FrancophonIA/ELRC3.0 huggingface dataset:
English: ** Includes all events reported over a median of 3.3 years in the Phase 3 studies, and a median of approximately 7 years in the Phase 2 study.
Croatian: ** Uključuje sve događaje zabilježene tijekom medijana od 3,3 godine u ispitivanjima Faze III, i medijana od približno 7 godina u ispitivanju Faze II.
English: The safety and efficacy of belatacept in children and adolescents 0 to 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost belatacepta u djece i adolescenata u dobi od 0 do 18 godina nisu još ustanovljene.
English: NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Croatian: NULOJIX se nije ispitivao u djece i adolescenata mlađih od 18 godina, stoga se ne preporučuje u ovoj dobnoj skupini.
English: Unopened vials 3 years
Croatian: Neotvorene bočice 3 godine
English: Up to Year 3*,**
Croatian: Do 3. godine*,**
English: Study 2: extended criteria donors
Croatian: Ispitivanje 2: darivatelji prema proširenim kriterijima
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Croatian: Ispitivanja u odraslih štakora i majmuna nisu dala slične nalaze.
English: People are at a higher risk of developing PTLD in the following cases:
Croatian: Povišen rizik od razvoja PTLD postoji u sljedećim slučajevima:
English: This medicine will be stored in the healthcare facility where it is administered.
Croatian: Ovaj se lijek čuva u zdravstvenoj ustanovi gdje se primjenjuje.
English: From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks.
Croatian: Od 4. tjedna nakon presađivanja organa primat ćete terapiju lijekom NULOJIX svaka 4 tjedna.
English: The distribution of the card will also prompt dialogue on any new or changes in symptoms since the prior visit.
Croatian: Distribucija kartice također će potaknuti razgovor o bilo kakvim novim promjenama u simptomima od prethodnoga kontrolnog posjeta.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machines.
Croatian: Bolesnicima treba savjetovati da, ako osjete ove simptome, izbjegavaju obavljanje potencijalno rizičnih zadataka kao što su upravljanje vozilima i rad na strojevima.
English: Plasmapheresis may accelerate removal of belatacept.
Croatian: Plazmafereza može ubrzati uklanjanje belatacepta.
English: This card should be provided in each pack, the text of which is included in Annex III.
Croatian: Ta Kartica mora biti dostupna u svakom pakiranju, a tekst je uključen u PrilogIII.
English: Please take the exact steroid dose as determined by your doctor.
Croatian: Uzmite točnu dozu steroida koju Vam je propisao liječnik.
English: Do not use NULOJIX if you are pregnant unless your doctor specifically recommends it.
Croatian: Nemojte primati NULOJIX ako ste trudni, osim ako liječnik to nije posebno preporučio.
English: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Croatian: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italija
English: If you are not sure if you have been infected with the virus before, ask your doctor.
Croatian: Ako niste sigurni jeste li ikad prije bili inficirani virusom, upitajte svog liječnika.
English: These are medicines that reduce the activity of the immune system, the body's natural defences.
Croatian: To su lijekovi koji potiskuju aktivnost imunološkog sustava, prirodnog obrambenog sustava tijela.
English: Poor appetite, loss of taste, decreased hearing
Croatian: Slab apetit, gubitak okusa, oslabljen sluh
English: Ciclosporin N= 476
Croatian: Ciklosporin N= 476
English: Most events were not serious, were mild to moderate in intensity, and did not recur.
Croatian: U većine slučajeva nisu bile ozbiljne, imale su blagi do umjereni intenzitet i nisu se ponavljale.
English: Immunosuppressant therapy may affect response to vaccination.
Croatian: Imunosupresivna terapija može utjecati na odgovor na cijepljenje.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Take all medicines as instructed by your doctor.
Croatian: Uzimajte sve lijekove prema uputama liječnika.
English: Single doses up to 20 mg/kg have been administered without apparent toxic effect.
Croatian: Primjena jednokratnih doza do 20 mg/kg nije imala vidljive toksične učinke.
