FrancophonIA/ELRC3.0 huggingface dataset:
English: Belatacept is not expected to interrupt the enterohepatic recirculation of MPA.
Croatian: Ne očekuje se da će belatacept ometati enterohepatičku cirkulaciju MPA.
English: Chemical and physical in-use stability of the solution for infusion has been demonstrated for 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Kemijska i fizikalna stabilnost u primjeni otopine za infuziju dokazana je tijekom 24 sata ako se čuva u hladnjaku (2°C - 8°C).
English: Acute infusion-related reactions (reactions occurring within one hour of infusion) occurred in 5.5% of patients in the belatacept MI group and 4.4% of patients in the belatacept LI group up to Year 3.
Croatian: Akutne reakcije povezane s infuzijom (reakcije koje nastaju u roku od jednoga sata nakon infuzije) nastale su u 5,5% bolesnika u skupini liječenoj MI režimom belatacepta i u 4,4% bolesnika liječenih LI režimom belatacepta do 3. godine.
English: NULOJIX will be given to you by a healthcare professional.
Croatian: NULOJIX će Vam davati zdravstveni radnik.
English: If you have been given a therapy for treatment of acute rejection, such as antithymocyte globulin to reduce T-cells.
Croatian: ako ste primili terapiju za liječenje akutnog odbacivanja, kao što je antitimocitni globulin za smanjenje broja T-stanica.
English: The potential impact of pre-existing antibodies to belatacept should be taken into account when considering retreatment with belatacept following prolonged discontinuation, particularly in patients who have not received continuous immunosuppression.
Croatian: Mogući učinak već postojećih protutijela na belatacept treba uzeti u obzir kad se razmatra ponovno uvođenje liječenja belataceptom nakon duljeg prekida, osobito u bolesnika u kojih imunosupresija nije bila kontinuirana.
English: Packs of either 1 glass vial and 1 syringe or 2 glass vials and 2 syringes.
Croatian: Pakiranja od 1staklene bočice i 1 štrcaljke ili 2 staklene bočice i 2 štrcaljke.
English: If you have not been exposed to it, you are at a higher risk of getting a type of cancer called posttransplant lymphoproliferative disorder (PTLD).
Croatian: Ako mu niste bili izloženi, imate povećan rizik od dobivanja jedne vrste raka koji se zove posttransplantacijska limfoproliferativna bolest (PTLD).
English: The trough concentration of belatacept was consistently maintained up to 5 years post-transplant.
Croatian: Najniža koncentracija belatacepta dosljedno se održavala do 5 godina nakon presađivanja.
English: What NULOJIX contains
Croatian: Što NULOJIX sadrži
English: Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers.
Croatian: Izgleda da belatacept nema nikakve značajne izravne učinke na razine citokina u primatelja transplatanata jetre ili u zdravih dobrovoljaca.
English: Studies in rats have shown excretion of belatacept in milk.
Croatian: Ispitivanja na štakorima pokazala su da se belatacept izlučuje u mlijeko.
English: What NULOJIX is and what it is used for 2.
Croatian: Što je NULOJIX i za što se koristi 2.
English: New Onset Diabetes Mellitus and Blood Pressure
Croatian: Novonastala šećerna bolest i krvni tlak
English: Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Croatian: Informacije za medicinsko osoblje i zdravstvene radnike o izračunavanju doze, pripremi i primjeni lijeka NULOJIX nalaze se na kraju ove upute.
English: Initial phase
Croatian: Početna faza
English: NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.
Croatian: NULOJIX sadrži djelatnu tvar belatacept i pripada skupini lijekova koji se zovu imunosupresivi.
English: Important information about some of the ingredients of NULOJIX Tell your doctor if you are on a low-sodium (low-salt) diet before you are treated with NULOJIX.
Croatian: Važne informacije o nekim sastojcima lijeka NULOJIX Obavijestite liječnika ako ste na dijeti s ograničenim unosom natrija (soli) prije nego što započnete liječenje lijekom NULOJIX.
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats) as well as inflammation of the thyroid and pancreas (both juvenile and adult rats).
Croatian: Ispitivanja u štakora izloženih abataceptu pokazala su abnormalnosti imunološkog sustava uključujući nisku incidenciju infekcija koje dovode do smrti (mladi štakori) kao i upalu štitne žlijezde i gušterače (i u mladih i u odraslih štakora).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with belatacept in one or more subsets of the paediatric population in renal transplantation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka belatacepta u jednoj ili više podskupina pedijatrijske populacije u presađivanju bubrega (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: NULOJIX should not be used with siliconised syringes in order to avoid aggregate formation (see section 6.6).
