FrancophonIA/ELRC3.0 huggingface dataset:
English: The steady-state trough ustekinumab levels resulting from 90 mg ustekinumab every 8 weeks were associated with higher clinical remission rates as compared to the steady-state trough levels following 90 mg every 12 weeks.
Slovenian: Vrednosti najmanjše koncentracije v stanju dinamičnega ravnovesja po injiciranju 90 mg ustekinumaba na 8 tednov so bile povezane z večjo stopnjo klinične remisije kot vrednosti po injiciranju 90 mg ustekinumaba na 12 tednov.
English: Baseline disease characteristics were generally consistent across all treatment groups in Psoriasis Studies 1 and 2 with a median baseline PASI score from 17 to 18, median baseline Body Surface Area (BSA) ≥ 20, and median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Slovenian: Mediana vrednost indeksa PASI na začetku študije je bila od 17 do 18, mediana vrednost ocene prizadete telesne površine (Body Surface Area-BSA) na začetku študije je bila ≥ 20, mediana vrednost dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index - DLQI) se je gibala v razponu od 10 do 12.
English: Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT) Psoriasis Study 3
Slovenian: Preglednica 5 Povzetek rezultatov kliničnega odziva po 12 tednih v 3. študiji psoriaze (ACCEPT) 3. študija psoriaze etanercept 24 odmerkov (50 mg dvakrat na teden)
English: No specific studies have been conducted with intravenous ustekinumab in elderly or paediatric patients.
Slovenian: Pri starejših ali pediatričnih bolnikih specifične študije z intravensko danim ustekinumabom niso bile opravljene.
English: The solution in the STELARA vial or pre-filled syringe should not be shaken.
Slovenian: Raztopine v viali ali napolnjeni injekcijski brizgi zdravila STELARA ne smete stresati.
English: VIAL LABEL TEXT (45 mg)
Slovenian: BESEDILO NA NALEPKI VIALE (45 mg)
English: When using the single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch (13 mm) needle is recommended.
Slovenian: Pri uporabi viale z enim odmerkom se priporoča uporaba 1-ml brizge z iglo velikosti G27 x 13 mm.
English: The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Slovenian: Mediana vrednost CL/F pri bolnikih s telesno maso > 100 kg je bila za približno 55% večja kot pri tistih s telesno maso ≤ 100 kg, medtem ko je bila mediana vrednost V/F za približno 37% večja pri bolnikih s telesno maso > 100 kg kot pri tistih s telesno maso ≤ 100 kg. Mediana vrednost najnižje serumske koncentracije ustekinumaba pri bolnikih z večjo telesno maso (> 100 kg) v skupini za odmerek 90 mg je bila podobna kot pri bolnikih z manjšo telesno maso (≤ 100 kg) v skupini za prejemanje 45 mg odmerka.
English: Calculate the dose and the number of STELARA vials needed based on patient weight (see section 3, Table 1).
Slovenian: Odmerek in potrebno število vial zdravila STELARA izračunajte na osnovi bolnikove telesne mase (glejte poglavje 4.1, Preglednica 1).
English: PASI 75 response N (%)
Slovenian: odziv PASI 75 r N (%)
English: Visually inspect the diluted solution before infusion.
Slovenian: Pred odmerjanjem preverite izgled razredčene raztopine.
English: You may cover the injection site with a small adhesive bandage, if necessary.
Slovenian: Če je potrebno, lahko na mesto injiciranja prilepite majhen obliž.
English: 90mg ustekinumab every 12 Weeks N = 172
Slovenian: 90 mg ustekinumaba na 12 tednov N = 172
English: Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion.
Slovenian: Ena viala vsebuje 130 mg ustekinumaba v 26 ml koncentrata za raztopino za infundiranje.
English: What Stelara looks like and contents of the pack Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection.
Slovenian: Zdravilo Stelara je bistra do rahlo opalescentna (z bisernim sijajem), brezbarvna do svetlo rumena raztopina za injiciranje.
English: Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Slovenian: Zdravilo Stelara boste uporabljali pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnostiko in zdravljenjem Crohnove bolezni oziroma ulceroznega kolitisa.
