FrancophonIA/ELRC3.0 huggingface dataset:
English: In postmarketing experience, use of belatacept in conjunction with basiliximab induction, mycophenolate mofetil and corticosteroid taper to 5 mg/day by Week 6 post-transplant was associated with an increased rate of acute rejection, particularly Grade III rejection.
Croatian: Nakon stavljanja lijeka u promet, primjena belatacepta u kombinaciji s uvodnom terapijom baziliksimabom te mofetilmikofenolatom i dozom kortikosteroida smanjenom na 5 mg/dan do 6. tjedna nakon presađivanja bila je povezana s povećanom stopom akutnog odbacivanja, osobito odbacivanja stupnja III.
English: Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development at doses up to 16-fold and 19-fold a human 10 mg/kg dose based on AUC.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na embrionalni/fetalni razvoj pri dozama koje su, na temelju AUC, 16 i 19 puta veće od doze od 10 mg/kg koja se primjenjuje u ljudi.
English: EBV seronegative patients receiving immunosuppressants are at a particularly increased risk for PTLD (see sections 4.3 and 4.4).
Croatian: Bolesnici seronegativni na EBV koji su primali imunosupresive imali su osobito povišen rizik od PTLD-a (vidjeti dijelove 4.3 i 4.4).
English: There is no data available in patients with hepatic impairment.
Croatian: Nema dostupnih podataka o bolesnicima s oštećenjem funkcije jetre.
English: No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
Croatian: Abatacept nije pokazao mutagenost ili klastogenost u bateriji in vitro ispitivanja.
English: Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
Croatian: Posttransplantacijska limfoproliferativna bolest (PTLD) U ispitivanjima Faze II i III (3 ispitivanja), incidencija PTLD-a bila je viša u bolesnika liječenih belataceptom nego u bolesnika liječenih ciklosporinom (vidjeti dio 4.8).
English: Pain when passing urine, blood in the urine
Croatian: Bol pri mokrenju, krv u mokraći
English: Every 4 weeks (± 3 days) starting at end of week 16 after transplantation
Croatian: Svaka 4 tjedna (± 3 dana) počevši od kraja 16. tjedna nakon presađivanja organa
English: In a single Phase 2 clinical study in de novo liver transplant patients, an increase in the number of deaths was observed in 2 of 3 belatacept-containing regimens studied.
Croatian: U jednom kliničkom ispitivanju Faze II u de novo bolesnika s presađenom jetrom opažen je povećan broj smrti u 2 od 3 režima u sklopu kojih se primjenjivao belatacept.
English: Practical details on the reconstitution of vials
Croatian: Praktični detalji o rekonstituciji otopine za infuziju
English: The use of live vaccines should be avoided (see section 4.4).
Croatian: Primjenu živih cjepiva treba izbjegavati (vidjeti dio 4.4).
English: In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept.
Croatian: U kliničkom je ispitivanju nakon početne primjene belatacepta bilo opaženo približno 90% zasićenosti CD86 receptora na površini stanica koje predočuju antigene u perifernoj krvi.
English: In general, these events occurred early and the majority resulted in graft loss.
Croatian: Tromboza presatka općenito bi rano nastupila i uglavnom rezultirala gubitkom presatka.
English: It is unknown whether belatacept is excreted in human milk (see section 5.3).
Croatian: Nije poznato izlučuje li se belatacept u majčino mlijeko (vidjeti dio 5.3).
English: In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
Croatian: U kliničkim ispitivanjima, primatelji presađenog organa liječeni betalaceptom s EBV seronegativnim statusom imali su povišen rizik od PTLD-a u usporedbi s onima koji su bili seropozitivni na EBV (7,7% ili 7/91 seronegativnih nasuprot 0,7% ili 6/810 seropozitivnih).
English: Serious infections Serious infections can happen with NULOJIX treatment and can lead to death.
Croatian: Ozbiljne infekcije Za vrijeme liječenja lijekom NULOJIX mogu se razviti ozbiljne infekcije i dovesti do smrti.
