FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)).
Croatian: Između bolesnika liječenih basiliksimabom i onih koji su primali placebo nije bilo značajne razlike glede preživljavanja presatka nakon 6 i 12 mjeseci (nakon 12 mjeseci 32 gubitka presatka s basiliksimabom (9%) i 37 gubitaka presatka s placebom (10%)).
English: Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Croatian: Odrasle osobe Standardna ukupna doza iznosi 40 mg, a daje se u dvije doze od po 20 mg.
English: The second dose should not be given if severe hypersensitivity reactions to Simulect or graft loss occur.
Croatian: Druga doza se ne smije primijeniti u slučaju teških reakcija preosjetljivosti na Simulect ili pojave gubitka presatka.
English: Other malignancies were reported among 1.0% (7/701) of patients in the basiliximab group compared with 1.2% (7/595) of placebo patients.
Croatian: Ostale zloćudne bolesti zabilježene su u 1,0% (7/701) bolesnika u skupini s basiliksimabom u odnosu na 1,2% (7/595) bolesnika koji su primili placebo.
English: This solvent is used to dissolve the powder before it is given to you.
Croatian: To otapalo se koristi za otapanje praška prije primjene.
English: These events were not influenced by basiliximab.
Croatian: Basiliksimab nije imao utjecaja na ove događaje.
English: Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Croatian: Farmakokinetičke studije provedene su s pojedinačnim i višekratnim dozama u odraslih bolesnika podvrgnutih presađivanju bubrega.
English: Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation.
Croatian: Rezultati dviju ključnih 12-mjesečnih multicentričnih studija (ukupno 722 bolesnika), u kojima je basiliksimab uspoređen s placebom, pokazuju da basiliksimab uz istovremenu primjenu ciklosporina u mikroemulziji i kortikosteroida, značajno smanjuje incidenciju akutnih epizoda odbacivanja unutar 6 (31% naspram 45%, p<0,001) i 12 (33% naspram 48%, p<0,001) mjeseci nakon presađivanja.
English: In a pooled analysis of two fiveyear extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/295) and placebo 7% (21/291) (see section 4.4).
Croatian: Objedinjena analiza dviju petogodišnjih proširenih studija pokazala je jednaku incidenciju limfoproliferativnih poremećaja i zloćudnih bolesti između basiliksimaba 7% (21/295) i placeba 7% (21/291) (vidjeti dio 4.4).
English: Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Croatian: Upotrijebiti odmah nakon rekonstitucije (kemijski i fizikalno stabilan 24 sata na temperaturama 2°C - 8°C ili 4 sata na sobnoj temperaturi).
English: INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
Croatian: UPUTE ZA REKONSTITUCIJU
English: There is no animal or human data available concerning excretion of basiliximab into breast milk.
Croatian: Nema podataka glede izlučivanja basiliksimaba u mlijeko životinja ili u majčino mlijeko.
English: A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric renal allograft recipients.
Croatian: Dvanaestomjesečna, randomizirana, placebom kontrolirana, dvostruko slijepa, multicentrična studija kojom se ocjenjivao basiliksimab u kombinaciji s ciklosporinom u mikroemulziji, mikofenolat mofetilom i steroidima u pedijatrijskih primatelja bubrežnog presatka.
English: The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs.  35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Croatian: Najčešće zabilježeni (>20%) štetni događaji nakon dvostruke terapije u obje (<35 kg naspram ≥35 kg tjelesne težine) kohorte bile su infekcija mokraćnog sustava, hipertrihoza, rinitis, vrućica, hipertenzija, infekcija gornjih dišnih puteva, virusna infekcija, sepsa i konstipacija.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I PRIMJENU
English: The first 20 mg dose should be given within 2 hours prior to transplantation surgery.
Croatian: Prvu dozu od 20 mg treba dati unutar 2 sata prije kirurškog presađivanja.
English: The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
Croatian: Prvu dozu treba dati unutar 2 sata prije kirurškog presađivanja, a drugu dozu 4 dana nakon presađivanja.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Croatian: U odraslih su najčešće zabilježene nuspojave bile zatvor, mučnina, proljev, porast tjelesne težine, glavobolja, bol, oticanje ruku, zglobova ili stopala, povišeni krvni tlak, anemija, promjene nalaza krvnih pretraga (npr. kalija, kolesterola, fosfata, kreatinina), komplikacije kirurške rane i različite vrste infekcija.
English: Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
Croatian: Rekonstituirani Simulect se primjenjuje intravenskom infuzijom kroz 20 do 30 minuta ili bolus injekcijom.
