FrancophonIA/ELRC3.0 huggingface dataset:
English: At the recommended dosing regimen, serum concentration generally reached steady-state by Week 8 in the initial phase following transplantation and by Month 6 during the maintenance phase.
Slovenian: Pri priporočenem režimu odmerjanja so serumske koncentracije v stanju dinamičnega ravnovesja v začetnem obdobju zdravljenja običajno dosežene v 8. tednu po presaditvi, med vzdrževalnim obdobjem zdravljenja pa v 6. mesecu.
English: Pack sizes: 1 vial and 1 syringe or 2 vials and 2 syringes.
Slovenian: Velikosti pakiranja: 1 viala in 1 injekcijska brizga ali 2 viali in 2 injekcijski brizgi.
English: Belatacept, a selective costimulation blocker, is a soluble fusion protein consisting of a modified extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody.
Slovenian: Belatacept, selektivni zaviralec kostimulacije, je topna fuzijska beljakovina, sestavljena iz modificirane zunajcelične domene humanega citotoksičnega T limfocitnega antigena 4 (CTLA-4; “cytotoxic T-lymphocyte-associated antigen 4”), vezane na del Fc domene (segmenta zglob-CH2CH3) humanega imunoglobulinskega protitelesa G1.
English: Belatacept binds to CD80 and CD86 on antigen presenting cells.
Slovenian: Belatacept se veže na molekuli CD80 in CD86 na antigen predstavljajočih celicah.
English: The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis (see section 4.4).
Slovenian: Tuberkuloza se je v večini primerov pojavila pri bolnikih, ki živijo ali so v preteklosti živeli v državah z visoko prevalenco tuberkuloze (glejte poglavje 4.4).
English: PTLD in belatacept-treated patients most often presented in the central nervous system (CNS).
Slovenian: Pri bolnikih, ki so se zdravili z belataceptom, je PTLB najpogosteje prizadela centralni živčni sistem (CŽS).
English: Remove the flip off seal from the vial and wipe the top with an alcohol swab.
Slovenian: Z viale odstranite dvižno zaporko in vrh viale obrišite z alkoholnim robčkom.
English: The use of live vaccines should be avoided (see section 4.5).
Slovenian: Izogibati se je treba uporabi živih cepiv (glejte poglavje 4.5).
English: As compared to the results from the initial 3 years, no new adverse reactions or increasing incidence of adverse reactions (listed above from the initial 3-year period) were detected during the 4-year long-term open label extension.
Slovenian: V primerjavi z rezultati iz prvih 3 let zdravljenja med 4 letnim dolgoročnim odprtim podaljškom niso ugotovili novih neželenih učinkov ali večje pojavnosti neželenih učinkov (neželeni učinki iz začetnega 3 letnega obdobja zdravljenja so navedeni zgoraj).
English: The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
Slovenian: Koncentracija belatacepta v infuziji bo med 2 mg in 10 mg belatacepta na mililiter raztopine.
English: Up to Year 3*
Slovenian: do 1. leta do 3. leta*
English: Year 1 and Year 3 frequencies of infections occurring by treatment group are shown in Table 4.
Slovenian: Pogostnost okužb po 1-letnem ali 3-letnem zdravljenju je po skupinah zdravljenja prikazana v preglednici 4.
English: For Studies 1 and 2 at Years 1 and 3, belatacept was associated with 6 to 9 mmHg lower mean systolic blood pressure, approximately 2 to 4 mmHg lower mean diastolic blood pressure, and less use of antihypertensive medicinal products than ciclosporin.
Slovenian: V Študiji 1 in 2 je bila uporaba belatacepta v 1. in 3. letu povezana z za 6 do 9 mmHg nižjo srednjo vrednostjo sistoličnega krvnega tlaka, z za približno 2 do 4 mmHg nižjo srednjo vrednostjo diastoličnega krvnega tlaka in manjšo uporabo antihipertenzivov kot uporaba ciklosporina.
English: Patients are not required to be pre-treated to prevent allergic reactions (see section 4.8).
Slovenian: Predhodna uporaba zdravil za preprečevanje pojava alergijskih reakcij ni potrebna (glejte poglavje 4.8).
English: To minimise foam formation, gently swirl and invert the vial for at least 30 seconds or until the powder is completely dissolved.
Slovenian: Da bi bilo penjenje raztopine čim manjše, vialo nežno obračajte vsaj 30 sekund ali dokler se prašek popolnoma ne raztopi.
English: Belatacept LI N= 472
Slovenian: belatacept MI n = 472
English: No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of NULOJIX with other agents.