English: Abnormal swelling of the brain, increased pressure inside the skull and brain, seizure, weakness causing loss of movement on one side of the body, loss of the covering around nerves, inability of muscles to move in the face
Croatian: Abnormalno oticanje mozga, povišen tlak u lubanji i mozgu, epileptički napadaji, slabost koja uzrokuje gubitak pokreta na jednoj strani tijela, gubitak ovojnice oko živaca, nesposobnost pomicanja mišića lica
English: Study 1 excluded (1) recipients undergoing a first transplant whose current PRA were ≥50%; (2) recipients undergoing a retransplantation whose current PRA were ≥30%; (3) recipients when previous graft loss was due to acute rejection and in case of a positive T-cell lymphocytotoxic cross match.
Croatian: U ispitivanje 1 nisu bili uključeni (1) primatelji koji su prvi puta podvrgnuti presađivanju i čiji je trenutni PRA bio ≥ 50%; (2) primatelji podvrgnuti ponovnom presađivanju čiji je trenutni PRA bio ≥ 30%; (3) primatelji u kojih je prethodni gubitak presatka bio posljedica akutnog odbacivanja te primatelji s pozitivnim nalazom na limfocitotoksičnost T-stanica u testu križne reakcije.
English: Allergic reactions related to belatacept use have been reported in the clinical studies.
Croatian: Alergijske reakcije povezane s primjenom belatacepta zabilježene su u kliničkim ispitivanjima.
English: In addition to PTLD, patients receiving immunosuppressive regimens, including belatacept, are at increased risk of malignancies, including skin cancer (see section 4.8).
Croatian: Uz PTLD, bolesnici koji primaju imunosupresivnu terapiju, uključujući belatacept, imaju povišen rizik od zloćudnih bolesti, uključujući rak kože (vidjeti dio 4.8).
English: This medicinal product contains 0.65 mmol or 15 mg sodium per vial.
Croatian: Ovaj lijek sadrži 0,65 mmol ili 15 mg natrija po bočici.
English: As an increased risk of PML and of other infections has been associated with high levels of overall immunosuppression, the recommended doses of belatacept and concomitant immunosuppressives, including MMF or MPA, should not be exceeded (see section 4.5).
Croatian: Kako je povećan rizik od PML-a i drugih infekcija povezan s visokim razinama ukupne imunosupresije, belatacept i istovremeno primjenjivani imunosupresivi, uključujući MMF ili MPA, ne smiju se davati u dozama koje su veće od preporučenih (vidjeti dio 4.5).
English: Do not use NULOJIX if you notice any particles or discolouration in the reconstituted or diluted solution.
Croatian: NULOJIX se ne smije upotrijebiti ako primijetite čestice ili promjenu boje pripremljene ili razrijeđene otopine.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i kutiji iza „Rok valjanosti“ ili kratice EXP.
English: The use of live vaccines should be avoided (see section 4.5).
Croatian: Primjenu živih cjepiva treba izbjegavati (vidjeti dio 4.5).
English: For Studies 1 and 2 at Years 1 and 3, belatacept was associated with 6 to 9 mmHg lower mean systolic blood pressure, approximately 2 to 4 mmHg lower mean diastolic blood pressure, and less use of antihypertensive medicinal products than ciclosporin.
Croatian: Ispitivanjima 1 i 2 u 1. i 3. godini belatacept je, u usporedbi s ciklosporinom, bio povezan sa 6 do 9 mm Hg nižim prosječnim sistoličkim krvnim tlakom, približno 2 do 4 mm Hg nižim prosječnim dijastoličkim krvnim tlakom te manjom uporabom antihipertenzivnih lijekova.
English: Abnormal collection of fluid
Croatian: Abnormalno nakupljanje tekućine.
English: The solution for infusion may be stored for a maximum of 4 hours of the total 24 hours below 25°C.
Croatian: Otopina za infuziju može se čuvati najviše 4 sata od ukupno 24 sata na temperaturi ispod 25°C.
English: Number of vials required equals the belatacept dose in mg divided by 250 rounded up to the next full number of vials.
Croatian: Broj potrebnih bočica jednak je dozi belatacepta u mg podijeljenoj s 250 zaokruženo na sljedeći cijeli broj bočica.
English: During clinical studies, there was no dose modification of belatacept for a change in body weight of less than 10%.
Croatian: Doza belatacepta se za vrijeme kliničkih ispitivanja nije prilagođivala u slučaju promjene tjelesne težine manje od 10%.
