FrancophonIA/ELRC3.0 huggingface dataset:
English: What NULOJIX looks like and contents of the pack
Slovenian: Izgled zdravila NULOJIX in vsebina pakiranja
English: NULOJIX powder for concentrate for solution for infusion (powder for concentrate) is a white to offwhite powder that can appear solid or broken into pieces.
Slovenian: NULOJIX prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) je beli do sivobeli prašek, ki je lahko v obliki celega ali razdrobljenega skupka.
English: Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: Belatacept je fuzijska beljakovina, pridobljena s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
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.
Slovenian: V Študiji 1 je bil celokupni delež umrlih bolnikov ali bolnikov z izgubo presadka manjši pri bolnikih, ki so se zdravili z belataceptom (BI režim: 11,4 %, MI režim: 11,9 %), v primerjavi z bolniki, ki so se zdravili s ciklosporinom (17,6 %).
English: NULOJIX will be given to you by a healthcare professional.
Slovenian: Zdravilo NULOJIX vam bo vedno dal zdravstveni delavec.
English: How to use NULOJIX 4.
Slovenian: Kako uporabljati zdravilo NULOJIX 4.
English: In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
Slovenian: V kliničnih študijah je bilo tveganje za razvoj PTLB večje pri EBV seronegativnih bolnikih s presajeno ledvico, ki so se zdravili z belataceptom, kot pri bolnikih, ki so bili EBV seropozitivni (7,7 %; 7/91 v primerjavi z 0,7 %; 6/810).
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.
Slovenian: V Študiji 2 so pri bolnikih, ki so bili v času presaditve EBV seropozitivni, poročali o enem primeru PTLB v vsaki od treh skupin zdravljenja.
English: An additional 51 patients were treated for an average of 7 years in the long-term extension of a Phase 2 study.
Slovenian: V dolgoročnem podaljšku študije 2. faze se je v povprečju 7 let zdravilo še 51 dodatnih bolnikov.
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.
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem z belataceptom in še do 8 tednov po prejemu zadnjega odmerka belatacepta uporabljati učinkovito metodo kontracepcije, saj možno tveganje za razvoj zarodka/plodu ni znano.
English: NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function).
Slovenian: Zdravilo NULOJIX je v kombinaciji s kortikosteroidi in z mikofenolno kislino indicirano za preprečevanje zavrnitve ledvice pri odraslih po presaditvi ledvice (za podatke o delovanju ledvic glejte poglavje 5.1).
English: In a six-month and one-year toxicity study in cynomolgus monkeys with belatacept and abatacept, respectively, no significant toxicity was observed.
Slovenian: Pri šestmesečni študiji toksičnosti belatacepta in enoletni študiji toksičnosti abatacepta pri opicah cinomolgus niso odkrili pomembnejšega toksičnega delovanja.
English: EBV seronegative patients receiving immunosuppressants are at a particularly increased risk for PTLD (see sections 4.3 and 4.4).
Slovenian: Pri EBV seronegativnih bolnikih, ki se zdravijo z imunosupresivnimi zdravili, je tveganje za razvoj PTLB še posebej veliko (glejte poglavji 4.3 in 4.4).
English: Malignancies and post-transplant lymphoproliferative disease Year 1 and 3 frequencies of malignancies are shown in Table 3, except for cases of PTLD which are presented at 1 year and > 3 years (median days of follow-up were 1,199 days for belatacept MI, 1,206 days for belatacept LI, and 1,139 days for ciclosporin).
Slovenian: Novotvorbe in potransplantacijska limfoproliferativna bolezen Pogostnost novotvorb po 1-letnem in 3-letnem zdravljenju je prikazana v preglednici 3, razen za primere PTLB, ki so prikazani po 1-letnem in več kot 3-letnem zdravljenju (mediano število dni spremljanja je pri BI režimu zdravljenja z belataceptom 1.199 dni, pri MI režimu uporabe belatacepta 1.206 dni in pri ciklosporinu 1.139 dni).
English: These belatacept dosing regimens differed from those studied in renal transplant recipients (see section 5.1).
Slovenian: Režimi zdravljenja z belataceptom so se razlikovali od raziskovanih režimov zdravljenja pri bolnikih s presajeno ledvico (glejte poglavje 5.1).
English: This medicine contains 0.65 mmol (or 15 mg) sodium per vial which corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of three vials.
Slovenian: To zdravilo vsebuje 0,65 mmol (ali 15 mg) natrija na vialo, kar ustreza 1,95 mmol (ali 45 mg) natrija na največji odmerek (tri viale).
