qanastek/EMEA-V3 huggingface dataset:
Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ ml (0.9%) solution for infusion.
Iddeċiedi l- volum totali ta ’ infużjoni bbażat fuq il- piż tal- pazjent individwali, jew 100 ml (jekk il- piż tal- ġisem hu ta ’ 20 kg jew inqas) jew 250 ml (jekk il- piż tal- ġisem hu ta ’ iktar minn 20 kg) ta ’ soluzzjoni għall- infużjoni ta ’ 0. 9% ta ’ sodium chloride.
Withdraw and discard a volume of the sodium chloride 9 mg/ ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Iġbed u armi volum tas- soluzzjoni għall- infużjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride mill- borża ta ’ l- infużjoni li jkun daqs il- volum totali ta ’ Aldurazyme li jrid jiġi miżjud.
Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
Iġbed il- volum meħtieġ mill- kunjetti ta ’ Aldurazyme u ħallat il- volumi li ġbidt.
Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ ml (0.9%) solution for infusion.
Żid il- volumi mħallta ta ’ Aldurazyme mas- soluzzjoni għall- infużjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride.
Mix the solution for infusion gently.
Ħallat is- soluzzjoni għall- infużjoni bil- mod.
Prior to use visually inspect the solution for particulate matter.
Qabel ma tuża s- soluzzjoni, eżaminaha viżwalment biex tara jekk hemmx xi frak.
Only clear and colourless solutions without visible particles should be used.
Soluzzjonijiet trasparenti, mingħajr kulur u mingħajr partikuli viżibbli biss għandhom jintużaw.
Genzyme Europe B. V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands.
Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD Naarden, l- Olanda.
10/ 06/ 2003 Date of latest renewal:
10/ 06/ 03 Data ta ’ l- aħħar tiġdid:
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu / 0H
11 A.
11 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA
BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, Stati Uniti ta ’ l- Amerika
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, ir- Renju Unit
Summary of Product Characteristics, section 4.2)
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2).
The Marketing Authorisation Holder will continue to submit yearly PSURs unless otherwise specified by the CHMP
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ser ikompli jissottometti l- PSURs ħlief jekk ikun speċifikat mod ieħor mis- CHMP. fuq bażi annwali.
Regarding the MPS I registry already implemented.
Ir- reġistru ta ’ MPS I li diġà hu implimentat.
This Registry will collect long-term safety and efficacy data in patients treated with Aldurazyme as well as data on the natural progression of the disease in patients not on treatment.
Dan ir- Reġistru ser jiġbor informazzjoni fit- tul dwar is- sigurtà u l- effikaċja f’ pazjenti kkurati b’ Aldurazyme, kif ukoll informazzjoni dwar fuq il- progressjoni naturali tal- marda f’ pazjenti li mhux qegħdin fuq il- kura.
Annual updates will be provided at the time of the annual reassessments.
L- aġġornamenti annwali ser ikunu pprovduti meta jsiru l- evalwazzjonijiet annwali mill- ġdid.
Aldurazyme 100 U/ ml concentrate for solution for infusion laronidase
Aldurazyme 100 U/ ml konċentrat għal soluzzjoni għall- infużjoni. laronidase
Each vial of 5 ml contains 500 U of laronidase.
1 ml fih 100 U ta ’ laronidase Kull kunjett ta ’ 5 ml fih 500 U ta ’ laronidase.
Sodium chloride, Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80, Water for injections
Sodium chloride, Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80, Ilma għall- injezzjonijiet
1 vial of concentrate for solution for infusion.
1 kunjett ta ’ konċentrat għal soluzzjoni għall- infużjoni.
10 vials of concentrate for solution for infusion.
10 kunjetti ta ’ konċentrat għal soluzzjoni għall- infużjoni.
25 vials of concentrate for solution for infusion.
25 kunjett ta ’ konċentrat għal soluzzjoni għall- infużjoni.
Gooimeer 10 NL-1411 DD Naarden The Netherlands
Gooimeer 10 NL- 1411 DD Naarden L- Olanda
EU/ 1/ 03/ 253/ 001 1 Vial EU/ 1/ 03/ 253/ 002 10 Vials EU/ 1/ 03/ 253/ 003 25 Vials
EU/ 1/ 03/ 253/ 001 1 Kunjett EU/ 1/ 02/ 216/ 002 10 Kunjetti EU/ 1/ 03/ 253/ 003 25 Kunjett
Aldurazyme 100 U/ ml concentrate for solution for infusion laronidase Intravenous use
Aldurazyme 100 U/ ml konċentrat għal soluzzjoni għall- infużjoni laronidase Użu għal ġol- vini
Store at 2°C – 8°C
Aħżen f’ temperatura ta ’ 2°C – 8°C
What Aldurazyme is and what it is used for 2.
X’ inhu Aldurazyme u għalxiex jintuża 2.
Before you use Aldurazyme 3.
Qabel ma tuża Aldurazyme 3.
How to use Aldurazyme 4.
Kif għandek tuża Aldurazyme 4.
Possible side effects 5 How to store Aldurazyme 6.
Effetti sekondarji li jista ’ jkollu Kif taħżen Aldurazyme 5 6.
WHAT ALDURAZYME IS AND WHAT IT IS USED FOR
X’ INHU ALDURAZYME U GĦALXIEX JINTUŻA
Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I).
Aldurazyme jintuża biex jikkura pazjenti bil- marda MPS I (Mucopolysaccharidosis I).
It is given to treat the non-neurological manifestations of the disease.
Jingħata biex jikkura manifestazzjonijiet mhux newroloġiċi tal- marda.
People with MPS I disease have either a low level or no level of an enzyme called α -L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body.
Nies li jkollhom il- marda MPS I, jew ikollhom livell baxx jew l- ebda livell ta ’ enzima msejħa α- L - iduronidase, li tkisser sustanzi speċifiċi (glycosaminoglycans) fil- ġisem.
As a result, these substances do not get broken down and processed by the body as they should.