Croatian: NULOJIX se ne smije primjenjivati silikoniziranim štrcaljkama kako bi se izbjeglo stvaranje agregata (vidjeti dio 6.6).
English: It is used with other immunosuppressive medicines, including mycophenolic acid and corticosteroids.
Croatian: Koristi se s drugim imunosupresivima, uključujući mikofenolnu kiselinu i kortikosteroide.
English: Common depression
Croatian: Često depresija
English: This will avoid aggregate formation.
Croatian: Tako će se izbjeći stvaranje agregata.
English: The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
Croatian: Koncentracija belatacepta u infuziji treba biti između 2 mg i 10 mg belatacepta po ml otopine.
English: Belatacept is therefore not expected to affect cytochrome P450 enzymes via effects on cytokines.
Croatian: Stoga se ne očekuje da će belatacept utjecati na enzime citokroma P450 preko učinaka na citokine.
English: Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Croatian: Ovisno o vrsti bubrežnog presatka koji ste dobili, možete imati povišen rizik od zgrušavanja krvi u presađenom bubregu.
English: Exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Croatian: Potrebno je ograničiti izlaganje sunčevom svjetlu i ultraljubičastom (UV) zračenju nošenjem zaštitne odjeće i uporabom preparata s visokim faktorom zaštite.
English: Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.
Croatian: Belatacept ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, budući da može izazvati umor, malaksalost i/ili mučninu.
English: Activated T cells are the predominant mediators of immunologic response to the transplanted kidney.
Croatian: Aktivirane Tstanice glavni su posrednici imunološkog odgovora na presađeni bubreg.
English: Dates of NULOJIX Treatment:
Croatian: Datumi primanja lijeka NULOJIX:
English: Gently mix the infusion container.
Croatian: Nježno promiješajte spremnik infuzije.
English: The active substance is belatacept.
Croatian: Djelatna tvar je belatacept.
English: Tests may show:
Croatian: Pretrage mogu pokazati:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Croatian: Datum prvog odobrenja: 17. lipnja 2011.
English: Please make sure you have this card with you at all times and a list of all your other medicines with you at any visit to a healthcare professional.
Croatian: Pazite da prilikom svakog posjeta zdrastvenom radniku uvijek sa sobom donesete ovu karticu i popis svih drugih lijekova koje uzimate.
English: Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents.
Croatian: Zbog sličnosti strukture i mehanizma djelovanja abatacepta i belatacepta te jačeg djelovanja abatacepta u glodavaca, abatacept se koristio kao djelatniji homolog belatacepta u glodavaca.
English: For more details on the dose calculation, see section 6.6.
Croatian: Za detaljniji opis izračunavanja doze, vidjeti dio 6.6.
English: Up to Year 3*
Croatian: Do 3. godine*
English: When the clinical suspicion for PML is high, brain biopsy should be considered in subjects if the diagnosis of PML cannot be established via CSF PCR and neuroimaging.
Croatian: Kad se ozbiljno klinički sumnja na PML, potrebno je razmotriti biopsiju mozga ako se dijagnoza PML-a u bolesnika ne može utvrditi putem PCR-a cerebrospinalnog likvora i neuroslikovnih pretraga.
English: Too rapid reduction of steroid intake can increase the risk that your body may reject the transplanted kidney.
Croatian: Prebrzo smanjenje unosa steroida može povećati rizik od odbacivanja presađenoga bubrega.
English: Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Croatian: Belatacept se nije ispitivao u bolesnika u kojih je PRA > 30% (vidjeti dio 4.2).
English: Cancer and non-cancerous growths of the skin
Croatian: Rak i nekancerozne izrasline na koži
English: In Study 2, approximately 40% reduction in this risk was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Croatian: U Ispitivanju 2 primijećeno je smanjenje tog rizika za približno 40% u bolesnika u skupinama liječenima belataceptom u odnosu na one randomizirane za primanje ciklosporina.
English: This should be taken into consideration when treating patients on a controlled sodium diet.
Croatian: To se treba uzeti u obzir kod liječenja bolesnika na dijeti s kontroliranim unosom natrija.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja preporučuje se pratiti bolesnika zbog znakova ili simptoma nuspojava i uvesti odgovarajuće simptomatsko liječenje.
