natgillin/translations-raw huggingface dataset:
Caspofungin also has in vitro activity against Candida species (Candida albicans [N = 1,032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
In vitro je kaspofungin učinkovit tudi proti Candida sp. (Candida albicans n = 1.032, Candida dubliniensis n = 100, Candida glabrata n = 151, Candida guilliermondii n = 67, Candida kefyr n = 62, Candida krusei n = 147, Candida lipolytica n = 20, Candida lusitaniae n = 80, Candida parapsilosis n = 215, Candida rugosa n = 1 in Candida tropicalis n = 258, vključno z izolati s prenosnimi mutacijami, ki so odgovorne za odpornost proti številnim antibiotikom, in tistimi s pridobljeno ali intrinzično odpornostjo proti flukonazolu, amfotericinu B in 5-flucitozinu.
* 10.5 ml should be used for reconstitution of all vials.
*Za rekonstitucijo vseh vial je treba uporabiti 10,5 ml vehikla.
Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day.
Zdravnik bo določil trajanje zdravljenja in dnevni odmerek zdravila Cancidas.
Cancidas makes fungal cells fragile and stops the fungus from growing properly.
Zdravilo Cancidas povzroča krhkost glivnih celic in ustavi pravilno rast gliv.
In a double-blind, randomized (2:1) comparator-controlled study safety, tolerability and efficacy of caspofungin (2 mg/kg/d intravenously, infused over 2 hours) vs amphotericin B deoxycholate (1 mg/kg/d) was evaluated in neonates and infants less than 3 months of age with (culture-confirmed) invasive candidiasis.
V dvojno slepi, randomizirani (2:1), primerjalni nadzorovani študiji so ocenjevali varnost, prenašanje in učinkovitost kaspofungina (2 mg/kg/dan intravensko, infundiran v 2 urah) v primerjavi z amfotericin B deoksiholatom (1 mg/kg/dan) pri novorojenčkih in dojenčkih, mlajših od 3 mesecev, z invazivno kandidiazo (potrjena kultura).
The overall success rates in the MITT analysis results, adjusted by risk strata, were as follows: 46.6 % (26/56) for caspofungin and 32.2 % (8/25) for liposomal amphotericin B.
Celotna deleža uspeha po rezultatih MITT analize, prilagojenih glede na stratume tveganja, sta bila: 46,6 % (26/56) za kaspofungin in 32,2 % (8/25) za liposomski amfotericin B.
Isolates of Candida with reduced susceptibility to caspofungin have been identified in a small number of patients during treatment (MICs for caspofungin >2 mg/L (4- to 30-fold MIC increases) have been reported using standardized MIC testing techniques approved by the CLSI).
Pri manjšem številu bolnikov so med zdravljenjem odkrili izolate vrste Candida z zmanjšano občutljivostjo za kaspofungin (poročali so o MIC za kaspofungin > 2 mg/l (4-do 30-kratno povečanje MIC), pri čemer so uporabili standardizirane tehnike za testiranje MIC, odobrene s strani CLSI).
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Pustite, da se ohlajena viala z zdravilom CANCIDAS ogreje na sobno temperaturo.
However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/ml, range 2.63 to 22.05 µg/ml) and C24 hr (Day 4 geometric mean 3.55 µg/ml, range 0.13 to 7.17 µg/ml).
Vendar pa je bila variabilnost opazna tako pri C1 h (geometrična sredina 4. dan 11,73 µg/ml, razpon od 2,63 do 22,05 µg/ml) kot pri C24 h (geometrična sredina 4. dan 3,55 µg/ml, razpon od 0,13 do 7,17 µg/ml).
For adult patients with mild hepatic impairment (Child-Pugh score 5 to 6), no dosage adjustment is needed.
Pri odraslih bolnikih z blago jetrno okvaro (stopnja Child-Pugh 5 do 6 točk) prilagoditev odmerka ni potrebna.
The proportion of patients with fungal-free survival at 2 weeks post-therapy in the caspofungin treatment group (71.0 %) was similar to that seen in the amphotericin B deoxycholate treatment group (68.8 %).
Delež bolnikov s preživetjem brez gliv pri 2 tednih po zdravljenju je bil v skupini, ki je prejemala kaspofungin (71,0 %), podoben kot v skupini z amfotericin B deoksiholatom (68,8 %).
Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration
Standardna priprava (koncentrat zdravila CANCIDAS dodan v 250 ml) končna koncentracija
What Cancidas looks like and contents of the pack Cancidas is a sterile, white to off-white compact powder.
Izgled zdravila Cancidas in vsebina pakiranja Zdravilo Cancidas je sterilen, bel do skoraj bel, kompakten prašek.
Talk to your doctor, nurse or pharmacist before you are given Cancidas if:
Posvetujte se z zdravnikom, medicinsko sestro ali farmacevtom, preden dobite zdravilo Cancidas:
• Sensation of fast or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• občutek hitrega ali nepravilnega utripanja srca, pospešen srčni utrip, nepravilen srčni utrip, nenormalni srčni ritem, srčno popuščanje
To reconstitute the powder, bring the vial to room temperature and aseptically add 10.5 ml of water for injection.
Za pripravo koncentrata prenesite vialo na sobno temperaturo in vanjo aseptično dodajte 10,5 ml vode za injekcije.
**If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials.
**Če viale po 70 mg ni na voljo, lahko odmerek 70 mg pripravimo iz dveh vial po 50 mg.
Renal impairment: In a clinical study of single 70 mg doses, caspofungin pharmacokinetics were similar in adult volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and control subjects.
Okvara ledvic: V klinični študiji enkratnih 70 mg odmerkov je bila farmakokinetika kaspofungina pri odraslih prostovoljcih z blago ledvično okvaro (kreatininski očistek 50 do 80 ml/min) podobna kot pri kontrolnih preiskovancih.
• Women given Cancidas should not breast-feed.
• Ženske, ki uporabljajo zdravilo Cancidas, ne smejo dojiti.
Susceptibility testing was performed according to a modification of both the Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) method M38-A2 (for Aspergillus species) and method M27-A3 (for Candida species).
Testiranje občutljivosti je bilo izvedeno po modifikaciji metode M38A2 (za Aspergillus sp.) kot tudi metode M27-A3 (za Candida sp.) Inštituta za klinične in laboratorijske standarde (CLSI, prej znanega pod imenom Nacionalni odbor za klinične laboratorijske standarde [National Committee for Clinical Laboratory Standard - NCCLS]).
Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injection.
Stabilnostni podatki kažejo, da koncentrat za pripravo raztopine za infundiranje, ki smo ga pripravili z vodo za injekcije, lahko shranjujemo do 24 ur pri temperaturi 25 °C ali manj.
b This will give a final caspofungin concentration in the vial of
b Končna koncentracija kaspofungina v viali bo tako
Instructions of how to reconstitute and dilute CANCIDAS:
Navodilo za pripravo in razredčevanje zdravila CANCIDAS:
In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has been observed.
V omejenih kliničnih izkušnjah so pri bolnikih z invazivno aspergilozo opazili odpornost proti kaspofunginu.
The favourable response rate, by indication, at the end of caspofungin therapy was as follows in the MITT analysis: 81 % (30/37) in invasive candidiasis, 50 % (5/10) in invasive aspergillosis, and 100 % (1/1) in oesophageal candidiasis.
Deleži ugodnega odziva za posamezno indikacijo so bili na koncu zdravljenja s kaspofunginom v analizi MITT naslednji: 81 % (30/37) pri invazivni kandidiazi, 50 % (5/10) pri invazivni aspergilozi in 100 % (1/1) pri ezofagealni kandidiazi.
If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.
Če kaj od zgoraj naštetega velja za vas (ali pa niste prepričani), se pogovorite z zdravnikom, medicinsko sestro ali farmacevtom, preden dobite zdravilo Cancidas.
How Cancidas works
Kako zdravilo Cancidas deluje
Unopened vials: store in a refrigerator (2°C - 8°C).
Neodprte viale: shranjujte v hladilniku (2 C - 8 C).
For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), caspofungin 35 mg daily is recommended based upon pharmacokinetic data.
Pri odraslih bolnikih z zmerno jetrno okvaro (stopnja Child-Pugh 7 do 9 točk) glede na farmakokinetične podatke priporočamo kaspofungin v odmerku 35 mg dnevno.
CANCIDAS contains no preservatives.
