FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis (see section 4.4).
Croatian: Tuberkuloza se u većine slučajeva razvila u bolesnika koji su u to vrijeme ili prethodno živjeli u zemljama s visokom prevalencijom tuberkuloze (vidjeti dio 4.4).
English: All patients received basiliximab, MMF, and corticosteroids.
Croatian: Svi su bolesnici primali baziliksimab, MMF i kortikosteroide.
English: Consultation with a neurologist is recommended for any suspected or confirmed cases of PML.
Croatian: Preporučuje se potražiti savjet neurologa u svim slučajevima kad se sumnja ili dokaže PML.
English: PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus.
Croatian: PML rijetka je oportunistička infekcija središnjeg živčanog sustava koja često brzo napreduje i ima smrtni ishod, a uzrokuje je John Cunningham (JC) virus.
English: 1 vial 1 syringe
Croatian: 1 bočica 1 štrcaljka
English: The higher calculated GFR observed in belatacept-treated patients relative to ciclosporin-treated patients during the first 3 years was maintained over the long-term extension period.
Croatian: Viši izračunati GFR koji je tijekom prve 3 godine primijećen u bolesnika liječenih belataceptom u odnosu na one liječene ciklosporinom održao se i tijekom dugoročnog nastavka.
English: It is important that you read the entire PL for more information.
Croatian: Važno je da, zbog dodatnih informacija, pročitate cijelu uputu o lijeku.
English: What you need to know before you use NULOJIX
Croatian: Što morate znati prije nego počnete primjenjivati Nulojix
English: Treatment with NULOJIX increases the risk of getting a type of cancer called post-transplant lymphoproliferative disorder (PTLD).
Croatian: Liječenje lijekom NULOJIX povećava rizik od dobivanja jedne vrste raka koja se zove posttransplantacijska limfoproliferativna bolest (PTLD).
English: When belatacept was compared to placebo infusions, there were no differences in event rates (placebo infusions were administered at Weeks 6 and 10 of the belatacept LI regimen to blind the MI and LI regimens).
Croatian: Kada se belatacept usporedio s infuzijama placeba, nije bilo razlike u učestalosti događaja (infuzije placeba primijenile su se u 6. i 10. tjednu LI režima belatacepta zbog maskiranja MI i LI režima).
English: PTLD in belatacept-treated patients most often presented in the central nervous system (CNS).
Croatian: PTLD u bolesnika liječenih belataceptom najčešće se manifestirao znakovima i simptomima središnjeg živčanog sustava (CNS).
English: The most frequently reported acute infusion-related reactions in combined belatacept regimens were hypotension, hypertension, flushing and headache.
Croatian: Najčešće zabilježene akutne reakcije povezane s infuzijom u kombiniranim režimima s belataceptom bile su hipotenzija, hipertenzija, crvenilo i glavobolja.
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary tumours (in females) occurred.
Croatian: U ispitivanju kancerogenosti u miša bila je povećana incidencija malignih limfoma i tumora mliječnih žlijezda (u ženki).
English: Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived.
Croatian: Belatacept, prilagođeni oblik CTLA4-Ig, veže se za CD80 i CD86 većim afinitetom nego prekursorna CTLA4-Ig molekula iz koje potječe.
English: Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
Croatian: Liječenje lijekom NULOJIX propisat će i nadzirati liječnik specijalist u području presađivanja bubrega.
English: NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function).
Croatian: NULOJIX je, u kombinaciji s kortikosteroidima i mikofenolatnom kiselinom (MPA), indiciran za profilaksu odbacivanja presađenog bubrega u odraslih primatelja (vidjeti dio 5.1 za podatke o funkciji bubrega).
English: Belatacept is produced by recombinant DNA technology in a mammalian cell expression system.
Croatian: Belatacept se proizvodi tehnologijom rekombinantne DNK u sustavu ekspresije stanica sisavaca.
English: Belatacept binds to CD80 and CD86 on antigen presenting cells.
Croatian: Belatacept se veže za CD80 i CD86 na stanicama koje predočuju antigen.
English: Belatacept has a minor influence on the ability to drive and use machines.
Croatian: Belatacept ima slab učinak na sposobnost upravljanja vozilima i rada na strojevima.
English: Changes in blood levels of different salts or electrolytes Increased amounts of cholesterol and triglyceride (blood fats) High levels of sugar in your blood
Croatian: Promjene u razini različitih soli i elektrolita u krvi Povećane količine kolesterola i triglicerida (masnoće u krvi) Povišene razine šećera u Vašoj krvi
English: Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6.
