
                 190 
                 75 
                 187.5 
                 0 
                 0 
                 187.5 
                 −1.3 
               
               
                 2 
                 200 
                 80 
                 200 
                 0 
                 0 
                 200 
                 0.0 
               
               
                 2.1 
                 210 
                 80 
                 200 
                 50 
                 10 
                 210 
                 0.0 
               
               
                 2.2 
                 220 
                 80 
                 200 
                 50 
                 10 
                 210 
                 −4.5 
               
               
                 2.3 
                 230 
                 90 
                 225 
                 0 
                 0 
                 225 
                 −2.2 
               
               
                 2.4 
                 240 
                 90 
                 225 
                 50 
                 10 
                 235 
                 −2.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (61) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; azacitidine 
                 containers; azacitidine 
               
               
                 concentration 2.5 mg/ml 
                 concentration 0.2 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 55 
                 A 
                 50 
                 F 
               
               
                 65 
                 B 
                   
                   
               
               
                 75 
                 C 
                   
                   
               
               
                 80 
                 D 
                   
                   
               
               
                 90 
                 E 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (61) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.4 
                 Infuse the full volume from one 55 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 1.5 
                 Connect one 55 ml container having an alphabetical code A 
               
               
                   
                 with one 50 ml container having an alphabetical code F and 
               
               
                   
                 Infuse the full volume 
               
               
                 1.6 
                 Infuse the full volume from one 65 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 1.8 
                 Connect one 65 ml container having an alphabetical code B 
               
               
                   
                 with one 50 ml container having an alphabetical code F and 
               
               
                   
                 Infuse the full volume 
               
               
                 1.9 
                 Infuse the full volume from one 75 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 2.0 
                 Infuse the full volume from one 80 ml container having an 
               
               
                   
                 alphabetical code D 
               
               
                 2.1 and 2.2 
                 Connect one 80 ml container having an alphabetical code D 
               
               
                   
                 with one 50 ml container having an alphabetical code F and 
               
               
                   
                 Infuse the full volume 
               
               
                 2.3 
                 Infuse the full volume from one 90 ml container having an 
               
               
                   
                 alphabetical code E 
               
               
                 2.4 
                 Connect one 90 ml container having an alphabetical code E 
               
               
                   
                 with one 50 ml container having an alphabetical code F and 
               
               
                   
                 Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers and full volume is infused to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of arsenic trioxide or its pharmaceutically acceptable salt. Table 62 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 62 
               
             
            
               
                   
               
               
                 Perfusion system of arsenic trioxide: 
               
            
           
           
               
               
            
               
                   
                 From set of container of the perfusion system 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                   
                 First set 
                 of top up 
                 of top up 
               
               
                   
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                   
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.03-0.2 
                 0.03-0.07 
                 0.03-0.07 
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.05-0.1 
                 0.03-0.05 
                 0.03-0.05 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  50-500 
                  50-250 
                  25-200 
               
               
                 Preferred volume range 
                  100-250 
                  50-100 
                  50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 63-65. 
     
       
         
           
               
             
               
                 TABLE 63 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having arsenic trioxide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 100 
                 110 
                 140 
                 150 
                 190 
                 200 
                 230 
               
               
                   
               
               
                 Arsenic trioxide amount per bag  
                 7 
                 7.7 
                 9.8 
                 10.5 
                 13.3 
                 14.0 
                 16.1 
               
               
                 (mg) (at a concentration of 0.07  
                   
                   
                   
                   
                   
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 64 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having arsenic trioxide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
               
               
                   
               
               
                 Arsenic trioxide amount per bag 
                 1.5 
                 2.25 
                 3.0 
               
               
                 (mg) (at a concentration of 0.03 
                   
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 65 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having arsenic trioxide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 80 
               
               
                   
               
               