Bħala riżultat, dawn is - sustanzi ma jitkissrux u ma jkunux ipproċessati mill- ġisem kif suppost.
They accumulate in many tissues in the body, which causes the symptoms of MPS I.
Jakkumulaw f’ ħafna tessuti fil - ġisem, u dan jikkawża s- sintomi ta ’ MPS I.
Aldurazyme is an artificial enzyme called laronidase.
Aldurazyme hu enzima artifiċjali msejħa laronidase.
This can replace the natural enzyme which is lacking in MPS I disease.
Din tista ’ tissostitwixxi l- enzima naturali li tkun nieqsa fil- marda MPS I.
BEFORE YOU USE ALDURAZYME
QABEL MA TUŻA ALDURAZYME
Do not use Aldurazyme If you are allergic (hypersensitive) to any of the ingredients of Aldurazyme or if you have experienced a severe allergic reaction to laronidase.
Tużax Aldurazyme Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi sustanzi ta ’ Aldurazyme jew jekk kellek xi reazzjoni allerġika severa ta ’ sensittività eċċessiva jew reazzjoni anafilattika għal laronidase.
Take special care with Aldurazyme If you are treated with Aldurazyme, you may develop infusion-associated reactions.
Oqgħod attent ħafna b’ Aldurazyme Jekk qed tingħata Aldurazyme, tista ’ tiżviluppa reazzjonijiet marbuta ma ’ l- infużjoni.
An infusion- associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see 4 “ Possible Side Effects”).
Reazzjoni marbuta ma ’ l- infużjoni hi kwalunkwe effett sekondarju li jseħħ matul l- infużjoni jew sat- tmiem tal - jum ta ’ l- infużjoni (ara 4 “ Effetti Sekondarji li Jista ’ Jkollu ”).
Some of these reactions may be severe.
X’ uħud minn dawn ir- reazzjonijiet jistgħu jkunu severi.
When you experience such a reaction, you should immediately contact your doctor.
Meta jkollok reazzjoni bħal din, għandek tikkuntattja lit- tabib tiegħek immedjatament.
If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
Jekk dawn ir- reazzjonijiet iseħħu, l- infużjoni ta ’ Aldurazyme għandha titwaqqaf immedjatament, u kura adattata għandha tinbeda mit- tabib tiegħek.
These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction.
Dawn ir- reazzjonijiet jistgħu jkunu partikularment severi jekk ikollok ostruzzjoni fin- naħa ta ’ fuq fil - pajp tan- nifs marbuta ma ’ MPS I, li tkun teżisti minn qabel.
You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions.
Tista ’ tingħata mediċini addizzjonali bħal antistamini u paracetamol biex jgħinu fil- prevenzjoni ta ’ reazzjonijiet li jixbhu lil dawk ta ’ l- allerġija.
19 Using other medicines Please inform your doctor if you use medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme.
20 Meta tuża mediċini oħra Jekk jogħġbok għarraf lit- tabib tiegħek jekk qed tieħu mediċini li fihom chloroquine jew procaine, minħabba riskju possibbli ta ’ tnaqqis ta ’ l- azzjoni ta ’ Aldurazyme.
Pregnancy and breast-feeding There is not enough experience of the use of Aldurazyme in pregnant women.
Tqala u treddigħ M’ hemmx esperjenza biżżejjed dwar l- użu ta ’ Aldurazyme f’ nisa tqal.
Aldurazyme should not be used during pregnancy unless clearly necessary.
Aldurazyme m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
It is not known whether Aldurazyme appears in breast milk.
Mhux magħruf jekk Aldurazyme jidhirx fil- ħalib tas- sider.
It is recommended to stop breast-feeding during treatment with Aldurazyme.
Hu rakkomandat li t- treddigħ jitwaqqaf matul il- kura b’ Aldurazyme.
Driving and using machines The effects on the ability to drive and to use machines have not been studied.
Sewqan u tħaddim ta ’ magni Ma saru l- ebda studji dwar l- effetti fuq il- ħila biex issuq u tuża l- magni.
Important information about some of the ingredients of Aldurazyme This medicinal product contains 1.29 mmol sodium per vial.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Aldurazyme Dan il- prodott mediċinali fih madwar 1. 29 mmol ta ’ sodium f’ kull kunjett.
HOW TO USE ALDURAZYME
KIF TUŻA ALDURAZYME
Instruction for use - dilution and administration The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals).
Struzzjonijiet għall- użu - dilwizzjoni u għoti Il- konċentrat għal soluzzjoni għall- infużjoni għandu jkun dilwit qabel l- għoti u hu għall- użu għal ġol- vini (ara l- informazzjoni għal professjonisti fil- qasam tas- saħħa).
Dosage The recommended dosage regimen of Aldurazyme is 100 U/ kg body weight given once every week as an intravenous infusion.
Dożaġġ Il- kors tad- dożaġġ rakkomandat ta ’ Aldurazyme hu ta ’ 100 U/ kg ta ’ piż tal- ġisem, mogħti darba kull ġimgħa bħala infużjoni ġol- vini.
The initial infusion rate of 2 U/ kg/ h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/ kg/ h.
Ir- rata inizjali ta ’ l- infużjoni ta ’ 2 U/ kg/ siegħa tista ’ tiżdied b’ mod gradwali kull ħmistax- il minuta, jekk tkun ittollerata, sa massimu ta ’ 43 U/ kg/ siegħa.
If you forget to use Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor.
Jekk tinsa tuża Aldurazyme Jekk tkun insejt tieħu infużjoni ta ’ Aldurazyme, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
If you use more Aldurazyme than you should No case of overdose of Aldurazyme has been reported.
Jekk tuża Aldurazyme aktar milli suppost L- ebda każ ta ’ doża eċċessiva b’ Aldurazymema ma kien irrappurtat.
Like all medicines, Aldurazyme can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aldurazyme jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects were mainly seen while patients were being given the medicine or shortly after (infusion- associated reactions).