Croatian: Približno 80% epizoda akutnog odbacivanja zabilježeno je do 3. mjeseca, dok su nakon 6. mjeseca bile rjeđe.
English: Lymphocyte Depleting Therapies and MPA: As the total burden of immunosuppression is a risk factor for malignancies and opportunistic infections, higher than the recommended doses of concomitant immunosuppressive agents should be avoided.
Croatian: Terapije koje dovode do smanjenja broja limfocita i MPA: Kako je ukupna jačina imunosupresije čimbenik rizika za zloćudne bolesti i oportunističke infekcije, treba izbjegavati istovremenu primjenu imunosupresiva u dozama koje su više od preporučenih.
English: Special caution should be exercised in patients with a history of allergic reactions to belatacept or to any of the excipients.
Croatian: Poseban oprez potreban je u bolesnika koji su imali alergijske reakcije na belatacept ili neku od pomoćnih tvari.
English: However, at 200 mg/kg, 11 times the MRHD exposure, alterations in immune function were observed consisting of a 9-fold increase in T-cell dependent antibody response in female pups and thyroid inflammation in one female pup.
Croatian: Međutim, pri dozi od 200 mg/kg, odnosno 11 puta većoj izloženosti od one uz MRHD, bile u opažene promjene u imunološkoj funkciji potomstva koje su se sastojale od deveterostruko povećanog odgovora protutijela ovisnog o T-stanicama u mladih ženki i upale štitne žlijezde u jedne mlade ženke.
English: NULOJIX is supplied in a 20 ml vial (Type I flint glass) with a stopper (20 mm grey butyl rubber) and flip off seal (aluminum).
Croatian: NULOJIX je dostupan u bočici od 20 ml (kristalno staklo tip I) s čepom (20 mm siva butilna guma) i zaštitnom kapicom (aluminij).
English: Use of immunosuppressants, including belatacept, can increase susceptibility to infection, including fatal infections, opportunistic infections, tuberculosis, and herpes (see progressive multifocal leukoencephalopathy (PML) warning below and also section 4.8).
Croatian: Primjena imunosupresiva, pa tako i belatacepta, može povećati sklonost infekcijama, uključujući infekcije sa smrtnim ishodom, oportunističke infekcije, tuberkulozu i herpes (vidjeti u daljnjem tekstu upozorenje na progresivnu multifokalnu leukoencefalopatiju (PML) i dio 4.8).
English: The reconstituted solution should be clear to slightly opalescent and colourless to pale yellow.
Croatian: Rekonstituirana otopina treba biti bistra do lagano zamućena i bezbojna do blijedožute boje.
English: 2 vials 2 syringes
Croatian: 2 bočice 2 štrcaljke
English: No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of NULOJIX with other agents.
Croatian: Nisu provedene studije fizikalne ili biokemijske kompatibilnosti kako bi se procijenila mogućnost istovremene primjene lijeka NULOJIX s drugim lijekovima.
English: Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS).
Croatian: U 9 od 14 slučajeva PTLD-a u bolesnika liječenih belataceptom zahvaćen je bio središnji živčani sustav; u promatranom razdoblju, 8 od 14 slučajeva imalo je smrtni ishod (u 6 tih slučajeva sa smrtnim ishodom zahvaćen je bio središnji živčani sustav).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2.
English: Based on population pharmacokinetic analysis of 944 renal transplant patients up to 1 year posttransplant, the pharmacokinetics of belatacept were similar at different time periods post-transplant.
Croatian: Analiza populacijske farmakokinetike u 944 bolesnika s bubrežnim presatkom do 1. godine nakon presađivanja pokazala je da belatacept ima sličnu farmakokinetiku u različitim vremenskim razdobljima nakon presađivanja.
English: Swelling of back of the eye causing changes in sight, eye inflamed, uncomfortable/increased sensitivity to light, swelling of the eyelid
Croatian: Oticanje stražnjeg dijela oka što uzrokuje promjene vida, upala oka, nelagoda/pojačana osjetljivost na svjetlo, oticanje vjeđe
English: NULOJIX is used in adults to prevent the immune system from attacking your transplanted kidney and causing transplant rejection.
Croatian: NULOJIX se primjenjuje u odraslih bolesnika kako bi se spriječio napad imunološkog sustava na presađeni bubreg, što uzrokuje odbacivanje presađenog organa.
English: This corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of 3 vials.
