FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti PrilogI: Sažetak opisa svojstava lijeka, dio 4.2).
English: The median age was 45 years; 58% of donor organs were from living patients; 3% were re-transplanted; 69% of the study population was male; 61% of patients were white, 8% were black/African-American, 31% were categorised as of other races; 16% had PRA  10%; and 41% had 4 to 6 HLA mismatches.
Croatian: Medijan dobi iznosio je 45 godina; 58% darovanih organa poteklo je od živih bolesnika; u 3% slučajeva radilo se o ponovnom presađivanju organa; 69% ispitivane populacije činili su muškarci; 61% bolesnika bili su bijelci, 8% crnci/Afroamerikanci, a 31% bolesnika svrstano je u druge rasne kategorije; 16% ispitanika imalo je PRA ≥ 10%, a 41% imalo je 4 do 6 nepodudarnih humanih leukocitnih antigena.
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: In Study 2, among patients who were EBV seropositive at the time of transplant, there was one case of PTLD in each of the three treatment groups.
Croatian: U Ispitivanju 2 je među bolesnicima koji su u trenutku presađivanja bili seropozitivni na EBV zabilježen po jedan slučaj PTLD-a u svakoj od tri terapijske skupine.
English: Study 1: Recipients of Living Donor and Standard Criteria Deceased Donor Kidneys Standard criteria donor organs were defined as organs from a living donor, or a deceased donor with anticipated cold ischemia time of < 24 hours and not meeting the definition of extended criteria donor organs.
Croatian: Organi darivatelja koji zadovoljavaju standardne kriterije definirani su kao organi sa živih darivatelja ili preminulih donora s očekivanim trajanjem hladne ishemije < 24 sata koji ne zadovoljavaju definiciju darivatelja organa prema proširenim kriterijima.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za jednokratnu primjenu.
English: Abatacept administered to female rats every three days during gestation and throughout the lactation period, produced no adverse effects in offspring at doses up to 45 mg/kg, representing 3 times the exposure associated with the MRHD of 10 mg/kg based on AUC.
Croatian: Abatacept primijenjen ženkama štakora svaka tri dana tijekom gestacije i cijelog razdoblja laktacije nije izazvao štetne učinke kod potomstva u dozama do 45 mg/kg, što je predstavljalo 3 puta veću izloženost od one uz MRHD od 10 mg/kg na temelju AUC.
English: No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Croatian: spola, rase, funkcije bubrega (izračunati GFR), šećerne bolesti ili istovremene dijalize na klirens belatacepta.
English: Blood clotting in your transplanted kidney
Croatian: Zgrušavanje krvi u presađenom bubregu
English: Do not use NULOJIX
Croatian: Nemojte primjenjivati NULOJIX
English: Depression, fatigue, feeling of tiredness, drowsiness, or lack of energy, general feeling of being unwell, difficulty breathing when laying down, nose bleeding Typical appearance of a person with high levels of steroids, such as moon face, hump back, upper body obesity
Croatian: Depresija, umor, osjećaj umora, omamljenost ili nedostatak energije, opće loše osjećanje, poteškoće s disanjem u ležećem položaju, krvarenje iz nosa Tipičan izgled osobe s visokim razinama steroida, kao što je mjesečasto lice, bivolja grba, debljina u gornjem dijelu tijela
English: A dedicated Alert Card has been developed to prompt the patient to reference the package leaflet and HCPs to reference the SmPC for more details on the benefits and risks associated with NULOJIX.
Croatian: Osmišljena je namjenska Kartica s upozorenjima za bolesnika kojom se bolesnika potiče da pročita Uputu o lijeku, a zdravstvene radnike da pročitaju Sažetak opisa svojstava lijeka kako bi doznali više o koristima i rizicima povezanima s primjenom lijeka NULOJIX.
English: EBV serology should be ascertained before starting administration of belatacept.
Croatian: Prije početka primjene belatacepta potrebno je utvrditi serološki status na EBV.
English: In the renal transplant studies of belatacept, one case of PML was reported in a patient who received an IL-2 receptor antagonist, mycophenolate mofetil (MMF) and corticosteroids as concomitant treatment.