English: Physicians should consider PTLD in the differential diagnosis in patients with new or worsening neurologic, cognitive or behavioural signs or symptoms.
Croatian: Liječnici trebaju uzeti u obzir PTLD u sklopu diferencijalne dijagnoze u bolesnika s novim ili pogoršavajućim neurološkim, kognitivnim ili bihevioralnim znakovima ili simptomima.
English: Constipation, diarrhoea, nausea, vomiting, abdominal pain High blood pressure, low blood pressure
Croatian: Zatvor, proljev, mučnina, povraćanje, bol u trbuhu Visok krvni tlak, niski krvni tlak
English: Acute rejection (AR) occurred more frequently with belatacept versus ciclosporin in Study 1 and with similar frequency with belatacept versus ciclosporin in Study 2.
Croatian: Akutno odbacivanje bilo je češće uz belatacept nego uz ciklosporin u Ispitivanju 1, dok je u Ispitivanju 2 bilo jednako često uz belatacept i ciklosporin.
English: At Month 1, 4, and 6 post-transplant, the mean (range) trough concentrations of belatacept were 22.7 (11.1-45.2), 7.6 (2.1-18.0), and 4.0 (1.5-6.6) μg/ml, respectively.
Croatian: U 1., 4. odnosno 6. mjesecu nakon presađivanja, prosječne (raspon) najniže koncentracije belatacepta bile su 22,7 (11,1-45,2), 7,6 (2,1-18,0) odnosno 4,0 (1,5-6,6) μg/ml.
English: Volume of the reconstituted solution required (ml) equals total belatacept dose in mg divided by 25.
Croatian: Volumen rekonstituirane potrebne otopine (ml) jednak je ukupnoj dozi belatacepta u mg podijeljenoj s 25.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/694/001-002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/694/001
English: A single, randomised, multi-center, controlled Phase 2 trial of belatacept in de novo orthotopic liver transplant recipients was conducted.
Croatian: Provedeno je jedno randomizirano, multicentrično, kontrolirano ispitivanje belatacepta Faze II u de novo primatelja ortotopičnog presatka jetre.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurologic, cognitive or behavioural signs or symptoms.
Croatian: Liječnici trebaju uključiti PML u diferencijalnu dijagnozu u bolesnika s pojavom novih ili pogoršanjem postojećih neuroloških, kognitivnih ili bihevioralnih znakova ili simptoma.
English: Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 4.2).
Croatian: Ukupna doza belatacepta u mg jednaka je tjelesnoj težini bolesnika u kg pomnoženoj s dozom belatacepta u mg/kg (5 ili 10 mg/kg, vidjeti dio 4.2).
English: Cases of PTLD varied by serostatus.
Croatian: 2. Slučajevi PTLD-a razlikovali su se prema serološkom statusu.
English: This medicine contains 0.65 mmol (or 15 mg) sodium per vial which corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of three vials.
Croatian: Ovaj lijek sadrži 0,65 mmol (ili 15 mg) natrija po bočici, što odgovara 1,95 mmol (ili 45 mg) natrija po maksimalnoj dozi od tri bočice.
English: Uncommon acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular
Croatian: Manje često akutni koronarni sindrom, atrioventrikularni blok drugog stupnja, bolest aortalne valvule, supraventrikularna aritmija
English: Poor blood flow to the heart, blocked heart beats, abnormal aorta heart valve, abnormal rapid heart rate
Croatian: Slab dotok krvi u srce, blokirani otkucaji srca, abnormalni aortalni srčani zalistak, abnormalno ubrzan rad srca
English: The other case of PML was reported in a liver transplant recipient in a Phase 2 trial who received 6 months of treatment with an augmented belatacept MI regimen, MMF at doses higher than the recommended dose and corticosteroids (see section 4.4).
Croatian: Drugi slučaj PML-a bio je zabilježen u primatelja presatka jetre u ispitivanju Faze II koji je 6 mjeseci primao pojačani MI režim belatacepta, MMF u dozama višima od preporučene i kortikosteroide (vidjeti dio 4.4).
English: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients with 4 to 6 human leukocyte antigen (HLA) mismatches (see sections 4.4 and 5.1)
Croatian: Postupno smanjivanje doze kortikosteroida u bolesnika koji primaju belatacept treba provoditi uz oprez, osobito u bolesnika s 4 do 6 nepodudarnih humanih leukocitnih antigena (HLA) (vidjeti dijelove 4.4 i 5.1).