English: The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).
Croatian: U dvostrukom, kao i u trostrukom režimu terapije, incidencija CMV infekcija bila je slična u obje skupine (14,6% naspram 17,3%) (vidjeti dio 4.4).
English: sodium chloride; sucrose; mannitol (E421); glycine.
Croatian: saharoza; manitol (E421); glicin.
English: The first dose should be given within 2 hours prior to transplantation surgery.
Croatian: Prvu dozu treba dati unutar 2 sata prije kirurškog presađivanja.
English: Disposition parameters were not influenced to a clinically relevant extent by age (1-11 years), body weight (9-37 kg) or body surface area (0.44-1.20 m
Croatian: U ovoj dobnoj skupini starost (1-11 godina), tjelesna težina (9-37 kg) ili tjelesna površina (0,44-1,20 m nisu u klinički značajnoj mjeri utjecali na farmakokinetičke parametre.
English: Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%).
Croatian: Rezultati dviju dvostrukoslijepih multicentričnih studija u kojima je basiliksimab uspoređivan s placebom (ukupno 463 bolesnika) pokazuju da basiliksimab značajno smanjuje incidenciju akutnih epizoda odbacivanja unutar 6 mjeseci nakon presađivanja, ako se istovremeno koristi s ciklosporinom u mikroemulziji, kortikosteroidima i bilo azatioprinom (21% naspram 35%) ili mikofenolat mofetilom (15% naspram 27%).
English: In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
Croatian: Za pedijatrijske bolesnike tjelesne težine manje od 35 kg preporučena ukupna doza iznosi 20 mg, koja se daje u dvije doze od po 10 mg.
English: The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Croatian: Ukupni tjelesni klirens basiliksimaba bio je smanjen za prosječno 22% kada je azatioprin bio dodan režimu koji se sastojao od ciklosporina u emulziji i kortikosteroida.
English: Disposition in adolescents was similar to that in adult renal transplantation patients.
Croatian: Farmakokinetika u adolescenata bila je slična kao u odraslih bolesnika s presađenim bubregom.
English: Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression.
Croatian: Simulect se treba koristiti uz istovremenu primjenu imunosupresije bazirane na ciklosporinu u mikroemulziji i kortikosteroidima.
English: Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Croatian: Bezbojna staklena ampula, staklo tipa I, sadržava 5 ml vode za injekcije.
English: One ml of the reconstituted solution contains 4 mg basiliximab.
Croatian: Jedan ml rekonstituirane otopine sadrži 4 mg basiliksimaba.
English: If you are unsure about anything, ask your doctor, nurse or pharmacist.
Croatian: Ako u bilo što niste sigurni, upitajte svog liječnika, medicinsku sestru ili ljekarnika.
English: In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each.
Croatian: Za pedijatrijske bolesnike tjelesne težine 35 kg ili više, preporučena doza odgovara dozi za odrasle, tj. ukupna doza iznosi 40 mg, koja se daje u dvije doze od po 20 mg.
English: Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Croatian: Simulect se ne smije primjenjivati ako ne postoji potpuna sigurnost da će bolesnik dobiti presadak i prateću imunosupresiju.
English: The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Croatian: Najčešće zabilježeni (>20%) štetni događaji nakon dvostruke ili trostruke terapije u obje skupine (basiliksimab naspram placebo) bile su konstipacija, infekcija mokraćnog sustava, bol, mučnina, periferni edemi, hipertenzija, anemija, glavobolja, hiperkalijemija, hiperkolesterolemija, postoperativna komplikacija rane, porast tjelesne težine, povišeni kreatinin u krvi, hipofosfatemija, proljev i infekcija gornjih dišnih putova.
English: When borderline rejections were included, the rates were 20.8% and 19.6%, respectively (HR: 1.01, 90% CI: [0.59; 1.72]).
Croatian: Kad su uključeni i granični slučajevi odbacivanja, stope su bile 20,8% odnosno 19,6% (HR: 1,01, 90% CI: [0,59; 1,72]).
English: Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
Croatian: U periodu do 6 mjeseci, gubitak presatka javio se u 6% bolesnika koji su primali basiliksimab i 10% koji su primali placebo.
English: Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability.
Croatian: U kliničkoj studiji s 172 bolesnika liječenih basiliksimabom zabilježene su reakcije na ljudska antimišja antitijela (HAMA) bez prediktivne vrijednosti za kliničku podnošljivost.
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: The body's immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.
Croatian: Imunološki sustav Vašeg organizma smatra presađeni organ stranim tijelom i pokušava ga odbaciti.
