natgillin/translations-raw huggingface dataset:
Uncommon transplant failure, transfusion reaction, wound dehiscence, fracture, tendon rupture, procedural hypotension, procedural hypertension, post-procedural haematoma, procedural pain, procedural headache, contusion
Često kronična nefropatija presatka (CAN), incizijska hernija Manje često zatajenje presatka, transfuzijska reakcija, dehiscijencija rane, fraktura, ruptura tetive, proceduralna hipotenzija, proceduralna hipertenzija, postproceduralni hematom, proceduralna bol, proceduralna glavobolja, kontuzija
Patient and graft survival were similar between belatacept and ciclosporin.
Preživljenje bolesnika i presatka bilo je slično u skupinama koje su primale belatacept i onima koje su primale ciklosporin.
More patients discontinued in the ciclosporin group (34.5%) versus each belatacept group (28.8% and 25.7% for MI and LI groups, respectively) during the long-term extension period.
Liječenje je tijekom dugoročnog nastavka prekinuo veći broj bolesnika u skupini liječenoj ciklosporinom (34,5%) nego i u jednoj skupini liječenoj belataceptom (28,8% uz MI režim i 25,7% uz LI režim).
Uncommon acute respiratory distress syndrome, pulmonary hypertension, pneumonitis, haemoptysis, bronchopneumopathy, painful respiration, pleural effusion, sleep apnoea syndrome, dysphonia, oropharyngeal blistering
Manje često akutni respiratorni distres sindrom, plućna hipertenzija, pneumonitis, hemoptiza, bronhopneumopatija, bolno disanje, pleuralni izljev, sindrom apneje u snu, disfonija, pojava mjehurića u orofarinksu
In postmarketing experience in patients with other predisposing risk factors for thrombosis of the renal allograft, renal allograft thrombosis has been reported when the initial dose of anti-thymocyte globulin was coadministered at the same or nearly the same time with the first dose of belatacept.
Nakon stavljanja lijeka u promet primijećeno je da se u bolesnika s drugim predisponirajućim čimbenicima rizika za razvoj tromboze renalnog alografta, pojavila tromboza renalnog alografta kada je početna doza anti-timocitnog globulina,, bila primjenjena u isto vrijeme ili skoro u isto vrijeme kao i prva doza belatacepta. (vidjeti dio 4.4.).
There was an increase in viral and fungal infections in the belatacept groups versus the tacrolimus groups, however overall frequency of serious infections was not different among all treatment groups (see section 4.4).
Međutim, nije bilo razlike u ukupnoj učestalosti ozbiljnih infekcija u svim terapijskim skupinama (vidjeti dio 4.4).
During the long-term extension period, malignancies (including PTLD) were reported in 10.3%, 8.4%, and 14.7% of patients in the belatacept MI, belatacept LI, and ciclosporin groups, respectively, in Study 1; and in 19.2%, 13.3% and 16.1% of patients in the belatacept MI, belatacept LI, and ciclosporin groups, respectively, in Study 2.
Tijekom dugoročnog nastavka ispitivanja, zloćudne bolesti (uključujući PTLD) prijavljene su u 10,3%, 8,4% i 14,7% bolesnika u skupini koja je primala belatacept MI režim, belatacept LI režim odnosno ciklosporin u Ispitivanju 1; te u 19,2%, 13,3% i 16,1% bolesnika u skupini koja je primala belatacept MI režim, belatacept LI režim odnosno ciklosporin u Ispitivanju
It is not known whether belatacept, the active substance, passes into human milk.
Nije poznato izlučuje li se djelatna tvar belatacept, u majčino mlijeko.
In a Phase 2 study, there were 2 cases of graft thrombosis, 1 each in MI and LI (incidence of 1.4% for both) versus 0 in the ciclosporin group.
U ispitivanju Faze II bila su 2 slučaja tromboze presatka, jedan u skupini liječenoj MI režimom i jedan u skupini liječenoj LI režimom belatacepta (incidencija 1,4% u obje skupine), nasuprot 0 slučajeva u skupini liječenoj ciklosporinom.
During the long-term extension period, autoimmune events occurred in 2.6% and 3.0% of patients in the belatacept MI and LI groups, respectively, and in 3.7% of patients in the ciclosporin group in Study 1; and in 5.8% and 3.5% of patients in the belatacept MI and LI groups, respectively, and in 0% of patients in ciclosporin group in Study 2.