Croatian: To odgovara 1,95 mmol (ili 45 mg) natrija po maksimalnoj dozi od 3 bočice.
English: In a pre- and postnatal development study in rats, limited changes in immune function were observed at 19-fold a human 10 mg/kg dose based on AUC (see section 5.3).
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja u štakora, primijećene su ograničene promjene u imunološkoj funkciji pri 19 puta većoj dozi od 10 mg/kg koja se primjenjuje u ljudi na temelju AUC (vidjeti dio 5.3).
English: End of Week 8 and Week 12 after transplantation Maintenance Phase
Croatian: Na kraju 8. tjedna i 12. tjedan nakon presađivanja organa Faza održavanja
English: They may cause rejection of your transplanted kidney.
Croatian: One mogu prouzročiti odbacivanje presađenog bubrega.
English: Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Croatian: Belatacept je fuzijski protein proizveden u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (IFTA) The prevalence of CAN/IFTA at Year 1 in Studies 1 and 2, was numerically lower with belatacept than ciclosporin (~ 9.4% and 5%, respectively).
Croatian: Kronična nefropatija presatka (CAN)/intersticijska fibroza i tubularna atrofija (IFTA) Prevalencija CAN/IFTA u 1. godini Ispitivanja 1 i 2 bila je numerički niža uz belatacept nego uz ciklosporin (~ 9,4% odnosno 5%).
English: At the recommended dosing regimen of belatacept there were 404 EBV positive recipients and 4 cases of PTLD occurred (1.0%); 2 of these presented in the CNS.
Croatian: Pri preporučenom režimu doziranja belatacepta u 404 primatelja pozitivna na EBV dogodila su se 4 slučaja PTLD-a (1,0%); u 2 od tih slučajeva bio je zahvaćen središnji živčani sustav.
English: Malignancies and post-transplant lymphoproliferative disease Year 1 and 3 frequencies of malignancies are shown in Table 3, except for cases of PTLD which are presented at 1 year and > 3 years (median days of follow-up were 1,199 days for belatacept MI, 1,206 days for belatacept LI, and 1,139 days for ciclosporin).
Croatian: Učestalost zloćudnih bolesti u 1. i 3. godini prikazana je u tablici 3, osim slučajeva PTLD koji su prikazani nakon 1 godine i > 3 godine (medijan dana praćenja iznosio je 1199 dana za belatacept MI, 1206 dana za belatacept LI i 1139 dana za ciklosporin).
English: Excipient with known effect Each vial contains 0.65 mmol sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica sadrži 0,65 mmol natrija.
English: Overall, the few reports across clinical studies suggest that prolonged exposure to belatacept does not predispose patients to an increased risk of development of autoimmune events.
Croatian: Općenito mali broj zabilježenih slučajeva u kliničkim ispitivanjima ukazuje na to da se rizik od razvoja autoimunih događaja ne povećava s dužim trajanjem izloženosti bolesnika belataceptu.
English: Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders
Croatian: Manje često hipogamaglobulinemija, sezonska alergija Endokrini poremećaji
English: The adverse reaction profile associated with immunosuppressive agents is often difficult to establish due to the underlying disease and the concurrent use of multiple medicinal products.
Croatian: Profil nuspojava povezan s imunosupresivnim lijekovima često je teško utvrditi zbog osnovne bolesti i istodobne primjene više lijekova.
English: Every 4 weeks (± 3 days), starting at the end of week 16 after transplantation
Croatian: Svaka 4 tjedna (± 3 dana), počevši na kraju 16. tjedna nakon presađivanja organa
English: Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4.
Croatian: U regiji vezanja liganda na CTLA-4 zamijenjene su dvije aminokiseline (L104 u E; A29 u Y).
English: Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of renal transplant patients.
Croatian: Liječenje treba propisati i nadgledati liječnik specijalist s iskustvom u primjeni imunosupresivne terapije i liječenju bolesnika s presađenim bubregom.
English: Nervous system symptoms may include memory lapse; speech and communication difficulties; a change in your mood or behaviour; confusion or inability to control your muscles; weakness on one side of the body; vision changes; or headache.
Croatian: Simptomi živčanog sustava mogu uključivati gubitak pamćenja; poteškoće u govoru i komunikaciji; promjenu raspoloženja ili ponašanja; smetenost ili nemogućnost kontroliranja mišića; slabost na jednoj strani tijela; promjene vida; ili glavobolju.
