FrancophonIA/ELRC3.0 huggingface dataset:
English: Daclizumab binds with high specificity to the alpha or Tac subunit of the high affinity IL-2 receptor complex (expressed on activated T cells), and inhibits IL-2 binding and biological activity.
Slovenian: Daclizumab se veže visoko specifično na alfa ali Tac podenoto visoko afinitetnega IL-2 receptorskega kompleksa (izražen na aktiviranih T-celicah) in zavira vezavo ter biološko aktivnost IL-2.
English: At 1 year post-transplant 14 of 216 patients (6.5%) who received Zenapax and 4 of 207 (1.9%) patients who received placebo died of an infection, a difference of 4.6% (95% CI: 0.3%, 8.8%).
Slovenian: 1 leto po prejetju presadka je pri 14 od 216 (6,5 %) bolnikov, ki so jemali Zenapax in pri 4 od 207 (1,9 %) bolnikov, ki so prejemali placebo, nastopila smrt zaradi okužbe (razlika 4,6 %; 95-% interval zaupanja: 0,3 %, 8,8 %).
English: Adverse event
Slovenian: Neželeni dogodek
English: Paediatric Patients: Pharmacokinetic and pharmacodynamic properties were evaluated in 61 paediatric patients treated with 1 mg/kg IV dose of Zenapax every 14 days for a total of 5 doses.
Slovenian: Pediatrični bolniki: farmakokinetične in farmakodinamične lastnosti so ocenjevali pri 61 pediatričnih bolnikih, ki so prejemali Zenapax intravensko v odmerku 1 mg/kg vsakih 14 dni, skupno 5 odmerkov.
English: Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.
Slovenian: Krvni sladkor na tešče so merili pri majhnem številu bolnikov, zdravljenih s placebom in Zenapaxom.
English: In a single dose toxicity study a dose of 125 mg/kg was administered intravenously to mice and showed no evidence of toxicity.
Slovenian: V preskušanju toksičnosti enkratnega odmerka so miši intravensko dali odmerek 125 mg/kg in pri tem niso opazili znakov toksičnosti.
English: Other drug/substances should not be added or infused simultaneously through the same intravenous line.
Slovenian: Z isto infuzijo ne smemo sočasno dajati drugih zdravil ali snovi.
English: In clinical trials involving renal allograft patients-treated with 1 mg/kg of Zenapax every 14 days for a total of 5 doses, average peak serum concentrations (mean ± standard deviation) rose between the first dose (21 ± 14 µg/ml) and fifth doses (32 ± 22 µg/ml).
Slovenian: V kliničnih preskušanjih, ki so vključevale bolnike z ledvičnim presadkom, zdravljene z 1 mg/kg Zenapaxa vsakih 14 dni, do skupno pet odmerkov, je povprečni vrh serumske koncentracije (srednja vrednost ± standardna deviacija) naraščal med prvim (21 ± 14 µg/ml) in petim odmerkom (32 ± 22 µg/ml).
English: These side effects can be serious and you may need urgent medical attention.
Slovenian: Ti neželeni učinki se lahko pojavijo pri uporabi zdravila Zenapax, lahko so resni in morda boste potrebovali nujno medicinsko pomoč.
English: What Zenapax is and what it is used for Before you use Zenapax How to use Zenapax Possible side effects How to store Zenapax Further information
Slovenian: Kaj je zdravilo Zenapax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zenapax Kako uporabljati zdravilo Zenapax Možni neželeni učinki
English: Severe, acute (onset within 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.
Slovenian: Hude akutne (nastop v 24 urah) preobčutljivostne reakcije po prvi in po naslednjih izpostavitvah zdravilu Zenapax so se pojavile redko.
English: No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed.
Slovenian: Med Zenapaxom in vrečkami iz polivinilklorida ali infuzijskimi seti niso opazili inkompatibilnosti.
English: Zenapax contains daclizumab, a recombinant, humanized IgG1 anti-Tac antibody, and functions as an interleukin 2 (IL-2) receptor antagonist.