Tijekom dugoročnog nastavka ispitivanja, autoimuni događaji nastupili su u 2,6% i 3,0% bolesnika u skupini koja je primala belatacept MI odnosno LI režim i u 3,7% bolesnika u skupini koja je primala ciklosporin u Ispitivanju 1; te u 5,8% i 3,5% bolesnika u skupini koja je primala belatacept MI odnosno LI režim i u 0% bolesnika u skupini koja je primala ciklosporin u Ispitivanju
Cracking of the corner of the mouth, swollen gums, salivary gland pain Increased sexual desire
Pucanje kože u kutu usnica, otečene desni, bol u žlijezdama slinovnicama Pojačana spolna želja
PTLD occurred at a higher rate in both belatacept treatment groups versus ciclosporin (see section 4.4).
PTLD se učestalije javljao u skupinama liječenima belataceptom nego u skupini liječenoj ciklosporinom (vidjeti dio 4.4).
After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately.
Nakon rekonstitucije Rekonstituirana otopina se mora odmah prenijeti iz bočice u infuzijsku vrećicu ili bocu.
Each vial contains 250 mg belatacept.
Jedna bočica sadrži 250 mg belatacepta.
More patients discontinued in the ciclosporin group (32.4%) versus each belatacept group (17.4% and 18.1% in MI and LI groups, respectively) during the long-term extension period.
Liječenje je tijekom dugoročnog nastavka prekinuo veći broj bolesnika u skupini liječenoj ciklosporinom (32,4%) nego i u jednoj skupini liječenoj belataceptom (17,4% uz MI režim i 18,1% uz LI režim).
During the long-term extension period, serious infections occurred in 30.3% and 23.5% of patients in the belatacept MI and LI groups, respectively, and in 27.2% of patients in the ciclosporin group in Study 1; and in 35.6% and 38.1% of patients in the belatacept MI and LI groups, respectively, and in 37.9% of patients in the ciclosporin group in Study 2.
Tijekom dugoročnog nastavka ispitivanja, ozbiljne infekcije nastupile su u 30,3% i 23,5% bolesnika u skupini koja je primala belatacept MI režim, odnosno belatacept LI režim, i u 27,2% bolesnika u skupini koja je primala ciklosporin u Ispitivanju 1; te u 35,6% i 38,1% bolesnika u skupini koja je primala belatacept MI režim, odnosno belatacept LI režim i u 37,9% bolesnika u skupini koja je primala ciklosporin u Ispitivanju
Patients do not require pre-medication prior to administration of belatacept.
Prije primjene belatacepta bolesnicima nije potrebna premedikacija.
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.
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).
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.
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.
The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
O odluci da prestanete primati NULOJIX trebate razgovarati s Vašim liječnikom.
It is recommended to transfer the reconstituted solution from the vial to the infusion bag or bottle immediately.
Preporučuje se odmah prenijeti rekonstituiranu otopinu iz bočice u infuzijsku vrećicu ili bocu.
What you need to know before you use NULOJIX 3.
Što morate znati prije nego počnete primjenjivati NULOJIX 3. Kako primjenjivati NULOJIX 4. Moguće nuspojave
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
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
How to use NULOJIX
Kako primjenjivati NULOJIX
The dose and treatment frequency is given below.
Veličina doze i učestalost primjene navedeni su u daljnjem tekstu.
The NULOJIX infusion must be completed within 24 hours of reconstitution of the powder.
Infuzija lijeka NULOJIX mora se završiti u roku od 24 sata nakon pripreme praška za primjenu.
Bladder or kidney infection, upper respiratory infection, CMV infection (can cause serious blood and tissue infections), fever, cough, bronchitis
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
Discard the solution if any particulate matter or discolouration is observed.
Bacite otopinu ako opazite prisutnost ikakvih čestica ili promjene boje.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 250 mg belatacept.
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 250 mg belatacepta.
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.
8 tjedana nakon zadnje doze lijeka, budući da nije poznat mogući rizik za razvoj embrija/fetusa.
Each vial is co-packaged with a disposable polypropylene syringe.
Jedna bočica pakirana je zajedno s polipropilenskom štrcaljkom za jednokratnu uporabu.
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.
Nuspojave možete prijaviti izravno putem putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
Package leaflet: Information for the user NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Uputa o lijeku: Informacije za korisnika NULOJIX 250 mg prašak za koncentrat za otopinu za infuziju belatacept
After reconstitution, each ml of concentrate contains 25 mg belatacept.
Nakon rekonstitucije, jedan ml koncentrata sadrži 25 mg belatacepta.
In clinical trials, an increased incidence of graft thrombosis was observed in the post-transplant period in recipients of extended criteria donor allografts.
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).
Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
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.