English: The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Croatian: Kategorije po učestalosti definiraju se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 i < 1/100).
English: The card will have your doctor's name and phone number and the date when you started treatment, your last treatment visit, and your next visit for treatment.
Croatian: Na kartici će pisati ime i broj telefona Vašeg liječnika te datum kad ste započeli liječenje, datum zadnje doze i datum kad trebate primiti sljedeću dozu.
English: Long-term extension in Study 1 and Study 2
Croatian: Dugoročan nastavak u Ispitivanju 1 i Ispitivanju 2
English: Belatacept should not be used in pregnant women unless clearly necessary.
Croatian: Belatacept se ne smije primjenjivati u trudnica ukoliko za tim ne postoji jasna potreba.
English: Patients with high PRA often require increased immunosuppression.
Croatian: Bolesnicima s visokom vrijednošću PRA često treba pojačana imunosupresija.
English: Table 4: Infections occurring by treatment group (%)
Croatian: Tablica 4: Infekcije po terapijskim skupinama (%)
English: If you are allergic to belatacept or any of the other ingredients of the medicine (listed in section 6).
Croatian: Ako ste alergični na belatacept ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It will be given to you by infusion (as a "drip") into one of your veins over a period of about 30 minutes.
Croatian: Lijek ćete dobiti infuzijom (u obliku “dripa”) u jednu od vena u trajanju od približno 30 minuta.
English: Day of transplantation, prior to implantation (Day 1)
Croatian: Dan presađivanja organa, prije implantacije (1. dan)
English: An additional 51 patients were treated for an average of 7 years in the long-term extension of a Phase 2 study.
Croatian: Dodatno 51 bolesnik liječio se u prosjeku 7 godina u dugotrajnom produžetku ispitivanja Faze II.
English: Dead tissue because of stopped blood supply
Croatian: Odumiranje tkiva zbog prestanka opskrbe krvlju
English: Other medicines and NULOJIX
Croatian: Drugi lijekovi i NULOJIX
English: Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the transplant vascular anastomoses.
Croatian: Infuzija prve doze treba se dati neposredno prije operacije ili za vrijeme operacije, ali prije završetka uspostave vaskularnih anastomoza presatka.
English: Direct the stream of fluid to the glass wall of the vial and not into the powder.
Croatian: Usmjerite mlaz prema staklenoj stijenci bočice, a ne u prašak.
English: A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept.
Croatian: Ukupno je 45 od 847 bolesnika (5,3%) razvilo protutijela tijekom liječenja belataceptom.
English: Wear protective clothing and use a sunscreen with a high protection factor.
Croatian: Nosite zaštitnu odjeću i koristite preparate za zaštitu od sunca s visokim zaštitnim faktorom.
English: What NULOJIX looks like and contents of the pack
Croatian: Kako NULOJIX izgleda i sadržaj pakiranja
English: Tell your family or caregiver about your treatment as you might get symptoms that you might not be aware of yourself.
Croatian: Obavijestite svoju obitelj ili njegovatelja o tome da primate ovaj lijek, jer možete dobiti simptome kojih ne morate biti sami svjesni.
English: The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional.
Croatian: Preporučena doza temelji se na tjelesnoj težini (u kg) i izračunat će je zdravstveni radnik.
English: It is also recommended to administer an interleukin(IL)-2 receptor antagonist during the first week after transplantation.
Croatian: Preporučuje se i primjena antagonista receptora interleukina(IL)-2 za vrijeme prvog tjedna nakon presađivanja.
English: The effects of NULOJIX in pregnant women are not known.
Croatian: Učinci lijeka NULOJIX u trudnica nisu poznati.
English: Each pack of the medicine contains an alert card that should be given to the patient.
Croatian: Pogledajte dio 4. Svako pakiranje lijeka sadrži karticu s upozorenjima koja se mora dati bolesniku.