Slovenian: Zenapax vsebuje daclizumab, rekombinantno humanizirano IgG1 anti-Tac protitelo in ima funkcijo interlevkin 2 (IL-2) receptorskega antagonista.
English: These medicines help to suppress your body's natural response to reject your transplanted organ.
Slovenian: Ta zdravila pomagajo oslabiti naravni obrambni odziv vašega telesa, da ne bi prišlo do zavrnitve presadka.
English: Rarely, allergic reactions (hypersensitivity) to Zenapax may occur.
Slovenian: Redko se lahko pojavijo alergijske reakcije (preobčutljivost) na zdravilo Zenapax.
English: Overall, use of polyclonal antilymphocyte antibody therapy (OKT3, ATG, ATGAM) was similar in patients who received Zenapax and in patients who received placebo, 18.5% and 17.9%, respectively.
Slovenian: V splošnem je zdravljenje s poliklonskimi antilimfocitnimi protitelesi (OKT3, ATG, ATGAM) prejelo podobno število bolnikov, ki so jemali Zenapax (18,5 %) ali placebo (17,9 %).
English: Administration of Zenapax inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
Slovenian: Zenapax zavira z IL-2 vodeno aktivacijo limfocitov, kritično pot v celičnem imunskem odzivu, ki je vpleten pri zavrnitvi presadka.
English: The three year patient survival rate was significantly different between placebo and daclizumab in the double immunosuppressant trial (88% Vs. 96%; p = 0.017), but not in the triple immunosuppressant trial (94% Vs. 92%).
Slovenian: Triletna stopnja preživetja bolnikov je bila signifikatno različna med placebom in daclizumabom v dvojnem preskušanju imunosupresivov (88 % placebo, 96 % daclizumab; p = 0,017), v trojnem preskušanju imunosupresivov pa ne (94 % placebo, 92 % daclizumab).
English: If diluted aseptically it may be stored for 24 hours when refrigerated between 2 °C - 8 °C or for 4 hours at 25 °C.
Slovenian: Če je pripravljena pod aseptičnimi pogoji, jo lahko hranimo v hladilniku pri 2 °C do 8 °C 24 ur ali 4 ure pri 25 °C.
English: Zenapax may cause damage to your unborn or breast-feeding baby.
Slovenian: Zdravilo Zenapax lahko poškoduje še nerojenega ali dojenega otroka.
English: Anaphylactic reactions following the administration of proteins can occur.
Slovenian: Lahko se pojavijo anafilaktične reakcije, ki sledijo aplikaciji beljakovin.
English: No dosage adjustments based on other identified covariates (gender, proteinuria, race and age) are required for renal allograft patients.
Slovenian: Za bolnike z ledvičnim presadkom ni potrebno prilagajanje odmerkov na osnovi drugih ugotovljenih parametrov (spol, proteinurija, rasa in starost).
English: Patients with severe renal impairment
Slovenian: Bolniki s hudo ledvično okvaro
English: What Zenapax looks like and contents of the pack
Slovenian: Izgled zdravila Zenapax in vsebina pakiranja
English: Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.
Slovenian: Nekateri neželeni učinki so bolj verjetni pri otrocih kot pri odraslih, ti vključujejo drisko, bolečino po operaciji, povišano telesno temperaturo, bruhanje, povišan krvni tlak, srbečo kožo, okužbe nosu in žrela, okužbe sečil.
English: The three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs. 84%) or the double immunosuppressant trial (78% Vs. 82%).
Slovenian: Triletno preživetje presadka ni bilo statistično različno med placebom in daclizumabom v trojnem preskušanju imunosupresivov (83 % placebo, 84 % daclizumab) ali v dvojnem preskušanju imunosupresivov (78 % placebo, 82 % daclizumab).
English: Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group.
Slovenian: Okužbe s citomegalovirusom so se pojavile pri 16 % bolnikov v placebo skupini in pri 13 % bolnikov v skupini, zdravljenih z Zenapaxom.