Croatian: U ispitivanjima belatacepta kod presađivanja bubrega zabilježen je jedan slučaj PML-a u bolesnika koji je istovremeno primao terapiju antagonistom IL-2 receptora, mofetilmikofenolatom (MMF) i kortikosteroide.
English: Belatacept administered to female rats daily during gestation and throughout the lactation period was associated with infections in a small percentage of dams at all doses (≥ 20 mg/kg, ≥ 3 times the MRHD exposure based on AUC), and produced no adverse effects in offspring at doses up to 200 mg/kg representing 19 times the MRHD exposure based on AUC.
Croatian: Belatacept koji se svakodnevno primjenjivao ženkama štakora tijekom gestacije i cijelog razdoblja laktacije bio je povezan s infekcijama u malom postotku okota pri svim veličinama doza (≥ 20 mg/kg, ≥ 3 puta veća izloženost nego uz MRHD na temelju AUC), a nije izazvao nikakve štetne učinke kod potomstva pri dozama do 200 mg/kg koje su predstavljale 19 puta veću izloženost od one uz MRHD na temelju AUC.
English: Infections involving the CNS were more frequent in the belatacept MI group (8 cases, including the PML case discussed above; 1.7%) than the belatacept LI (2 cases, 0.4%) and ciclosporin (one case; 0.2%) groups.
Croatian: Infekcije koje zahvaćaju središnji živčani sustav bile su učestalije u skupini liječenoj MI režimom belatacepta (8 slučajeva, uključujući ranije opisani slučaj PML-a; 1,7%) nego u skupini liječenoj LI režimom belatacepta (2 slučaja, 0,4%) i skupini liječenoj ciklosporinom (jedan slučaj; 0,2%).
English: Make up each vial with 10.5 ml reconstitution solution.
Croatian: Pripremite otopinu u svakoj bočici pomoću 10,5 ml otopine za rekonstituciju.
English: Fewer patients met the composite renal impairment endpoint and mean GFR was higher with belatacept compared to ciclosporin.
Croatian: Manje je bolesnika postiglo složenu mjeru ishoda oštećenja funkcije bubrega i prosječni je GFR bio viši uz belatacept nego ciklosporin.
English: In rats, belatacept had no undesirable effects on male or female fertility.
Croatian: Belatacept nije imao neželjene učinke na plodnost mužjaka i ženki štakora.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should use effective contraception during treatment with belatacept and up to 8 weeks after the last dose of treatment since the potential risk to embryonic/foetal development is unknown.
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena Budući da nije poznat mogući rizik za razvoj embrija/fetusa, žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja belataceptom i do 8 tjedana nakon posljednje doze liječenja.
English: Common tremor, paraesthesia, cerebrovascular accident, dizziness, syncope, lethargy, neuropathy peripheral
Croatian: Često tremor, parestezije, cerebrovaskularni incident, omaglica, sinkopa, letargija, periferna neuropatija
English: If you stop using NULOJIX
Croatian: Ako prestanete primati NULOJIX
English: Fast heart rate, slow heart rate, abnormal and irregular heart beat, weak heart Diabetes
Croatian: Ubrzan rad srca, usporen rad srca, abnormalan ili nepravilan rad srca, slabo srce Šećerna bolest
English: Dose selection and reconstitution of the vials Calculate the dose and number of NULOJIX vials required.
Croatian: Odabir doze i rekonstitucija otopine u bočicama Izračunajte dozu i potreban broj bočica lijeka NULOJIX.
English: Low platelet counts in your blood, too many white blood cells, too many red blood cells Changes in blood levels of carbon dioxide, fluid retention, low protein in the blood Abnormal liver function tests, blood parathyroid hormone increased Increased protein (c-reactive protein) in blood indicating inflammation A decrease of antibodies (proteins that fight infection) in your blood
Croatian: Nizak broj krvnih pločica u krvi, previše bijelih krvnih stanica, previše crvenih krvnih stanica Promjene u razini ugljičnog dioksida u krvi, zadržavanje tekućine, niska razina proteina u krvi Poremećaj u nalazima jetrenih pretraga, povišen paratiroidni hormon u krvi Povišeni protein (C-reaktivni protein) u krvi što ukazuje na upalu Smanjenje protutijela (proteina koji suzbijaju infekciju) u krvi.