                 Arsenic trioxide amount per bag 
                 1.0 
                 1.6 
               
               
                 (mg) (at a concentration of 0.02 
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is Arsenic trioxide, the first set of infusion containers comprise perfusion solution having Arsenic trioxide at a concentration ranging from about 0.03 mg/ml to 0.2 mg/ml and volume of solution ranging from about 50 ml to about 500 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Arsenic trioxide at a concentration ranging from about 0.03-0.07 mg/ml and volume of solution ranging from about 20 ml to about 100 ml. 
     According to one embodiment, the dose of Arsenic trioxide for a particular indication is 0.15 mg/Kg based on body weight as the patient parameter. There is provided instructions for calculating the total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of Arsenic trioxide from different sets, to deliver the calculated dose within ±5% variance and is presented in table (66): 
     
       
         
           
               
             
               
                 TABLE 66 
               
             
            
               
                   
               
               
                 Description of perfusion system of Arsenic trioxide: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container; Arsenic Trioxide 
                 containers; Arsenic Trioxide 
                   
               
               
                   
                 concentration—0.07 mg/mL 
                 concentration—0.03 mg/mL 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total Dose 
                 from delivered 
               
               
                 Body 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs. calculated 
               
               
                 Weight 
                 D (mg) 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 a + b (mg) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 50 
                 7.50 
                 110 
                 7.7 
                 0 
                 0 
                 7.7 
                 2.7 
               
               
                 55 
                 8.25 
                 100 
                 7 
                 50 
                 1.5 
                 8.5 
                 3.0 
               
               
                 60 
                 9.00 
                 110 
                 7.7 
                 50 
                 1.5 
                 9.2 
                 2.2 
               
               
                 65 
                 9.75 
                 140 
                 9.8 
                 0 
                 0 
                 9.8 
                 0.5 
               
               
                 70 
                 10.50 
                 150 
                 10.5 
                 0 
                 0 
                 10.5 
                 0.0 
               
               
                 75 
                 11.25 
                 140 
                 9.8 
                 50 
                 1.5 
                 11.3 
                 0.4 
               
               
                 80 
                 12.00 
                 150 
                 10.5 
                 50 
                 1.5 
                 12.0 
                 0.0 
               
               
                 85 
                 12.75 
                 190 
                 13.3 
                 0 
                 0 
                 13.3 
                 4.3 
               
               
                 90 
                 13.50 
                 190 
                 13.3 
                 0 
                 0 
                 13.3 
                 −1.5 
               
               
                 95 
                 14.25 
                 190 
                 13.3 
                 50 
                 1.5 
                 14.8 
                 3.7 
               
               
                 100 
                 15.00 
                 190 
                 13.3 
                 50 
                 1.5 
                 14.8 
                 −1.3 
               
               
                 105 
                 15.75 
                 230 
                 16.1 
                 0 
                 0 
                 16.1 
                 2.2 
               
               
                 110 
                 16.50 
                 230 
                 16.1 
                 0 
                 0 
                 16.1 
                 −2.4 
               
               
                 115 
                 17.25 
                 230 
                 16.1 
                 50 
                 1.5 
                 17.6 
                 2.0 
               
               
                 120 
                 18.00 
                 230 
                 16.1 
                 50 
                 1.5 
                 17.6 
                 −2.2 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (66) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; Arsenic Trioxide 
                 containers; Arsenic Trioxide 
               
               
                 concentration 0.07 mg/ml 
                 concentration 0.03 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 100 
                 A 
                 50 
                 G 
               
               
                 110 
                 B 
                   
                   
               
               
                 140 
                 C 
                   
                   
               
               
                 150 
                 D 
                   
                   
               
               
                 190 
                 E 
                   
                   
               
               
                 230 
                 F 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (66) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 Body 
                   
               
               
                 Weight 
                 Instructions 
               
               
                   
               
             
            
               
                 50 
                 Infuse the full volume from one 110 ml container having 
               
               
                   
                 an alphabetical code B 
               
               
                 55 
                 Connect one 100 ml container having an alphabetical  
               
               
                   
                 code A with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                 60 
                 Connect one 110 ml container having an alphabetical  
               
