FrancophonIA/ELRC3.0 huggingface dataset:
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 4.2).
Slovenian: Skupni odmerek belatacepta (v mg) izračunate tako, da bolnikovo telesno maso (v kg) pomnožite z odmerkom belatacepta (v mg/kg) (5 ali 10 mg/kg, glejte poglavje 4.2).
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary tumours (in females) occurred.
Slovenian: V študijah kancerogenega potenciala so pri miših opazili večjo pojavnost limfomov in tumorjev mlečne žleze (pri samicah).
English: This card should be provided in each pack, the text of which is included in Annex III.
Slovenian: Opozorilna kartica za bolnika mora biti priložena vsakemu pakiranju zdravila, vsebina besedila opozorilne kartice za bolnika pa je vključena v Prilogo III.
English: Uncommon infusion related reaction*, irritability, fibrosis, inflammation, disease recurrence, feeling hot, ulcer
Slovenian: Občasni infuzijska reakcija*, razdražljivost, fibroza, vnetje, ponovitev bolezni, občutek vročine, razjeda
English: Please make sure you have this card with you at all times and a list of all your other medicines with you at any visit to a healthcare professional.
Slovenian: Ob vsakem obisku zdravnika, imejte pri sebi tudi seznam vseh ostalih zdravil, ki jih jemljete.
English: If you become pregnant while using NULOJIX, tell your doctor.
Slovenian: Če med zdravljenjem z zdravilom NULOJIX zanosite, o tem obvestite zdravnika.
English: No patients with hepatic impairment were studied in renal transplant protocols, therefore dose modification of belatacept in hepatic impairment can not be recommended.
Slovenian: V raziskavah presaditev ledvice uporabe zdravila pri bolnikih z okvaro jeter niso raziskovali, zato pri bolnikih z okvaro jeter ne moremo podati priporočil za prilagoditev odmerka belatacepta.
English: A total of 321 belatacept (MI: 155 and LI: 166) and 136 ciclosporin patients completed 3 years of treatment in Study 1 and entered the 4-year long-term open label extension period (up to 7 years in total).
Slovenian: Skupno 321 bolnikov, ki so se zdravili z belataceptom (BI režim: 155 in MI režim: 166) ter 136 bolnikov, ki so se zdravili s ciklosporinom, je bilo po dokončanem 3 letnem zdravljenju v Študiji 1 vključenih v 4 letno dolgoročno odprto podaljšano obdobje (v celoti do 7 let).
English: In a prespecified pooled analysis of Studies 1 and 2 at Year 1, the incidence of new onset diabetes mellitus (NODM), defined as use of an antidiabetic agent for ≥ 30 days or ≥ 2 fasting plasma glucose values > 126 mg/dl (7.0 mmol/l) post-transplantation, was 5% with belatacept and 10% with ciclosporin.
Slovenian: Pri vnaprej določenih združenih analizah Študij 1 in 2 je bila v 1. letu pojavnost novo nastale sladkorne bolezni, opredeljene kot uporaba antidiabetika za ≥ 30 dni ali ≥ 2 vrednosti glukoze v plazmi na tešče > 126 mg/dl (7,0 mmol/l) po presaditvi, pri uporabi belatacepta 5 %, pri uporabi ciklosporina pa 10 %.
English: Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections.
Slovenian: V primeru pojava nekaterih simptomov bo zdravnik morda moral opraviti določene preiskave, da bo lahko izključil pojav progresivne multifokalne levkoencefalopatije (PML), potransplantacijske limfoproliferativne bolezni (PTLB) ali drugih okužb.
English: Concomitant use with other immunosuppressive agents Belatacept has been administered with the following immunosuppressive agents in clinical studies: basiliximab, an MPA and corticosteroids.
Slovenian: Sočasna uporaba z drugimi imunosupresivnimi zdravili V kliničnih študijah so bolniki belatacept prejemali skupaj z naslednjimi imunosupresivnimi zdravili: z baziliksimabom, mikofenolno kislino in s kortikosteroidi.
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).
Slovenian: Skupno 217 bolnikov, ki so se zdravili z belataceptom (BI režim: 104 in MI režim: 113) ter 87 bolnikov, ki so se zdravili s ciklosporinom, je bilo po dokončanem 3 letnem zdravljenju v Študiji 2 vključenih v 4 letno dolgoročno odprto podaljšano obdobje (v celoti do 7 let).
English: Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG Plaza 254
Slovenian: Imetnik dovoljenja za promet z zdravilom: Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Acute rejection (AR) occurred more frequently with belatacept versus ciclosporin in Study 1 and with similar frequency with belatacept versus ciclosporin in Study 2.