English: Remove the syringe and needle after 10.5 ml of reconstitution fluid has been added to the vial.
Croatian: Izvadite iglu i štrcaljku nakon što ste u bočicu dodali 10,5 ml otapala za rekonstituciju.
English: In a six-month and one-year toxicity study in cynomolgus monkeys with belatacept and abatacept, respectively, no significant toxicity was observed.
Croatian: U ispitivanju toksičnosti belatacepta u trajanju od 6 mjeseci i abatacepta u trajanju od 1 godine u makaki majmuna nije bila primijećena značajna toksičnost.
English: Dose modification of NULOJIX is not recommended for a change in body weight of less than
Croatian: Ne preporučuje se prilagođivati dozu lijeka NULOJIX kod promjene tjelesne težine manje od
English: Burning sensation
Croatian: Osjećaj žarenja
English: Patients on controlled sodium diet
Croatian: Bolesnici na dijeti s kontroliranim unosom natrija
English: In the 3 studies (one Phase 2 and two Phase 3 studies, Study 1 and Study 2), the cumulative frequency of PTLD was higher in belatacept treated patients at the recommended dosing regimen (LI) (1.3%; 6/472) than in the ciclosporin group (0.6%; 3/476), and was highest in the belatacept MI group (1.7%; 8/477).
Croatian: U 3 ispitivanja (jednom ispitivanju Faze II i dva ispitivanja Faze III, Ispitivanju 1 i Ispitivanju 2), kumulativna učestalost PTLD-a bila je viša u bolesnika liječenih belataceptom u preporučenom režimu doziranja (LI) (1,3%; 6/472) nego u bolesnika liječenih ciklosporinom (0,6%; 3/476), a najviša je bila u skupini liječenoj belataceptom prema MI režimu (1,7%; 8/477).
English: Minimal systemic accumulation of belatacept occurred upon multiple infusions of 5 or 10 mg/kg doses in renal transplant patients every 4 weeks.
Croatian: Sistemsko nakupljanje belatacepta bilo je minimalno nakon višestrukih infuzija doza od 5 ili 10 mg/kg svaka 4 tjedna u bolesnika s bubrežnim presatkom.
English: See leaflet for shelf-life after reconstitution and dilution.
Croatian: Pogledajte Uputu o lijeku za rok valjanosti nakon rekonstitucije i razrjeđivanja.
English: As compared to ciclosporin and assessed by the hazard ratio (HR) estimates (for death or graft loss) from an ad hoc Cox regression analysis, overall patient and graft survival was higher for belatacepttreated patients in Study 1, HR 0.588 (95% CI: 0.356-0.972) for the MI group and HR 0.585 (95% CI: 0.356-0.961) for the LI group, and comparable across treatment groups in Study 2, HR 0.932 (95% CI: 0.635-1.367) for the MI group and HR 0.944 (95% CI: 0.644-1.383) for the LI group.
Croatian: U usporedbi s ciklosporinom, ukupno preživljenje bolesnika i presatka ocijenjeno na temelju procijenjenih vrijednosti omjera hazarda (HR) (za smrt ili gubitak presatka) iz ad hoc Coxove regresijske analize bilo je dulje u bolesnika liječenih belataceptom u ispitivanju 1, HR 0,588 (95% CI: 0,356 - 0,972) za skupinu koja je primala MI režim i HR 0,585 (95% CI: 0,356 - 0,961) za skupinu koja je primala LI režim, te usporedivo u svim terapijskim skupinama u Ispitivanju 2, HR 0,932 (95% CI: 0,635 - 1,367) za skupinu koja je primala MI režim i HR 0,944 (95% CI: 0,644 - 1,383) za skupinu koja je primala LI režim.