English: Never re-use needles and syringes, for your safety and health, and for the safety of others.
Slovenian: Te posode odstranite skladno z lokalnimi predpisi Zaradi vaše varnosti in zdravja in varnosti drugih, uporabljene igle ali brizge ne smete ponovno uporabiti.
English: Approximately 6 mg/kg
Slovenian: 520 mg približno 6 mg/kg
English: Recommended dose of ustekinumab N = 209
Slovenian: Priporočeni odmerek ustekinumaba n = 209
English: During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Slovenian: Do 12. tedna zdravljenja, nadzorovanega s placebom je bila učinkovitost primarnih ciljev pri skupini, ki je prejemala priporočeni odmerek in pri skupini, ki je prejemala polovico priporočenega odmerka v splošnem primerljiva (69,4% oziroma 67,6%).
English: If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Stelara, kot bi smeli Če ste sami uporabili prevelik odmerek zdravila Stelara oziroma so vam ga dali drugi, se morate nemudoma posvetovati z zdravnikom ali farmacevtom.
English: 90mg ustekinumab every 8 Weeks N = 176
Slovenian: 90 mg ustekinumaba na 8 tednov N=176
English: The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg.
Slovenian: Sistemska izpostavljenost ustekinumabu (Cmax in AUC) po enkratni intravenski injekciji odmerkov od 0,09 mg/kg do 4,5 mg/kg je naraščala približno sorazmerno z odmerkom.
English: The solution in the STELARA vial should not be shaken.
Slovenian: Raztopine v viali zdravila STELARA ne smete stresati.
English: • Inject the dose promptly after removing the needle cover.
Slovenian: • Po odstranitvi pokrovčka z igle takoj injicirajte zdravilo.
English: Recommended dose of ustekinumab N = 322
Slovenian: Priporočeni odmerek ustekinumaba N =322
English: STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
Slovenian: Zdravilo STELARA se lahko redči samo z 9 mg/ml (0,9%) raztopino natrijevega klorida.
English: • Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
Slovenian: • Primite telo brizge tako, da pokrovček igle gleda navzgor.
English: Patients who were not in clinical response to ustekinumab induction at week 8 of the UNFI-I study but were in response at week 16 (157 patients) entered into the non-randomized portion of UNIFI-M and continued to receive maintenance dosing every 8 weeks; among these patients, a majority (62%) maintained response and 30% achieved remission at week 44.
Slovenian: Bolniki, ki niso dosegli kliničnega odziva na indukcijski odmerek ustekinumaba v 8. tednu študije UNFI-I, so pa dosegli odziv v 16. tednu (157 bolnikov), so vstopili v nerandomiziran del študije UNIFI-M in nadaljevali s prejamanjem vzdrževalnega odmerjanja vsakih 8 tednov.
English: STELARA 45 mg solution for injection 2 years
Slovenian: STELARA 45 mg raztopina za injiciranje 2 leti
English: Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Slovenian: Bolniki, ki so bili najprej naključno uvrščeni v skupino za prejemanje placeba v 0. ali 4. tednu, pa so prešli v skupino za prejemanje ustekinumaba (bodisi v odmerku 45 mg ali 90 mg) v 12. in 16. tednu.
English: The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
Slovenian: po enkratni subkutani injekciji bodisi 45 mg ali 90 mg zdravila, pri bolnikih s psoriazo so bile podobne kot pri zdravih preizkušancih.
English: Keep the vial or pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Vialo ali napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: • Inflammation of tissue under the skin (‘cellulitis') is uncommon (may affect up to 1 in
Slovenian: • Občasno je vnetje podkožnega tkiva (‘celulitis') (pojavi se lahko pri največ 1 od
English: • You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
Slovenian: • Na mesto injiciranja lahko za 10 sekund pritisnete vato ali gazo.
English: STELARA is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Zdravilo STELARA se redči z 9 mg/ml (0,9%) raztopino natrijevega klorida.
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 9).
Slovenian: V študijah UNITI-1 in UNITI-2 je v skupini, ki je prejemala ustekinumab, statistično značilno večji delež bolnikov dosegel klinični odziv in remisijo, v primerjavi s skupino, ki je prejemala placebo (Preglednica 9).