English: A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Zenapax uporabljati učinkovito kontracepcijsko metodo in z njo nadaljevati še dodatne 4 mesece po prejemu zadnjega odmerka zdravila Zenapax.
English: Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax.
Slovenian: Zdravnik vam bo svetoval, da uporabljate kontracepcijo pred začetkom in med zdravljenjem z zdravilom Zenapax in še 4 mesece po zadnjem odmerku zdravila.
English: No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells.
Slovenian: Z analizo FACS (s fluorescenco aktivirano celično razvrščevanje) niso opazili nobenih drugih očitnih sprememb v številu krožečih limfocitov ali celičnih fenotipih, kot pričakovano prehodno znižanje Tac+ celic.
English: You will receive 4 subsequent doses which are spaced 14 days apart from each other.
Slovenian: Naslednje štiri odmerke boste prejeli v štirinajstdnevnih razmikih.
English: Do not use Zenapax - if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax.
Slovenian: Ne uporabljajte zdravila Zenapax - če ste alergični na (preobčutljivi za) daclizumab ali katerokoli drugo pomožno snov zdravila
English: Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group.
Slovenian: Resni neželeni učinki so se pojavili pri 44,4 % bolnikov, zdravljenih s placebom, in pri 39,9 % bolnikov, zdravljenih z Zenapaxom.
English: The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period.
Slovenian: Volumen Zenapaxa, ki vsebuje ustrezen odmerek, dodamo k 50 ml sterilne 0,9-% raztopine natrijevega klorida in apliciramo intravensko v obdobju 15 minut.
English: Hyperglycaemia: No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose.
Slovenian: Hiperglikemija: med patološkimi hematološkimi ali kemičnimi laboratorijskimi testnimi rezultati ni bilo razlik med skupino, ki je jemala placebo in skupino, ki je jemala Zenapax, razen pri vrednostih krvnega sladkorja na tešče.
English: Instructions for use and handling
Slovenian: Navodila za pripravo in ravnanje
English: Adverse events were reported by 95% of placebo and 96% of daclizumab treated patients.
Slovenian: Neželeni učinki so se pojavili pri 95 % bolnikov, zdravljenih s placebom, in pri 96 % bolnikov, zdravljenih z daclizumabom.
English: Daclizumab*…………5 mg per 1 ml infusion
Slovenian: daclizumab*…………..5 mg v 1 ml infuzije
English: Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Slovenian: Zenapax se uporablja skupaj z drugimi imunosupresivnimi zdravili, vključno s ciklosporinom in kortikosteroidi.
English: HOW TO USE ZENAPAX
Slovenian: KAKO UPORABLJATI ZDRAVILO ZENAPAX
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 5 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 viala (5 ml)
English: There is no experience of the use of Zenapax in patients who are highly immunised.
Slovenian: Za uporabo Zenapaxa pri visoko senzibiliziranih bolnikih ni izkušenj.
English: However due to potential harmful effects for the newborn, breast-feeding is contraindicated during the treatment and up to 4 months following the last dose of Zenapax.
Slovenian: Zaradi možnega škodljivega učinka na novorojenčka je dojenje med zdravljenjem in 4 mesece po zadnjem odmerku zdravila Zenapax kontraindicirano.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Daclizumab*…………5 mg per 1 ml infusion
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA daclizumab*…………5 mg v 1 ml infuzije
English: The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
Slovenian: Varnostni profil Zenapaxa so primerjali s placebom pri bolnikih, ki so sočasno prejemali imunosupresivna zdravila, ki so vključevala ciklosporin in kortikosteroide same ali sočasno z azatioprinom ali mofetilmikofenolatom.
English: The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
Slovenian: Pri kliničnih preskušanjih z Zenapaxom ni bilo medsebojnih delovanj z naslednjimi zdravili za transplantacijo: ciklosporinom, mofetilmikofenolatom, ganciklovirjem, aciklovirjem, takrolimusom, azatioprinom, antitimocitnim imunoglobulinom, muromonabom-CD3 (OKT3) in kortikosteroidi.