English: Simulect can be given to children and adolescents.
Croatian: Djeca i adolescenti (u dobi od jedne do 17 godina) Simulect se može davati djeci i adolescentima.
English: It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections.
Croatian: U pakiranju se nalazi i bezbojna staklena ampula s 5 ml sterilne vode za injekcije.
English: 5.2 Pharmacokinetic properties
Croatian: 5.2 Farmakokinetička svojstva Odrasle osobe
English: - The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous;
Croatian: - Drugi sastojci su: kalijev dihidrogenfosfat; natrijev hidrogenfosfat, bezvodni; natrijev klorid;
English: Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
Croatian: Basiliksimab je mišje/ljudsko kimerično monoklonalno antitijelo (IgG1κ) koje djeluje na interleukin-2 receptor alfa lanca (CD25 antigen), koji se nalazi na površini T-limfocita, a odgovoran je za antigenost.
English: - If you have any further questions, ask your doctor, nurse or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, medicinskoj sestri ili ljekarniku.
English: Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome (see section 4.4).
Croatian: Preosjetljivost/anafilaktoidne reakcije kao što su osip, urtikarija, svrbež, kihanje, piskanje pri disanju, bronhospazam, dispneja, plućni edem, zatajenje srca, hipotenzija, tahikardija, zatajenje disanja i sindrom povećane kapilarne propustljivosti (vidjeti dio 4.4).
English: Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg. - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg.
Croatian: Uobičajena doza za djecu i adolescente (u dobi od jedne do 17 godina) - Za djecu i adolescente s tjelesnom težinom manjom od 35 kg, doza Simulecta dana u svakoj infuziji ili injekciji iznosi 10 mg.
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Croatian: Bezbojna staklena bočica, staklo tipa I, sa sivim butilnim gumenim čepom obloženim fluoriranom smolom, s aluminijskim prstenom i plavom polipropilenskom „flip-off” kapicom, sadržava 20 mg basiliksimaba u obliku praška za otopinu za injekciju ili infuziju.
English: Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion.
Croatian: Bezbojna staklena bočica, staklo tipa I, sa sivim butilnim gumenim čepom obloženim fluoriranom smolom, s aluminijskim prstenom i plavom polipropilenskom „flip-off“ kapicom, sadržava 10 mg basiliksimaba u obliku praška za otopinu za injekciju ili infuziju.
English: Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose
Croatian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat, bezvodni Natrijev klorid
English: The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Croatian: Ukupni tjelesni klirens basiliksimaba bio je smanjen za prosječno 51%, kada je režimu koji se sastojao od ciklosporina u emulziji i kortikosteroida bio dodan mikofenolat mofetil.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
Croatian: Nakon rekonstitucije, kemijska i fizikalna stabilnost u primjeni iznosi 24 sata na temperaturi od 2°C - 8C ili 4 sata na sobnoj temperaturi.
English: The adverse event profile remained comparable between treatment groups.
Croatian: Profil nuspojava za obje skupine ostao je usporediv.
English: Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg. - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg.
Croatian: Uobičajena doza za djecu i adolescente (u dobi od jedne do 17 godina) - Za djecu i adolescente s tjelesnom težinom od 35 kg i većom, doza Simulecta dana u svakoj infuziji ili injekciji iznosi 20 mg.
English: Your doctor may discuss this with you before you are given Simulect.
Croatian: Prije nego dobijete Simulect, liječnik može o tome s vama raspraviti.
English: Simulect is also available in vials with 20 mg basiliximab.
Croatian: Simulect je dostupan i u bočicama s 20 mg basiliksimaba.
English: In a clinical trial with 172 patients receiving basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients who received muromonab-CD3 concomitantly.
Croatian: U kliničkoj studiji s 172 bolesnika koji su primali basiliksimab, incidencija ljudskih antimišjih antitijela (HAMA) u bolesnika s bubrežnim presatkom liječenih basiliksimabom bila je 2/138 u bolesnika koji nisu bili izloženi muromonabu-CD3, a 4/34 u bolesnika koji su istovremeno dobivali muromonab-CD3. Raspoloživi klinički podaci o primjeni muromonaba-CD3 u bolesnika prethodno liječenih basiliksimabom ne sugeriraju da bi se naknadna primjena muromonaba-CD3 ili nekog drugog pripravka mišjih antilimfocitnih antitijela trebala izbjegavati.
English: Simulect is also available in vials with 10 mg basiliximab.
Croatian: Simulect je dostupan i u bočicama s 10 mg basiliksimaba.