Slovenian: V Študiji 1 je bila akutna zavrnitev (AZ) pri uporabi belatacepta pogostejša kot pri uporabi ciklosporina, v Študiji 2 pa je bila akutna zavrnitev pri uporabi belatacepta podobno pogosta kot pri uporabi ciklosporina.
English: It will be given to you by infusion (as a "drip") into one of your veins over a period of about 30 minutes.
Slovenian: Zdravilo boste prejeli v eno od ven v obliki kapljične infuzije, ki bo trajala približno 30 minut.
English: It is used with other immunosuppressive medicines, including mycophenolic acid and corticosteroids.
Slovenian: Zdravilo uporabljamo skupaj z drugimi zdravili za zaviranje imunske odzivnosti, vključno z mikofenolno kislino in s kortikosteroidi.
English: Lymphocyte depleting therapies to treat acute rejection should be used cautiously.
Slovenian: V primeru akutne zavrnitve je treba zdravljenje z uničenjem limfocitov uporabljati previdno.
English: Treatment with NULOJIX increases the risk of getting a type of cancer called post-transplant lymphoproliferative disorder (PTLD).
Slovenian: Zdravljenje z zdravilom NULOJIX je povezano z večjim tveganjem za pojav maligne bolezni, imenovane potransplantacijska limfoproliferativna bolezen (PTLB).
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).
Slovenian: Očitne povezave med razvojem protiteles in kliničnim odzivom ali neželenimi učinki sicer niso zaznali, vendar pa pridobljeni podatki ne zadostujejo za dokončno oceno (glejte poglavje 4.8).
English: The median corticosteroid doses administered with the belatacept recommended regimen up to months 1, 3, and 6 were 21 mg, 13 mg and 10 mg, respectively.
Slovenian: Srednji odmerek kortikosteroidov, uporabljen s priporočenim režimom belatacepta, je do 1. meseca znašal 21 mg, do 3. meseca 13 mg, do 6. meseca pa 10 mg.
English: The NULOJIX infusion must be completed within 24 hours of reconstitution of the powder.
Slovenian: Infundiranje zdravila NULOJIX je treba dokončati v 24 urah po raztapljanju praška.
English: Any malignant neoplasm Non-melanoma skin cancer Malignant neoplasms excluding nonmelanoma skin cancers
Slovenian: Kateri koli maligni tumor Nemelanomski rak kože Maligne novotvorbe brez nemelanomskega raka kože PTLB
English: Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (IFTA) The prevalence of CAN/IFTA at Year 1 in Studies 1 and 2, was numerically lower with belatacept than ciclosporin (~ 9.4% and 5%, respectively).
Slovenian: Kronična nefropatija alogenskega presadka/intersticijska fibroza in tubularna atrofija V Študijah 1 in 2 je bila prevalenca kronične nefropatije alogenskega presadka/intersticijske fibroze in tubularne atrofije v 1. letu numerično manjša pri uporabi belatacepta kot pri uporabi ciklosporina (približno 9,4 % in 5 %).
English: However, NULOJIX can cause serious side effects that may need treatment.
Slovenian: Nekateri neželeni učinki zdravila NULOJIX so lahko resni in jih bo morda treba ustrezno zdraviti.
English: Cardiac disorders Common tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy
Slovenian: Srčne bolezni Pogosti tahikardija, bradikardija, atrijska fibrilacija, srčna insuficienca, angina pektoris, hipertrofija levega prekata
English: NULOJIX is used in adults to prevent the immune system from attacking your transplanted kidney and causing transplant rejection.
Slovenian: Deluje tako, da imunskemu sistemu preprečuje, da bi napadel presajeno ledvico in povzročil njeno zavrnitev.
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%).
Slovenian: MI režimom zdravljenja v Študiji 2 je bil predvsem posledica novotvorb (BI režim: 3,8 %, MI režim: 7,1 %, ciklosporin: 2,3 %).
English: To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Slovenian: Da bi ugotovili prisotnost nevtralizirajočih protiteles, so z in vitro testom ovrednotili vzorce 29 bolnikov s potrjeno vezavno aktivnostjo na modificirano regijo molekule citotoksičnega T limfocitnega antigena 4 (CTLA-4).
English: All patients received basiliximab, MMF, and corticosteroids.
Slovenian: Vsi bolniki so prejemali baziliksimab, mofetilmikofenolat in kortikosteroide.
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.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom NULOJIX in še vsaj 8 tednov po prejemu zadnjega odmerka uporabljati učinkovito obliko kontracepcije, saj možno tveganje za razvoj zarodka/plodu ni znano.