English: Headache, difficulty sleeping, feeling nervous or anxious, swelling of the hands and feet Joint pain, back pain, pain in the extremities
Croatian: Glavobolja, poteškoće sa spavanjem, osjećaj nervoze ili tjeskobe, oticanje šaka i stopala Bol u zglobovima, križobolja, bol u udovima
English: Any malignant neoplasm Non-melanoma skin cancer Malignant neoplasms excluding nonmelanoma skin cancers
Croatian: Bilo koja zloćudna novotvorina Nemelanomski karcinom kože Zloćudne novotvorine isključujući nemelanomski karcinom kože PTLD
English: The entire, fully diluted infusion should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Croatian: Svu potpuno razrijeđenu infuziju treba primijeniti u razdoblju od 30 minuta pomoću seta za infuziju i sterilnog, nepirogenog filtra s niskim vezanjem proteina (veličina pora od 0,2 μm do 1,2 μm).
English: Therefore, the recommended dose of belatacept is the LI dosage regimen.
Croatian: Stoga se preporučuje doza belatacepta kakva se primjenjuje u LI režimu doziranja.
English: An excess in mortality and graft loss was observed in the belatatacept LI + MMF group and an excess in mortality was observed in the belatacept MI + MMF group.
Croatian: Povećana smrtnost i gubitak presatka primijećen je u skupini koja je primala LI režim belatacepta i MMF, dok je u skupini koja je primala MI režim belatacepta i MMF bila povećana samo smrtnost.
English: Gastrointestinal symptoms may include pain on swallowing; painful mouth ulcers; white patches in the mouth or throat; upset stomach; stomach pain; vomiting; or diarrhoea.
Croatian: Simptomi probavnog sustava mogu uključivati bol pri gutanju; bolne ranice u ustima; bijele mrlje u ustima i grlu; nadražaj želuca; bol u želucu; povraćanje; ili proljev.
English: You are being treated with a potent medicine that suppresses the immune system.
Croatian: U sklopu liječenja primate vrlo jaki lijek koji potiskuje funkciju obrambenog sustava tijela.
English: Abnormal dreams, mood swings, abnormal lack of ability to focus and sit still, difficulty understanding or thinking, poor memory, migraine, irritability Numbness or weakness from poorly controlled diabetes, changes in the foot from diabetes, inability to keep legs still
Croatian: Abnormalni snovi, promjene raspoloženja, izraženi nedostatak sposobnosti zadržavanje pažnje i mirnog sjedenja, otežano shvaćanje ili razmišljanje, slabo pamćenje, migrena, razdražljivost Utrnutost ili slabost zbog loše kontrolirane šećerne bolesti, promjene na stopalu zbog šećerne bolesti, nemogućnost održavanja mirnih nogu
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije ili razrjeđivanja vidjeti u dijelu 6.3.
English: A total of 217 belatacept (MI: 104 and LI: 113) and 87 ciclosporin patients completed 3 years of treatment in Study 2 and entered the 4-year long-term open label extension period (up to 7 years in total).
Croatian: Ukupno je 217 bolesnika liječenih belataceptom (MI režim: 104 i LI režim: 113) i 87 bolesnika liječenih ciklosporinom završilo 3 godine liječenja u Ispitivanju 2 i ušlo u 4 godišnji dugoročni otvoreni nastavak (do ukupno 7 godina liječenja).
English: The higher proportion of deaths in the LI group in Study 2 was mainly due to neoplasms (MI: 3.8%, LI: 7.1%, ciclosporin: 2.3%).
Croatian: Veći udio smrtnih ishoda u skupini koja je primala LI režim u Ispitivanju 2 prvenstveno je bio posljedica novotvorina (MI režim: 3,8%;LI režim: 7,1%; ciklosporin: 2,3%).