English: • Slow down the damage to your joints.
Slovenian: • upočasnitev napredovanja sprememb v sklepih.
English: Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that were similar to the patients who initially responded to ustekinumab induction.
Slovenian: Med bolniki, ki so nadaljevali z vzdrževalnim odmerjanjem, jih je večina vzdrževala odziv na zdravljenje (68,1%) oz. so dosegli remisijo (50,2%) v 44. tednu.
English: Recommended dose of ustekinumab N = 249
Slovenian: Priporočeni odmerek ustekinumaba n = 249
English: STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).
Slovenian: Zdravilo STELARA je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se niso ustrezno odzvali, so izgubili odziv na zdravljenje ali niso prenašali konvencionalnega zdravljenja ali zdravljenja z biološkim zdravilom oziroma je takšno zdravljenje kontraindicirano (glejte poglavje 5.1).
English: IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL-23 induces the T helper 17 (Th17) pathway.
Slovenian: IL-12 stimulira naravne celice ubijalke (celice NK) in usmerja diferenciacijo celic CD4+T k fenotipu celic T pomagalk 1 (Th1).
English: STELARA 90 mg solution for injection 2 years
Slovenian: STELARA 90 mg raztopina za injiciranje 2 leti
English: Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Slovenian: Pri bolnikih s telesno maso > 100 kg je odmerek lahko 90 mg.
English: STELARA 45 mg solution for injection 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
Slovenian: STELARA 45 mg raztopina za injiciranje 0,5 ml raztopine v 2 ml viali (steklo tipa I), zaprti z obloženo zaporko iz butilirane gume.
English: In the treatment regimen, the first dose of STELARA is administered intravenously.
Slovenian: Prvi odmerek zdravila STELARA se injicira intravensko.
English: Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Slovenian: Preglednica 6: Povzetek glavnih kazalcev učinkovitosti v študiji UNIFI-M (po 44 tednih; 52 tednov po začetnem indukcijskem odmerku)
English: VIAL LABEL TEXT (90 mg)
Slovenian: BESEDILO NA NALEPKI VIALE (90 mg)
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 3).
Slovenian: V študijah UNITI-1 in UNITI-2 je v skupini, ki je prejemala ustekinumab, statistično značilno večji delež bolnikov dosegel klinični odziv in remisijo, v primerjavi s skupino, ki je prejemala placebo (Preglednica 3).
English: Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
Slovenian: Klinični odziv je definiran kot znižanje ocene Mayo od izhodiščne vrednosti za ≥ 30% in za ≥ 3 točke skupaj z znižanjem podocene krvavitve iz danke od izhodiščne vrednosti za ≥1 ali podocena krvavitve iz danke 0 ali1.
English: Patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see Table 1, section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.
Slovenian: Bolniki so bili randomizirani na enkratno intravensko odmerjanje bodisi priporočenega odmerka, prirejenega na približno 6 mg/kg (glejte Preglednico 1 v poglavju 4.2), fiksnega odmerka 130 mg ustekinumaba ali placeba v tednu 0.
English: 80, sucrose and water for injections.
Slovenian: L-metionin, polisorbat 80, saharoza in voda za injekcije.
English: • The recommended starting dose is 45 mg Stelara.
Slovenian: • Priporočeni začetni odmerek zdravila Stelara je 45 mg. Bolniki, ki tehtajo več kot
English: However, if you stop, your symptoms may come back.
Slovenian: Ni nevarno, če prenehate z jemanjem zdravila Stelara, vendar se vam lahko v tem primeru simptomi povrnejo.
English: STELARA 90 mg solution for injection 1 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
Slovenian: STELARA 90 mg raztopina za injiciranje 1 ml raztopine v 2 ml viali (steklo tipa I), zaprti z obloženo zaporko iz butilirane gume.
English: Talk to your doctor if you are on a low salt diet.
Slovenian: Če ste na dieti z malo soli, se pogovorite z zdravnikom.