English: It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Croatian: Može se koristiti u trostrukom režimu imunosupresije koji sadržava ciklosporin u mikroemulziji, kortikosteroide te azatioprin ili mikofenolat mofetil.
English: What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab.
Croatian: Simulect je bijeli prašak u bezbojnoj staklenoj bočici koja sadržava 20 mg basiliksimaba.
English: These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.
Croatian: Radilo se o anafilaktoidnom tipu reakcija kao što su osip, urtikarija, svrbež, kihanje, piskanje pri disanju, hipotenzija, tahikardija, dispneja, bronhospazam, plućni edem, zatajenje srca, zatajenje disanja i sindrom povećane kapilarne propustljivosti.
English: Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients.
Croatian: Kod ponovne primjene Simulecta prilikom sljedećeg presađivanja, kod nekih od ovih bolesnika primijećene su akutne reakcije preosjetljivosti.
English: If you are given too much Simulect
Croatian: Ako primite više Simulecta nego što ste trebali
English: What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab.
Croatian: Simulect je bijeli prašak u bezbojnoj staklenoj bočici koja sadržava 10 mg basiliksimaba.
English: The reconstituted solution is isotonic.
Croatian: Pripremljena otopina je izotonična.
English: 1 vial with 10 mg powder 1 ampoule with 5 ml solvent
Croatian: 1 ampula s 5 ml otapala
English: How Simulect is given
Croatian: Kako primjenjivati Simulect
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Croatian: Rekonstituirana otopina je izotonična i može se dati kao bolus injekcija ili kao infuzija razrijeđena na volumen od 25 ml ili veći, pomoću fiziološke otopine ili 50 mg/ml (5%) otopine glukoze za infuziju.
English: The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Croatian: Rekonstituirana otopina je izotonična i može se dati kao bolus injekcija ili kao infuzija razrijeđena na volumen od 50 ml ili veći, pomoću fiziološke otopine ili 50 mg/ml (5%) otopine glukoze za infuziju.
English: To prepare the solution for infusion or injection, add 5 ml water for injections from the accompanying ampoule to the vial containing the Simulect powder, using aseptic technique.
Croatian: Za pripremu otopine za infuziju ili injekciju, dodajte 5 ml vode za injekcije iz priložene ampule u bočicu koja sadrži Simulect prašak koristeći aseptičku tehniku.
English: To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder.
Croatian: Za pripremu otopine za infuziju ili injekciju, aseptički uzmite 2,5 ml vode za injekcije iz priložene ampule od 5 ml vode i aseptički dodajte tih 2,5 ml vode za injekcije u bočicu koja sadrži Simulect prašak.
English: Simulect 10 mg powder and solvent for solution for injection or infusion
Croatian: Simulect 10 mg prašak i otapalo za otopinu za injekciju ili infuziju
English: Simulect 20 mg powder and solvent for solution for injection or infusion
Croatian: Simulect 20 mg prašak i otapalo za otopinu za injekciju ili infuziju
English: Discard the reconstituted solution if not used within 24 hours.
Croatian: Ako se ne upotrijebi unutar 24 sata, rekonstituiranu otopinu treba odbaciti.
English: Store and transport refrigerated (2°C - 8°C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati i prevoziti na hladnom (2ºC - 8ºC).
English: Intravenous use
Croatian: Primjena u venu
English: To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml water for injections to the vial containing the Simulect powder, using aseptic technique.
Croatian: Za pripremu otopine za infuziju ili injekciju, aseptički uzmite 2,5 ml vode za injekcije iz priložene ampule od 5 ml i primjenom aseptičke tehnike dodajte tih 2,5 ml vode za injekcije u bočicu koja sadrži Simulect prašak.
English: Sudden severe allergic reactions have been reported in patients treated with Simulect.
Croatian: U bolesnika koji su liječeni Simulectom uočena je iznenadna pojava teških alergijskih reakcija.
English: Listing of adverse reactions from post-marketing spontaneous reports
Croatian: Nuspojave zabilježene nakon stavljanja lijeka u promet
English: The volume of distribution at steady state was 8.64.1 l. The extent and degree of distribution to various body compartments have not been fully studied.
Croatian: Opseg i stupanj distribucije u pojedinim tjelesnim odjeljcima nije u potpunosti proučen.
English: Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00
Croatian: Pharma Tel.: +36 1 457 65 00
English: Powder and solvent for solution for injection or infusion
Croatian: Prašak i otapalo za otopinu za injekciju ili infuziju Bijeli prašak