English: Malignancies excluding nonmelanoma skin cancer and PTLD
Croatian: Zloćudne bolesti isključujući nemelanomski karcinom kože i PTLD
English: Year 3 [95% CI] Death (%) Year 1 Year 3 Graft Loss (%) Year 1 Year 3 % of Patients meeting Composite renal impairment endpoint at
Croatian: 3. godina [95% CI] Smrt (%) 1. godina 3. godina Gubitak presatka (%) 1. godina 3. godina % bolesnika sa složenom mjerom ishoda oštećenja bubrega u 1. godinia P-vrijednost AR (%) 1. godina (%) [95% CI] 3. godina (%) [95% CI]
English: In both studies, in patients with AR by Year 2, donor-specific antibodies, one of the criteria for diagnosis of antibody-mediated rejection, were present in 6% (2/32, Study 2)-8% (3/39, Study 1) and 20% (4/20, Study 1)-26% (7/27, Study 2) in the belatacept and ciclosporin groups by year 3, respectively.
Croatian: U oba su ispitivanja u bolesnika s akutnim odbacivanjem do 2. godine, protutijela specifična na darivatelja, što je jedan od kriterija za dijagnozu protutijelima posredovanog odbacivanja, bila prisutna u 6% (2/32, Ispitivanje 2) do 8% (3/39, Ispitivanje 1) u skupini koja je primala belatacept i 20% (4/20, Ispitivanje 1) do 26% (7/27, Ispitivanje 2) u skupini koja je primala ciklosporin do 3. godine.
English: Very Common proteinuria, blood creatinine increased, dysuria, haematuria
Croatian: Vrlo često proteinurija, povišen kreatinin u krvi, dizurija, hematurija
English: Concomitant use with other immunosuppressive agents Belatacept has been administered with the following immunosuppressive agents in clinical studies: basiliximab, an MPA and corticosteroids.
Croatian: Istovremena primjena drugih imunosupresivnih lijekova Belatacept se u kliničkim ispitivanjima primjenjivao sa sljedećim imunosupresivnim lijekovima: baziliksimabom, MPA i kortikosteroidima.
English: In both studies, mean GFR following AR was similar in belatacept and ciclosporin treated patients.
Croatian: U oba je ispitivanja prosječni GFR nakon akutnog odbacivanja bila slična u bolesnika liječenih belataceptom i onih liječenih ciklosporinom.
English: Very Common insomnia, anxiety
Croatian: Psihijatrijski poremećaji Vrlo često nesanica, anksioznost
English: The Year 3 frequency of malignant neoplasms, excluding non-melanoma skin cancers, was similar in the belatacept LI and ciclosporin groups and higher in the belatacept MI group.
Croatian: Učestalost zloćudnih novotvorina u 3. godini, isključujući nemelanomske karcinome kože, bila je slična u skupinama liječenima LI režimom belatacepta i ciklosporinom te povišena u skupini liječenoj MI režimom belatacepta.
English: AR was treated more often with lymphocyte depleting therapy (a risk factor for PTLD; see section 4.4) in the belatacept group than the ciclosporin group.
Croatian: Akutno odbacivanje češće je bilo liječeno terapijom koja smanjuje broj limfocita (čimbenik rizika za PTLD; vidjeti dio 4.4) u skupini koja je primala belatacept nego u skupini koja je primala ciklosporin.
English: End of Week 8 and Week 12 after transplantation
Croatian: Na kraju 8. tjedna i 12. tjedna nakon presađivanja organa
English: A total of 321 belatacept (MI: 155 and LI: 166) and 136 ciclosporin patients completed 3 years of treatment in Study 1 and entered the 4-year long-term open label extension period (up to 7 years in total).
Croatian: Ukupno je 321 bolesnik liječen belataceptom (MI režim: 155 i LI režim: 166) i 136 bolesnika liječenih ciklosporinom završilo 3 godine liječenja u Ispitivanju 1 i ušlo u 4 godišnji dugoročni otvoreni produžetak (do ukupno 7 godina liječenja).
English: Slowly add the required amount of reconstituted belatacept solution from each vial to the infusion bag or bottle using the same disposable syringe used for reconstitution of the powder.
Croatian: Polako dodajte potrebnu količinu rekonstituirane otopine belatacepta iz svake bočice u infuzijsku vrećicu ili bocu koristeći istu štrcaljku za jednokratnu uporabu koju ste koristili za rekonstituciju praška.
English: In a prespecified pooled analysis of Studies 1 and 2 at Year 1, the incidence of new onset diabetes mellitus (NODM), defined as use of an antidiabetic agent for ≥ 30 days or ≥ 2 fasting plasma glucose values > 126 mg/dl (7.0 mmol/l) post-transplantation, was 5% with belatacept and 10% with ciclosporin.