English: NULOJIX powder for concentrate for solution for infusion (powder for concentrate) is a white to offwhite powder that can appear solid or broken into pieces.
Croatian: NULOJIX prašak za koncentrat za otopinu za infuziju (prašak za koncentrat) bijeli je do bjelkasti prašak koji može izgledati kao jedan ili više komada krutine.
English: The safety and efficacy of retreatment with belatacept has not been studied.
Croatian: Djelotvornost i sigurnost ponovnog liječenja belataceptom nije ispitana.
English: The safety and efficacy of belatacept have not been established in liver transplant patients, and therefore such use is not recommended.
Croatian: Nije utvrđena djelotvornost i sigurnost primjene belatacepta u bolesnika kojima je presađena jetra, pa se stoga takva primjena ne preporučuje.
English: At the recommended dosing regimen, serum concentration generally reached steady-state by Week 8 in the initial phase following transplantation and by Month 6 during the maintenance phase.
Croatian: Kod režima doziranja u preporučenim dozama, serumske koncentracije općenito su postizale stanje dinamičke ravnoteže do 8. tjedna u početnoj fazi nakon presađivanja i do 6. mjeseca u fazi održavanja.
English: Study 1 and 2: Phase 3 studies in renal transplant recipients The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Croatian: Ispitivanja 1 i 2: ispitivanja Faze III u primatelja bubrežnog presatka Djelotvornost i sigurnost primjene belatacepta u sklopu imunosupresivnog režima nakon presađivanja bubrega procjenjivale su se u dva randomizirana, djelomično slijepa, multicentrična ispitivanja u trajanju od 3 godine s primarnom završnom točkom specificiranom u 1. godini.
English: This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction.
Croatian: Taj povećani afinitet osigurava razinu imunosupresije koja je neophodna za sprječavanje imunološki posredovanog zatajenja presatka i gubitka njegove funkcije.
English: Table 3: Malignancies occurring by treatment group (%) Up to Year 1
Croatian: Tablica 3: Zloćudne bolesti u terapijskim skupinama (%) Do 1. godine
English: PML is usually diagnosed by brain imaging, including magnetic resonance imaging (MRI) or computed tomography (CT) scan, and cerebrospinal fluid (CSF) testing for JC viral DNA by polymerase chain reaction (PCR).
Croatian: PML se obično dijagnosticira pomoću metoda slikovnog prikaza mozga, kao što su magnetska rezonancija (MR) i kompjutorizirana tomografija (CT), te pretragom cerebrospinalnog likvora na JC virusnu DNK lančanom reakcijom polimeraze (PCR).
English: NULOJIX should not be infused concomitantly in the same intravenous line with other agents.
Croatian: NULOJIX se ne smije primijeniti u infuziji u istoj intravenskoj liniji s drugim lijekovima.
English: As compared to the results from the initial 3 years, no new adverse reactions or increasing incidence of adverse reactions (listed above from the initial 3-year period) were detected during the 4-year long-term open label extension.
Croatian: U usporedbi s rezultatima iz prve 3 godine, tijekom 4-godišnjeg dugoročnog otvorenog produžetka nisu otkrivene nove nuspojave niti povećana incidencija nuspojava (prethodno navedenih i utvrđenih u početnom 3-godišnjem razdoblju).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
English: This Patient Alert Card includes information that will be helpful to you and alert other doctors that you have a transplanted kidney and are on a potent medicine to keep your kidney working.
Croatian: Ova kartica s upozorenjima za bolesnika sadrži korisne informacije i služi kao upozorenje drugim liječnicima da imate presađen bubreg i uzimate jaki lijek koji održava rad tog bubrega.
English: The dose of corticosteroids used in all treatment groups was tapered during the first 6 months following transplantation.
Croatian: Doza kortikosteroida koja se primjenjivala u svim ispitivanim skupinama postupno se smanjivala tijekom prvih 6 mjeseci nakon presađivanja.
English: What NULOJIX is and what it is used for
Croatian: Što je Nulojix i za što se koristi
English: The more intensive (MI) regimen, which included higher and more frequent dosing during the first 6 months post transplant, resulted in 2-fold higher exposure to belatacept than the less intensive (LI) regimen during Months 2 through 7 post transplant.
Croatian: Intenzivniji režim (MI), koji je uključivao veće doze i učestalije doziranje tijekom prvih 6 mjeseci nakon presađivanja organa, rezultirao je dvostruko većom izloženošću belataceptu od manje intenzivnog (LI) režima od 2. do 7. mjeseca nakon presađivanja organa.