English: Common: Oropharyngeal pain Uncommon: Nasal congestion Rare: Allergic alveolitis, eosinophilic pneumonia Very rare: Organising pneumonia*
Slovenian: Pogosti: bolečine v ustih in žrelu Občasni: oteklost nosne sluznice Redki: alergijski alveolitis, eozinofilna pljučnica
English: Water for injection
Slovenian: Navodilo za injiciranje zdravila
English: Rare side effects (may affect up to 1 in 1000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Stelara and for at least 15 weeks after the last Stelara treatment.
Slovenian: Ženske v rodni dobi naj med in še najmanj 15 tednov po uporabi zdravila Stelara za preprečevanje nosečnosti uporabljajo ustrezno kontracepcijo.
English: STELARA is supplied as a sterile, single-use vial or singleuse pre-filled syringe.
Slovenian: Zdravilo STELARA je na voljo v sterilnih vialah za enkratno uporabo ali v napolnjenih injekcijskih brizgah za enkratno uporabo.
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 and followed by the same dose every 12 weeks.
Slovenian: Bolniki, ki so bili naključno uvrščeni v skupino za prejemanje ustekinumaba, so prejeli 45 mg ali 90 mg odmerek v 0. in 4. tednu, potem pa so prejemali enak odmerek na 12 tednov.
English: STELARA 45 mg solution for injection in pre-filled syringe 0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex).
Slovenian: STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v 1 ml injekcijski brizgi (steklo tipa I) z iglo iz nerjavečega jekla in pokrovčkom iz naravne gume (lateks).
English: What Stelara contains
Slovenian: Kaj vsebuje zdravilo Stelara
English: Instructions for administration
Slovenian: Navodila za redčenje
English: • Used syringes and needles should be placed in a puncture-resistant container, like a sharps container.
Slovenian: • Uporabljene igle in brizge zavrzite v za to namenjene posode za odstranjevanje ostrih predmetov, ki so narejene tako, da preprečujejo vbod z iglo.
English: Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose.
Slovenian: Če 16 tednov po prejemu intravenskega indukcijskega odmerka ali 16 tednov po prehodu na vzdrževalno shemo odmerjanja na 8 tednov pri bolnikih ni opaziti znakov terapevtske koristi, je treba razmisliti o ukinitvi zdravljenja.
English: The primary endpoint was change from baseline in Simplified Endoscopic Disease Severity Score for Crohn's Disease (SES-CD), a composite score across 5 ileocolonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
Slovenian: skupna ocena 5 ileo-količnih segmentov glede prisotnosti/velikosit razjed; deleža površine sluznice, ki ga predstavljajo razjede; deleža površine sluznice, ki ga predstavljajo druge lezije in prisotnosti/vrste zoženja/strikture.
English: STELARA 90 mg solution for injection in pre-filled syringe 1 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex).
Slovenian: STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v 1 ml injekcijski brizgi (steklo tipa I) z iglo iz nerjavečega jekla in pokrovčkom iz naravne gume (lateks).
English: Tell your doctor or get emergency medical help straight away if you notice any of the following signs.
Slovenian: Alergijske reakcije - če opazite katerega koli od naslednjih znakov, se takoj posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč, saj boste morda potrebovali takojšnje zdravljenje.
English: • If you are having or have ever had injections to treat allergies - it is not known if Stelara may affect these.
Slovenian: • če dobivate ali ste kdaj dobili injekcije za zdravljenje alergij.
English: Table 10: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Slovenian: Preglednica 10: Vzdrževanje kliničnega odziva in klinične remisije v študiji IM-UNITI (44 tednov; 52 tednov od indukcijskega odmerka) placebo*
English: You must look out for certain signs of illness while you are taking Stelara.
Slovenian: Med jemanjem zdravila Stelara bodite pozorni na določene znake bolezni.
English: Disposal:
Slovenian: Odstranjevanje
English: The safety and efficacy of ustekinumab was assessed in 927 patients in two randomised, double-blind, placebo-controlled studies in patients with active PsA (≥ 5 swollen joints and ≥ 5 tender joints) despite non-steroidal anti-inflammatory (NSAID) or disease modifying antirheumatic (DMARD) therapy.