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.
Slovenian: Skupna pojavnost okužb s poliomavirusom in glivičnih okužb je bila številčno manjša v skupini, ki je belatacept prejemala po MI režimu kot pa v skupinah, ki so prejemale BI režim belatacepta ali ciklosporin.
English: Your doctor will advise you what to do.
Slovenian: Zdravnik vam bo svetoval ali je cepljenje za vas primerno.
English: Please take the exact steroid dose as determined by your doctor.
Slovenian: Odmerek kortikosteroida morate vedno jemati natančno po navodilih zdravnika.
English: Infusion-related reactions Anaphylaxis has been reported post marketing(see section 4.4).
Slovenian: Infuzijske reakcije V obdobju po prihodu zdravila na trg so poročali o anafilaksiji (glejte poglavje 4.4).
English: AR was treated more often with lymphocyte depleting therapy (a risk factor for PTLD; see section 4.4) in the belatacept group than the ciclosporin group.
Slovenian: Akutno zavrnitev so z uničenjem limfocitov (dejavnik tveganja za PTLB; glejte poglavje 4.4) pogosteje zdravili v skupini, ki je prejemala belatacept, kot v skupini, ki je prejemala ciklosporin.
English: Non-melanoma skin cancers occurred less frequently with the belatacept LI regimen than with the ciclosporin or belatacept MI regimens.
Slovenian: Nemelanomske oblike kožnega raka so bile pri MI režimu zdravljenja z belataceptom manj pogoste kot pri uporabi ciklosporina ali BI režimu zdravljenja z belataceptom.
English: Tuberculosis was more frequently observed in patients receiving belatacept than ciclosporin in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah so o tuberkulozi pogosteje poročali pri bolnikih, ki so prejemali belatacept, kot pri bolnikih, ki so prejemali ciklosporin (glejte poglavje 4.8).
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).
Slovenian: Vso količino popolnoma razredčene raztopine morate aplicirati v obliki 30-minutne intravenske infuzije preko infuzijskega sistema in sterilnega apirogenega filtra, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm).
English: In the 3 studies (one Phase 2 and two Phase 3 studies, Study 1 and Study 2), the cumulative frequency of PTLD was higher in belatacept treated patients at the recommended dosing regimen (LI) (1.3%; 6/472) than in the ciclosporin group (0.6%; 3/476), and was highest in the belatacept MI group (1.7%; 8/477).
Slovenian: Faze; Študija 1 in Študija 2) je bila kumulativna pogostnost PTLB večja pri bolnikih, ki so se zdravili s priporočenim režimom zdravljenja z belataceptom (MI) (1,3 %; 6/472), kot pri bolnikih, ki so prejemali ciklosporin (0,6 %; 3/476), najvišja pa je bila v skupini bolnikov, ki so belatacept prejemali po BI režimu (1,7 %; 8/477).
English: Patients should be evaluated for tuberculosis and tested for latent infection prior to initiating belatacept.
Slovenian: Pred uvedbo zdravljenja z belataceptom je treba bolnika ustrezno ovrednotiti glede tuberkuloze in testirati na prisotnost latentne okužbe.
English: Each vial contains 250 mg belatacept.
Slovenian: Ena viala vsebuje 250 mg belatacepta.
English: The median corticosteroid doses administered with the belatacept recommended regimen up to months 1, 3, and 6 were 20 mg, 12 mg and 10 mg, respectively.
Slovenian: Srednji odmerek kortikosteroidov, uporabljen s priporočenim režimom belatacepta, je do 1. meseca znašal 20 mg, do 3. meseca 12 mg, do 6. meseca pa 10 mg.
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.
Slovenian: V vseh treh skupinah bolnikov s presajenimi jetri, ki so prejemali belatacept, so bili uporabljeni višji odmerki belatacepta, kot v študijah 2. in 3. faze pri bolnikih s presajeno ledvico.
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate, sucrose, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
Slovenian: Druge sestavine zdravila so natrijev klorid, natrijev dihidrogenfosfat monohidrat, saharoza, natrijev hidroksid (za uravnavo pH) in klorovodikova kislina (za uravnavo pH).
English: Kidney or bladder symptoms may include tenderness at the site of your transplanted kidney; difficulty passing urine; changes in the amount of urine you produce; blood in the urine; pain or burning on urination.
Slovenian: Simptomi prizadetosti ledvic ali sečnega mehurja lahko vključujejo: občutljivost na mestu presajene ledvice, težave pri uriniranju, spremembe v količini izločenega urina, kri v urinu, boleč ali pekoč občutek pri uriniranju.