               
                   
                 code B with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                 65 
                 Infuse the full volume from one 140 ml container having 
               
               
                   
                 an alphabetical code C 
               
               
                 70 
                 Infuse the full volume from one 150 ml container having 
               
               
                   
                 an alphabetical code D 
               
               
                 75 
                 Connect one 140 ml container having an alphabetical  
               
               
                   
                 code C with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                 80 
                 Connect one 150 ml container having an alphabetical  
               
               
                   
                 code D with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                 85 and 90 
                 Infuse the full volume from one 190 ml container having 
               
               
                   
                 an alphabetical code E 
               
               
                  95 and 100 
                 Connect one 190 ml container having an alphabetical  
               
               
                   
                 code E with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                 105 and 110 
                 Infuse the full volume from one 230 ml container having 
               
               
                   
                 an alphabetical code F 
               
               
                 115 and 120 
                 Connect one 230 ml container having an alphabetical  
               
               
                   
                 code F with one 50 ml container having an alphabetical  
               
               
                   
                 code G and Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers and full volume is infused to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of fluorouracil or its pharmaceutically acceptable salt. Table 67 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 67 
               
             
            
               
                   
               
               
                 Perfusion system of fluorouracil: 
               
            
           
           
               
               
            
               
                   
                 From set of container of the perfusion system 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                   
                 First set 
                 of top up 
                 of top up 
               
               
                   
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                   
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.50 to 6.0 
                 0.1-1.0 
                 0.1-1.0 
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.85 to 2.6 
                 1.0 
                 0.5 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 50-1000 mL 
                 25-100 mL 
                 20-100 mL 
               
               
                 Preferred volume range 
                 200-500 mL 
                    50 mL 
                    50 mL 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 68-70. 
     
       
         
           
               
             
               
                 TABLE 68 
               
             
            
               
                   
               
               
                 Other Perfusion containers of the first set having 0.85 mg/ml fluorouracil: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 200 
                 250 
                 300 
                 350 
                 400 
                 450 
                 500 
               
               
                   
               
               
                 Fluorouracil amount per bag (mg) 
                 170 
                 212.5 
                 255 
                 297.5 
                 340 
                 382.5 
                 425 
               
               
                 (at a concentration of 0.85 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 69 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having fluorouracil: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 25 
                 50 
                 75 
                 100 
               
               
                   
               
               
                 Fluorouracil amount per bag 
                 12.5 
                 25 
                 37.5 
                 50 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 0.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 70 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having fluorouracil: 
               
            
           
           
               
               
               
            
               
                   
                 Perfusion containers of third set 
                   
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 20 
                 50 
                 75 
                 100 
               
               
                   
               
               
                 Fluorouracil amount per bag 
                 5 
                 12.5 
                 18.75 
                 25 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 0.25 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is Fluorouracil, the first set of infusion containers comprise perfusion solution having Fluorouracil at a concentration ranging from about 0.5 mg/ml to 6.0 mg/ml and volume of solution ranging from about 50 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Fluorouracil at a concentration ranging from about 0.1-1.0 mg/ml and volume of solution ranging from about 20 ml to about 100 ml. 
     According to one embodiment, the dose of Fluorouracil for a particular indication is 5 mg/Kg based on body weight as the patient parameter. There is provided instructions for calculating the total dose to be delivered to a patient based on the body weight and instructions for selecting one or more perfusion containers of Fluorouracil from different sets, to deliver the calculated dose within ±5% variance and is presented in table (71): 
     
       
         
           
               
             
               
                 TABLE 71 
               
             
            
               
                   
               
               
                 Description of perfusion system of Fluorouracil: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container; Fluorouracil 
                 container; Fluorouracil 
                   
               
               