Slovenian: Študij fizikalne ali biokemijske kompatibilnosti pri sočasni uporabi zdravila NULOJIX skupaj z drugimi zdravili niso izvedli.
English: Do not shake the vials.
Slovenian: Vial ne stresajte.
English: If you are infected with a virus called cytomegalovirus (CMV)
Slovenian: če ste okuženi s citomegalovirusom (CMV).
English: What NULOJIX is and what it is used for 2.
Slovenian: Kaj je zdravilo NULOJIX in za kaj ga uporabljamo 2.
English: Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4.
Slovenian: Na regiji vezavnega liganda CTLA-4 sta bili narejeni dve aminokislinski substituciji (L104 v E in A29 v Y).
English: Number of vials required equals the belatacept dose in mg divided by 250 rounded up to the next full number of vials.
Slovenian: Število potrebnih vial ustreza odmerku belatacepta (v mg) deljeno z 250, zaokroženo navzgor do naslednjega celega števila vial.
English: Overall, the few reports across clinical studies suggest that prolonged exposure to belatacept does not predispose patients to an increased risk of development of autoimmune events.
Slovenian: Glede na redkost poročil iz kliničnih študij kaže, da se pri dolgotrajni izpostavljenosti belataceptu tveganje za pojav avtoimunskih dogodkov pri bolniku ne poveča.
English: Excipient with known effect Each vial contains 0.65 mmol sodium.
Slovenian: Pomožna snov z znanim učinkom: Ena viala vsebuje 0,65 mmol natrija.
English: Within each frequency category adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: This corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of 3 vials.
Slovenian: To ustreza 1,95 mmol (ali 45 mg) natrija na največji odmerek 3 vial.
English: The trough concentration of belatacept was consistently maintained up to 5 years post-transplant.
Slovenian: Najmanjše koncentracije belatacepta v stanju dinamičnega ravnovesja so se dosledno ohranile do 5 let po presaditvi.
English: Uncommon abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased
Slovenian: Občasni nenormalne sanje, nihanje razpoloženja, pomanjkanje pozornosti/hiperaktivnostna motnja, povečanje libida
English: NULOJIX should not be infused concomitantly in the same intravenous line with other agents.
Slovenian: Zdravila NULOJIX ne smete infundirati sočasno z drugimi zdravili preko iste intravenske linije.
English: In Study 1, one additional case of PTLD was reported in the ciclosporin group, in a patient who was EBV seropositive at the time of transplant.
Slovenian: V Študiji 1 so poročali o enem dodatnem primeru PTLB v skupini zdravljenja s ciklosporinom pri bolniku, ki je bil v času presaditve EBV seropozitiven.
English: Chemical and physical in-use stability of the solution for infusion has been demonstrated for 24 hours when stored in a refrigerator (2°C - 8°C).
Slovenian: Dokazano je bilo, da je raztopina za infundiranje kemijsko in fizikalno stabilna do 24 ur, če se jo shranjuje v hladilniku (2°C - 8°C).
English: When belatacept was compared to placebo infusions, there were no differences in event rates (placebo infusions were administered at Weeks 6 and 10 of the belatacept LI regimen to blind the MI and LI regimens).
Slovenian: Pri primerjavi belatacepta z infundiranjem placeba ni bilo razlike v deležu dogodkov (placebo infuzije so aplicirali v 6. in 10. tednu pri MI režimu zdravljenja z belataceptom, da so prikrili BI in MI režim).
English: In rats, belatacept had no undesirable effects on male or female fertility.
Slovenian: Pri podganah belatacept ni imel neželenih učinkov na plodnost samcev ali samic.
English: Transplant recipients who are EBV seronegative or serostatus unknown should not receive belatacept (see section 4.3).
Slovenian: Bolniki s presajeno ledvico, ki so seronegativni za EBV, ali pa njihovo serološko stanje ni znano, belatacepta ne smejo prejeti (glejte poglavje 4.3).
English: Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived.
Slovenian: Belatacept, modificirana oblika CTLA4-Ig, ima večjo afiniteto za vezavo na CD80 in CD86 kot izvorna molekula CTLA4-Ig, iz katere je pridobljen.
English: Belatacept is produced by recombinant DNA technology in a mammalian cell expression system.
Slovenian: Belatacept je pridobljen s tehnologijo rekombinantne DNA na ekspresijskem sistemu sesalskih celic.
English: Important information about some of the ingredients of NULOJIX Tell your doctor if you are on a low-sodium (low-salt) diet before you are treated with NULOJIX.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila NULOJIX Če ste na dieti z omejenim vnosom natrija (soli), o tem pred začetkom zdravljenja z zdravilom NULOJIX obvestite zdravnika.