English: As compared to ciclosporin and assessed by the hazard ratio (HR) estimates (for death or graft loss) from an ad hoc Cox regression analysis, overall patient and graft survival was higher for belatacepttreated patients in Study 1, HR 0.588 (95% CI: 0.356-0.972) for the MI group and HR 0.585 (95% CI: 0.356-0.961) for the LI group, and comparable across treatment groups in Study 2, HR 0.932 (95% CI: 0.635-1.367) for the MI group and HR 0.944 (95% CI: 0.644-1.383) for the LI group.
Slovenian: V primerjavi s ciklosporinom in glede na ocenjeno razmerje ogroženosti (HR - hazard ratio) (za smrt bolnika ali izgubo presadka) iz ad-hoc Coxove regresijske analize je bilo v Študiji 1 celokupno preživetje bolnika in presadka večje pri bolnikih, ki so se zdravili z belataceptom: HR 0,588 (95 % IZ: 0,356-0,972) za skupino z BI režimom zdravljenja in HR 0,585 (95 % IZ: 0,356-0,961) za skupino z MI režimom zdravljenja, v Študiji 2 pa primerljivo v vseh skupinah zdravljenja: HR 0,932 (95 % IZ: 0,635-1,367) za skupino z BI režimom zdravljenja in HR 0,944 (95 % IZ: 0,644-1,383) za skupino z MI režimom zdravljenja.
English: Nervous system symptoms may include memory lapse; speech and communication difficulties; a change in your mood or behaviour; confusion or inability to control your muscles; weakness on one side of the body; vision changes; or headache.
Slovenian: Simptomi prizadetosti živčevja lahko vključujejo: izgubo spomina, težave pri govoru in sporazumevanju, spremembe v razpoloženju ali vedenju, zmedenost ali nezmožnost nadzorovanja mišic, oslabelost ene strani telesa, motnje vida ali glavobol.
English: The use of live vaccines should be avoided with the use of NULOJIX.
Slovenian: Med zdravljenjem z zdravilom NULOJIX se je treba izogibati cepljenju z živimi cepivi.
English: The dose and treatment frequency is given below.
Slovenian: Odmerek in pogostnost uporabe zdravila prikazuje spodnja preglednica.
English: As an increased risk of PML and of other infections has been associated with high levels of overall immunosuppression, the recommended doses of belatacept and concomitant immunosuppressives, including MMF or MPA, should not be exceeded (see section 4.5).
Slovenian: Ker je močna imunosupresija povezana z večjim tveganjem za pojav PML in drugih okužb, se priporočenega odmerka belatacepta in drugih sočasno uporabljenih imunosupresivnih zdravil, vključno z mofetilmikofenolatom ali mikofenolno kislino, ne sme preseči (glejte poglavje 4.5).
English: If you forget to use NULOJIX
Slovenian: Če ste pozabili uporabiti zdravilo NULOJIX
English: NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.
Slovenian: Zdravilna učinkovina zdravila NULOJIX je belatacept, ki spada v skupino zdravil za zaviranje imunske odzivnosti.
English: Phase 2 liver transplant study
Slovenian: Študija 2. faze pri bolnikih s presajenimi jetri
English: This medicinal product contains 0.65 mmol or 15 mg sodium per vial.
Slovenian: Ena viala tega zdravila vsebuje 0,65 mmol ali 15 mg natrija.
English: *Median follow-up excluding PTLD for pooled studies is 1,092 days for each treatment group.
Slovenian: *Mediani čas spremljanja (brez PTLB) za združene študije je 1.092 dni za vsako od skupin zdravljenja.
English: Belatacept is therefore not expected to affect cytochrome P450 enzymes via effects on cytokines.
Slovenian: Vpliv belatacepta na encime citokroma P450 preko učinkov na citokine ni pričakovan.
English: At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
Slovenian: V 3. letu je bila pojavnost novo nastale sladkorne bolezni pri uporabi belatacepta 8 % in pri uporabi ciklosporina 10 %.
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po raztapljanju praška ali redčenju zdravila glejte poglavje 6.3.
English: When reconstitution and dilution are performed under aseptic conditions, the NULOJIX infusion should be started immediately or must be completed within 24 hours of reconstitution of the powder.
Slovenian: Če ste raztapljanje praška in redčenje izvedli v aseptičnih pogojih, lahko NULOJIX raztopino za infundiranje infundirate takoj ali kasneje, vendar pa morate infundiranje zdravila dokončati v 24 urah po raztapljanju praška.