                   
                 concentration 0.85 mg/ml 
                 concentration 0.5 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                 Body 
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 Weight 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 kg 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 50 
                 250 
                 300 
                 255 
                 0 
                 0 
                 255 
                 2.0 
               
               
                 55 
                 275 
                 300 
                 255 
                 50 
                 25 
                 280 
                 1.8 
               
               
                 60 
                 300 
                 300 
                 255 
                 100 
                 50 
                 305 
                 1.7 
               
               
                 65 
                 325 
                 400 
                 340 
                 0 
                 0 
                 340 
                 4.6 
               
               
                 70 
                 350 
                 400 
                 340 
                 0 
                 0 
                 340 
                 −2.9 
               
               
                 75 
                 375 
                 400 
                 340 
                 50 
                 25 
                 365 
                 −2.7 
               
               
                 80 
                 400 
                 400 
                 340 
                 100 
                 50 
                 390 
                 −2.5 
               
               
                 85 
                 425 
                 500 
                 425 
                 0 
                 0 
                 425 
                 0.0 
               
               
                 90 
                 450 
                 500 
                 425 
                 50 
                 25 
                 450 
                 0.0 
               
               
                 95 
                 475 
                 500 
                 425 
                 100 
                 50 
                 475 
                 0.0 
               
               
                 100 
                 500 
                 600 
                 510 
                 0 
                 0 
                 510 
                 2.0 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (71) may be alphabetically coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; Fluorouracil 
                 containers; Fluorouracil 
               
               
                 concentration 0.85 mg/ml 
                 concentration 0.5 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
            
           
           
               
               
               
               
            
               
                 300 
                 A 
                 50 
                 E 
               
               
                 400 
                 B 
                 100 
                 F 
               
               
                 500 
                 C 
                   
                   
               
               
                 600 
                 D 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (71) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 Body 
                   
               
               
                 Weight 
                 Instructions 
               
               
                   
               
             
            
               
                 50 
                 Infuse the full volume from one 300 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 55 
                 Connect one 300 ml container having an alphabetical code  
               
               
                   
                 A with one 50 ml container having an alphabetical code E  
               
               
                   
                 and Infuse the full volume 
               
               
                 60 
                 Connect one 300 ml container having an alphabetical code  
               
               
                   
                 A with one 100 ml container having an alphabetical code F  
               
               
                   
                 and Infuse the full volume 
               
               
                 65 and 70 
                 Infuse the full volume from one 400 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 75 
                 Connect one 400 ml container having an alphabetical code  
               
               
                   
                 B with one 50 ml container having an alphabetical code E  
               
               
                   
                 and Infuse the full volume 
               
               
                 80 
                 Connect one 400 ml container having an alphabetical code  
               
               
                   
                 B with one 100 ml container having an alphabetical code F  
               
               
                   
                 and Infuse the full volume 
               
               
                 85 
                 Infuse the full volume from one 500 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 90 
                 Connect one 500 ml container having an alphabetical code  
               
               
                   
                 C with one 50 ml container having an alphabetical code E  
               
               
                   
                 and Infuse the full volume 
               
               
                 95 
                 Connect one 500 ml container having an alphabetical code  
               
               
                   
                 C with one 100 ml container having an alphabetical code F  
               
               
                   
                 and Infuse the full volume 
               
               
                 100  
                 Infuse the full volume from one 600 ml container having an 
               
               
                   
                 alphabetical code D 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers and full volume is infused to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of paclitaxel or its pharmaceutically acceptable salt. Table 72 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 72 
               
             
            
               
                   
               
               
                 Perfusion system of paclitaxel: 
               
            
           
           
               
               
            
               
                   
                 From set of container of the perfusion system 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                   
                 First set 
                 of top up 
                 of top up 
               
               
                   
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                   
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                 0.1 to 2   
                 0.1 to 2   
                 0.1 to 2   
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 0.3 to 1.2 
                 0.3 to 1.2 
                 0.3 to 1.2 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                 40-600 
                 50-150 
                 50-150 
               
               
                 Preferred volume range 
                 50-500 
                 50-100 
                 50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 73-75. 
     