English: Changes in blood levels of different salts or electrolytes Increased amounts of cholesterol and triglyceride (blood fats) High levels of sugar in your blood
Slovenian: spremembe vrednosti različnih soli ali elektrolitov v krvi, zvišanje vrednosti holesterola in trigliceridov (krvne maščobe), zvišanje vrednosti krvnega sladkorja.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika nadzirati glede pojava kakršnegakoli znaka ali simptoma neželenih učinkov in po potrebi uvesti ustrezno simptomatsko zdravljenje.
English: The adverse reaction profile associated with immunosuppressive agents is often difficult to establish due to the underlying disease and the concurrent use of multiple medicinal products.
Slovenian: Profil neželenih učinkov zdravil za zaviranje imunske odzivnosti je pogosto težko ovrednotiti, tako zaradi osnovne bolezni, kot zaradi sočasne uporabe številnih drugih zdravil.
English: Corticosteroid Taper: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients at high immunologic risk, such as those with 4 to 6 human leukocyte antigen (HLA) mismatches.
Slovenian: Zmanjševanje odmerka kortikosteroida: Pri bolnikih, ki se zdravijo z belataceptom, je treba odmerek kortikosteroida zmanjševati previdno, še posebej pri bolnikih z velikim imunološkim tveganjem, kot so bolniki z neujemanjem humanega levkocitnega antigena (HLA) 4 do 6.
English: The most frequently reported acute infusion-related reactions in combined belatacept regimens were hypotension, hypertension, flushing and headache.
Slovenian: Najpogostejše opisane akutne infuzijske reakcije pri kombiniranem režimu zdravljenja z belataceptom so bile hipotenzija, hipertenzija, vročinski oblivi in glavobol.
English: 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).
Slovenian: V skupinah, ki so prejemale belatacept, je bilo več primerov virusnih in glivičnih okužb, kot v skupinah, ki so prejemale takrolimus, vendar pa se celotna pojavnost resnih okužb med vsemi skupinami zdravljenja ni razlikovala (glejte poglavje 4.4).
English: If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account the risk to the graft.
Slovenian: Če se ugotovi PML, je priporočljivo zmanjšati odmerek ali imunosupresivno zdravljenje ukiniti, vendar pa je pri tem treba upoštevati tveganje za presadek.
English: More detailed information on the benefits, risks, and precautions for usage of NULOJIX are described in the Summary of Product Characteristics (SmPC) for health care professionals and a package leaflet (PL) for patients.
Slovenian: Podrobnejše informacije o koristih, tveganjih in potrebnih previdnostih ukrepih pri uporabi zdravila NULOJIX so na voljo v povzetku glavnih značilnosti zdravila, ki je namenjen zdravstvenim delavcem, in navodilu za uporabo, ki je namenjeno bolnikom.
English: In rats, belatacept had no undesirable effects on male or female fertility (see section 5.3).
Slovenian: Pri podganah belatacept ni imel neželenih učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
English: Dates of NULOJIX Treatment:
Slovenian: Datumi aplikacije zdravila NULOJIX:
English: GFRb ml/min/1.73 m2 Year 1
Slovenian: GFRc ml/min/1,73 m2 1. mesec
English: In Study 2, approximately 40% reduction in this risk was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Slovenian: V Študiji 2 so pri bolnikih v skupini zdravljenja z belataceptom opazili približno 40 % zmanjšanje teh tveganj v primerjavi z bolniki v skupini zdravljenja s ciklosporinom.
English: In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept.
Slovenian: V klinični študiji so po uvodni aplikaciji belatacepta opazili približno 90 % zasičenost CD86 receptorjev na površini antigen predstavljajočih celic v periferni krvi.
English: In clinical studies with belatacept, 2 cases of PML were reported in patients receiving belatacept at doses higher than the recommended regimen.
Slovenian: V kliničnih študijah belatacepta so poročali o 2 primerih PML pri bolnikih, ki sta belatacept prejemala v odmerkih, višjih od priporočenega.
English: 1 vial 1 syringe
Slovenian: 1 viala 1 injekcijska brizga
English: Antibodies directed against the belatacept molecule were assessed in 796 kidney transplant recipients (551 of these treated for at least 3 years) in the two Phase 3 studies.
Slovenian: Protitelesa proti molekuli belatacepta so ovrednotili pri 796 bolnikih s presajeno ledvico (551 od ovrednotenih bolnikov se je zdravilo vsaj 3 leta) v dveh študijah 3. faze.
English: What you need to know before you use NULOJIX 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo NULOJIX 3.
English: Packs of either 1 glass vial and 1 syringe or 2 glass vials and 2 syringes.