English: Regular administration of NULOJIX is essential for your transplanted kidney to function.
Slovenian: Redna uporaba zdravila NULOJIX je zelo pomembna za ohranitev delovanja presajene ledvice.
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.
Slovenian: Srednja vrednost starosti bolnikov je bila 45 let, 58 % darovanih organov je izviralo od živega darovalca, pri 3 % bolnikov je bila opravljena ponovna presaditev, 69 % bolnikov v študiji je bilo moškega spola, 61 % je bilo belcev, 8 % črncev/Afroameričanov in 31 % bolnikov drugih ras, 16 % bolnikov je imelo vrednost PRA  10 % in 41 % bolnikov je imelo neujemanje HLA 4 do 6.
English: In addition to PTLD, patients receiving immunosuppressive regimens, including belatacept, are at increased risk of malignancies, including skin cancer (see section 4.8).
Slovenian: Poleg PTLB, pri bolnikih, ki se zdravijo z imunosupresivnimi režimi zdravljenja, vključno z belataceptom, obstaja večje tveganje za razvoj novotvorb, vključno s kožnim rakom (glejte poglavje 4.8).
English: The median age was 58 years; 67% of the study population was male; 75% of patients were white, 13% were black/African-American, 12% were categorised as of other races; 3% had PRA  10%; and 53% had 4 to 6 HLA mismatches.
Slovenian: Srednja vrednost starosti bolnikov je bila 58 let, 67 % bolnikov v študiji je bilo moškega spola, 75 % je bilo belcev, 13 % črncev/Afroameričanov in 12 % bolnikov drugih ras, 3 % bolnikov je imelo vrednost PRA  10 % in 53 % bolnikov je imelo neujemanje HLA 4 do 6.
English: In a single Phase 2 clinical study in de novo liver transplant patients, an increase in the number of deaths was observed in 2 of 3 belatacept-containing regimens studied.
Slovenian: V eni sami klinični študiji 2. faze pri bolnikih z na novo presajenimi jetri so pri dveh od treh raziskovanih režimov zdravljenja z belataceptom poročali o večjem številu smrtnih primerov.
English: As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Slovenian: Na ta način zavre s CD28 posredovano kostimulacijo limfocitov T in posledično njihovo aktivacijo.
English: No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Slovenian: Starost, spol, rasa, delovanje ledvice (izračunana vrednost GFR), sladkorna bolezen ali sočasna dializa niso imeli klinično pomembnih vplivov na očistek belatacepta.
English: Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
Slovenian: Potransplantacijska limfoproliferativna bolezen (PTLB) V študijah 2. in 3. faze (3 študije) je bila pojavnost PTLB večja pri bolnikih, ki so se zdravili z belataceptom, kot pri bolnikih, ki so se zdravili s ciklosporinom (glejte poglavje 4.8).
English: Patient and graft survival were similar between belatacept and ciclosporin.
Slovenian: Preživetje bolnikov in presadka je bilo pri uporabi belatacepta podobno kot pri uporabi ciklosporina.
English: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients with 4 to 6 human leukocyte antigen (HLA) mismatches (see sections 4.4 and 5.1)
Slovenian: Pri bolnikih, ki se zdravijo z belataceptom, je treba odmerek kortikosteroida zmanjševati previdno, še posebej pri bolnikih z neujemanjem humanega levkocitnega antigena (HLA) 4 do 6 (glejte poglavji 4.4 in 5.1).
English: Uncommon hypophosphatasia
Slovenian: Občasni hipofosfatazija
English: Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%.
Slovenian: Pri priporočenem režimu odmerjanja je nivo zasičenosti CD86 do 3. meseca po presaditvi ostal približno 70 %, do 12. meseca po presaditvi pa približno 65 %.
English: The more intensive (MI) regimen, which included higher and more frequent dosing during the first 6 months post transplant, resulted in 2-fold higher exposure to belatacept than the less intensive (LI) regimen during Months 2 through 7 post transplant.
Slovenian: Pri bolj intenzivnem (BI) režimu zdravljenja z belataceptom, ki je vključeval pogostejšo uporabo večjih odmerkov zdravila med prvimi 6 meseci po presaditvi, je bila izpostavljenost belataceptu od 2. do 7. meseca po presaditvi približno 2-krat večja kot pri manj intenzivnem (MI) režimu zdravljenja.
English: Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Slovenian: Pri bolnikih z vrednostjo PRA, večjo od 30 %, uporabe belatacepta niso raziskovali (glejte poglavje 4.2).