Zdravilo CANCIDAS ne vsebuje konzervansov.
• Itching at the injection site.
• srbenje na mestu injiciranja
Eligible patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation, and presented with neutropaenia (<500 cells/mm
Za študijo ustrezni bolniki so dobivali kemoterapijo zaradi malignoma ali so prestali presaditev hematopoetskih matičnih celic ter so imeli nevtropenijo (< 500 celic/mm
Moderate (creatinine clearance 31 to 49 ml/min), advanced (creatinine clearance 5 to 30 ml/min), and end-stage (creatinine clearance <10 ml/min and dialysis dependent) renal impairment moderately increased caspofungin plasma concentrations after single-dose administration (range: 30 to 49 % for AUC).
Zaradi zmerne okvare (kreatininski očistek 31 do 49 ml/min), napredovale okvare (kreatininski očistek 5 do 30 ml/min) in končne ledvične odpovedi (kreatininski očistek < 10 ml/min in na dializi) se je plazemska koncentracija kaspofungina po enem odmerku zmerno povečala (razpon: za 30 do 49 % AUC).
Laboratories Merck Sharp & Dohme- Chibret, Route de Marsat-RIOM, 63963 Clermont-Ferrand Cedex 9, France
Laboratories Merck Sharp & Dohme- Chibret, Route de Marsat-RIOM, 63963 Clermont-Ferrand Cedex 9, Francija
Renal impairment No dosage adjustment is necessary based on renal impairment (see section 5.2).
Okvara ledvic Prilagoditev odmerka glede na ledvično okvaro ni potrebna (glejte poglavje 5.2).
Excipients with known effect: Each 50 mg vial contains 35.7 mg of sucrose.
Pomožne snovi z znanim učinkom: Ena 50 mg viala vsebuje 35,7 mg saharoze.
The concentrations of the reconstituted vials will be 5.2 mg/ml.
Koncentracija pripravljenega koncentrata bo 5,2 mg/ml.
Psychiatric disorders anxiety, disorientation, insomnia
Psihiatrične motnje anksioznost, zmedenost, nespečnost
Laboratories Merck Sharp & Dohme- Chibret Route de Marsat-RIOM 63963 Clermont-Ferrand Cedex 9 France
Laboratories Merck Sharp & Dohme- Chibret Route de Marsat-RIOM 63963 Clermont-Ferrand Cedex 9 Francija
Common (≥1/100 to
(≥ 1/100 do
50 mg at reduced volume
50 mg / zmanjšana prostornina infuzije
If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor, nurse or pharmacist before you are given this medicine.
Če vam je zdravnik povedal, da ne prenašate ali prebavljate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
Pediatrični bolniki (stari od 12 mesecev do 17 let) Pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) je treba odmerjanje določiti glede na bolnikovo telesno površino (glejte Navodila za uporabo pri pediatričnih bolnikih, Mostellerjeva formula).
There is no clinical experience in adult patients with severe hepatic impairment and in paediatric patients with any degree of hepatic impairment.
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih s katero koli stopnjo jetrne okvare ni.
• The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide (please see section 2.
• Druge sestavine zdravila so: saharoza, manitol, koncentrirana ocetna kislina (ledocet) in natrijev hidroksid (prosimo, glejte Poglavje 2 Kaj morate vedeti preden boste uporabili zdravilo Cancidas).
50-mg/m daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m 2 daily (not to exceed an actual daily dose of 70 mg).
Če bolnik dnevni odmerek 50 mg/m 2 dobro prenaša, vendar ta odmerek ne prinese ustreznega kliničnega odziva, je mogoče dnevni odmerek povečati na 70 mg/m 2 na dan (pri čemer absolutni dnevni odmerek ne sme preseči 70 mg).
Hepatobiliary disorders elevated liver values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase, bilirubin conjugated, blood bilirubin)
Bolezni jeter, žolčnika in žolčevodov zvišane vrednosti jetrnih testov (alanin aminotransferaze, aspartat aminotransferaze, alkalne fosfataze v krvi, konjugiranega bilirubina, bilirubina v krvi)
Excipients with known effect Each 70 mg vial contains 50.0 mg of sucrose.
Pomožne snovi z znanim učinkom: Ena 70 mg viala vsebuje 50,0 mg saharoze.
Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration
Infuzija z zmanjšano prostornino (koncentrat zdravila CANCIDAS dodan v 100 ml) končna koncentracija
This will give a final caspofungin concentration in the vial of
Končna koncentracija kaspofungina v viali bo tako
The concentrations of the reconstituted vials will be: 7.2 mg/ml.
Koncentracija pripravljenega koncentrata bo 7,2 mg/ml.
Cancidas contains a medicine called caspofungin.
Zdravilo Cancidas vsebuje učinkovino kaspofungin.
70 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
VIALA po 70 mg: PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Izračun telesne površine za pediatrično odmerjanje Pred pripravo infuzije izračunajte bolnikovo telesno površino po naslednji formuli (Mostellerjeva formula):
50 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
VIALA po 50 mg: PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
For all indications, a single 70-mg/m2 loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/m2 daily thereafter (not to exceed an actual dose of 70 mg daily).
Za vse indikacije je treba 1. dan uporabiti en uvajalni odmerek 70 mg/m2 (vendar absolutni odmerek ne sme preseči 70 mg), čemur sledi uporaba 50 mg/m 2 dnevno (pri čemer absolutni odmerek ne sme preseči 70 mg na dan).
An overall favourable response required meeting each of 5 criteria: (1) successful treatment of any baseline fungal infection (caspofungin 51.9 % [14/27], liposomal amphotericin B 25.9 % [7/27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8 % [527/556], liposomal amphotericin B 95.5 % [515/539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6 % [515/556], liposomal amphotericin B 89.2 % [481/539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7 % [499/556], liposomal amphotericin B 85.5 % [461/539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2 % [229/556], liposomal amphotericin B 41.4 % [223/539]).
liposomski amfotericin B 95,5 % [515/539]), (3) preživetje 7 dni po zaključku raziskovane terapije (kaspofungin 92,6 % [515/556], liposomski amfotericin B 89,2 % [481/539]), (4) brez prekinitve raziskovanega zdravila zaradi z njim povezane toksičnosti ali nezadostne učinkovitosti (kaspofungin 89,7 % [499/556], liposomski amfotericin B 85,5 % [461/539]), (5) izginotje zvišane telesne temperature med obdobjem nevtropenije (kaspofungin 41,2 % [229/556], liposomski amfotericin B 41,4 % [223/539]).
Sucrose, mannitol, glacial acetic acid and sodium hydroxide.
Saharoza, manitol, koncentrirana ocetna kislina (ledocet) in natrijev hidroksid.
The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis,
Druga študija je bila prospektivna, odprta, neprimerjalna študija varnosti in učinkovitosti kaspofungina pri pediatričnih bolnikih (starih od 6 mesecev do 17 let) z invazivno kandidiazo, ezofagealno kandidiazo in invazivno aspergilozo (kot rešilno zdravljenje).
a This reconstituted solution may be stored for up to 24 hours at or below 25°C.
Tako pripravljeno raztopino lahko shranite za največ 24 ur pri temperaturi 25 C ali manj.
• Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
• bolečina na mestu vstavljenega katetra, zapleti na mestu injiciranja (rdečina, otrdlina, bolečina, otekanje, draženje, izpuščaj, koprivnica, uhajanje tekočine iz katetra v tkivo), vnetje vene na mestu injiciranja
Remove the volume of medicinal product equal to the calculated daily maintenance dose (Step 1) from the vial.
Količino zdravila, ki ustreza izračunanemu dnevnemu vzdrževalnemu odmerku, potegnite iz viale (1. korak).
c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml.
c pripravljene raztopine zdravila CANCIDAS dodate zmanjšani količini 0,9 %, 0,45 % ali 0,225 % raztopine natrijevega klorida za injekcije ali raztopine Ringerjevega laktata, vendar končna koncentracija ne sme preseči 0,5 mg/ml.
Each vial contains: 70 mg caspofungin.
Ena viala vsebuje 70 mg kaspofungina.
Step 2 Addition of reconstituted CANCIDAS to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer's solution.
2. korak: Priprava končne raztopine zdravila CANCIDAS za infundiranje Vehikla za pripravo končne raztopine za infundiranje sta raztopina natrijevega klorida za injiciranje ali raztopina Ringerjevega laktata.