L- effetti sekondarji kienu osservati primarjament waqt li l- pazjenti kienu qed jingħataw il- mediċina jew ftit wara (reazzjonijiet marbuta ma ’ l- infużjoni).
If you experience any reaction like this, please tell your doctor immediately.
Jekk ikollok xi reazzjoni bħal din, jekk jogħġbok għid lit- tabib tiegħek immedjatament.
The number of these reactions decreased the longer that patients were on Aldurazyme.
In- numru ta ’ dawn ir- reazzjonijiet naqas aktar ma l- pazjenti damu fuq Aldurazyme.
The majority of these reactions were mild or moderate in intensity.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet kienu ta ’ intensità ħafifa jew moderata.
However, a few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and swelling of the face.
Madankollu, ftit pazjenti li kellhom storja medika fil- passat ta ’ involviment tal- passaġġ ta ’ fuq tan- nifs u pulmonari marbut ma ’ MPS I, kellhom reazzjonijiet severi li jinkludu bronkospażmu, waqfien respiratorju, u nefħa fil- wiċċ.
In clinical trials the following side effects were reported:
21 Fil- provi kliniċi, l- effetti sekondarji li ġejjin kienu rrappurtati:
20 Very common (occurring in more than 1 in 10 patients) • headache • nausea • abdominal pain • rash • joint disease, joint pain, back pain, pain in arms or legs • flushing • fever • chills • increased heart rate • increased blood pressure • less oxygen in the blood • reaction at the infusion site
Komuni ħafna (li jseħħu f’ aktar minn 1 minn kull 10 pazjenti): • uġigħ ta ’ ras • tqalligħ • uġigħ addominali • raxx • mard fil- ġogi, uġigħ fil- gogi, uġigħ fid- dahar, uġigħ fid- dirgħajn jew fir- riġlejn • fwawar • deni • tertir • żieda fir- rata tat- taħbit tal- qalb • żieda fil- pressjoni tad- demm • inqas ossiġnu fid- demm • reazzjoni fis- sit ta ’ l- infużjoni
Common (occurring in more than 1 in 100 patients and less than 1 in 10 patients) • increased body temperature • tingling • dizziness • cough • difficulty in breathing which may be extreme • vomiting • diarrhoea • swelling of the face or neck • hives • itching • hair loss • cold sweat, heavy sweating • muscle pain • low blood pressure • paleness • cold hands or feet • feeling hot, feeling cold • fatigue • influenza like illness • allergic reaction • restlessness
Komuni (li jseħħu f’ aktar minn 1 minn kull 100 pazjent u f’ inqas minn 1 minn kull 10 pazjenti) • żieda fit- temperatura tal- ġisem • tnemnim • sturdament • sogħla • diffikultà biex tieħu n- nifs, li tista tkun estrema • rimettar • dijarea • nefħa tal- wiċċ jew ta ’ l- għonq • urtikarja • ħakk • telf ta ’ xagħar • għaraq kiesaħ, għaraq eċċessiv • uġigħ tal- muskoli • pressjoni tad- demm baxxa • sfura • idejn jew saqajn kesħin • tħoss is- sħana, tħoss il- ksieħ • għeja kbira • mard bħal dak ta ’ l- influwenza • reazzjoni allerġika • nuqqas ta ’ kwiet f’ ġismek
HOW TO STORE ALDURAZYME
KIF TAĦŻEN ALDURAZYME
Do not use Aldurazyme after the expiry date which is stated on the label after the letters EXP.
Tużax Aldurazyme wara d- data ta ’ skadenza li tidher fuq it- tikketta wara l- ittri JIS.
What Aldurazyme contains
X’ fih Aldurazyme
- The active substance is laronidase.
- Is- sustanza attiva hi laronidase.
One ml of the solution in the vial contains 100 U of
Millitru wieħed tas- soluzzjoni fil- kunjett fih 100 U ta ’ laronidase
Sodium chloride, Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80, Water for injections
heptahydrate, Polysorbate 80, Ilma għall- injezzjonijiet
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
Id- dehra ta ’ Aldurazyme u l- kontenuti tal- pakkett Aldurazyme hu fornut bħala konċentrat għal soluzzjoni għall- infużjoni.
It is a solution that is clear to slightly opalescent, and colourless to pale yellow.
Hu soluzzjoni ċara sa kemm kemm opalexxenti, u bla kulur jew isfar ċar.
1, 10 and 25 vials per carton.
1, 10 u 25 kunjett f’ kull kaxxa tal- kartun.
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, NL-1411 DD, Naarden, The Netherlands.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD, Naarden, l- Olanda.
22 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
23 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Deutschland Genzyme GmbH, Tel: +49 610236740
Deutschland Genzyme GmbH, Tel: +49 610236740 Ελλάδα/ Κύπρος Genzyme Hellas Ltd.
România Genzyme CEE GmbH- Reprezentanta pentru Romania Tel: +40 21 243 42 28
Portugal Genzyme Portugal, Tel: +351 21 422 0100 România Genzyme CEE GmbH - Reprezentanta pentru Romania Tel: +40 21 243 42 28
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Din il- mediċina kienet awtorizzata taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’ Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari, kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
23 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħrajn dwar mard 1H
< -------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
24 --------------------------------------------------------------------------------------------------------------------------- -- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter.
Hu rakkomandat li s- soluzzjoni dilwita ta ’ Aldurazyme tingħata lill - pazjenti permezz ta ’ sett ta ’ l- infużjoni mgħammar b’ filtru in- line ta ’ 0. 2 µm.
Aldurazyme should not be mixed with other medicinal products in the same infusion.
Alderazyme m’ għandux jitħallat ma ’ prodotti mediċinali oħra fl- istess infużjoni.
Preparation of the Aldurazyme Infusion (Use Aseptic Technique) Determine the number of vials to be diluted based on the individual patient's weight.