English: However you should not drive or operate any machines if you are feeling tired or unwell after receiving NULOJIX.
Croatian: Međutim, ne smijete voziti niti raditi na strojevima ako se nakon primanja lijeka NULOJIX ne osjećate dobro ili osjećate umor.
English: NULOJIX Patient Alert Card
Croatian: NULOJIX kartica s upozorenjima za bolesnika
English: Inflammation of the stomach and intestines, usually caused by a virus Upset stomach
Croatian: Upala želuca i crijeva, obično prouzročena virusom Nadražen želudac
English: In the individual studies, the percentage of patients with antibodies ranged from 4.5% and 5.2% in the Phase 3 studies to 11.8% in the long-term extension of the Phase 2 study.
Croatian: U pojedinačnim ispitivanjima postotak bolesnika s protutijelima kretao se u rasponu od 4,5% i 5,2% u ispitivanjima Faze III do 11,8% u dugotrajnom produžetku ispitivanja Faze II.
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Croatian: Povećana incidencija limfoma i tumora mliječnih žlijezda primijećena u miševa liječenih abataceptom mogla je biti povezana sa smanjenom kontrolom virusa mišje leukemije i virusa mišjeg tumora mliječnih žlijezda u prisutnosti dugotrajne imunomodulacije.
English: You must not get pregnant while using NULOJIX.
Croatian: Ne smijete zatrudnjeti za vrijeme primanja lijeka NULOJIX.
English: Phase 2 liver transplant study
Croatian: Faza II ispitivanja kod presađivanja jetre
English: Serious infections can include Tuberculosis Cytomegalovirus (CMV), a virus that can cause serious tissue and blood infections Shingles Other herpes virus infections.
Croatian: Ozbiljne infekcije mogu uključivati tuberkulozu citomegalovirus (CMV), virus koji može prouzročiti ozbiljne infekcije tkiva i krvi herpes zoster druge infekcije herpes virusom.
English: In this study, 666 patients were enrolled, randomised, and transplanted; 219 to belatacept MI, 226 to belatacept LI, and 221 to ciclosporin.
Croatian: U to je ispitivanje bilo uključeno 666 bolesnika, koji su bili randomizirani i presađen im je organ; 219 je primalo MI režim belatacepta, 226 je primalo LI režim belatacepta, a 221 je primao ciklosporin.
English: Antibodies directed against the belatacept molecule were assessed in 796 kidney transplant recipients (551 of these treated for at least 3 years) in the two Phase 3 studies.
Croatian: Protutijela usmjerena protiv molekule belatacepta utvrđivala su se u 796 primatelja presađenog bubrega (od kojih je 551 liječen najmanje 3 godine) u dva ispitivanja Faze III.
English: Belatacept, a selective costimulation blocker, is a soluble fusion protein consisting of a modified extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody.
Croatian: Belatacept, selektivni blokator kostimulacije, topivi je fuzijski protein koji se sastoji od modificirane izvanstanične domene antigena 4 ljudskog citotoksičnog T limfocita (CTLA-4) spojene s dijelom (hinge-CH2-CH3 domene) Fc domene ljudskog imunoglobulinskog G1 protutijela.
English: Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) and UDP-glucuronosyltransferases (UGTs).
Croatian: Belatacept je fuzijski protein i ne očekuje se da će ga metabolizirati enzimi citokroma P450 (CYP) i UDP-glukuronozil-transferaze (UGT).
English: After dilution, and from a microbiological point of view, the product should be used immediately.
Croatian: Nakon razrjeđenja i s mikrobiološkog stajališta, lijek treba odmah primijeniti.
English: Keep this Alert Card with you at all times.
Croatian: Uvijek nosite karticu s upozorenjima sa sobom.
English: Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains.
Croatian: Belatacept djeluje slabije u glodavaca od abatacepta, fuzijskog proteina koji se razlikuje od belatacepta u dvije aminokiseline u CD80/86 domenama vezanja.
English: **Median follow-up for PTLD for pooled studies is 1,199 days for MI, 1,206 days for LI, and 1,139 days for ciclosporin.
Croatian: **Medijan praćenja PTLD-a u svim ispitivanjima zajedno iznosio je 1199 dana za MI, 1206 dana za LI i 1139 dana za ciklosporin.