Croatian: U unaprijed zadanoj analizi objedinjenih podataka iz Ispitivanja 1 i 2 u 1. godini incidencija novonastale šećerne bolesti (NODM), definirane kao uzimanje antidijabetičkog lijeka ≥ 30 dana ili ≥ 2 vrijednosti glukoze u plazmi natašte > 126 mg/dl (7,0 mmol/l) nakon presađivanja, iznosila je 5% uz belatacept i 10% uz ciklosporin.
English: Corticosteroid Taper: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients at high immunologic risk, such as those with 4 to 6 human leukocyte antigen (HLA) mismatches.
Croatian: Postupno smanjenje doze kortikosteroida: Postupno smanjenje doze kortikosteroida u bolesnika koji primaju belatacept treba provoditi uz oprez, osobito u bolesnika u kojih postoji visok imunološki rizik, poput bolesnika s 4 do 6 nepodudarnih humanih leukocitnih antigena.
English: The median age was 58 years; 67% of the study population was male; 75% of patients were white, 13% were black/African-American, 12% were categorised as of other races; 3% had PRA  10%; and 53% had 4 to 6 HLA mismatches.
Croatian: Medijan dobi iznosio je 58 godina; 67% ispitivane populacije bili su muškarci; 75% bolesnika bili su bijelci, 13% crnci/Afroamerikanci, a 12% bolesnika svrstano je u druge rasne kategorije; 3% ispitanika imalo je PRA ≥ 10%, a 53% imalo je 4 do 6 nepodudarnih humanih leukocitnih antigena.
English: Slowly add the required amount of reconstituted NULOJIX solution from each vial to the infusion bag or bottle using the same disposable syringe used for reconstitution of the powder.
Croatian: Polako dodajte potrebnu količinu rekonstituirane otopine lijeka NULOJIX iz svake bočice u infuzijsku vrećicu ili bocu koristeći istu štrcaljku za jednokratnu uporabu koju ste koristili za rekonstituciju praška.
English: *Median exposure for pooled studies is 1,092 days for each treatment group.
Croatian: *Medijan trajanja izloženosti u svim ispitivanjima zajedno iznosio je 1092 dana u svakoj terapijskoj skupini.
English: If not used immediately, the solution for infusion may be stored in the refrigerator (2°C - 8°C) for up to 24 hours.
Croatian: Ako se ne primijeni odmah, otopina za infuziju može se čuvati u hladnjaku (2°C - 8°C) najduže 24 sata.
English: The mean (range) pharmacokinetic parameters of belatacept after multiple intravenous infusions at doses of 5 and 10 mg/kg in renal transplant subjects were: terminal half-life, 8.2 (3.1-11.9) and 9.8 (6.1-15.1) days, respectively; systemic clearance 0.51 (0.33-0.75) and 0.49 (0.23-0.70) ml/h/kg, respectively; and distribution volume at steady state, 0.12 (0.09-0.17) and 0.11 (0.067-0.17) l/kg, respectively.
Croatian: Prosječne vrijednosti (raspon) farmakokinetičkih parametara belatacepta nakon višestrukih intravenskih infuzija doze od 5 odnosno 10 mg/kg u ispitanika s bubrežnim presatkom bile su sljedeće: terminalni poluvijek, 8,2 (3,1-11,9) odnosno 9,8 (6,1-15,1) dana; sistemski klirens 0,51 (0,33-0,75) odnosno 0,49 (0,23-0,70) ml/h/kg; i volumen raspodjele u stanju dinamičke ravnoteže 0,12 (0,09-0,17) odnosno 0,11 (0,067-0,17) l/kg.
English: Mean Calculated GFRc ml/min/1.73 m2 Month 1 Year 1 Year 2 Year 3
Croatian: Prosječni izračunati GFRc ml/min/1,73 m2 1. mjesec 1. godina 2. godina 3. godina a
English: The solution for infusion is to be used in conjunction with a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 µm to 1.2 µm).
Croatian: Otopina za infuziju primjenjuje se uz sterilni, nepirogeni filtar s niskim vezanjem proteina (veličina pora od 0,2 µm do 1,2 µm).