English: A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.
Slovenian: Pri odmerku 1,5 mg/kg, ki je bil dan prejemnikom transplantata kostnega mozga, ni bilo nobenih škodljivih učinkov.
English: Zenapax should initially be given within 24 hours before transplantation.
Slovenian: Prvi odmerek Zenapaxa moramo aplicirati 24 ur pred transplantacijo.
English: Incidence of malignancies: Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
Slovenian: Incidenca malignih obolenj: tri leta po zdravljenju je bila incidenca malignih obolenj 7,8-% v placebo skupini in 6,4-% v skupini, zdravljeni z Zenapaxom.
English: In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax.
Slovenian: Pri prejemnikih presadkov do zdaj še ni izkušenj z dvakratnim ali večkratnim zdravljenjem z Zenapaxom.
English: Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ml) and the fifth dose (21 + 14 µg/ml).
Slovenian: Najvišje serumske koncentracije (vrh ± standardna deviacija) so naraščale med prvim (16 ± 12 µg/ml) in petim odmerkom (21 ± 14 µg/ml).
English: The mean ± standard deviation trough serum concentration prior to fifth dose was 7.6 ± 4.0 µg/ml.
Slovenian: Srednja vrednost ± standardna deviacija najnižjih serumskih koncentracij pred petim odmerkom je bila 7,6 ± 4,0 µg/ml.
English: There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, da bi Zenapax vplival na sposobnost za vožnjo z avtom ali upravljanje s stroji.
English: METHOD OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Slovenian: POSTOPEK UPORABE Za intravensko uporabo po razdredčitvi Pred uporabo preberite priloženo navodilo
English: Because Zenapax is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Slovenian: Zenapax je imunoglobulin, zato ni pričakovati metaboličnih medsebojnih delovanj z drugimi zdravili.
English: One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml).
Slovenian: Ena 5 ml viala vsebuje 25 mg daclizumaba* (5 mg/ml).
English: One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
Slovenian: Ena viala s 5 ml koncentrata za raztopino za infundiranje vsebuje 25 mg daclizumaba.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, for infusion after dilution Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo, za infuzijo po razredčitvi Pred uporabo preberite priloženo navodilo
English: The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus.
Slovenian: Klinični znaki teh reakcij so vključevali hipotenzijo, tahikardijo, hipoksijo, dispnejo, sopenje, edem grla, pljučni edem, rdečico, diaforezo, porast telesne temperature, izpuščaj in koprivnico.
English: Serious allergic reactions may occur following the administration of proteins.
Slovenian: Beljakovine lahko povzročijo resne alergijske reakcije.
English: Store in a refrigerator (2 °C - 8 °C) Do not freeze
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C) Ne zamrzujte
English: The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups.
Slovenian: Incidenca mrtvorojenosti, carskega reza in poroda z zadnjično vstavo je bila v kontrolni in zdravljeni skupini živali primerljiva.
English: The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ml.
Slovenian: Pred petim odmerkom je bila srednja serumska koncentracija 5,0 ± 2,7 µg/ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/098/001
English: Pharyngitis
Slovenian: faringitis
English: - difficulty breathing - constipation; diarrhoea; vomiting; nausea; or heartburn - pain in joints and muscles - excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema) - problems with wound healing
Slovenian: - oteženo dihanje, - zaprtje, driska, bruhanje, slabost ali zgaga, - bolečina v sklepih in mišicah, - nakopičenje tekočine v telesu (edem), otekanje rok in nog (periferni edem), - težave pri celjenju ran.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/098/002
English: PHARMACEUTICAL FORM AND CONTENTS 3 vials of 5 ml each
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 3 viale (5 ml)
English: In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4).
Slovenian: V redkih primerih so se po dajanju Zenapaxa pojavile resne preobčutljivostne reakcije (glejte poglavje
English: Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.