Uncommon: may affect up to 1 in 100 people:
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov:
What Cancidas is used for
Za kaj se uporablja zdravilo Cancidas
• If you have further questions, please ask your doctor, nurse or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
CANCIDAS 50 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with a red aluminium band.
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje 10 ml viala iz stekla tipa I s sivim zamaškom iz butilne gume in plastično zaporko z rdečim aluminijastim obročkom.
Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) for infusion, or lactated Ringer's solution.
Stabilnostni podatki kažejo, da raztopino, ki smo jo pripravili z raztopino natrijevega klorida za infundiranje 9 mg/ml (0,9 %), 4,5 mg/ml (0,45 %) ali 2,25 mg/ml (0,225 %) ali raztopino Ringerjevega laktata, lahko uporabimo v 24 urah, če smo jo shranjevali pri 25 °C ali manj, oziroma v 48 urah, če smo infuzijsko vrečo (steklenico) shranjevali na hladnem pri temperaturi 2 do 8 °C.
How to use Cancidas
Kako uporabljati zdravilo Cancidas
Each vial contains: 50 mg caspofungin.
Ena viala vsebuje 50 mg kaspofungina.
This is because it does not contain any ingredients to stop the growth of bacteria.
Ko je zdravilo Cancidas pripravljeno, ga je treba uporabiti takoj, ker ne vsebuje snovi, ki bi ustavile rast bakterij.
Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Bolezni kože in podkožja izpuščaj, srbenje, eritem, hiperhidroza multiformni eritem, makularni izpuščaj, makulopapulozni izpuščaj, srbeč izpuščaj, urtikarija, alergijski dermatitis, generalizirano srbenje, eritematozni izpuščaj, generalizirani izpuščaj, ošpicam podoben izpuščaj,
CANCIDAS 70 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with an orange aluminium band.
CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje 10 ml viala iz stekla tipa I s sivim zamaškom iz butilne gume in plastično zaporko z oranžnim aluminijastim obročkom.
Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Pediatrični bolniki: Pri mladostnikih (starih od 12 do 17 let), ki so dobivali kaspofungin v odmerku 50 mg/m2 na dan (največ 70 mg na dan) je bila AUC0-24h kaspofungina v plazmi na splošno primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan.
Reconstitution of CANCIDAS
Priprava zdravila CANCIDAS
c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
c pripravljene raztopine zdravila CANCIDAS aseptično prenesite v intravensko vrečko (ali steklenico), ki vsebuje 250 ml 0,9 %, 0,45 % ali 0,225 % raztopine natrijevega klorida za injekcije ali raztopine Ringerjevega laktata.
Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Količino zdravila, ki ustreza izračunanemu uvajalnemu odmerku, potegnite iz viale (1. korak).
This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C
24 urah, če je shranjena pri temperaturi 25 °C ali manj, ali v 48 urah, če je shranjena na hladnem pri temperaturi od 2 do 8 °C.
Glacial acetic acid Sodium hydroxide (to adjust the pH)
6.1 Seznam pomožnih snovi saharoza manitol koncentrirana ocetna kislina (ledocet) natrijev hidroksid (za uravnavanje pH)
c. CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.
c. Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (70 mg), če iz viale potegnete 10 ml.
General disorders and administration site conditions pyrexia, chills, infusion-site pruritus pain, catheter site pain, fatigue, feeling cold, feeling hot, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation,
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, mrzlica, srbenje na mestu infundiranja bolečina, bolečina na mestu vstavljenega katetra, utrujenost, občutek mraza, občutek vročine, eritem na mestu infundiranja, induracija na mestu infundiranja, bolečina na mestu infundiranja, oteklina na mestu infundiranja, flebitis na mestu injiciranja, periferni edem, občutljivost, nelagodje v prsnem košu, bolečina v prsnem košu, edem obraza, občutek spremembe telesne temperature, induracija, ekstravazacija na mestu infundiranja, draženje na mestu infundiranja, flebitis na mestu infundiranja, izpuščaj na mestu infundiranja, urtikarija na mestu infundiranja, eritem na mestu injiciranja, edem na mestu injiciranja, bolečina na mestu injiciranja, oteklina na mestu injiciranja, splošno slabo počutje, edem