English: If you are not sure about any of these conditions, ask you doctor.
Slovenian: Če ste o katerem od navedenih stanj kakorkoli v dvomih, se posvetujte z zdravnikom.
English: Adequate treatment of latent tuberculosis infection should be instituted prior to belatacept use.
Slovenian: Pred uvedbo zdravljenja z belataceptom je treba zagotoviti ustrezno zdravljenje latentne oblike tuberkuloze.
English: NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Slovenian: Zdravilo NULOJIX je treba uporabljati v kombinaciji z baziliksimabom za indukcijo in mofetilmikofenolatom ter s kortikosteroidi.
English: If you are not sure if you have been infected with the virus before, ask your doctor.
Slovenian: Če ste glede predhodne izpostavljenosti temu virusu kakorkoli v dvomih, se posvetujte z zdravnikom.
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.
Slovenian: V študijah belatacepta pri bolnikih s presajeno ledvico so poročali o enem primeru PML pri bolniku, ki se je sočasno zdravil z antagonistom za receptor IL-2, mofetilmikofenolatom in s kortikosteroidi.
English: A total of 250 subjects were randomised to 1 of 5 treatment groups (3 belatacept and 2 tacrolimus groups).
Slovenian: V eno od petih skupin zdravljenja (tri skupine z belataceptom in dve skupini s takrolimusom) je bilo v celoti randomiziranih 250 oseb.
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.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom NULOJIX, so poročali o redki obliki okužbe možganov, ki jo imenujemo progresivna multifokalna levkoencefalopatija (PML).
English: Belatacept-treated transplant recipients who are EBV seronegative are at an increased risk for PTLD compared with those who are EBV positive (see section 4.8).
Slovenian: Pri bolnikih s presajeno ledvico, ki so seronegativni za EBV, je tveganje za razvoj PTLB med zdravljenjem z belataceptom večje kot pri bolnikih, ki so seropozitivni za EBV (glejte poglavje 4.8).
English: Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
Slovenian: Med zdravljenjem z zdravilom NULOJIX se posvetujte z zdravnikom ali farmacevtom preden začnete jemati katero koli drugo zdravilo.
English: If you are allergic to belatacept or any of the other ingredients of the medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila NULOJIX če ste alergični na belatacept ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: The most common serious adverse reactions (≥ 2%) reported with belatacept in both regimens (more intensive [MI] and less intensive [LI]) cumulative up to Year 3 were urinary tract infection, CMV infection, pyrexia, increased blood creatinine, pyelonephritis, diarrhoea, gastroenteritis, graft dysfunction, leukopenia, pneumonia, basal cell carcinoma, anaemia, dehydration.
Slovenian: Najpogostejši resni neželeni učinki (≥ 2 %), o katerih so poročali pri obeh režimih zdravljenja z belataceptom (bolj intenzivnem [BI] in manj intenzivnem [MI]) kumulativno do 3. leta zdravljenja, so bili: okužba sečil, okužba s CMV, zvišana telesna temperatura, zvišana vrednost kreatinina v krvi, pielonefritis, driska, gastroenteritis, motnje delovanja presadka, levkopenija, pljučnica, bazalnocelični karcinom, anemija in dehidracija.
English: Belatacept has a minor influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Belatacept ima blag vpliv na sposobnost upravljanja vozil ali strojev.
English: Make up each vial with 10.5 ml reconstitution solution.
Slovenian: V vsako vialo dodajte 10,5 ml vehikla.
English: It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Slovenian: Režimu zdravljenja z belataceptom je za indukcijo zdravljenja priporočljivo dodati antagonist receptorja za interlevkin (IL)-2.
English: EBV serology should be ascertained before starting administration of belatacept.
Slovenian: Pred uvedbo zdravljenja z belataceptom je treba izvesti serološke preiskave za EBV.
English: Consultation with a neurologist is recommended for any suspected or confirmed cases of PML.
Slovenian: Pri vsakem sumljivem ali potrjenem primeru PML je priporočljiv posvet z nevrologom.
English: Uncommon adrenal insufficiency Metabolism and nutrition disorders Very Common hypophosphataemia, hypokalaemia, dyslipidaemia, hyperkalaemia, hyperglycaemia, hypocalcaemia
Slovenian: Občasni insuficienca nadledvične žleze Presnovne in prehranske motnje Zelo pogosti hipofosfatemija, hipokaliemija, dislipidemija, hiperkaliemija, hiperglikemija, hipokalciemija
English: Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX.