English: Liver inflammation (cytolytic hepatitis)
Croatian: Upala jetre (citolitički hepatitis)
English: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italy
Croatian: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italija
English: Dangerous decrease of blood pressure which, if untreated, may lead to collapse, coma and death Stroke
Croatian: Opasno sniženje krvnog tlaka koje, ako se ne liječi, može dovesti do kolapsa, kome i smrti Moždani udar
English: Therefore, during treatment with belatacept, vaccinations may be less effective although this has not been studied in clinical trials.
Croatian: Stoga za vrijeme liječenja belataceptom, cjepiva mogu biti manje učinkovita, iako se to nije ispitalo u kliničkim ispitivanjima.
English: The accumulation index for belatacept at steady state is 1.1.
Croatian: Indeks nakupljanja belatacepta u stanju dinamičke ravnoteže iznosi 1,1.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma u EU (EURD popis) predviđenom člankom 107c)stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijamaobjavljenima na europskom internetskom portalu za lijekove.
English: Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX.
Croatian: Ograničite izlaganje sunčevom svjetlu i ultraljubičastom (UV) zračenju dok primate NULOJIX.
English: The recommended dose is based on patient body weight (kg).
Croatian: Preporučena doza ovisi o tjelesnoj težini bolesnika (kg).
English: Tell your doctor immediately if you or your family notice any symptoms listed below:
Croatian: Odmah obavijestite liječnika ako Vi ili netko iz Vaše obitelji primijeti da imate sljedeće simptome:
English: The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well.
Croatian: U ispitivanju belatacepta nije bio utvrđen virusni status, no kako je ovaj virus čest u majmuna, najvjerojatnije je bio prisutan i u ovih majmuna.
English: However, NULOJIX can cause serious side effects that may need treatment.
Croatian: Međutim, NULOJIX može uzrokovati ozbiljne nuspojave koje će možda trebati liječiti.
English: The most common CNS infection was cryptococcal meningitis.
Croatian: Najčešća infekcija središnjeg živčanog sustava bila je kriptokokni meningitis.
English: People who use NULOJIX have a higher risk of getting certain other types of cancer, especially skin cancer.
Croatian: Osobe koje primaju NULOJIX imaju povišen rizik od dobivanja određenih drugih vrsta raka, osobito raka kože.
English: If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account the risk to the graft.
Croatian: Ako se postavi dijagnoza PML-a, preporučuje se smanjiti ili obustaviti imunosupresiju uzimajući pritom u obzir rizik za presadak.
English: There are no adequate data from use of belatacept in pregnant women.
Croatian: Ne postoje prikladni podaci o primjeni belatacepta u trudnica.
English: This will avoid foam formation.
Croatian: Tako će se izbjeći stvaranje pjene.
English: Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek dok primate NULOJIX.
English: If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before.
Croatian: Ako tijekom dužeg razdoblja prestanete primati NULOJIX i za to vrijeme ne uzimate druge lijekove za sprječavanje odbacivanja organa, a zatim ponovno počnete primati belatacept, nije poznato hoće li taj lijek imati isti učinak kao prije.
English: Belatacept was shown to cross the placenta in rats and rabbits.
Croatian: Pokazalo se da belatacept prelazi placentu u štakora i kunića.
English: With NULOJIX treatment, this more often develops in the brain and can lead to death.
Croatian: Uz liječenje lijekom NULOJIX, ta se bolest češće razvija u mozgu i može imati smrtni ishod.
English: Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Croatian: Belatacept se nije ispitivao u bolesnika s panelom reaktivnih protutijela (PRA, Panel Reactive Antibody) većim od 30% (kojima je često potrebna pojačana imunosupresija).
English: It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Croatian: Nije poznato ukazuju li ovi nalazi na rizik od razvoja autoimune bolesti u ljudi izloženih in utero abataceptu ili belataceptu.
English: At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
Croatian: U 3. godini incidencija NODM iznosila je 8% uz belatacept i 10% uz ciklosporin.