Slovenian: Pakiranja vsebujejo 1 stekleno vialo in 1 injekcijsko brizgo ali 2 stekleni viali in 2 injekcijski brizgi.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: *Median exposure for pooled studies is 1,092 days for each treatment group.
Slovenian: *Mediani čas izpostavljenosti za združene študije je 1.092 dni za vse skupine zdravljenja.
English: End of Week 8 and Week 12 after transplantation
Slovenian: Konec 8. tedna in konec 12. tedna po presaditvi
English: Other medicines and NULOJIX
Slovenian: Druga zdravila in zdravilo NULOJIX
English: Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Slovenian: Glede na vrsto ledvice, ki ste jo prejeli, lahko obstaja večje tveganje za pojav krvnih strdkov v presajeni ledvici.
English: Use of immunosuppressants, including belatacept, can increase susceptibility to infection, including fatal infections, opportunistic infections, tuberculosis, and herpes (see progressive multifocal leukoencephalopathy (PML) warning below and also section 4.8).
Slovenian: Zdravila za zaviranje imunske odzivnosti, vključno z belataceptom, lahko povečajo dovzetnost za okužbe, vključno z življenjsko nevarnimi okužbami, oportunističnimi okužbami, tuberkulozo in okužbo z virusi herpesa (glejte opozorilo o progresivni multifokalni encefalopatiji (PML) v nadaljevanju in poglavje 4.8).
English: This Patient Alert Card includes information that will be helpful to you and alert other doctors that you have a transplanted kidney and are on a potent medicine to keep your kidney working.
Slovenian: Opozorilni kartonček bo v pomoč vam in v opozorilo drugim zdravnikom, da imate presajeno ledvico in se sedaj zdravite z močnim zdravilom, ki ohranja njeno delovanje.
English: Too rapid reduction of steroid intake can increase the risk that your body may reject the transplanted kidney.
Slovenian: V primeru prehitrega zmanjšanja odmerka kortikosteroida se lahko poveča tveganje za zavrnitev presajene ledvice.
English: Table 5 summarises results for belatacept LI compared with ciclosporin for the co-primary efficacy endpoints of death and graft loss, composite renal impairment, and acute rejection (defined as clinically suspected biopsy proven acute rejection).
Slovenian: Preglednica 5 prikazuje povzetek rezultatov pri MI režimu zdravljenja z belataceptom v primerjavi s ciklosporinom za soprimarne opazovane dogodke učinkovitosti in sicer smrt bolnika in izguba presadka, okvara ledvic in akutna zavrnitev (po kliničnem sumu z biopsijo dokazana akutna zavrnitev).
English: The potential impact of pre-existing antibodies to belatacept should be taken into account when considering retreatment with belatacept following prolonged discontinuation, particularly in patients who have not received continuous immunosuppression.
Slovenian: Pri ponovni uvedbi zdravljenja z belataceptom po daljši prekinitvi je treba upoštevati možen vpliv pojava protiteles proti belataceptu pri predhodnem zdravljenju, še posebej pri bolnikih, ki se niso kontinuirano zdravili z zdravili za zaviranje imunske odzivnosti.
English: Study 1 excluded (1) recipients undergoing a first transplant whose current PRA were ≥50%; (2) recipients undergoing a retransplantation whose current PRA were ≥30%; (3) recipients when previous graft loss was due to acute rejection and in case of a positive T-cell lymphocytotoxic cross match.
Slovenian: Iz študije 1 so bili izključeni (1) prejemniki organa po prvi presaditvi, katerih trenutna vrednost PRA je bila ≥ 50 %, (2) prejemniki po ponovni presaditvi organa, katerih trenutna vrednost PRA je bila ≥ 30 %, (3) prejemniki organa pri katerih je prišlo do izgube predhodnega presadka zaradi akutne zavrnitve in v primeru pozitivnega T-limfocitotoksičnega navzkrižnega preizkusa.
English: If any serious allergic or anaphylactic reaction occurs, belatacept therapy should be discontinued immediately and appropriate therapy initiated (see section 4.4).
Slovenian: V primeru pojava kakršnekoli resne alergijske ali anafilaktične reakcije je treba zdravljenje z belataceptom nemudoma prekiniti in uvesti ustrezno zdravljenje (glejte poglavje 4.4).
English: If you are given more NULOJIX than you should If this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Slovenian: Če ste prejeli večji odmerek zdravila NULOJIX, kot bi smeli V tem primeru vas bo zdravnik nadziral glede morebitnega pojava znakov ali simptomov neželenih učinkov in po potrebi uvedel njihovo ustrezno zdravljenje.