English: If any serious allergic or anaphylactic reaction occurs, belatacept therapy should be discontinued immediately and appropriate therapy initiated (see section 4.4).
Croatian: Ako nastupi neka ozbiljna alergijska ili anafilaktička reakcija, potrebno je odmah prekinuti terapiju belataceptom i uvesti odgovarajuće liječenje (vidjeti dio 4.4).
English: Within the belatacept clinical program, there were 2 patients diagnosed with PML.
Croatian: U sklopu kliničkog programa za belatacept u 2 bolesnika je dijagnosticiran PML.
English: Following administration, it is recommended that the intravenous line be flushed with infusion fluid to ensure administration of the complete dose.
Croatian: Nakon primjene, preporučuje se isprati intravensku liniju infuzijskom tekućinom kako bi se osigurala primjena potpune doze.
English: To minimise foam formation, gently swirl and invert the vial for at least 30 seconds or until the powder is completely dissolved.
Croatian: Da bi se smanjilo stvaranje pjene, nježno kružnim pokretima promućkajte i okrećite sadržaj bočice najmanje 30 sekundi ili dok se prašak potpuno ne otopi.
English: More detailed information on the benefits, risks, and precautions for usage of NULOJIX are described in the Summary of Product Characteristics (SmPC) for health care professionals and a package leaflet (PL) for patients.
Croatian: Detaljnije informacije o koristima, rizicima i mjerama opreza kod primjene lijeka NULOJIX navedene su u Sažetku opisa svojstava lijeka za zdravstvene radnike i Uputi o lijeku za bolesnike.
English: Skin changes may include unexpected bruising or bleeding; brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other; a change in the size and colour of a mole; or a new skin lesion or bump.
Croatian: Promjene na koži mogu uključivati neočekivane modrice ili krvarenje; smeđe ili crne kožne lezije nepravilnih rubova ili jedan dio lezije ne izgleda kao drugi dio; promjenu veličine i boje madeža; ili novu kožnu leziju ili čvorić.
English: Although some foam may remain on the surface of the reconstituted solution, a sufficient excess of belatacept is included in each vial to account for withdrawal losses.
Croatian: Iako može zaostati nešto pjene na površini rekonstituirane otopine, u svakoj se bočici nalazi dovoljna količina belatacepta da nadoknadi gubitak zbog izvlačenja.
English: Uncommon abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased
Croatian: Manje često abnormalni snovi, promjene raspoloženja, nedostatak pozornosti/hiperaktivni poremećaj, pojačan libido
English: Pack sizes: 1 vial and 1 syringe or 2 vials and 2 syringes.
Croatian: Veličina pakiranja: 1 bočica i 1 štrcaljka ili 2 bočice i 2 štrcaljke.
English: There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
Croatian: Autoimuni proces Teoretski bi liječenje belataceptom moglo povećati rizik od autoimunih procesa (vidjeti dio 4.8).
English: No evidence of lymphomas or preneoplastic morphologic changes was observed in either study.
Croatian: Niti u jednom ispitivanju nije dokazana pojava limfoma ili preneoplastičkih morfoloških promjena.
English: In Study 1, one additional case of PTLD was reported in the ciclosporin group, in a patient who was EBV seropositive at the time of transplant.
Croatian: U Ispitivanju 1 prijavljen je jedan dodatan slučaj PTLD-a u skupini liječenoj ciklosporinom, u bolesnika koji je u trenutku presađivanja bio seropozitivan na EBV.
English: Transplant recipients who are EBV seronegative or serostatus unknown should not receive belatacept (see section 4.3).
Croatian: Primatelji presatka koji su seronegativni na EBV ili čiji serološki status nije poznat ne smiju primati belatacept (vidjeti dio 4.3).
English: To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Croatian: Da bi se procijenila prisutnost neutralizirajućih protutijela, napravio se in vitro test kojim su ispitani uzorci 29 bolesnika u kojih je potvrđeno aktivno vezanje za modificiranu regiju molekule antigena 4 povezanog s citotoksičnim T limfocitima (CTLA-4); pokazalo se da 8 (27,6%) bolesnika ima neutralizirajuća protutijela.
English: In clinical studies with belatacept, 2 cases of PML were reported in patients receiving belatacept at doses higher than the recommended regimen.
Croatian: U kliničkim ispitivanjima belatacepta zabilježena su 2 slučaja PML-a u bolesnika koji su primali belatacept u dozama višima od preporučenog režima.
English: Elderly patients demonstrated consistency with the overall study population for safety and efficacy as assessed by patient and graft survival, renal function, and acute rejection.