English: In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
Croatian: U 153 bolesnika pregledanih na protutijela najmanje 56 dana (približno 7 poluvremena) nakon prestanka primjene belatacepta, još je 10 (6,5%) razvilo protutijela.
English: NULOJIX weakens the body's ability to fight infections.
Croatian: NULOJIX slabi sposobnost tijela da se obrani od infekcija.
English: There are no data on use of belatacept and effect on fertility in humans.
Croatian: Nema podataka o primjeni belatacepta i njegovom učinku na plodnost u ljudi.
English: The powder is a white to off-white whole or fragmented cake.
Croatian: Prašak je bijele do bjelkaste boje u obliku cijelog ili razlomljenog kolačića.
English: Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml.
Croatian: Štrcaljke su označene u jedinicama od 0,5 ml; stoga, izračunata doza treba se zaokružiti na najbližu oznaku od 0,5 ml.
English: Tell your family or caregiver about your treatment.
Croatian: Obavijestite svoju obitelj ili njegovatelja o svom liječenju.
English: During the first month post-transplantation, 85% saturation of CD86 was maintained.
Croatian: Tijekom 1. mjeseca nakon presađivanja organa zadržalo se 85% zasićenosti CD86.
English: It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Croatian: Najvjerojatnije je povećana osjetljivost na oportunističke infekcije primijećena u mladih štakora povezana s izloženošću abataceptu prije razvoja memorijskog odgovora.
English: One patient on belatacept MI regimen developed Guillian-Barré syndrome which led to treatment discontinuation and subsequently resolved.
Croatian: Jedan bolesnik koji je primao MI režim belatacepta razvio je Guillian-Barréov sindrom, koji je doveo do prekida liječenja i nakon toga se povukao.
English: However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Croatian: Međutim, normalizirana učestalost imunogeničnosti tijekom trajanja izloženosti dosljedno je iznosila 2,0 do 2,1 na 100 bolesnik-godina u tri ispitivanja.
English: Therapeutic monitoring of belatacept is not required.
Croatian: Nije potrebno terapijsko praćenje belatacepta.
English: If you have not been exposed to the Epstein-Barr virus (EBV) or are uncertain of previous exposure, you must not be treated with NULOJIX.
Croatian: Ako niste bili izloženi Epstein-Barrovom virusu (EBV) ili niste sigurni jeste li mu bili izloženi, ne smijete se liječiti lijekom NULOJIX.
English: CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection.
Croatian: Preporučuje se primjenjivati profilaksu CMV-a tijekom najmanje 3 mjeseca nakon presađivanja organa, osobito u bolesnika s povećanim rizikom od CMV infekcije.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA28.
English: T-cells are cells responsible for maintaining your body's ability to resist disease and infections.
Croatian: T-stanice odgovorne su za održavanje sposobnosti tijela da se obrani od bolesti i infekcija.
English: The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis.
Croatian: U većine slučajeva tuberkuloza se razvila u bolesnika koji su u to vrijeme ili prethodno živjeli u zemljama s visokom prevalencijom tuberkuloze.
English: Efficacy was similar between MI and LI while the overall safety profile was better for the LI.
Croatian: Djelotvornost MI i LI režima je bila slična, dok je LI režim imao bolji ukupni sigurnosni profil.
English: In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment.
Croatian: Titar protutijela općenito je bio nizak, obično nije dugo trajao i često je prestajao biti mjerljiv s nastavkom liječenja.
English: Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation.
Croatian: Primjena profilakse pneumocistične upale pluća preporučuje se tijekom najmanje 6 mjeseci nakon presađivanja organa.
English: Tell your doctor if you need to have vaccinations.
Croatian: Obavijestite svog liječnika ako se trebate cijepiti.
English: Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections.
Croatian: Liječnik će Vas možda trebati pregledati zbog tih simptoma kako bi isključio PML, PTLD ili druge infekcije.
English: This was despite the presence in the abatacept study of a virus, lymphocryptovirus, known to cause these lesions in immunosuppressed monkeys within the time frame of these studies.