Preparazzjoni ta ’ l- Infużjoni ta ’ Aldurazyme (Uża t- Teknika Asettika) Iddeċiedi n- numru ta ’ kunjetti li trid tiddilwa, skond il- piż tal- pazjent individwali.
Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if bodyweight is less or equal than 20 kg) or 250 ml (if bodyweight is more than 20 kg) of 0.9% sodium chloride intravenous solution.
Iddeċiedi l- volum totali ta ’ infużjoni bbażat fuq il- piż tal- pazjent individwali, jew 100 ml (jekk il- piż tal- ġisem hu ta ’ 20 kg jew inqas) jew 250 ml (jekk il- piż tal- ġisem hu ta ’ iktar minn 20 kg) ta ’ soluzzjoni ġol- vini ta ’ 0. 9% ta ’ sodium chloride.
Withdraw and discard a volume of sodium chloride 9 mg/ ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Iġbed u armi volum tas- soluzzjoni għall- infużjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride mill - borża ta ’ l- infużjoni li jkun daqs il- volum totali ta ’ Aldurazyme li jrid jiġi miżjud.
What is Alimta?
X' inhu Alimta?
Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Alimta huwa trab li jiġi mħallat f' soluzzjoni għall- infużjoni (drip għal ġol- vina).
It contains the active substance pemetrexed.
Fih is- sustanza attiva pemetrexed.
What is Alimta used for?
Għal xiex jintuża Alimta?
Alimta is used to treat two types of cancer: • pleural mesothelioma (cancer of the lining of the lungs that is usually caused by exposure to asbestos).
Alimta jintuża biex jittratta żewġ tipi ta 'kanċer: • mesoteljoma plewrika (pleural mesothelioma - kanċer tar- rita tal- pulmuni li ġeneralment huwa kkaġunat minn espożizzjoni għall- asbestos).
Alimta is used together with cisplatin (another anticancer medicine) when the cancer is ‘ unresectable’ (cannot be removed by surgery alone) and ‘ malignant’ (has spread, or is likely to spread easily, to other parts of the body), in patients who have not received chemotherapy (medicines for cancer) before. • advanced or metastatic ‘ non-small cell’ lung cancer that is not affecting the ‘ squamous’ cells.
Alimta jintuża flimkien maċ- ċisplatin (cisplatin - mediċina oħra kontra l- kanċer) meta l- kanċer ma jkunx jista 'jinqata' (unresectable - ma jkunx jista 'jitneħħa permezz tal- kirurġija waħedha) u hu' malinn '(mifrux, jew x' aktarx jinfirex faċilment, għal partijiet oħra tal- ġisem), f' pazjenti li ma rċevewx kemjoterapija (mediċini għal kontra l - kanċer) qabel. • kanċer tal- pulmun mhux f' ċelluli żgħar fi stadju avvanzat jew metastatiku li mhuwiex qiegħed jolqot ċelluli' squamous '.
Alimta is used in combination with cisplatin in patients who have not been treated before, and on its own in patients who have received another type of chemotherapy in the past.
Alimta jintuża flimkien maċ- ċisplatin f' pazjenti li ma ġewx ttrattati qabel, u waħdu f' pazjenti li rċevew tip ieħor ta 'kemjoterapija fl- imgħoddi.
The medicine can only be obtained with a prescription.
Din il- mediċina tista 'tinkiseb biss permezz ta' riċetta ta 'tabib.
How is Alimta used?
Kif tintuża Alimta?
Alimta should only be given under the supervision of a doctor who is qualified in the use of anti-cancer chemotherapy.
Alimta għandu jingħata biss taħt is- superviżjoni ta 'tabib ikkwalifikat fl- użu ta' Alimta kontra l- kanċer.
The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient ’ s height and weight).
Id- doża ta 'Alimta rakkomandata hija 500 mg kull metru kwadru ta' l- erja tas- superfiċje tal- ġisem (ikkalkulata permezz ta 'l- użu tat- tul u l- piż tal- pazjent).
It is given once every three weeks as an intravenous infusion lasting 10 minutes.
Għandu jingħata darba kull tliet ġimgħat bħala infużjoni intravenuża li ddum 10 minuti.
To reduce side effects, patients should take a corticosteroid and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Biex jitnaqqsu l- effetti sekondarji, il- pazjenti għandhom jieħdu kortikosterojde u aċidu foliku (tip ta 'vitamina) u jirċievu injezzjonijiet ta' vitamina B12 waqt it- trattament b' Alimta.
When Alimta is given with cisplatin, an ‘ anti-emetic’ medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Meta Alimta jingħata maċ- ċisplatin, mediċina 'antiemetika' (biex timpedixxi r- remettar) jew ma 'xi fluwidi (biex jimpedixxu diżidratazzjoni), dawn ukoll għandhom jingħataw qabel jew wara d- doża ta' ċisplatin.
Treatment should be delayed or discontinued, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
It- trattament għandu jiġi ttardjat jew imwaqqaf, jew id- doża għandha titnaqqas, f' pazjenti li l- għadd tad- demm tagħhom huwa anomalu jew li għandhom ċerti effetti sekondarji oħra.
Alimta is not recommended for use in patients with moderate or severe kidney problems.
Alimta mhuwiex irrakkomandat f' pazjenti bi problemi tal- kliewi moderati jew gravi.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
Reproduction is authorised provided the source is acknowledged. pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘ nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells).
Is- sustanza attiva f' Alimta, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ- ċelluli li jkunu qed jiddividu, bħal ma huma ċelluli tal- kanċer), li jappartjenu għall- grupp ta '' antimetaboliti '.
As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Fil- ġisem, pemetrexed huwa maqlub f' forma attiva li timblokka l- attività ta 'l- enzimi li huma involuti fil - produzzjoni ta' 'nukleotidi' (l- elementi tal- bini tad- DNA u l- RNA, il- materjal ġenetiku taċ- ċelluli).