Blood and lymphatic system disorders Very Common anaemia, leukopenia Common thrombocytopenia, neutropenia, leukocytosis, polycythaemia, lymphopenia
Poremećaji krvi i limfnog sustava Vrlo često anemija, leukopenija
Table 2: Adverse reactions in clinical trials Infections and infestations Very Common urinary tract infection, upper respiratory infection, cytomegalovirus infection*, bronchitis
Vrlo često infekcija mokraćnih puteva, infekcija gornjih dišnih puteva, citomegalovirusna infekcija*, bronhitis
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
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
Common renal tubular necrosis, renal vein thrombosis*, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
Često renalna tubularna nekroza, tromboza bubrežne vene*, stenoza bubrežne arterije, glikozurija, hidronefroza, vezikoureteralni refluks, urinarna inkontinencija, retencija urina, nokturija
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.
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).
Injury, poisoning and procedural complications Very Common graft dysfunction Common chronic allograft nephropathy (CAN), incisional hernia
Ozljede, trovanja i proceduralne komplikacije Vrlo često poremećaj funkcije presatka
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
6.1 Popis pomoćnih tvari saharoza natrijev dihidrogenfosfat hidrat natrijev klorid natrijev hidroksid (za prilagodbu pH) kloridna kiselina (za prilagodbu pH)
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
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.
Your body may reject the transplanted kidney if you stop using NULOJIX.
Ako prestanete primati NULOJIX, Vaše tijelo može odbaciti presađeni bubreg.
PTLD
Cijepljenje
How to store NULOJIX
Kako čuvati Nulojix
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,
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
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
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
Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
U 3 od 6 slučajeva PTLD koji se javio pri liječenju belataceptom prema LI režimu zahvatio je središnji živčani sustav i imao smrtni ishod.
The use of live vaccines should be avoided with the use of NULOJIX.
Za vrijeme liječenja lijekom NULOJIX treba izbjegavati cijepljenje živim cjepivima.
NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate belatacept
NAZIV LIJEKA NULOJIX 250 mg prašak za koncentrat belatacept
NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion
NAZIV LIJEKA NULOJIX 250 mg prašak za koncentrat za otopinu za infuziju
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
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
Uncommon encephalitis, Guillain-Barré syndrome*, brain oedema, intracranial pressure increased, encephalopathy, convulsion, hemiparesis, demyelination, facial palsy,
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
Vascular disorders
Tromboza presatka
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
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).
See section 4.
U ispitivanju 1,
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.
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.
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
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
Fungal infections Tuberculosis
Gljivične infekcije 13,8 Tuberkuloza
Each NULOJIX vial provides 250 mg of belatacept.
Jedna bočica lijeka NULOJIX osigurava 250 mg belatacepta.
You must stop breast-feeding if you are being treated with NULOJIX.
Dojenje treba prekinuti za vrijeme liječenja lijekom NULOJIX.
Common weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypercalcaemia, hypoproteinaemia
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
Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
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.
Dose of belatacept for renal transplant recipients
Doza belatacepta u primatelja bubrežnog presatka
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.
U slučaju prekida primjene lijeka NULOJIX, sačuvajte ovu karticu još sljedeća 3 mjeseca.
Cardiac disorders Common tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy
Često vrtoglavica, bol u uhu, tinitus Manje često hipoakuzija Srčani poremećaji Često tahikardija, bradikardija, atrijska fibrilacija, zatajenje srca, angina pektoris, hipertrofija lijeve srčane klijetke
Uncommon infusion related reaction*, irritability, fibrosis, inflammation, disease recurrence, feeling hot, ulcer
Često bol u prsištu, umor, malaksalost, poremećeno cijeljenje Manje često reakcija povezana s infuzijom*, razdražljivost, fibroza, upala, povratak bolesti, osjećaj vrućine, ulkus
Common cushingoid
Kušingoidni izgled
Blood clotting in kidney artery
Stvaranje krvnih ugrušaka u bubrežnoj arteriji
Uncommon cholelithiasis, hepatic cyst, hepatic steatosis Skin and subcutaneous tissue disorders Common acne, pruritis, alopecia, skin lesion, rash, night sweats, hyperhidrosis
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
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.
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.
OTHER SPECIAL WARNING(S), IF NECESSARY Only use co-packed syringe for reconstitution and dilution.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
Infusion-related reactions have been reported with belatacept administration in clinical studies.
U kliničkim ispitivanjima primjene belatacepta zabilježene su reakcije povezane s infuzijom.
Uncommon hypophosphatasia
hiperkoagulacija
Uncommon retinitis, conjunctivitis, eye inflammation, keratitis, photophobia, eyelid oedema Ear and labyrinth disorders
Poremećaji oka Često katarakta, okularna hiperemija, zamagljen vid Manje često retinitis, konjunktivitis, upala oka, keratitis, fotofobija, edem vjeđa Poremećaji uha i labirinta