       
         
           
               
             
               
                 TABLE 73 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having paclitaxel: 
               
            
           
           
               
               
            
               
                 Volume of solution  
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
               
               
            
               
                 in bag (ml) 
                 120 
                 130 
                 140 
                 160 
                 175 
                 205 
                 245 
                 290 
                 350 
               
               
                   
               
               
                 Paclitaxel amount  
                 60 
                 65 
                 70 
                 80 
                 87.5 
                 102.5 
                 122.5 
                 145 
                 175 
               
               
                 per bag (mg) (at a  
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                 concentration  
                   
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                 of 0.5 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 74 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having paclitaxel: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
                 150 
               
               
                   
               
               
                 Paclitaxel amount per bag 
                 20 
                 30 
                 40 
                 60 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 0.4 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 75 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having paclitaxel: 
               
            
           
           
               
               
               
            
               
                   
                 Perfusion containers of third set 
                   
               
            
           
           
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
                 150 
               
               
                   
               
               
                 Paclitaxel amount per bag 
                 12.5 
                 18.75 
                 25 
                 37.5 
               
               
                 (mg) (at a concentration of 
                   
                   
                   
                   
               
               
                 0.25 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is Paclitaxel, the first set of infusion containers comprise perfusion solution having Paclitaxel at a concentration ranging from about 0.1 mg/ml to 2.0 mg/ml and volume of solution ranging from about 40 ml to about 600 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Paclitaxel at a concentration ranging from about 0.1-2.0 mg/ml and volume of solution ranging from about 25 ml to about 150 ml. 
     According to one embodiment, the dose of Paclitaxel for a particular indication is 50 mg/m 2  based on body surface area as the patient parameter. There is provided instructions for calculating the total dose to be delivered to a patient based on the body surface area and instructions for selecting one or more perfusion containers of Paclitaxel from different sets, to deliver the calculated dose within ±5% variance and is presented in table (76): 
     
       
         
           
               
             
               
                 TABLE 76 
               
             
            
               
                   
               
               
                 Description of perfusion system of Paclitaxel: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of top-up perfusion 
                   
               
               
                   
                 container Paclitaxel 
                 containers; Paclitaxel 
                   
               
               
                   
                 concentration 0.5 mg/ml 
                 concentration 0.4 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume of 
                 Dose delivered 
                   
                 % Variation** 
               
               
                   
                 Dose to be 
                 perfusion 
                 from perfusion 
                 top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 BSA 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (m 2 ) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 1.4 
                 70.0 
                 145.0 
                 72.5 
                 0 
                 0.0 
                 72.5 
                 3.6 
               
               
                 1.5 
                 75.0 
                 145.0 
                 72.5 
                 0 
                 0.0 
                 72.5 
                 −3.3 
               
               
                 1.6 
                 80.0 
                 160.0 
                 80.0 
                 0 
                 0.0 
                 80.0 
                 0.0 
               
               
                 1.7 
                 85.0 
                 175.0 
                 87.5 
                 0 
                 0.0 
                 87.5 
                 2.9 
               
               
                 1.8 
                 90.0 
                 175.0 
                 87.5 
                 0 
                 0.0 
                 87.5 
                 −2.8 
               
               
                 1.9 
                 95.0 
                 145.0 
                 72.5 
                 50.0 
                 20.0 
                 92.5 
                 −2.6 
               
               
                 2 
                 100.0 
                 160.0 
                 80.0 
                 50.0 
                 20.0 
                 100 
                 0 
               
               
                 2.1 
                 105.0 
                 210.0 
                 105.0 
                 0 
                 0.0 
                 105 
                 0 
               
               
                 2.2 
                 110.0 
                 175.0 
                 87.5 
                 50.0 
                 20.0 
                 107.5 
                 2.3 
               