The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Il- bidla ta 'pemetrexed għall- forma attiva tiegħu sseħħ aktar malajr f' ċelluli tal- kanċer milli f' ċelluli normali, u dan iwassal għal livelli aktar għoljin tal- forma attiva tal- mediċina u tul ta' żmien ta 'azzjoni itwal f' ċelluli tal- kanċer.
This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Dan jirriżulta fit- tnaqqis tad- diviżjoni taċ- ċelluli tal- kanċer, filwaqt li ċelluli normali jiġu biss ftit affettwati.
How has Alimta been studied?
Kif ġie studjat Alimta?
For the treatment of malignant pleural mesothelioma, Alimta has been studied in one main study in 456 patients who had not received chemotherapy for their disease before.
Għat- trattament ta 'mesoteljoma plewrika malinja, Alimta ġie studjat fi studju ewlieni fuq 456 pazjent li ma kinux irċevew kemjoterapija għall- marda tagħhom qabel.
The effects of Alimta in combination with cisplatin were compared with those of cisplatin alone.
L- effetti ta 'Alimta f' kombinazzjoni maċ- ċisplatin tqabblu ma' dawk taċ- ċisplatin waħdu.
For the treatment of non-small cell lung cancer, the effects of Alimta were compared with those of docetaxel (another anticancer medicine) in one study involving 571 patients with locally advanced or metastatic disease who had received chemotherapy in the past.
Għat- trattament ta 'kanċer tal- pulmun mhux f' ċelluli żgħar, l- effetti ta' Alimta tqabblu ma 'dawk ta' docetaxel (mediċina kontra l- kanċer oħra) fi studju li involva 571 pazjent b' mard lokali fi stadju avvanzat jew metastatiku li rċevew kemjoterapija fl- imgħoddi.
Alimta was also compared with gemcitabine (another anticancer medicine), both in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy for lung cancer in the past.
Alimta tqabbel ukoll mal- ġemċitabina (gemcitabine - mediċina oħra kontra l- kanċer), kemm flimkien maċ- ċisplatin, fi studju li involva 1, 725 pazjent li ma rċevux kemjoterapija għall- kanċer fil- pulmun fl- imgħoddi.
In all three studies, the main measure of effectiveness was how long the patients survived.
Fit- tliet studji, il- kejl ewlieni ta 'l- effikaċja kienet kemm damu jgħixu l- pazjenti.
What benefit has Alimta shown during the studies?
X' benefiċċju wera Alimta waqt l- istudji?
Alimta increased the survival time of patients with malignant pleural mesothelioma.
Alimta żied iż- żmien ta 'sopravivenza ta' pazjenti li jbatu minn mesoteljoma plewrika malinja.
Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
Pazjenti li kienu qed jirċievu Alimta u ċisplatin għexu għal medja ta '12. 1 xahar, meta mqabbla ma' 9. 3 xhur f' dawk li kienu qed jirċievu ċisplatin waħdu.
In the treatment of patients with non-small cell lung cancer, Alimta was as effective as the comparators.
Fit- trattament ta 'pazjenti b' kanċer tal- pulmun mhux f' ċelluli żgħar, Alimta kien effikaċi daqs il- mezzi li tqabbel magħhom.
In patients who had received chemotherapy in the past, the average survival time was 8.3 months with Alimta, compared with 7.9 months with docetaxel.
Fil- pazjenti li fl- imgħoddi rċevew il- kemjoterapija, iż- żmien ta 'sopravivenza medju kien ta' 8. 3 xhur b' Alimta, meta mqabbel ma '7. 9 xhur b' docetaxel.
In patients who had not received chemotherapy in the past, the average survival time was 10.3 months in both groups.
Fil- pazjenti li fl- imgħoddi ma rċevux il- kemjoterapija, iż- żmien ta 'sopravivenza medju kien ta' 10. 3 xhur fiż- żewġ gruppi.
However, in both studies, patients whose cancer was not affecting squamous cells had longer survival times if they received Alimta than if they received the comparator.
Madankollu, fiż- żewġ studji, il- pazjenti bil- kanċer li ma kienx qiegħed jolqot iċ- ċelluli 'squamous' kellhom żmien ta 'sopravivenza itwal f' każ li kienu rċevew Alimta milli kieku rċevew mezz li miegħu tqabbel Alimta.
In contrast, patients whose cancer was affecting squamous cells had had shorter survival times if they received Alimta.
F' kuntrast ma 'dan, il- pazjenti li l- kanċer tagħhom kien qiegħed jolqot iċ- ċelluli' squamous 'kellhom żmien ta' sopravivenza iqsar milli kieku rċevew Alimta.
What is the risk associated with Alimta?
X' inhu r- riskju assoċjat ma' Alimta?
The most common side effects with Alimta (seen in more than 1 patient in 10) are decreased levels of neutrophils or granulocytes and of leucocytes (types of white blood cell), decreased levels of haemoglobin (the protein found in red blood cells that carries oxygen around the body), diarrhoea, vomiting, stomatitis or pharyngitis (inflammation of the lining of the mouth or throat), nausea (feeling sick), anorexia (loss of appetite), fatigue (tiredness), and rash or desquamation (shedding of the upper layers of the skin).
L- aktar effetti sekondarji komuni b' Alimta (dehru f' aktar minn pazjent 1 minn kull 10) huma livelli mnaqqsa ta 'newtrofili jew granuloċiti u ta' lewkoċiti (tipi ta 'ċelluli bojod tad- demm), livelli mnaqqsa ta' emoglobina (il- proteina li tinsab fiċ- ċelluli ħomor tad- demm li ġġorr l- ossiġenu madwar il- ġisem), dijarrea, remettar, stomatite jew farinġite (infjammazzjoni tal- mukuża tal- ħalq jew tal- gerżuma), nawżea (dardir), anoressija (telf ta 'aptit), għeja kbira, u raxx jew deskwamazzjoni (qxur tas- saffi ta' fuq tal- ġilda).
For the full list of all side effects reported with Alimta, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha irrapportati b' Alimta, ara l- Fuljett ta' Tagħrif.