Croatian: To je bilo usprkos tome što je u ispitivanju abatacepta bio prisutan virus, limfokriptovirus, za koji se zna da uzrokuje ove lezije u imunosuprimiranih majmuna unutar vremenskog okvira u kojem su provedena ta ispitivanja.
English: Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%.
Croatian: Do 3. mjeseca nakon presađivanja organa uz preporučeni režim doziranja, razina zasićenosti CD86 održala se na približno 70%, a u 12. mjesecu na približno 65%.
English: By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Croatian: Do 3. su godine recidivi akutnog odbacivanja bili slični u svim skupinama (< 3%), a supkliničko akutno odbacivanje utvrđeno u 1. godini protokolnom biopsijom iznosilo je 5% u obje skupine.
English: Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes.
Croatian: Reverzibilni farmakološki učinci sastojali su se od minimalnog smanjenja serumskog IgG i minimalne do teške limfoidne deplecije germinalnih centara u slezeni i/ili limfnim čvorovima.
English: Patients are not required to be pre-treated to prevent allergic reactions (see section 4.8).
Croatian: Bolesnici ne moraju prethodno biti liječeni zbog sprječavanja alergijskih reakcija (vidjeti dio 4.8).
English: The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Croatian: Razrijeđena otopina mora se primijeniti intravenskom infuzijom relativno stalne brzine u razdoblju od 30 minuta.
English: Although there were few patients that developed antibodies and there was no apparent correlation of antibody development to clinical response or adverse events, the data are too limited to make a definitive assessment (see section 4.8).
Croatian: Iako je svega nekoliko bolesnika razvilo protutijela i nije bilo očite korelacije između razvoja protutijela i kliničkog odgovora ili nuspojava, podaci su previše ograničeni da bi se mogla napraviti konačna procjena (vidjeti dio 4.8).
English: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A.
Croatian: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - SAD
English: There have been reports of a rare type of brain infection called progressive multifocal leukoencephalopathy (PML) that have occurred in patients who have been given NULOJIX.
Croatian: Zabilježeni su slučajevi rijetke vrste infekcije mozga koja se zove progresivna multifokalna leukoencefalopatija (PML) i nastala je u bolesnika kojima se davao NULOJIX.
English: The pharmacokinetics of belatacept was linear and the exposure to belatacept increased proportionally in healthy subjects after a single intravenous infusion dose of 1 to 20 mg/kg.
Croatian: Farmakokinetika belatacepta bila je linearna i izloženost belataceptu se u zdravih ispitanika proporcionalno povećala nakon jednokratne doze od 1 do 20 mg/kg primijenjene intravenskom infuzijom.
English: Up to Year 1
Croatian: Do 1. godine
English: Anti-belatacept antibody development was not associated with altered clearance of belatacept.
Croatian: Razvoj protutijela na belatacept nije bio povezan s promijenjenim klirensom belatacepta.
English: There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy).
Croatian: 2. U skupini koja je primala ciklosporin prijavljen je jedan slučaj PML-a (Ispitivanje 1) 82 mjeseca nakon presađivanja (više od 56 dana nakon prekida terapije).
English: Within each frequency category adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake učestalosti kategorije nuspojave su navedene prema sve manjoj ozbiljnosti.
English: If you miss receiving NULOJIX when you are supposed to, ask your doctor when to schedule your next dose.
Croatian: Ako propustite primiti NULOJIX kad ste trebali, upitajte liječnika kada trebate doći zbog primanja sljedeće doze.
English: Do not store any unused portion of the solution for infusion for reuse.
Croatian: Nemojte čuvati neiskorišteni dio otopine za infuziju za ponovnu primjenu.
English: Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors
Croatian: Tablica 5: Ključne mjere djelotvornosti u 1. i 3. godini Ispitivanje 1: živi darivatelji i preminuli koji zadovoljavaju standardne kriterije
English: As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Croatian: Posljedično, belatacept blokira CD28 posredovanu kostimulaciju T-stanica, inhibirajući njihovu aktivaciju.