English: In the liver transplant study, the patient received MMF and corticosteroids as concomitant treatment.
Croatian: U ispitivanju presađivanja jetre, bolesnik je istovremeno primao MMF i kortikosteroide.
English: The overall proportion of patients with death or graft loss was lower in belatacept-treated patients (MI: 11.4%, LI: 11.9%) as compared to ciclosporin-treated patients (17.6%) in Study 1.
Croatian: Ukupan udio bolesnika koji su umrli ili izgubili presadak u Ispitivanju 1 bio je manji među bolesnicima liječenima belataceptom (MI režim: 11,4%; LI režim: 11,9%) nego među onima koji su primali ciklosporin (17,6%).
English: No patients with hepatic impairment were studied in renal transplant protocols, therefore dose modification of belatacept in hepatic impairment can not be recommended.
Croatian: U protokolima presađivanja bubrega nisu se ispitivali bolesnici s oštećenjem funkcije jetre, pa se stoga ne mogu dati preporuke za prilagodbu doze belatacepta kod oštećenja funkcije jetre.
English: Allergic reactions may include, but are not limited to, rash; reddened skin; hives; itching; lip swelling; tongue swelling; swelling of the face; swelling over entire body; chest pain; shortness of breath; wheezing; or dizziness..
Croatian: Alergijske reakcije mogu uključivati, ali nisu ograničene na slijedeće: osip, crvenilo kože, koprivnjaču, svrbež, oticanje usnica, oticanje jezika, oticanje lica, oticanje po cijelom tijelu, bol u prsnom košu, nedostatak zraka, piskanje u plućima ili omaglicu.
English: Infusion-related reactions Anaphylaxis has been reported post marketing(see section 4.4).
Croatian: Reakcije povezane s infuzijom Prijavljena je anafilaksija nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: GFRb ml/min/1.73 m2 Year 1
Croatian: Prosječni izmjereni GFRb ml/min/1,73 m2 1. godina 2. godina
English: *Median follow-up excluding PTLD for pooled studies is 1,092 days for each treatment group.
Croatian: *Medijan praćenja, osim u slučaju PTLD-a, u svim ispitivanjima zajedno iznosio je 1092 dana u svakoj terapijskoj skupini.
English: Patients should be evaluated for tuberculosis and tested for latent infection prior to initiating belatacept.
Croatian: Prije početka primjene belatacepta bolesnike treba pregledati na tuberkulozu i testirati na latentnu infekciju.
English: Among Study 2 patients who were EBV seronegative at the time of transplant (for whom use of belatacept is not recommended), there were three cases of PTLD in the belatacept LI group, and none in the belatacept MI and ciclosporin groups.
Croatian: Među bolesnicima iz Ispitivanja 2 koji su u trenutku presađivanja bili seronegativni na EBV (za koje se primjena belatacepta ne preporučuje) zabilježena su tri slučaja PTLD-a u skupini koja je primala belatacept LI režim te nijedan u skupinama koje su primale belatacept MI režim odnosno ciklosporin.
English: The belatacept dosing used in this liver study was higher in all 3 belatacept arms than the belatacept dosing used in the Phase 2 and 3 renal transplant studies.
Croatian: Doze belatacepta je u ovom ispitivanju bila viša u sve tri skupine koje su primale belatacept nego u skupinama koje su primale belatacept u Fazi II i III ispitivanja bubrežnog presatka.
English: Nulojix is normally given with steroids.
Croatian: Primjena s drugim lijekovima koji potiskuju imunitet Nulojix se obično primjenjuje sa steroidima.
English: In Study 1, 11/39 belatacept and 3/21 ciclosporin acute rejections were Banff 97 grade ≥ IIb by Year 3.
Croatian: U Ispitivanju 1 je 11/39 akutnih odbacivanja uz belatacept i 3/21 akutnih odbacivanja uz ciklosporin imalo Banff 97 stupanj ≥ IIb do 3. godine.