Alimta should not be used in people who may be hypersensitive (allergic) to pemetrexed or any of the other ingredients.
Alimta ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal pemetrexed jew għal xi sustanzi oħra.
It should not be used during breast feeding or at the same time as the vaccine for yellow fever.
Ma għandux jintuża waqt it- treddigħ jew fl- istess waqt tal- vaċċin għad- deni isfar.
Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Alimta jaffettwa l- fertilità, għalhekk kemm l- irġiel kif ukoll in- nisa li jirċivuha jeħtieġ li jkunu konsapevoli ta 'dan.
Why has Alimta been approved?
Għaliex ġiet approvata Alimta?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Alimta’ s benefits are greater than its risks in combination with cisplatin for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma, and in combination with cisplatin for the first line treatment and as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- bniedem (CHMP) ikkonkluda li l- benefiċċji ta 'l - Alimta huma akbar mir- riskji tagħha f' kombinazzjoni maċ- ċisplatin għat- trattament ta' pazjenti li qatt ma ġew ittrattati qabel bil- kemjoterapija li jbatu minn mesoteljoma plewrika malinja ma tkunx tista 'tinqata', u f' kombinazzjoni maċ- ċisplatin għat- trattament ta 'l- ewwel linja u bħala monoterapija għat - trattament tat- tieni linja għal pazjenti b' kanċer tal- pulmun mhux f' ċelluli żgħar lokalment avvanzat jew metastatiku li mhuwiex predominantement l- istoloġija taċ- ċelluli' squamous '.
The Committee recommended that Alimta be given marketing authorisation.
Il- Kumitat irrakkomanda li Alimta jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Alimta:
2/ 3 Tagħrif ieħor dwar Alimta:
The European Commission granted a marketing authorisation valid throughout the European Union for Alimta to Eli Lilly Nederland B. V. on 20 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Alimta lil Eli Lilly Nederland B. V. fl- 20 ta 'Settembru 2004.
The full EPAR for Alimta can be found here.
L- EPAR sħiħ għal Alimta jista 'jiġi kkonsultat hawn.
EU Number EU/ 1/ 04/ 290/ 001 EU/ 1/ 04/ 290/ 002
Numru ta ’ l- EU EU/ 1/ 04/ 290/ 001 EU/ 1/ 04/ 290/ 002
Invented name Alimta Alimta
Isem inventat Alimta Alimta
Strength 500 mg 100 mg
Qawwa 500 mg 100 mg
Pharmaceutical Form Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion
Għamla farmaċewtika Trab għal konċentrat għal soluzzjoni għall- infużjoni Trab għal konċentrat għal soluzzjoni għall- infużjoni
Route of Administration Intravenous use Intravenous use
Mnejn jingħata Użu għal ġol- vini Użu għal ġol- vini
Packaging vial (glass) vial (glass)
Il- pakkett Kunjett (ħġieġ) Kunjett (ħġieġ)
Package size 1 vial 1 vial
Daqs tal- pakkett Kunjett 1 Kunjett 1
ALIMTA 100 mg powder for concentrate for solution for infusion
ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall- infużjoni
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Kull kunjett fih 100 mg ta ’ pemetrexed (bħala pemexetred disodium).
Each vial must be reconstituted with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection resulting in 25 mg/ ml of solution.
Kull kunjett għandu jkun rikostitwit ma ’ 4. 2 ml soluzzjoni għall- injezzjoni ta ’ 9mg/ ml (0. 9%) sodium chloride li jirriżulta f’ soluzzjoni ta ’ 25 mg/ ml.
The appropriate volume of required dose is removed from the vial and further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection (see section 6.6.).
Il- volum xieraq tad- doża meħtieġa jitneħħa mill- kunjett u jkompli jiġi dilwit sa 100 ml b’ soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml( 0. 9%) sodium chloride (ara sezzjoni 6. 6).
Powder for concentrate for solution for infusion.
Trab għal konċentrat għal soluzzjoni għall- infużjoni.
A white to either light yellow or green-yellow lyophilised powder.
Trab lajofilizzat bejn abjad u isfar ċar jew isfar ħadrani.
ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Mesoteljoma Plewrali Malinna ALIMTA flimkien ma ’ cisplatin hu indikat fil- kura ta ’ pazjenti li għadhom ma rċevew ebda tip ta ’ kimoterapija u li għandhom mesoteljoma plewrali malinna li ma tistax titneħħa kirurġikament.
ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Kanċer tal- pulmun mhux b' ċelluli żgħar ALIMTA flimkien ma ’ cisplatin hu indikat bħala l- ewwel linja ta ’ kura f' pazjenti li għandhom kanċer tal- pulmun mhux b' ċelluli żgħar u li jkun lokalment avanzat jew metastatiku.
ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Dan ħlief meta l- istoloġija turi li fil - biċċa l- kbira ċ- ċelluli jkunu tat- tip squamous (ara sezzjoni 5. 1).
ALIMTA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
ALIMTA għandu jingħata biss bis- superviżjoni ta ’ tabib ikkwalifikat fl- użu tal- kimoterapija kontra l - kanċer.
The ALIMTA solution must be prepared according to the instructions provided in section 6.6.
Is- soluzzjoni ta ’ ALIMTA għandha titħejja skond l- istruzzjonijiet li jidhru f’ sezzjoni 6. 6.
The recommended dose of ALIMTA is 500 mg/ m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
ALIMTA flimkien ma 'cisplatin: Id- doża rakkomandata ta ’ ALIMTA hi ta ’ 500 mg/ m2 ta ’ l- erja tas - superfiċje tal- ġisem (BSA) mogħtija bħala infużjoni minn ġol- vina fuq perijodu ta ’ 10 minuti fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 21 ġurnata.
The recommended dose of cisplatin is 75 mg/ m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Id- doża rakkomandata ta ’ cisplatin hi ta ’ 75 mg/ m2 BSA infuża fuq perijodu ta ’ sagħtejn madwar 30 minuta wara li tkun saret l- infużjoni ta ’ pemetrexed fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 21 ġurnata.
Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/ or after receiving cisplatin (See also cisplatin Summary of Product Characteristics for specific dosing advice).
Il- pazjenti għandhom jirċievu kura anti- emetika adegwata u idratazzjoni xierqa qabel u/ jew wara li jieħdu cisplatin (ara wkoll is- Sommarju tal- Karatteristiċi ta ’ cisplatin għal pariri speċifiċi dwar id- doża).
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of ALIMTA is 500 mg/ m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
2 ALIMTA mogħti waħdu: F’ pazjenti kkurati għall- kanċer tal- pulmun mhux b’ ċelluli żgħar wara kimoterapija preċedenti, id- doża rakkomandata ta ’ ALIMTA hi ta ’ 500 mg/ m2 BSA mogħtija b’ infużjoni minn ġol- vina fuq perijodu ta ’ 10 minuti fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 21 ġurnata.
Premedication regimen:
Proceduri ta ’ qabel il- medikazzjoni:
To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Biex tonqos l- inċidenza u l- gravità ta ’ reazzjonijiet fil- ġilda, għandu jingħata kortikosterojd il- ġurnata ta ’ qabel, dakinhar, u l- għada ta ’ l- għoti ta ’ pemetrexed.
The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Il- kortikosterojd għandu jkun ekwivalenti għal 4mg ta ’ dexamethasone meħud b’ mod orali darbtejn kuljum (ara sezzjoni 4. 4).
To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section 4.4).
Biex tonqos it- tossiċità, il- pazjenti kkurati b’ pemetrexed għandu jingħatawlhom ukoll supplimenti ta ’ vitamini (ara sezzjoni 4. 4).
Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Il- pazjenti għandhom jieħdu b’ mod orali folic acid jew xi prodott multivitaminiku li jkun fih folic acid (minn 350 sa 1, 000 mikrogramma) kuljum.
At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Għandhom jieħdu mill- inqas ħames dożi ta ’ folic acid matul is- sebat ijiem qabel tingħatalhom l- ewwel doża ta ’ pemetrexed, u dan is- suppliment għandhom jibqgħu jieħduh matul il- kors kollu ta ’ terapija u għal 21 ġurnata wara li jieħdu l- aħħar doża ta ’ pemetrexed.
Patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Il- pazjenti għandhom jirċievu wkoll injezzjoni intramuskolari ta ’ vitamina B12 (1, 000 mikrogramma) matul il- ġimgħa ta ’ qabel ma jieħdu l- ewwel doża ta ’ pemetrexed u mbagħad darba kull tliet ċikli.
Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
L- injezzjonijiet sussegwenti ta ’ vitamina B12 jistgħu jingħataw fl- istess ġurnata meta jingħata pemetrexed.
Monitoring:
Il- Monitoraġġ:
Patients receiving pemetrexed should be monitored before each dose with a complete blood count, including a differential white cell count (WCC) and platelet count.
Il- pazjenti li jirċievu pemetrexed għandhom ikunu monitorjati qabel kull doża permezz ta ’ l- għadd sħiħ taċ- ċelluli tad- demm, inkluż l- għadd taċ- ċelluli bojod differenzjat (WCC) u l- għadd tal- plejtlits.
Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Qabel l- għoti ta ’ kull kimoterapija għandhom jinġabru t- testijiet kimiċi tad- demm biex tkun evalwata l- funzjoni tal- kliewi u tal- fwied.
Absolute Neutrophil Count (ANC) should be ≥ 1500 cells/ mm3 and platelets should be ≥ 100,000 cells/ mm3.
Qabel ma jibda kull ċiklu ta ’ kimoterapija, il- pazjenti jeħtieġ ikollhom dan li ġej: l- Għadd Assolut ta ’ Newtrofili (ANC) għandu jkun ta ’ ≥ 1500 celluli/ mm3 u l - plejtlits għandhom ikunu ≥ 100, 000 ċelluli/ mm3.
Creatinine clearance should be ≥ 45 ml/ min.
It- tneħħija tal- krejatinina għandha tkun ta ’ ≥ 45 ml/ min.
The total bilirubin should be ≤ 1.5 times upper limit of normal.
It- total ta ’ bilirubina għandu jkun ≤ 1. 5 darbiet il- limitu massimu tan- normal.
Alkaline phosphatase, AST and ALT ≤ 5 times upper limit of normal is acceptable if liver has tumour involvement.
L - alkaline phosphatase (AP), l - aspartate transaminase (AST jew SGOT) u l - alanine transaminase (ALT jew SGPT) għandhom ikunu ≤ 3 darbiet il- limitu massimu tan- normal. Alkaline Phosphatase, AST u ALT ≤ 5 darbiet il- limitu massimu tan- normal hu aċċettabbli jekk il- fwied ikun sit ta ’ metastasi f’ każ ta ’ tumur.
Dose Adjustments:
Aġġustamenti tad- doża:
Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic toxicity from the preceding cycle of therapy.
L- aġġustament tad- doża fil- bidu ta ’ kull ċiklu sussegwenti għandu jkun ibbażat fuq l- għadd ematoloġiku l- iktar baxx jew fuq l- ogħla tossiċità li mhijiex ematoloġika taċ- ċiklu terapewtiku ta ’ qabel.
Treatment may be delayed to allow sufficient time for recovery.
Il- kura tista ’ tiġi ittardjata biex il- pazjent ikollu żmien biex jirkupra.
Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for ALIMTA used as a single agent or in combination with cisplatin.
Meta jirkupra, il- pazjent għandu jerġa ’ jingħatalu l- kura skond il- linji gwida fit- Tabelli 1, 2 u 3, li japplikaw kemm meta ALIMTA jintuża bħala sustanza waħdenija kif ukoll meta jintuża flimkien ma ’ cisplatin.