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats) as well as inflammation of the thyroid and pancreas (both juvenile and adult rats).
Slovenian: Študije pri podganah, ki so bile izpostavljene abataceptu, so pokazale nepravilnosti imunskega sistema, vključno z manjšo incidenco okužb, ki so povzročile pogine (mladiči podgan).
English: Patients do not require pre-medication prior to administration of belatacept.
Slovenian: Bolniki pred aplikacijo belatacepta ne potrebujejo premedikacije.
English: In addition to EBV seronegative status, other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy, which was more commonly used to treat acute rejection in belatacept-treated patients in Phase 3 clinical studies (see section 5.1).
Slovenian: Drugi znani dejavniki tveganja za razvoj PTLB poleg seronegativnega stanja za EBV so še okužba s citomegalovirusom (CMV) in zdravljenje z uničenjem limfocitov T, ki so ga v kliničnih študijah 3. faze pogosteje uporabili pri zdravljenju akutne zavrnitve pri bolnikih, ki so se zdravili z belataceptom (glejte poglavje 5.1).
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.
Slovenian: Okužbe CŽS so bile v skupini z BI režimom zdravljenja z belataceptom (8 primerov, vključno z zgoraj navedenim primerom PML; 1,7 %) pogostejše kot pri MI režimu zdravljenja z belataceptom (2 primera; 0,4 %) in uporabi ciklosporina (en primer; 0,2 %).
English: This will avoid foam formation.
Slovenian: S tem boste preprečili penjenje raztopine.
English: Most events were not serious, were mild to moderate in intensity, and did not recur.
Slovenian: Večinoma so bile blage ali zmerne in se niso ponovile.
English: Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Slovenian: Navodila za zdravstvene delavce o določitvi odmerka, pripravi raztopine za infundiranje in infundiranju zdravila NULOJIX se nahajajo na koncu tega navodila.
English: Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders
Slovenian: Občasni hipogamaglobulinemija, sezonska alergija Bolezni endokrinega sistema Pogosti kušingoid
English: Volume of the reconstituted solution required (ml) equals total belatacept dose in mg divided by 25.
Slovenian: Volumen potrebne pripravljene raztopine (ml) izračunate tako, da skupni odmerek belatacepta (v mg) delite s 25.
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.
Slovenian: Pri bolnikih v Študiji 2, ki so bili v času presaditve EBV seronegativni (pri katerih uporaba belatacepta ni priporočena), so poročali o treh primerih PTLB v skupini z MI režimom zdravljenja z belataceptom, v skupini z BI režimom zdravljenja z belataceptom in v skupini zdravljenja s ciklosporinom pa takšnih primerov ni bilo.
English: Table 2: Adverse reactions in clinical trials Infections and infestations Very Common urinary tract infection, upper respiratory infection, cytomegalovirus infection*, bronchitis
Slovenian: Preglednica 2: Neželeni učinki v kliničnih preskušanjih Infekcijske in parazitske bolezni Zelo pogosti okužba sečil, okužba zgornjih dihal, okužba s citomegalovirusom*, bronhitis
English: Insert the syringe needle into the vial through the centre of the rubber stopper.
Slovenian: Iglo injekcijske brizge zabodite v vialo skozi sredino gumijastega zamaška.
English: For more details on the dose calculation, see section 6.6.
Slovenian: Za podrobnosti o določitvi odmerka glejte poglavje 6.6.
English: The active substance is belatacept.
Slovenian: Zdravilna učinkovina je belatacept.
English: The reconstituted solution should be clear to slightly opalescent and colourless to pale yellow.
Slovenian: Nastala raztopina mora biti bistra do rahlo opalescentna in brezbarvna do svetlorumena.
English: Skin changes may include unexpected bruising or bleeding; brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other; a change in the size and colour of a mole; or a new skin lesion or bump.
Slovenian: Spremembe na koži lahko vključujejo: nepojasnjen pojav modric ali krvavitev, rjavo ali črno obarvane spremembe na koži, ki so neravno omejene, ali pa se en del kožne spremembe razlikuje od drugega, spremembe v velikosti in barvi znamenj ali pojav nove kožne spremembe ali bule.
English: What you need to know before you use NULOJIX
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo NULOJIX
English: Dose selection and reconstitution of the vials Calculate the dose and number of NULOJIX vials required.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila NULOJIX.
English: Cases of PTLD varied by serostatus.
Slovenian: Primeri PTLB so se razlikovali glede na serološko stanje.
English: If not used immediately, the solution for infusion may be stored in the refrigerator (2°C - 8°C) for up to 24 hours.
Slovenian: Če se raztopine za infundiranje ne uporabi takoj, se jo lahko shrani v hladilniku (2°C - 8°C) za največ 24 ur.
English: Investigations Common c-reactive protein increased, blood parathyroid hormone increased
Slovenian: Preiskave Pogosti zvišana vrednost C-reaktivnega proteina, zvišana vrednost parathormona v krvi
English: Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Slovenian: Pri bolnikih z vrednostjo panelnih reaktivnih protiteles (PRA; “Panel Reactive Antibody”), večjo od 30 %, uporabe belatacepta niso raziskovali.
English: The dose of corticosteroids used in all treatment groups was tapered during the first 6 months following transplantation.
Slovenian: Med prvimi 6. meseci po presaditvi so odmerek kortikosteroidov zmanjševali v vseh skupinah zdravljenja.
English: It is also recommended to administer an interleukin(IL)-2 receptor antagonist during the first week after transplantation.
Slovenian: V prvem tednu po presaditvi je priporočljiva še uporaba antagonista receptorja za interlevkin (IL)-2.
English: Special caution should be exercised in patients with a history of allergic reactions to belatacept or to any of the excipients.
Slovenian: Pri bolnikih s predhodnim pojavom alergijske reakcije na belatacept ali katerokoli pomožno snov je potrebna posebna previdnost.
English: There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
Slovenian: Teoretično se pri zdravljenju z belataceptom lahko poveča tveganje za pojav avtoimunskih procesov (glejte poglavje 4.8).
English: The other case of PML was reported in a liver transplant recipient in a Phase 2 trial who received 6 months of treatment with an augmented belatacept MI regimen, MMF at doses higher than the recommended dose and corticosteroids (see section 4.4).
Slovenian: O drugem primeru PML so poročali pri bolniku s presajenimi jetri v preskušanju 2. faze, ki se je 6 mesecev intenzivno zdravil z BI režimom zdravljenja z belataceptom, mofetilmikofenolatom v odmerkih, višjih od priporočenih, in s kortikosteroidi (glejte poglavje 4.4).
English: Do not use NULOJIX if you are pregnant unless your doctor specifically recommends it.
Slovenian: Med nosečnostjo zdravila NULOJIX ne smete uporabljati, razen na izrecno priporočilo zdravnika.
English: Within the belatacept clinical program, there were 2 patients diagnosed with PML.
Slovenian: V kliničnem programu uporabe belatacepta so PML ugotovili pri dveh bolnikih.
English: Acute infusion-related reactions (reactions occurring within one hour of infusion) occurred in 5.5% of patients in the belatacept MI group and 4.4% of patients in the belatacept LI group up to Year 3.
Slovenian: Do 3. leta zdravljenja so se akutne infuzijske reakcije (reakcije, ki se pojavijo v eni uri po začetku infundiranja) pri BI režimu zdravljenja z belataceptom pojavile pri 5,5 % bolnikov, pri MI režimu zdravljenja pa pri 4,4 % bolnikov.
English: One patient on belatacept MI regimen developed Guillian-Barré syndrome which led to treatment discontinuation and subsequently resolved.
Slovenian: Pri enem bolniku, ki je prejemal belatacept po BI režimu, se je pojavil Guillian-Barréjev sindrom.
English: When the clinical suspicion for PML is high, brain biopsy should be considered in subjects if the diagnosis of PML cannot be established via CSF PCR and neuroimaging.
Slovenian: Če je klinični sum na PML velik, diagnoze PML pa se s PCR preiskavo cerebrospinalne tekočine ali slikovno diagnostiko ne da potrditi, je treba razmisliti o biopsiji možganov.
English: Women should not breast-feed while on treatment with a belatacept-based regimen.
Slovenian: Ženske med zdravljenjem z belataceptom ne smejo dojiti.
English: Infusion must be completed within 24 hours of reconstitution of the powder.
Slovenian: Infundiranje morate dokončati v 24 urah po raztapljanju praška.
English: After reconstitution, each ml of concentrate contains 25 mg belatacept.
Slovenian: Po pripravi raztopine en ml koncentrata vsebuje 25 mg belatacepta.
English: Out of these 24 hours, the solution for infusion may be stored below 25°C for a maximum of 4 hours.
Slovenian: V teh 24 urah je raztopina za infundiranje lahko največ 4 ure shranjena pri temperaturi do 25°C.