               
                 2.3 
                 115.0 
                 200.0 
                 100 
                 50.0 
                 20.0 
                 120 
                 4.3 
               
               
                 2.4 
                 120.0 
                 245.0 
                 122.5 
                 0 
                 0.0 
                 122.5 
                 2.1 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (76) may be alphabetical coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; paclitaxel 
                 containers; paclitaxel 
               
               
                 concentration 0.5 mg/ml 
                 concentration 0.4 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 145 
                 A 
                 50 
                 G 
               
               
                 160 
                 B 
                   
                   
               
               
                 175 
                 C 
                   
                   
               
               
                 200 
                 D 
                   
                   
               
               
                 210 
                 E 
                   
                   
               
               
                 245 
                 F 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (76) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 BSA (m 2 ) 
                 Instructions 
               
               
                   
               
             
            
               
                 1.4 and 1.5 
                 Infuse the full volume from one 145 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 1.6 
                 Infuse the full volume from one 160 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 1.7 and 1.8 
                 Infuse the full volume from one 175 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 1.9 
                 Connect one 145 ml container having an alphabetical code 
               
               
                   
                 A with one 50 ml container having an alphabetical code G 
               
               
                   
                 and Infuse the full volume 
               
               
                 2.0 
                 Connect one 160 ml container with B with one 50 ml 
               
               
                   
                 container with G and Infuse the full volume 
               
               
                 2.1 
                 Infuse the full volume from one 210 ml container with E 
               
               
                 2.2 
                 Connect one 175 ml container with C with one 50 ml 
               
               
                   
                 container with G and Infuse the full volume 
               
               
                 2.3 
                 Connect one 200 ml container with D with one 50 ml 
               
               
                   
                 container with G and Infuse the full volume 
               
               
                 2.4 
                 Infuse the full volume from one 245 ml container with F 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers and full volume is infused to deliver the calculated target dose within ±5% of variation. 
     According to the present invention, the below embodiment provides perfusion system for administration of cyclophosphamide or its pharmaceutically acceptable salt. Table 77 below provides details of the perfusion system having containers of first, second and/or third set with the ranges of concentration and volume of the solution per set. 
     
       
         
           
               
             
               
                 TABLE 77 
               
             
            
               
                   
               
               
                 Perfusion system of cyclophosphamide: 
               
            
           
           
               
               
            
               
                   
                 From set of container of the perfusion system 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Second set 
                 Third set 
               
               
                   
                 First set 
                 of top up 
                 of top up 
               
               
                   
                 of perfusion 
                 perfusion 
                 perfusion 
               
               
                   
                 container 
                 container 
                 container 
               
               
                   
               
               
                 Concentration range 
                  5-30 
                 1-15 
                 1-15 
               
               
                 (mg/ml) 
                   
                   
                   
               
               
                 Preferred concentration 
                 15-25 
                 5-10 
                 1-10 
               
               
                 range (mg/ml) 
                   
                   
                   
               
               
                 Volume range (ml) 
                  100-1000 
                 30-150 
                 30-150 
               
               
                 Preferred volume range 
                 100-500 
                 50-100 
                 50-100 
               
               
                 (ml) 
               
               
                   
               
            
           
         
       
     
     The perfusion system may comprise one or more perfusion containers in the first set and one or more perfusion containers in the second and/or third set. The containers in different sets according to one preferred embodiment of the present invention are given below in Tables 78-80. 
     