English: People are at a higher risk of developing PTLD in the following cases:
Slovenian: Tveganje za razvoj potransplantacijske limfoproliferativne bolezni je večje v naslednjih primerih:
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neporabljeno raztopino zavrzite.
English: The safety and efficacy of belatacept have not been established in liver transplant patients, and therefore such use is not recommended.
Slovenian: Varnosti in učinkovitosti belatacepta pri bolnikih s presajenimi jetri niso dokazali, zato uporaba belatacepta pri teh bolnikih ni priporočljiva.
English: NULOJIX is supplied in a 20 ml vial (Type I flint glass) with a stopper (20 mm grey butyl rubber) and flip off seal (aluminum).
Slovenian: Zdravilo NULOJIX je na voljo v 20-ml viali (kremenčevo steklo tipa I), ki je zaprta z zamaškom (20mm siva butilna guma) in dvižno zaporko (aluminij).
English: Therefore, preclinical studies conducted with abatacept have been used to support the safety of belatacept in addition to the studies conducted with belatacept.
Slovenian: Poleg predkliničnih študij, izvedenih z belataceptom, so za podporo varnosti belataceptu tako uporabili tudi podatke iz predkliničnih študij, izvedenih z abataceptom.
English: If any serious allergic or anaphylactic reaction occurs, NULOJIX therapy should be discontinued immediately and appropriate therapy initiated.
Slovenian: V primeru pojava kakršnekoli resne alergijske ali anafilaktične reakcije je treba zdravljenje z zdravilom NULOJIX nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: Serious infections Serious infections can happen with NULOJIX treatment and can lead to death.
Slovenian: Resne okužbe Med zdravljenjem z zdravilom NULOJIX se lahko pojavijo resne okužbe, ki se lahko končajo s smrtjo.
English: For patients who may be switched from belatacept to another immunosuppressant, physicians should be aware of the 8-10 day half-life of belatacept to avoid potential under- or over-immunosuppression following discontinuation of belatacept.
Slovenian: Če se pri bolniku zdravljenje z belataceptom zamenja z drugim imunosupresivom, je treba upoštevati razpolovni čas belatacepta, ki je 8-10 dni, da se prepreči morebitno premajhno ali preveliko imunosupresijo po prekinitvi uporabe belatacepta.
English: Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
Slovenian: Iz študije 2 so bili izključeni prejemniki organa s trenutno vrednostjo PRA ≥ 30 %, prejemniki po ponovni presaditvi organa in v primeru pozitivnega T-limfocitotoksičnega navzkrižnega preizkusa.
English: Of the 1209 randomized and transplanted patients in the two Phase 3 studies (see section 5.1), 761 patients continued after Year 3 in a long-term extension period for up to an additional 4 years and continued to receive the study drug according to their original treatment assignment.
Slovenian: Od 1.209 randomiziranih bolnikov s presajenim organom iz dveh študij 3. faze (glejte poglavje 5.1) je 761 bolnikov po 3. letu nadaljevalo zdravljenje v dolgoročnem podaljšanem obdobju, ki je trajalo največ dodatna 4 leta, bolniki pa so v tem času nadaljevali z uporabo študijskega zdravila v skladu s prvotno dodeljenim režimom zdravljenja.
English: What NULOJIX is and what it is used for
Slovenian: Kaj je zdravilo NULOJIX in za kaj ga uporabljamo
English: In general, these events occurred early and the majority resulted in graft loss.
Slovenian: V splošnem je do tromboze presadka prišlo kmalu po presaditvi, večina primerov pa se je končala z izgubo presadka.
English: Practical details on the reconstitution of vials
Slovenian: Praktične podrobnosti za raztapljanje praška
English: It is not known whether belatacept, the active substance, passes into human milk.
Slovenian: Ni znano, če zdravilna učinkovina belatacept prehaja v materino mleko.
English: In both studies, in patients with AR by Year 2, donor-specific antibodies, one of the criteria for diagnosis of antibody-mediated rejection, were present in 6% (2/32, Study 2)-8% (3/39, Study 1) and 20% (4/20, Study 1)-26% (7/27, Study 2) in the belatacept and ciclosporin groups by year 3, respectively.
Slovenian: V obeh študijah so pri bolnikih z akutno zavrnitvijo do 2. leta ugotovili prisotnost darovalčevih specifičnih protiteles (eden od kriterijev za diagnozo s protitelesi povzročene zavrnitve) do 3. leta, in sicer pri 6 % (2/32, Študija 2)-8 % (3/39, Študija 1) bolnikov, ki so prejemali belatacept, in 20 % (4/20, Študija 1)-26 % (7/27, Študija 2) bolnikov, ki so prejemali ciklosporin.