Table 1 - Dose Modification Table for ALIMTA (as single agent or in combination) AND Cisplatin – Haematologic Toxicities
TABELLA 1 – Tabella Għall- Modifikazzjoni Fid- Doża ta ’ ALIMTA (bħala sustanza waħdenija jew f’ terapija kombinata) U Cisplatin – Tossiċitajiet Ematoloġiċi
Nadir ANC < 500 / mm3 and nadir platelets ≥ 50,000 / mm3 Nadir platelets < 50,000 / mm3 regardless of nadir ANC Nadir platelets < 50,000/ mm3 with bleedinga, regardless of nadir ANC. a
L- għadd l- iktar baxx ta ’ ANC < 500 / mm3 u l - għadd l- iktar baxx ta ’ plejtlits ≥ 50, 000 / mm3
75% of previous dose (both ALIMTA and cisplatin).
75% tad- doża ta ’ qabel (kemm ALIMTA kif ukoll cisplatin).
75% of previous dose (both ALIMTA and cisplatin).
L- għadd l- iktar baxx ta ’ plejtlits < 50, 000 / mm 75% tad- doża ta ’ qabel (kemm ALIMTA kif
50% of previous dose (both drugs).
hu x’ inhu l- għadd l- iktar baxx ta ’ ANC
These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding
L- għadd l- iktar baxx ta ’ plejtlits < 50, 000 / mm3 50% tad- doża ta ’ qabel (iż- żewġ mediċini). bi fsadaa, hu x’ inhu l- għadd l- iktar baxx ta ’ ANC a Dawn il- kriterji jissodisfaw id- definizzjoni ta '≥CTC Grad 2 ta' fsada tal- Kriterji ta 'Tossiċità Komuni (CTC) ta' l- Istitut Nazzjonali tal- Kanċer (CTC v2. 0; NCI 1998).
If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), ALIMTA should be withheld until resolution to less than or equal to the patient’ s pre-therapy value.
Jekk il- pazjenti jiżviluppaw tossiċitajiet li mhumiex ematoloġiċi ≥ Grad 3 (barra n- newrotossiċità), ALIMTA m’ għandux jingħata sakemm il- valur jerġa jkun inqas jew ugwali għal dak li l- pazjent kellu qabel ma bdiet it- terapija.
Treatment should be resumed according to the guidelines in Table 2.
Il- kura għandha titkompla skond il- linji gwida f’ Tabella 2.
3 Table 2 - Dose Modification Table for ALIMTA (as single agent or in combination) and Cisplatin– Non-haematologic Toxicities a, b
3 TABELLA 2 – Tabella Għall- Modifikazzjoni Fid- Doża ta ’ ALIMTA (bħala sustanza waħdenija jew f’ terapija kombinata) u Cisplatin – Tossiċitajiet li mhumiex ematoloġiċia, b Doża ta ’ cisplatin (mg/ m2) Doża ta ’ ALIMTA 2 (mg/ m)
Any Grade 3 or 4 toxicities except mucositis
Kull tossiċità ta ’ Grad 3 jew 4 minbarra mukożite
75% of previous dose
75% tad- doża ta ’ qabel
Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea.
Kull dijarrea li teħtieġ kura fi sptar (irrispettivament mill- grad) jew dijarrea ta ’ Grad 3 jew 4
Grade 3 or 4 mucositis a
Mukożite ta ’ Grad 3 jew 4 a
50% of previous dose
50% tad- doża ta ’ qabel
100% of previous dose b
100% tad- doża ta ’ qabel
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Kriterji ta ’ Tossiċità Komuni ta 'l- Istitut Nazzjonali tal- Kanċer (CTC; v2. 0; NCI 1998) b Minbarra n- newrotossiċità
In the event of neurotoxicity, the recommended dose adjustment for ALIMTA and cisplatin is documented in Table 3.
Fil- każ ta ’ newrotossiċità, l- aġġustament tad- doża rakkomandat għal ALIMTA u cisplatin hu dokumentat f’ Tabella 3.
Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
Il- pazjenti m’ għandhomx ikomplu bit- terapija jekk tkun osservata newrotossiċità ta ’ Grad 3 jew 4.
Table 3 - Dose Modification for ALIMTA (as single agent or in combination) and Cisplatin – Neurotoxicity
TABELLA 3 – Modifikazzjoni fid- Doża ta ’ ALIMTA (bħala sustanza waħdenija jew f’ terapija kombinata) u Cisplatin - Newrotossiċità
CTC a Grade
Grad CTCa
Dose of ALIMTA (mg/ m2)
Doża ta ’ ALIMTA (mg/ m2)
Dose for cisplatin (mg/ m2)
Doża ta ’ cisplatin (mg/ m2)
100% of previous dose
100% tad- doża ta ’ qabel
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Kriterji ta ’ Tossiċità Komuni ta 'l- Istitut Nazzjonali tal- Kanċer (CTC; v2. 0; NCI 1998)
Treatment with ALIMTA should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 doses reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Il- kura b’ ALIMTA għandha titwaqqaf jekk il- pazjent ikollu xi tossiċità ematoloġika jew tossiċità li mhijiex ematoloġika ta ’ Grad 3 jew 4 wara li d- doza tkun tnaqqset darbtejnjew minnufih jekk tkun osservata newrotossiċità ta ’ Grad 3 jew 4.
In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Fi studji kliniċi, ma kienx hemm indikazzjoni li pazjenti ta ’ 65 sena jew aktar għandhom riskju akbar ta ’ każijiet avversi meta mqabbla ma ’ pazjenti li għandhom inqas minn 65 sena.
No dose reductions other than those recommended for all patients are necessary.
Mhux meħtieġ li titnaqqas id- doża ħlief f’ dawk il- każijiet li huma rakkomandati għall- pazjenti kollha.
ALIMTA is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.
ALIMTA mhux rakkomandat biex jintuża f’ pazjenti ta ’ taħt it- 18- il sena, minħabba li m’ hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja.