FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study 2 by Year 3, mean calculated GFR was 11 ml/min/1.73 m2 higher with belatacept, and 27% and 44% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Croatian: U Ispitivanju 2 je, do 3. godine, prosječni izračunati GFR uz belatacept bio viši za 11 ml/min/1,73 m a 27% bolesnika liječenih belataceptom i 44% bolesnika liječenih ciklosporinom doseglo je stadij CKD 4/5 (GFR < 30 ml/min/1,73 m2).
English: The occurrence of autoimmune events across the core clinical studies was infrequent, occurring at rates of 1.7%, 1.7%, and 1.9% by Year 3 for the MI, LI, and ciclosporin groups respectively.
Croatian: Autoimuni događaji u svim ključnim kliničkim ispitivanjima nisu bili česti i zabilježeni su do 3. godine u 1,7% bolesnika u skupinama liječenima MI režimom belatacepta, 1,7% u skupinama liječenima LI režimom belatacepta i 1,9% u skupinama liječenima ciklosporinom.
English: The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
Croatian: O odluci da prestanete primati NULOJIX trebate razgovarati s Vašim liječnikom.
English: It is recommended to transfer the reconstituted solution from the vial to the infusion bag or bottle immediately.
Croatian: Preporučuje se odmah prenijeti rekonstituiranu otopinu iz bočice u infuzijsku vrećicu ili bocu.
English: What you need to know before you use NULOJIX 3.
Croatian: Što morate znati prije nego počnete primjenjivati NULOJIX 3. Kako primjenjivati NULOJIX 4. Moguće nuspojave
English: Dangerously low red blood cells, dangerously lowered white cell counts, destruction of red blood cells, blood clotting problems, acid in the blood from diabetes, lack of acid in the blood Improper production of hormones by the adrenal glands Low vitamin D levels
Croatian: Opasno nizak broj crvenih krvnih stanica, opasno snižen broj bijelih krvnih stanica, razaranje crvenih krvnih stanica, tegobe zbog zgrušavanja krvi, kiselost krvi zbog šećerne bolesti, nedostatak kiselosti krvi
English: How to use NULOJIX
Croatian: Kako primjenjivati NULOJIX
English: The dose and treatment frequency is given below.
Croatian: Veličina doze i učestalost primjene navedeni su u daljnjem tekstu.
English: The NULOJIX infusion must be completed within 24 hours of reconstitution of the powder.
Croatian: Infuzija lijeka NULOJIX mora se završiti u roku od 24 sata nakon pripreme praška za primjenu.
English: Bladder or kidney infection, upper respiratory infection, CMV infection (can cause serious blood and tissue infections), fever, cough, bronchitis
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) su: Infekcija mokraćnog mjehura ili bubrega, infekcija gornjih dišnih puteva, citomegalovirusna (CMV) infekcija (može prouzročiti ozbiljnu infekciju krvi i tkiva), vrućica, kašalj, bronhitis Nedostatak zraka
English: Discard the solution if any particulate matter or discolouration is observed.
Croatian: Bacite otopinu ako opazite prisutnost ikakvih čestica ili promjene boje.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 250 mg belatacept.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 250 mg belatacepta.
English: If you are of child bearing potential, you should use effective contraception during treatment with NULOJIX and up to 8 weeks after the last dose of treatment since the potential risk to embryonic/foetal development is unknown.
Croatian: 8 tjedana nakon zadnje doze lijeka, budući da nije poznat mogući rizik za razvoj embrija/fetusa.
English: Each vial is co-packaged with a disposable polypropylene syringe.
Croatian: Jedna bočica pakirana je zajedno s polipropilenskom štrcaljkom za jednokratnu uporabu.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Package leaflet: Information for the user NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Croatian: Uputa o lijeku: Informacije za korisnika NULOJIX 250 mg prašak za koncentrat za otopinu za infuziju belatacept
English: After reconstitution, each ml of concentrate contains 25 mg belatacept.
Croatian: Nakon rekonstitucije, jedan ml koncentrata sadrži 25 mg belatacepta.
English: In clinical trials, an increased incidence of graft thrombosis was observed in the post-transplant period in recipients of extended criteria donor allografts.
Croatian: U kliničkim ispitivanjima povišena incidencija tromboze presatka primijećena je u primatelja u razdoblju nakon presađivanja alografta s darivatelja prema proširenim kriterijima (vidjeti dio 4.8).
English: Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
Croatian: U ispitivanje 2 nisu bili uključeni primatelji čiji je trenutni PRA bio ≥ 30%, primatelji u kojih je organ ponovno presađen te primatelji s pozitivnim nalazom na limfocitotoksičnost T-stanica u testu križne reakcije.
English: Blood and lymphatic system disorders Very Common anaemia, leukopenia Common thrombocytopenia, neutropenia, leukocytosis, polycythaemia, lymphopenia
Croatian: Poremećaji krvi i limfnog sustava Vrlo često anemija, leukopenija
English: Table 2: Adverse reactions in clinical trials Infections and infestations Very Common urinary tract infection, upper respiratory infection, cytomegalovirus infection*, bronchitis
Croatian: Vrlo često infekcija mokraćnih puteva, infekcija gornjih dišnih puteva, citomegalovirusna infekcija*, bronhitis
English: Inflammation of the colon (large bowel) caused by the cytomegalovirus, inflammation of the pancreas, ulcer in the stomach, small intestines, or large intestine, blockage of the small intestine, black, tar-like stools, rectal bleeding, abnormal colour of the stool
Croatian: Upala debelog crijeva prouzročena citomegalovirusom, upala gušterače, čir želuca, tankog crijeva, ili debelog crijeva, blokada tankog crijeva, crna stolica poput katrana, krvarenje iz debelog crijeva, neprirodna boja stolice
English: Common renal tubular necrosis, renal vein thrombosis*, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
Croatian: Često renalna tubularna nekroza, tromboza bubrežne vene*, stenoza bubrežne arterije, glikozurija, hidronefroza, vezikoureteralni refluks, urinarna inkontinencija, retencija urina, nokturija
English: Progression of Chronic Kidney Disease (CKD) Staging In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Croatian: U Ispitivanju 1 je, do 3. godine, prosječni izračunati GFR uz belatacept bio viši za 21 ml/min/1,73 m2 a 10% bolesnika liječenih belataceptom i 20% bolesnika liječenih ciklosporinom doseglo je stadij CKD 4/5 (GFR < 30 ml/min/1,73 m2).
English: Injury, poisoning and procedural complications Very Common graft dysfunction Common chronic allograft nephropathy (CAN), incisional hernia
Croatian: Ozljede, trovanja i proceduralne komplikacije Vrlo često poremećaj funkcije presatka
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev dihidrogenfosfat hidrat natrijev klorid natrijev hidroksid (za prilagodbu pH) kloridna kiselina (za prilagodbu pH)
English: aProportion of Patients with Measured GFR < 60 ml/min/1.73 m2 or with a Decrease in Measured GFR ≥ 10 ml/min/1.73 m2 from Month 3 to Month 12. b Measured GFR was assessed by iothalamate at Year 1 and 2 only c Calculated GFR was assessed by MDRD formula at Month 1, Years 1, 2, and 3
Croatian: Udio bolesnika s izmjerenim GFR< 60 ml/min/1,73 m2 ili sa smanjenjem izmjerenog GFR za ≥ 10 ml/min/1,73 m2 od 3. do 12. mjeseca.
English: Your body may reject the transplanted kidney if you stop using NULOJIX.
Croatian: Ako prestanete primati NULOJIX, Vaše tijelo može odbaciti presađeni bubreg.
English: PTLD
Croatian: Cijepljenje
English: How to store NULOJIX
Croatian: Kako čuvati Nulojix
English: Fluid in the lungs, wheezing, chest pain or angina, enlarged heart muscle (bottom of the heart) Infection of the blood or tissues, respiratory infections, pneumonia, flu, sinus inflammation, runny nose, sore throat, pain in the mouth/throat region, herpes virus infections, shingles and other viral infections, mouth sores, thrush, kidney infection, fungal skin infections,fungal infections of the nails and other fungal infections, skin infection, infection of soft tissues, wound infection,
Croatian: Infekcija krvi ili tkiva, infekcije dišnih puteva, upala pluća, gripa, upala sinusa, curenje iz nosa, grlobolja, bol u području usta/grla, infekcije herpes virusom, herpes zoster i druge virusne infekcije, ranice u ustima, soor, infekcija bubrega, gljivične infekcije kože, gljivične infekcije noktiju i druge gljivične infekcije, kožne infekcije, infekcija mekih tkiva, infekcija rane, infekcija ograničena na jedno područje, usporeno cijeljenje rane, krvavi podljevi, nakupljanje limfe oko presađenog bubrega
English: Guillian-Barré syndrome (a condition that causes muscle weakness or paralysis) EBV (Epstein-Barr virus) lymphoproliferative disease Blood clotting in veins, inflamed veins, periodic leg cramps Abnormal arteries, scarring of the arteries, clotting in the arteries, narrowing of the arteries, temporary redness of the face/skin, swelling of the face Stones in the gallbladder, fluid filled pocket in the liver, fatty liver Skin disease with thickened patches of red skin, often with silvery scales, abnormal hair growth, excessive hair breakage, nails breaking, ulcer on the penis Abnormal balance of minerals in the body causing bone problems, bone inflammation, abnormal weakening of the bone leading to bone problems, inflammation of the lining of the joints, rare bone condition
Croatian: Žučni kamenci, džep ispunjen tekućinom u jetri, masna jetra Kožna bolest s zadebljanim područjima crvene kože, često sa srebrnkastim ljuskicama, poremećaj rasta kose, pretjerano lomljiva kosa, lomljivi nokti, ulkus penisa Poremećaj ravnoteže minerala u tijelu koja uzrokuje tegobe s kostima, upala kosti, abnormalno slabljenje kosti koje dovodi do koštanih tegoba, upala ovojnice zglobova, rijetka koštana bolest
English: Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
Croatian: U 3 od 6 slučajeva PTLD koji se javio pri liječenju belataceptom prema LI režimu zahvatio je središnji živčani sustav i imao smrtni ishod.
English: The use of live vaccines should be avoided with the use of NULOJIX.
Croatian: Za vrijeme liječenja lijekom NULOJIX treba izbjegavati cijepljenje živim cjepivima.
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate belatacept
Croatian: NAZIV LIJEKA NULOJIX 250 mg prašak za koncentrat belatacept
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA NULOJIX 250 mg prašak za koncentrat za otopinu za infuziju
English: Uncommon pancreatic enzymes increased, troponin increased, electrolyte imbalance, prostate-specific antigen increased, blood uric acid increased, urine output decreased, blood glucose decreased, CD4 lymphocytes decreased
Croatian: Pretrage Često povišen C-reaktivni protein, povišen paratiroidni hormon u krvi Manje često povišeni enzimi gušterače, povišen troponin, poremećaj ravnoteže elektrolita, povišen antigen specifičan za prostatu, povišena mokraćna kiselina u krvi, smanjeno izlučivanje mokraće, smanjena glukoza u krvi, smanjen broj CD4 limfocita
English: Uncommon encephalitis, Guillain-Barré syndrome*, brain oedema, intracranial pressure increased, encephalopathy, convulsion, hemiparesis, demyelination, facial palsy,
Croatian: Manje često encefalitis, Guillain-Barréov sindrom*, edem mozga, povišen intrakranijalni tlak, encefalopatija, konvulzije, hemipareza, demijelinizacija, facijalna paraliza, disgeuzija, kognitivni poremećaj, oštećenje memorije, migrena, osjećaj žarenja, dijabetička neuropatija, sindrom nemirnih nogu
English: Vascular disorders
Croatian: Tromboza presatka
English: Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 3) Dose modification of NULOJIX is not recommended for a change in body weight of less than
Croatian: Ukupna doza belatacepta u mg jednaka je tjelesnoj težini bolesnika u kg pomnoženoj s dozom belatacepta u mg/kg (5 ili 10 mg/kg, vidjeti dio 3).
English: See section 4.
Croatian: U ispitivanju 1,
English: In Study 2, mean calculated GFR at 7 years was 57.6, 59.1 and 44.6 mL/min/1.73 m2, in the same groups, respectively.
Croatian: U ispitivanju 2, srednja vrijednost izračunatog GFR-a nakon 7 godina iznosila je 57,6 ml/min/1,73 m2 uz belatacept MI režim, 59,1 ml/min/1,73 m2 uz belatacept LI režim te 44,6 ml/min/1,73 m2 uz ciklosporin.
English: Common sepsis, pneumonia, influenza, gastroenteritis, herpes zoster, sinusitis, herpes simplex, oral candidiasis, pyelonephritis, onychomycosis, BK virus infection, respiratory tract infection, candidiasis, rhinitis, cellulitis, wound infection, localised infection, herpes virus infection, fungal infection, fungal skin infection
Croatian: Često sepsa, pneumonija, influenca, gastroenteritis, herpes zoster, sinusitis, herpes simpleks, oralna kandidijaza, pijelonefritis, onihomikoza, infekcija BK virusom, infekcija dišnih puteva, kandidijaza, rinitis, celulitis, infekcija rane, lokalizirana infekcija, infekcija herpes virusom, gljivična infekcija, gljivična infekcija kože Manje često progresivna multifokalna leukoencefalopatija*, gljivična infekcija mozga, citomegalovirusni (CMV) kolitis, nefropatija povezana s poliomavirusom, genitalni herpes, stafilokokna infekcija, endokarditis, tuberkuloza*, bronhiektazije, osteomijelitis, strongiloidoza, blastocistična infekcija, giardiaza, limfangitis
English: Fungal infections Tuberculosis
Croatian: Gljivične infekcije 13,8 Tuberkuloza
English: Each NULOJIX vial provides 250 mg of belatacept.
Croatian: Jedna bočica lijeka NULOJIX osigurava 250 mg belatacepta.
English: You must stop breast-feeding if you are being treated with NULOJIX.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom NULOJIX.
English: Common weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypercalcaemia, hypoproteinaemia
Croatian: Često povećanje tjelesne težine, šećerna bolest, dehidracija, smanjenje tjelesne težine, acidoza, zadržavanje tekućine, hiperkalcijemija, hipoproteinemija Manje često dijabetička ketoacidoza, dijabetičko stopalo, alkaloza, smanjen apetit, nedostatak vitamina D
English: Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
Croatian: U jednom ispitivanju Faze II i dva ispitivanja Faze III bubrežnog presatka bilo je dvjesto sedamnaest (217) bolesnika u dobi od 65 ili više godina koji su primali belatacept.
English: Dose of belatacept for renal transplant recipients
Croatian: Doza belatacepta u primatelja bubrežnog presatka
English: Start (Day of Transplant):_______________ Most recent: _________________________ Next treatment date:____________________ Patient's Name:_______________________ Doctor's Name:_______________________ Doctor's Phone:_______________________ If NULOJIX is stopped, keep this card with you for an additional 3 months.
Croatian: U slučaju prekida primjene lijeka NULOJIX, sačuvajte ovu karticu još sljedeća 3 mjeseca.
English: Cardiac disorders Common tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy
Croatian: Često vrtoglavica, bol u uhu, tinitus Manje često hipoakuzija Srčani poremećaji Često tahikardija, bradikardija, atrijska fibrilacija, zatajenje srca, angina pektoris, hipertrofija lijeve srčane klijetke
English: Uncommon infusion related reaction*, irritability, fibrosis, inflammation, disease recurrence, feeling hot, ulcer
Croatian: Često bol u prsištu, umor, malaksalost, poremećeno cijeljenje Manje često reakcija povezana s infuzijom*, razdražljivost, fibroza, upala, povratak bolesti, osjećaj vrućine, ulkus
English: Common cushingoid
Croatian: Kušingoidni izgled
English: Blood clotting in kidney artery
Croatian: Stvaranje krvnih ugrušaka u bubrežnoj arteriji
English: Uncommon cholelithiasis, hepatic cyst, hepatic steatosis Skin and subcutaneous tissue disorders Common acne, pruritis, alopecia, skin lesion, rash, night sweats, hyperhidrosis
Croatian: Često citolitički hepatitis, poremećeni testovi jetrene funkcije Manje često kolelitijaza, jetrena cista, jetrena steatoza Poremećaji kože i potkožnog tkiva Često akne, pruritus, alopecija, kožna lezija, osip, noćno znojenje, hiperhidroza
English: In Study 1, mean calculated GFR at 7 years was 74.0, 77.9 and 50.7 mL/min/1.73 m2 in the belatacept MI, belatacept LI and ciclosporin groups, respectively.
Croatian: srednja vrijednost izračunatog GFR-a nakon 7 godina iznosila je 74,0 ml/min/1,73 m2 uz belatacept MI režim, 77,9 ml/min/1,73 m2 uz belatacept LI režim te 50,7 ml/min/1,73 m2 uz ciklosporin.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Only use co-packed syringe for reconstitution and dilution.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Infusion-related reactions have been reported with belatacept administration in clinical studies.
Croatian: U kliničkim ispitivanjima primjene belatacepta zabilježene su reakcije povezane s infuzijom.
English: Uncommon hypophosphatasia
Croatian: hiperkoagulacija
English: Uncommon retinitis, conjunctivitis, eye inflammation, keratitis, photophobia, eyelid oedema Ear and labyrinth disorders
Croatian: Poremećaji oka Često katarakta, okularna hiperemija, zamagljen vid Manje često retinitis, konjunktivitis, upala oka, keratitis, fotofobija, edem vjeđa Poremećaji uha i labirinta
English: Lung cancer, rectal cancer, breast cancer, a form of cancer in the bones, musles, or fat tissue, tumor of the skin and intestinal tract caused by a herpes virus and seen in patients with a weakened immune system, prostate cancer, cancer of the cervix, throat cancer, cancer of the lymph nodes, cancer of the bone marrow, cancer of the kidney, kidney tubes, or bladder Fungal infection of brain, inflammation of the brain, serious brain infection called PML (progressive multifocal leukoencephalopathy)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) su: Rak pluća, rak debelog crijeva, rak dojke, jedna vrsta raka kostiju, mišića ili masnog tkiva, tumor kože i crijeva prouzročen herpes virusom koji se vidi u bolesnika s oslabljenim imunološkim sustavom, rak prostate, rak grlića maternice, rak grla, rak limfnih čvorova, rak koštane srži, rak bubrega, mokraćovoda, ili mokraćnog mjehura
English: Very Common diarrhoea, constipation, nausea, vomiting, abdominal pain Common dyspepsia, aphthous stomatitis, abdominal hernia
Croatian: Poremećaji probavnog sustava Vrlo često proljev, konstipacija, mučnina, povraćanje, bol u abdomenu
English: The overall occurrence of tuberculosis infections and non-serious herpes infections were higher for belatacept regimens than for the ciclosporin regimen.
Croatian: Učestalosti infekcija u 1. i 3. godini po terapijskoj skupini prikazane su u tablici 4. Ukupna učestalost tuberkulozne infekcije i herpetične infekcije koja nije bila ozbiljna bila je viša uz primjenu režima belatacepta nego uz primjenu ciklosporina.
English: Uncommon monocytopenia, pure red cell aplasia, agranulocytosis, haemolysis, hypercoagulation Immune system disorders Common blood immunoglobulin G decreased, blood immunoglobulin M decreased,
Croatian: Često trombocitopenija, neutropenija, leukocitoza, policitemija, limfopenija Manje često monocitopenija, izolirana aplazija crvene loze, agranulocitoza, hemoliza,
English: Uncommon venous thrombosis, arterial thrombosis, thrombophlebitis, arterial stenosis, intermittent claudication, flushing
Croatian: Često šok, infarkt, hematom, limfokela, angiopatija, arterijska fibroza Manje često venska tromboza, arterijska tromboza, tromboflebitis, arterijska stenoza, intermitentna klaudikacija, crvenilo
English: Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00
Croatian: Česká republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
English: Uncommon gastrointestinal disorder, pancreatitis, large intestinal ulcer, melaena, gastroduodenal ulcer, rectal haemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, faeces discoloured Hepatobiliary disorders
Croatian: Često dispepsija, aftozni stomatitis, abdominalna hernija Manje često gastrointestinalni poremećaj, pankreatitis, ulkus debelog crijeva, melena, gastroduodenalni ulkus, rektalno krvarenje, opstrukcija tankog crijeva, heilitis, gingivalna hiperplazija, bol u žlijezdama slinovnicama, promjena boje stolice
English: Respiratory, thoracic and mediastinal disorders Very Common dyspnoea, cough Common pulmonary oedema, wheezing, hypocapnea, orthopnoea, epistaxis, oropharyngeal pain
Croatian: Često edem pluća, piskanje u plućima, hipokapnija, ortopneja, epistaksa, orofaringealna bol
English: Infusion-related reactions have been reported with belatacept administration in the clinical studies.
Croatian: U kliničkim su ispitivanjima kod primjene belatacepta bile zabilježene reakcije povezane s infuzijom.
English: EBV associated lymphoproliferative disorder**,lung cancer, rectal cancer, breast cancer, sarcoma, kaposi's sarcoma, prostate cancer, cervix carcinoma, laryngeal cancer, lymphoma, multiple myeloma, transitional cell carcinoma
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)* Često karcinom skvamoznih stanica kože, karcinom bazalnih stanica, kožni papilomi Manje često limfoproliferativna bolest povezana s EBV**, karcinom pluća, karcinom rektuma, karcinom dojke, sarkom, Kaposijev sarkom, karcinom prostate, karcinom grlića maternice, karcinom larinksa, limfom, multipli mijelom, karcinom prijelaznih stanica
English: Infection with the strongyloides worm, diarrheal infection with Giardia parasite Kidney disease that is caused by a virus (polyomavirus-associated nephropathy), inflammation of the kidneys, scarring of the kidneys, shrinkage of the small tubes in the kidney, inflammation of the bladder with bleeding
Croatian: Bakterijske infekcije, upala ili infekcija unutarnje ovojnice srca, tuberkuloza, infekcija kosti, upala limfnih čvorova, kronično proširenje dišnih puteva u plućima s čestim plućnim infekcijama Infekcija glistom Strongyloides, infekcija parazitom Giardia praćena proljevom Bolest bubrega koja je prouzročena virusom (nefropatija povezana s poliomavirusom), upala bubrega, stvaranje ožiljaka u bubregu, sužavanje kanalića u bubregu, upala mokraćnog mjehura s krvarenjem
English: Musculoskeletal and connective tissue disorders Very Common arthralgia, back pain, pain in extremity Common myalgia, muscular weakness, bone pain, joint swelling, intervertebral disc disorder, joint lock, muscle spasms, osteoarthritis
Croatian: Često mialgija, mišićna slabost, bol u kostima, oticanje zglobova, poremećaj intervertebralnih diskova, zakočenost zglobova, grčevi mišića, osteoartritis Manje često poremećaj koštanog metabolizma, osteitis, osteoliza, sinovitis Poremećaj bubrega i mokraćnog sustava
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Croatian: NULOJIX 250 mg prašak za koncentrat za otopinu za infuziju belatacept
English: It must also not be used together with medicines that affect the activity of certain enzymes that can raise or lower the level of the active substance in the blood.
Croatian: Također se ne smije primjenjivati zajedno s lijekovima koji utječu na djelovanje određenih enzima koji mogu povisiti ili sniziti razinu djelatne tvari u krvi.