       
         
           
               
             
               
                 TABLE 78 
               
             
            
               
                   
               
               
                 Perfusion containers of the first set having cyclophosphamide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of first set 
               
            
           
           
               
               
               
               
               
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 100 
                 115 
                 125 
                 135 
                 145 
                 160 
                 175 
                 200 
               
               
                   
               
               
                 Cyclophosphamide amount per bag  
                 2000 
                 2300 
                 2500 
                 2700 
                 2900 
                 3200 
                 3500 
                 4000 
               
               
                 (mg) (at a concentration of 20 mg/ml) 
                   
                   
                   
                   
                   
                   
                   
                   
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 79 
               
             
            
               
                   
               
               
                 Perfusion containers of the second set having cyclophosphamide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of second set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 75 
                 100 
                 150 
               
               
                   
               
               
                 Cyclophosphamide amount per bag 
                 750 
                 1000 
                 1500 
               
               
                 (mg) (at a concentration of 10 
                   
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 80 
               
             
            
               
                   
               
               
                 Perfusion containers of the third set having cyclophosphamide: 
               
            
           
           
               
               
            
               
                   
                 Perfusion containers of third set 
               
            
           
           
               
               
               
               
            
               
                 Volume of solution in bag (ml) 
                 50 
                 75 
                 100 
               
               
                   
               
               
                 Cyclophosphamide amount per bag 
                 250 
                 375 
                 500 
               
               
                 (mg) (at a concentration of 5 
                   
                   
                   
               
               
                 mg/ml) 
               
               
                   
               
            
           
         
       
     
     In one particularly preferred embodiment wherein the antineoplastic drug is Cyclophosphamide, the first set of infusion containers comprise perfusion solution having Cyclophosphamide at a concentration ranging from about 5 mg/ml to 30 mg/ml and volume of solution ranging from about 100 ml to about 1000 ml, further wherein the second or third set of infusion containers comprise perfusion solution having Cyclophosphamide at a concentration ranging from about 1-15 mg/ml and volume of solution ranging from about 30 ml to about 100 ml. 
     According to one embodiment, the dose of Cyclophosphamide for a particular indication is 40 mg/kg based on body weight as the patient parameter. There is provided instructions for calculating the total dose to be delivered to a patient based on the body weight and instructions for selecting one or more perfusion containers of Cyclophosphamide from different sets, to deliver the calculated dose within ±5% variance and is presented in table (81): 
     
       
         
           
               
             
               
                 TABLE 81 
               
             
            
               
                   
               
               
                 Description of perfusion system of Cyclophosphamide: 
               
            
           
           
               
               
               
               
            
               
                   
                 First set of Perfusion 
                 Second set of Top-up perfusion 
                   
               
               
                   
                 container; cyclophosphamide 
                 containers; cyclophosphamide 
                   
               
               
                   
                 concentration 20 mg/ml 
                 concentration 10 mg/ml: 
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                   
                 Total Target 
                 Volume of 
                 Dose delivered 
                 Volume 
                 Dose delivered 
                   
                 % Variation** 
               
               
                 Body 
                 Dose to be 
                 perfusion 
                 from perfusion 
                 of top up 
                 from top-up 
                 Total dose 
                 from delivered 
               
               
                 Weight 
                 delivered 
                 container 
                 container 
                 container 
                 container 
                 delivered 
                 dose Vs calculated 
               
               
                 (Kg) 
                 (mg) D 
                 (ml) 
                 (a) (mg) 
                 (ml) 
                 (b) (mg) 
                 (mg) (a + b) 
                 dose 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 50 
                 2000.0 
                 100 
                 2000.00 
                 0 
                 0 
                 2000.00 
                 0.0 
               
               
                 55 
                 2200.0 
                 105 
                 2100.00 
                 0 
                 0 
                 2100.00 
                 −4.5 
               
               
                 60 
                 2400.0 
                 115 
                 2300.00 
                 0 
                 0 
                 2300.00 
                 −4.2 
               
               
                 65 
                 2600.0 
                 125 
                 2500.00 
                 0 
                 0 
                 2500.00 
                 −3.8 
               
               
                 70 
                 2800.0 
                 135 
                 2700.00 
                 0 
                 0 
                 2700.00 
                 −3.6 
               
               
                 75 
                 3000.0 
                 145 
                 2900.00 
                 0 
                 0 
                 2900.00 
                 −3.3 
               