Slovenian: Varnost in učinkovitost ustekinumaba so ocenjevali pri 927 bolnikih z aktivnim PsA (≥ 5 oteklih sklepov in ≥ 5 občutljivih sklepov) v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah, ki so prejemali tudi nesteroidna protivnetna (NSAID) ali protirevmatična (DMARD)
English: At Week 44 maintenance of this effect was observed with significantly more patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups as compared to placebo (33%).
Slovenian: V 44. tednu so vzdrževanje tega učinka opazili kot ohranjanje histološke zacelitve pri statistično značilno več bolnikih iz skupine z ustekinumabom vsakih 12 tednov (54%) in iz skupine z ustekinumabom vsakih 8 tednov (59%) v primerjavi s skupino s placebom (33%).
English: Never re-use a syringe, for your safety and health and for the safety of others.
Slovenian: Zaradi vaše varnosti in zdravja in varnosti drugih, uporabljene brizge ne smete ponovno uporabiti.
English: Do not squeeze it tightly
Slovenian: Pazite, da je ne boste premočno stiskali.
English: Excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Slovenian: Pomožne snovi: EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinijev klorid monohidrat, Lmetionin, polisorbat 80, saharoza voda za injekcije.
English: Hospitalizations and ulcerative colits (UC) related surgeries Through week 8 of UNIFI-I, the proportions of subjects with UC disease related hospitalizations were significantly lower for subjects in the ustekinumab recommended dose group (1.6%, 5/322) compared with subjects in the placebo group (4.4%, 14/319) and no subjects underwent UC disease related surgeries in subjects receiving ustekinumab at the recommended induction dose compared to 0.6% (2/319) subjects in the placebo group.
Slovenian: Hospitalizacije in kirurški posegi zaradi ulceroznega kolitisa Do 8. tedna v študiji UNIFI-I je bil delež bolnikov, ki so bili hospitalizirani zaradi ulceroznega kolitisa, statistično značilno manjši v skupini bolnikov, ki je prejemala priporočeni odmerek ustekinumaba (1,6%, 5/322) kot pri bolnikih v skupini, ki so prejemali placebo (4,4%, 14/319).
English: • Peeling of the skin (skin exfoliation)
Slovenian: • luščenje kože
English: In patients who failed conventional therapy, but not a biologic
Slovenian: Zacelitev sluznice pri bolnikih z neuspešnim konvencionalnim zdravljenjem, ne pa neuspešnim zdravljenjem z biološkim zdravilom pri bolnikih z neuspešnim zdravljenjem z biološkim zdravilom
English: Treatment with ustekinumab resulted in significant improvements in the measures of disease activity compared to placebo at week 24.
Slovenian: Po 24 tednih zdravljenja je bil ustekinumab po kriterijih aktivnosti bolezni bistveno učinkovitejši kot placebo.
English: Number of patients ≤ 100 kg ACR 20 response, N (%)
Slovenian: Število randomiziranih bolnikov odziv ACR 20 N (%)
English: PRE-FILLED SYRINGE LABEL TEXT (45 mg)
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE (45 mg)
English: STELARA 90 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
Slovenian: STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 90 mg ustekinumaba v 1 ml raztopine.
English: Single dose versus multiple doses
Slovenian: Primerjava enkratnega in večkratnega odmerjanja
English: At week 44, maintenance of this effect was observed with significantly more patients in histo-endoscopic mucosal healing in the every 12 week (39%) and every 8 week (46%) ustekinumab groups as compared to placebo (24%).
Slovenian: V 44. tednu so vzdrževanje tega učinka opazili kot ohranjanje histološko endoskopske zacelitve pri statistično značilno več bolnikih iz skupine z ustekinumabom vsakih 12 tednov (39%) in iz skupine z ustekinumabom vsakih 8 tednov (46%) v primerjavi s skupino s placebom (24%).
English: It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial.
Slovenian: Pakirano je v kartonsko škatlico s 30 ml stekleno vialo z 1 odmerkom.
English: Common: Dizziness, headache Uncommon: Facial palsy
Slovenian: Pogosti: omotica, glavobol Občasni: paraliza obraznega živca
English: Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: saharoza, L-histidin, L-histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.