English: If you are infected with a virus called cytomegalovirus (CMV)
Croatian: ako prije presađivanja organa niste bili izloženi EBV-u ako ste inficirani virusom koji se zove citomegalovirus (CMV)
English: If you are given more NULOJIX than you should If this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Croatian: Ako se to dogodi, liječnik će Vas promatrati zbog moguće pojave znakova i simptoma nuspojava, koje će po potrebi liječiti.
English: Out of these 24 hours, the solution for infusion may be stored below 25°C for a maximum of 4 hours.
Croatian: Nakon tih 24 sata otopina za infuziju može se čuvati na temperaturi ispod 25°C najduže 4 sata.
English: Infection symptoms may include fever; unexplained weight loss; swollen glands; cold symptoms such as a runny nose or sore throat; cough with sputum; blood in your sputum; earache; cuts or scrapes that are red; warm and oozing pus.
Croatian: Simptomi infekcije mogu uključivati vrućicu; neobjašnjivi gubitak tjelesne težine; otečene limfne čvorove; simptome prehlade poput curenja iz nosa i grlobolje; kašalj s iskašljajem; krv u iskašljaju; uhobolju; promjene na koži u obliku posjekotina i crvenih ogrebotina; koje su tople i iz kojih curi gnoj.
English: If you forget to use NULOJIX
Croatian: Ako ste zaboravili primiti NULOJIX
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate).
Croatian: Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
English: The overall proportion of patients with death or graft loss was comparable across treatment groups (29.3%, 30.9%, and 28.3% for MI, LI and ciclosporin, respectively) in Study 2.
Croatian: Ukupan udio bolesnika koji su umrli ili izgubili presadak u Ispitivanju 2 bio je usporediv u svim terapijskim skupinama (29,3% uz MI režim, 30,9% uz LI režim te 28,3% uz ciklosporin).
English: Sudden problems with breathing leading to lung damage, increased blood pressure in the lungs, inflammation of the lungs, coughing up blood, abnormality of lungs and air tubes delivering air in and out of lungs, fluid in the sac around the lungs, breathing that stops temporarily during sleep, abnormal speaking sound
Croatian: Iznenadni problemi s disanjem koji vode do oštećenja pluća, povišen krvni tlak u plućima, upala pluća, iskašljavanje krvi, abnormalnost pluća i dišnih puteva koji vode zrak u pluća i iz pluća, tekućina u plućnoj maramici, privremeni prekid disanja u snu, abnormalni zvuk glasa pri govoru Genitalni herpes
English: Presented in Table 2, by system organ classification and frequency categories, is the list of adverse reactions with at least a suspected causal relationship, reported in clinical trials cumulatively up to Year 3 and pooled for both belatacept regimens (MI and LI).
Croatian: U tablici 2 je prema klasifikaciji organskih sustava i kategorijama učestalosti prikazan popis nuspojava kod oba režima belatacepta (MI i LI) za koje je postojala barem sumnja da su uzročno-posljedično povezane s belataceptom i koje su bile kumulativno zabilježene u kliničkim ispitivanjima tijekom 3 godine liječenja.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, sodium chloride, and for pH adjustment sodium hydroxide and hydrochloric acid.
Croatian: Pomoćne tvari: saharoza, natrijev dihidrogenfosfat hidrat, natrijev klorid, a za prilagodbu pH natrijev hidroksid i kloridna kiselina.
English: Belatacept was not teratogenic when administered to pregnant rats and rabbits at doses up to 200 mg/kg and 100 mg/kg daily, respectively, representing approximately 16 and 19 times the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg based on AUC.
Croatian: Nije imao teratogeno djelovanje kad se primjenjivao trudnim ženkama štakora u dozama do 200 mg/kg na dan i trudnim ženkama kunića u dozi do 100 mg/kg na dan, što je predstavljalo približno 16 odnosno 19 puta veću izloženost povezanu s maksimalnom preporučenom dozom od 10 mg/kg u ljudi (MRHD) na temelju AUC.
English: One fatal case of PML was reported in a renal transplant recipient treated with belatacept MI regimen, an IL-2 receptor antagonist, MMF, and corticosteroids for 2 years in a Phase 3 trial.
Croatian: Jedan smrtni slučaj zbog PML-a zabilježen je u primatelja bubrežnog presatka liječenog MI režimom belatacepta, antagonistom IL-2 receptora, MMF-om i kortikosteroidima tijekom 2 godine u ispitivanju Faze III.
English: Reaction to an infusion, scare tissue, inflammation, return of disease, feeling hot, ulcer Not making enough urine
Croatian: Reakcija na infuziju, ožiljno tkivo, upala, povratak bolesti, osjećaj vrućine, ulkus Nedostatno lučenje mokraće
English: NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Croatian: NULOJIX treba primjenjivati u kombinaciji s uvodnom terapijom baziliksimabom te mofetilmikofenolatom i kortikosteroidima.
English: Do not use if opaque particles, discolouration or other foreign particles are present.
Croatian: Nemojte primjenjivati otopinu ako su prisutne neprozirne čestice, promjena boje ili druge strane čestice.
English: Insert the syringe needle into the vial through the centre of the rubber stopper.
Croatian: Uvedite iglu štrcaljke u bočicu kroz sredinu gumenog čepa.
English: For patients who may be switched from belatacept to another immunosuppressant, physicians should be aware of the 8-10 day half-life of belatacept to avoid potential under- or over-immunosuppression following discontinuation of belatacept.
Croatian: Kod bolesnika u kojih se belatacept zamjenjuje drugim imunosupresivom, liječnici trebaju imati na umu da je poluvijek belatacepta 8-10 dana.
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate, sucrose, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
Croatian: Drugi sastojci su natrijev klorid, natrijev dihidrogenfosfat hidrat, saharoza, natrijev hidroksid (za podešavanje pH) i kloridna kiselina (za podešavanje pH). (Vidjeti dio 2.)
English: Overall occurrences of polyoma virus infections and fungal infections were numerically lower in the belatacept LI group compared with the belatacept MI and ciclosporin groups.
Croatian: Ukupna učestalost infekcije polioma virusom i gljivicama bila je brojčano niža u skupini liječenoj LI režimom belatacepta nego u skupinama liječenima MI režimom belatacepta ili ciklosporinom.
English: Infusion must be completed within 24 hours of reconstitution of the powder.
Croatian: Infuzija se mora završiti u roku od 24 sata od rekonstitucije praška.
English: Lymphocyte depleting therapies to treat acute rejection should be used cautiously.
Croatian: Terapiju za liječenje akutne reakcije odbacivanja koja dovodi do smanjenja broja limfocita treba primjenjivati s oprezom.
English: Tuberculosis was more frequently observed in patients receiving belatacept than ciclosporin in clinical studies (see section 4.8).
Croatian: U kliničkim je ispitivanjima tuberkuloza bila češće primijećena u bolesnika koji su primali belatacept nego u onih koji su primali ciklosporin (vidjeti dio 4.8).
English: Anaphylaxis has been reported during post marketing surveillance (see section 4.8).
Croatian: Prijavljena je anafilaksija tijekom praćenja lijeka nakon stavljanja lijeka u promet (vidjeti dio 4.8).
English: This will avoid aggregate formation (see section 6.2).
Croatian: Tako će se izbjeći stvaranje agregata (vidjeti dio 6.2) Ne tresite bočice.
English: Acne, hair loss, abnormal change to the skin, excessive sweating, night sweats Weakness/gap in abdominal muscles and out pouching of skin over healed incision, hernia on the stomach wall
Croatian: Akne, ispadanje kose, abnormalne promjene kože, pojačano znojenje, noćno znojenje Slabost/rascjep trbušnih mišića i izbočenje kože iznad zacijeljenog kirurškog reza, hernija na trbušnoj stijenci
English: Adequate treatment of latent tuberculosis infection should be instituted prior to belatacept use.
Croatian: Prije primjene belatacepta treba provesti odgovarajuće liječenje latentne infekcije tuberkulozom.
English: Do not shake the vials.
Croatian: Ne tresite bočice.