               
                 80 
                 3200.0 
                 160 
                 3200.00 
                 0 
                 0 
                 3200.00 
                 0.0 
               
               
                 85 
                 3400.0 
                 115 
                 2300.00 
                 100 
                 1000 
                 3300.00 
                 −2.9 
               
               
                 90 
                 3600.0 
                 135 
                 2700.00 
                 100 
                 1000 
                 3700.00 
                 2.8 
               
               
                 95 
                 3800.0 
                 135 
                 2700.00 
                 100 
                 1000 
                 3700.00 
                 −2.6 
               
               
                 100 
                 4000.0 
                 145 
                 2900.00 
                 100 
                 1000 
                 3900.00 
                 −2.5 
               
               
                   
               
               
                 **% Variation from delivered dose Vs calculated dose = [((a + b) − D]/D × 100 
               
            
           
         
       
     
     The containers of the perfusion system of Table (81) may be alphabetical coded as follows: 
     
       
         
           
               
               
            
               
                   
               
               
                 First set of Perfusion 
                 Second set of top-up perfusion 
               
               
                 containers; cyclophosphamide 
                 containers; cyclophosphamide 
               
               
                 concentration 0.85 mg/ml 
                 concentration 0.5 mg/ml 
               
            
           
           
               
               
               
               
            
               
                 Volume of perfusion 
                 Alphabetical 
                 Volume of top up 
                 Alphabetical 
               
               
                 container (ml) 
                 code 
                 container (ml) 
                 code 
               
               
                   
               
               
                 100 
                 A 
                 100 
                 H 
               
               
                 105 
                 B 
                   
                   
               
               
                 115 
                 C 
                   
                   
               
               
                 125 
                 D 
                   
                   
               
               
                 135 
                 E 
                   
                   
               
               
                 145 
                 F 
                   
                   
               
               
                 160 
                 G 
               
               
                   
               
            
           
         
       
     
     The perfusion system of Table (81) is accompanied by suitable instructions for example as below: 
     
       
         
           
               
               
             
               
                   
               
               
                 Body 
                   
               
               
                 Weight 
                 Instructions 
               
               
                   
               
             
            
               
                 50 
                 Infuse the full volume from one 100 ml container having an 
               
               
                   
                 alphabetical code A 
               
               
                 55 
                 Infuse the full volume from one 105 ml container having an 
               
               
                   
                 alphabetical code B 
               
               
                 60 
                 Infuse the full volume from one 115 ml container having an 
               
               
                   
                 alphabetical code C 
               
               
                 65 
                 Infuse the full volume from one 125 ml container having an 
               
               
                   
                 alphabetical code D 
               
               
                 70 
                 Infuse the full volume from one 135 ml container having an 
               
               
                   
                 alphabetical code E 
               
               
                 75 
                 Infuse the full volume from one 145 ml container having an 
               
               
                   
                 alphabetical code F 
               
               
                 80 
                 Infuse the full volume from one 160 ml container having an 
               
               
                   
                 alphabetical code G 
               
               
                 85 
                 Connect one 115 ml container having an alphabetical code  
               
               
                   
                 C with one 100 ml container having an alphabetical code H  
               
               
                   
                 and Infuse the full volume 
               
               
                 90 and 95 
                 Connect one 135 ml container having an alphabetical code  
               
               
                   
                 E with one 100 ml container having an alphabetical code A  
               
               
                   
                 and Infuse the full volume 
               
               
                 100  
                 Connect one 145 ml container having an alphabetical code F 
               
               
                   
                 with one 100 ml container having an alphabetical code H  
               
               
                   
                 and Infuse the full volume 
               
               
                   
               
            
           
         
       
     
     According to the instructions, one or more perfusion containers can be selected from first, second and/or third set of perfusion containers and full volume is infused to deliver the calculated target dose within ±5% of variation.