Croatian: Djelotvornost i sigurnost primjene u starijih bolesnika pokazala se sukladnom onoj u ukupne ispitivane populacije na temelju preživljenja bolesnika i presatka, funkcije bubrega i akutnog odbacivanja.
English: Method of administration NULOJIX is for intravenous use only.
Croatian: Način primjene NULOJIX je namijenjen samo za intravensku primjenu..
English: Of the 1209 randomized and transplanted patients in the two Phase 3 studies (see section 5.1), 761 patients continued after Year 3 in a long-term extension period for up to an additional 4 years and continued to receive the study drug according to their original treatment assignment.
Croatian: Od 1209 randomiziranih bolesnika s presatkom iz dva ispitivanja faze 3 (vidjeti dio 5.1), 761 bolesnik je nakon 3. godine uključen u dugoročan produžetak ispitivanja u trajanju od najviše 4 dodatne godine, tijekom kojega je nastavio primati ispitivani lijek koji mu je izvorno dodijeljen.
English: No dose adjustment is recommended in patients with renal impairment or undergoing dialysis (see section 5.2).
Croatian: Ne preporučuje se prilagođivati dozu u bolesnika s oštećenjem funkcije bubrega ili bolesnika na dijalizi (vidjeti dio 5.2).
English: In addition to EBV seronegative status, other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy, which was more commonly used to treat acute rejection in belatacept-treated patients in Phase 3 clinical studies (see section 5.1).
Croatian: Uz seronegativni status na EBV, ostali poznati čimbenici rizika za PTLD uključuju citomegalovirusnu (CMV) infekciju i terapiju koja smanjuje broj T-stanica, a koja se češće koristila za liječenje akutnog odbacivanja presatka u bolesnika liječenih belataceptom u kliničkim ispitivanjima Faze III (vidjeti dio 5.1).
English: When reconstitution and dilution are performed under aseptic conditions, the NULOJIX infusion should be started immediately or must be completed within 24 hours of reconstitution of the powder.
Croatian: Kad se rekonstitucija i razrjeđivanje provode u aseptičkim uvjetima, infuziju lijeka NULOJIX treba započeti odmah ili se mora završiti u roku od 24 sata od rekonstitucije praška.
English: These belatacept dosing regimens differed from those studied in renal transplant recipients (see section 5.1).
Croatian: Ovi režimi s belataceptom razlikovali su se od onih koji su se ispitivali u primatelja bubrežnog presatka (vidjeti dio 5.1).
English: Any disease of the brain causing headache, fever, hallucinations, confusion, abnormal speech and body movement
Croatian: Bilo koja bolest mozga koja uzrokuje glavobolju, vrućicu, halucinacije, smetenost, poremećaj govora i kretanja
English: Post-transplant lymphoproliferative disorder
Croatian: Posttransplantacijska limfoproliferativna bolest
English: Therefore, preclinical studies conducted with abatacept have been used to support the safety of belatacept in addition to the studies conducted with belatacept.
Croatian: Stoga su neklinička ispitivanja provedena s abataceptom, uz ispitivanja provedena s belataceptom, upotrijebljena kao potpora sigurnosti belatacepta.
English: If any serious allergic or anaphylactic reaction occurs, NULOJIX therapy should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako nastupi ozbiljna alergijska ili anafilaktička reakcija, terapiju lijekom NULOJIX treba odmah prekinuti i uvesti odgovarajuće liječenje.
English: In rats, belatacept had no undesirable effects on male or female fertility (see section 5.3).
Croatian: Belatacept nije imao neželjene učinke na plodnost mužjaka i ženki štakora (vidjeti dio 5.3).
English: At a given dose of MMF, MPA exposure is approximately 40% higher with belatacept coadministration than with ciclosporin coadministration.
Croatian: Pri danoj dozi MMF-a, izloženost MPA-u približno je 40% viša kod istodobne primjene belatacepta nego kod istodobne primjene ciklosporina.
English: Women should not breast-feed while on treatment with a belatacept-based regimen.
Croatian: Žene ne smiju dojiti za vrijeme liječenja belataceptom.
English: Remove the flip off seal from the vial and wipe the top with an alcohol swab.
Croatian: Uklonite aluminijsku zaštitnu kapicu s bočice i obrišite gornju površinu vatom natopljenom alkoholom.
English: * See section “Description of selected adverse reactions”.
Croatian: “Opis odabranih nuspojava”.