Slovenian: Sočasna uporaba Zenapaxa z drugim zdravljenjem z antilimfocitnimi protitelesi lahko v smislu intenzivne imunosupresije s ciklosporinom, mofetilmikofenolatom in kortikosteroidi privede do smrtne okužbe.
English: Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution.
Slovenian: Zenapax 5 mg/ml koncentrat za raztopino za infundiranje je bistra, brezbarvna do rahlo rumenkasta tekočina.
English: Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys.
Slovenian: Po enkratnih intravenskih bolusih ali subkutanih odmerkih v obsegu od 50 do 125 mg/kg pri miših, podganah in kuncih in po 28-dnevnem dajanju 15 mg/kg pri opicah so ugotovili dobro prenašanje daclizumaba.
English: A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
Slovenian: Visoke vrednosti krvnega sladkorja na tešče je imelo skupno 16 % bolnikov (10 od 64 bolnikov) v placebo skupini in 32 % (28 od 88 bolnikov) bolnikov, zdravljenih z Zenapaxom.
English: No data are available for patients with severe hepatic impairment.
Slovenian: Za bolnike s hudo jetrno okvaro ni podatkov.
English: Zenapax is used to prevent your body from rejecting transplanted kidneys.
Slovenian: Zenapax se uporablja za preprečevanje zavrnitve ledvičnega presadka.
English: In total you should receive 5 doses of Zenapax for a complete treatment course.
Slovenian: Med celotnim zdravljenjem z Zenapaxom boste skupno prejeli pet odmerkov.
English: The twelve months mortality was 4.4% in the placebo- and 1.5% in the Zenapax-treated groups.
Slovenian: Po dvanajstih mesecih je bilo v placebo skupini 4,4 % smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 1,5 %.
English: Injury and poisoning Common
Slovenian: Poškodbe in zastrupitve pogosti posttravmatska bolečina
English: * Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Slovenian: * Rekombinantno humanizirano IgG1 anti-Tac protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celične kulture mieloma NSO glodalcev s pomočjo ekspresijskega sistema glutamin sintetaze (NS_GSO, glutamin synthetase expression system).
English: There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
Slovenian: Med Zenapaxom in mikofenolno kislino, aktivnim presnovkom mofetilmikofenolata (CellCept®), ni farmakokinetičnih interakcij.
English: No dosage adjustment is necessary for patients with severe renal impairment.
Slovenian: Za bolnike s hudo ledvično okvaro ni treba prilagajati odmerka.
English: Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Slovenian: Zenapax 5 mg/ml koncentrat za raztopino za infundiranje daclizumab
English: While Zenapax is an immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax.
Slovenian: Od začetka uporabe Zenapaxa kot imunosupresivnega zdravila, pri bolnikih zdravljenih z Zenapaxom, niso opazili porasta LPD ali oportunističnih okužb.
English: Zenapax is a colourless solution provided as a single use vial.
Slovenian: Zenapax je brezbarvna raztopina v vialah za enkratno uporabo.
English: Pharmacotherapeutic group: selective immunosuppressive agents ATC code: L04A A08
Slovenian: Oznaka ATC: L04A A08.
English: Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Slovenian: Prvih šest mesecev po transplantaciji je bilo v placebo skupini 3,4 % smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 0,6 %.
English: Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Slovenian: Daclizumab je humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celične kulture mieloma NSO glodalcev s pomočjo glutamin sintetaznega ekspresijskega sistema (NS_GSO).
English: Do not use Zenapax after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: - The other ingredients are polysorbate 80, sodium chloride, sodium dihydrogen phosphate, anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injections.
Slovenian: - Pomožne snovi so polisorbat 80, natrijev klorid, brezvodni natrijev dihidrogenfosfat, brezvodni natrijev hidrogenfosfat, koncentrirana klorovodikova kislina, natrijev hidroksid in voda za injekcije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001 (single vial pack) EU/1/99/098/002 (3 vial pack)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/098/001 (pakiranje z 1 vialo)