English: Study 2: Recipients of Extended Criteria Donor Kidneys Extended criteria donors were defined as deceased donors with at least one of the following: (1) donor age ≥ 60 years; (2) donor age ≥ 50 years and other donor comorbidities (≥ 2 of the following: stroke, hypertension, serum creatinine > 1.5 mg/dl); (3) donation after cardiac death or (4) anticipated cold ischemia time of ≥ 24 hours.
Croatian: Ispitivanje 2: Primatelji organa darivatelja prema proširenim kriterijima Darivatelji prema proširenim kriterijima definirani su kao umrli darivatelji koji zadovoljavaju najmanje jedan od sljedećih kriterija: (1) dob darivatelja ≥ 60 godina; (2) dob darivatelja ≥ 50 godina i druge istovremeno prisutne bolesti (≥ 2 sljedeće bolesti: moždani udar, hipertenzija, serumski kreatinin > 1,5 mg/dl); (3) darivanje nakon srčane smrti ili (4) očekivano trajanje hladne ishemije ≥ 24 sata.
English: A total of 250 subjects were randomised to 1 of 5 treatment groups (3 belatacept and 2 tacrolimus groups).
Croatian: Ukupno je 250 ispitanika bilo randomizirano u jednu od 5 terapijskih skupina (3 su primale belatacept, a 2 takrolimus).
English: These studies compared two dose regimens of belatacept (MI and LI) with ciclosporin in recipients of standard criteria (Study 1) or extended criteria (Study 2) donor organs.
Croatian: Ta su ispitivanja uspoređivala dva režima doziranja belatacepta (MI i LI) s ciklosporinom u primatelja organa s darivatelja prema standardnim kriterijima (Ispitivanje 1) i proširenim kriterijima (Ispitivanje 2).
English: Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3 were renal vein thrombosis and CMV infection.
Croatian: Nuspojave koje su dovele do prekida ili prestanka primjene belatacepta u ≥ 1% bolesnika u 3 godine liječenja bile su tromboza bubrežne vene i CMV infekcija.
English: If you become pregnant while using NULOJIX, tell your doctor.
Croatian: Ako zatrudnite za vrijeme uzimanja lijeka NULOJIX, obavijestite o tome svog liječnika.
English: Elderly patients No dose adjustment is required (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagođivati dozu (vidjeti dijelove 5.1 i 5.2).
English: Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
Croatian: Primatelji presatka koji su seronegativni na Epstein-Barrov virus (EBV) ili čiji serološki status nije poznat.
English: Table 5 summarises results for belatacept LI compared with ciclosporin for the co-primary efficacy endpoints of death and graft loss, composite renal impairment, and acute rejection (defined as clinically suspected biopsy proven acute rejection).
Croatian: Tablica 5 prikazuje rezultate za LI režim belatacepta u usporedbi s ciklosporinom prema primarnim mjerama ishoda djelotvornosti: smrt i gubitak presatka, kompozitno oštećenje bubrega i akutno odbacivanje (definirano kao klinički sumnjivo biopsijom potvrđeno akutno odbacivanje).
English: Early diagnosis and treatment may mitigate the impact of PML.
Croatian: Rano postavljanje dijagnoze i uvođenje liječenja mogu ublažiti jačinu PML-a.
English: Because of the risk of a high total burden of immunosuppression, belatacept should only be used in these patients after consideration of alternative therapy (see section 4.4).
Croatian: Zbog rizika od velike ukupne imunosupresije, belatacept se u ovih bolesnika smije primjenjivati samo nakon što se razmotre druge terapijske opcije (vidjeti dio 4.4).
English: In this study, 543 patients were enrolled, randomised, and transplanted; 184 to belatacept MI, 175 to belatacept LI, and 184 to ciclosporin.
Croatian: Ovo je ispitivanje uključilo 543 bolesnika, koji su bili randomizirani i presađen im je organ; 184 je primalo belatacept prema MI režimu, 175 je primalo belatacept prema LI režimu, a 184 je primalo ciklosporin.
English: Population pharmacokinetic analyses in renal transplant patients revealed that there was a trend toward higher clearance of belatacept with increasing body weight.
Croatian: Analize populacijske farmakokinetike u bolesnika s bubrežnim presatkom pokazale su trend povećanja klirensa belatacepta s povećanjem tjelesne težine.
English: Any unused portion in the vials must be discarded in accordance with local requirements.
Croatian: Neiskorišteni dio u bočicama mora se baciti u skladu s lokalnim propisima.