Slovenian: Med zdravljenjem z zdravilom NULOJIX morate omejiti izpostavljenost kože sončni svetlobi in ultravijoličnim (UV) žarkom.
English: Very Common proteinuria, blood creatinine increased, dysuria, haematuria
Slovenian: Bolezni sečil Zelo pogosti proteinurija, zvišana vrednost kreatinina v krvi, disurija, hematurija
English: Use in liver transplants The use of NULOJIX is not recommended if you have had a liver transplant.
Slovenian: Uporaba zdravila pri presaditvi jeter Uporaba zdravila NULOJIX pri bolnikih po presaditvi jeter ni priporočljiva.
English: In a Phase 3 study in recipients of extended criteria donor (ECD) kidneys (Study 2), graft thrombosis occurred more frequently in the belatacept groups (4.3% and 5.1% for the MI and LI regimens respectively), versus 2.2% for ciclosporin.
Slovenian: Faze pri prejemnikih ledvice po razširjenih kriterijih za darovani organ (Študija 2), je bila pojavnost tromboze presadka pogostejša pri uporabi belatacepta (4,3 % pri BI režimu in 5,1 % pri MI režimu) kot pri uporabi ciklosporina (2,2 %).
English: Each vial is co-packaged with a disposable polypropylene syringe.
Slovenian: Vsaki viali je priložena injekcijska brizga iz polipropilena za enkratno uporabo.
English: Vascular disorders
Slovenian: Tromboza presadka
English: How to store NULOJIX 6.
Slovenian: Shranjevanje zdravila NULOJIX 6.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, sodium chloride, and for pH adjustment sodium hydroxide and hydrochloric acid.
Slovenian: Pomožne snovi: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev klorid, natrijev hidroksid (za uravnavo pH) in klorovodikova kislina (za uravnavo pH).
English: In clinical trials, an increased incidence of graft thrombosis was observed in the post-transplant period in recipients of extended criteria donor allografts.
Slovenian: V kliničnih preskušanjih so pri prejemnikih ledvice po razširjenih kriterijih za darovani organ po presaditvi poročali o večji pojavnosti tromboze presadka.
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.
Slovenian: Po enkratni intravenski infuziji belatacepta v odmerku od 1 do 20 mg/kg je bila farmakokinetika belatacepta pri zdravih osebah linearna, izpostavljenost belataceptu pa se je povečevala proporcionalno.
English: EBV is the virus that causes glandular fever.
Slovenian: Virus EBV povzroča infekcijsko mononukleozo.
English: Prior to administration, the solution for infusion should be inspected visually for particulate matter or discolouration.
Slovenian: Pred infundiranjem morate raztopino za infundiranje pregledati glede prisotnosti delcev ali spremembe barve.
English: In postmarketing experience, use of belatacept in conjunction with basiliximab induction, mycophenolate mofetil and corticosteroid taper to 5 mg/day by Week 6 post-transplant was associated with an increased rate of acute rejection, particularly Grade III rejection.
Slovenian: Med spremljanjem zdravila po pridobitvi dovoljenja za promet je bila uporaba belatacepta skupaj z baziliksimabom za indukcijo in mofetilmikofenolatom ter zmanjšanjem odmerka kortikosteroida na 5 mg/dan do 6. tedna po presaditvi povezana z večjim deležem akutne zavrnitve, še posebej zavrnitve stopnje III. Do zavrnitev stopnje III je prišlo pri bolnikih z neujemanjem HLA 4 do 6 (glejte poglavji 4.2 in 5.1).
English: The time to death, graft loss, or GFR <30 mL/min/1.73 m2 was analyzed over the 7-year period: in Study 1, approximately 60% reduction in the risk of death, graft loss, or GFR <30 mL/min/1.73 m2 was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Slovenian: Opravili so tudi analize časa do smrti bolnika, izgube presadka ali pojava vrednosti GFR < 30 ml/min/1,73 m2 v 7 letnem obdobju: v Študiji 1 so pri bolnikih v skupini zdravljenja z belataceptom opazili približno 60 % zmanjšanje tveganja za smrt, izgubo presadka ali vrednost GFR < 30 ml/min/1,73 m2 v primerjavi z bolniki v skupini zdravljenja s ciklosporinom.
English: A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept.
Slovenian: Med zdravljenjem z belataceptom so se protitelesa proti belataceptu pojavila pri 45 od 847 bolnikov (5,3 %).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Only use co-packed syringe for reconstitution and dilution.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Pri raztapljanju in redčenju zdravila uporabljajte le priloženo injekcijsko brizgo.
English: What NULOJIX contains
Slovenian: Kaj vsebuje zdravilo NULOJIX