FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors.
Slovenian: Ni verjetno, da bi ustekinumab z IL-12 in/ali IL-23 prispeval k citotoksičnemu učinku na receptorske celice, posredovanemu preko komplementa ali protiteles.
English: Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.
Slovenian: Zdravilo Stelara uporabljamo za zdravljenje zmerne do hude psoriaze s plaki pri otrocih in mladostnikih, starih 6 let in več, ki ne prenašajo fototerapije ali drugega sistemskega zdravljenja, ali ta zdravljenja pri njih niso bila uspešna.
English: Table 4: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Slovenian: Preglednica 4: Vzdrževanje kliničnega odziva in klinične remisije v študiji IM-UNITI (44 tednov; 52 tednov od indukcijskega odmerka) placebo*
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 followed by an additional dose at 16 weeks.
Slovenian: Bolniki, ki so bili naključno uvrščeni v skupino za prejemanje ustekinumaba, so prejeli odmerek 45 mg ali 90 mg v 0. ali 4. tednu, potem pa še dodatni odmerek v 16. tednu.
English: Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. p<0.001
Slovenian: Kombinacija simptomatske remisije in zacelitve sluznice je definiranakot podocena frekvence odvajanja blata 0 ali1, podocena krvavitve iz danke 0 in endoskopska podocena 0 ali 1. p < 0,001
English: Stelara contains sodium
Slovenian: Zdravilo Stelara vsebuje natrij
English: Common: Fatigue, injection site erythema, injection site pain Uncommon: Injection site reactions (including haemorrhage, haematoma, induration, swelling and pruritus), asthenia
Slovenian: Občasni: reakcije na mestu injiciranja (vključno s krvavitvijo, hematomom, otrdelostjo tkiva, otekanjem in srbenjem), astenija
English: STELARA 45 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Slovenian: STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 45 mg ustekinumaba v 0,5 ml raztopine.
English: Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. p<0.001 p<0.05
Slovenian: Kombinacija simptomatske remisije in zacelitve sluznice je definirana kot podocena frekvence odvajanja blata0 ali 1, podocena krvavitve iz danke 0 in endoskopska podocena 0 ali 1. p < 0,001 nominalno statistično značilno (p < 0,001) nominalno statistično značilno (p< 0,05)
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 followed by dosing every 12 weeks.
Slovenian: Bolniki, ki so bili naključno uvrščeni v skupino za prejemanje placeba v 0. in 4. tednu, so prešli na prejemanje ustekinumaba (v odmerku bodisi 45 mg ali 90 mg) v 12. in 16. tednu, potem pa so odmerke prejemali na 12 tednov.
English: PRE-FILLED SYRINGE LABEL TEXT (90 mg)
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE (90 mg)
English: In PsA Study 2 significant improvement in enthesitis score and numerical improvement (not statistically significant) in dactylitis score was observed in the ustekinumab 90 mg group compared with placebo at week 24.
Slovenian: Tudi v 2. študiji PsA so v skupini, ki je prejemala 90 mg ustekinumaba, po 24 tednih zdravljenja opazili pomembno izboljšanje ocene entezitisa (razlika ni bila statistično značilna) in boljšo oceno daktilitisa v primerjavi z bolniki, ki so prejemali placebo.
English: Each vial contains 90 mg ustekinumab in 1 mL.
Slovenian: Ena viala vsebuje 90 mg ustekinumaba v 1 ml.
English: STELARA 90 mg solution for injection Each vial contains 90 mg ustekinumab in 1 mL.
Slovenian: STELARA 90 mg raztopina za injiciranje Ena viala vsebuje 90 mg ustekinumaba v 1 ml raztopine.
English: Each vial contains 130 mg of ustekinumab in 26 mL.
Slovenian: Ena viala vsebuje 130 mg ustekinumaba v 26 ml.
English: VIAL CARTON TEXT (45 mg)
Slovenian: BESEDILO NA ŠKATLI VIALE (45 mg)
English: In both studies, patients were randomised to receive a single intravenous administration of either the recommended tiered dose of approximately 6 mg/kg (see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC), a fixed dose of 130 mg ustekinumab, or placebo at week 0.
Slovenian: V obeh študijah so bili bolniki randomizirani in so v tednu 0 prejeli enkratni intravenski odmerek približno 6 mg/kg ustekinumaba glede na telesno maso (glejte poglavje 4.2 v povzetku glavnih značilnosti zdravila STELARA 130 mg koncentrat za raztopino za infundiranje), fiksni odmerek 130 mg ustekinumaba ali placebo.
English: • the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
Slovenian: • da je raztopina v viali bistra do rahlo opalescentna (ima biserni sijaj) in brezbarvna do rumenkasta,
English: Patients were randomised to receive either placebo (n = 37), or the recommended dose of ustekinumab (see section 4.2; n = 36) or half of the recommended dose of ustekinumab (n = 37) by subcutaneous injection at Weeks 0 and 4 followed by every 12 week (q12w) dosing.
Slovenian: Bolnike so randomizirali v skupino, ki je prejemala placebo (n = 37), v skupino, ki je prejemala priporočeni odmerek ustekinumaba (glejte poglavje 4.2; n = 36) ali v skupino, ki je prejemala polovico priporočenega odmerka ustekinumaba (n = 37).
English: STELARA 90 mg solution for injection EU/1/08/494/002
Slovenian: STELARA 90 mg raztopina za injiciranje EU/1/08/494/002
English: Stelara is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which STELARA is intended.
Slovenian: Zdravilo Stelara boste uporabljali pod vodstvom in nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolezni, za katere je zdravilo namenjeno.
English: Number of patients with ≥ 3% BSA PASI 75 response, N (%) Number of patients > 100 kg ACR 20 response, N (%) Number of patients with ≥ 3% BSA PASI 75 response, N (%)
Slovenian: odziv PASI 75 N (%) Število bolnikov z maso > 100 kg odziv ACR 20 N (%) Število bolnikov z ≥ 3% BSA
English: However it is possible it may increase the chance of diseases related to a weaker immune system.
Slovenian: Kombinacija teh terapij sočasno z zdravilom Stelara ni bila preučevana in bi lahko zvečala tveganje za bolezni, ki so povezane z oslabljenim imunskim sistemom.
English: It is supplied as a carton pack containing 1 single-dose, glass 2 mL vial.
Slovenian: Pakirana je v kartonsko škatlico z 2 ml stekleno vialo z 1 odmerkom.
English: STELARA 45 mg solution for injection in pre-filled syringe 3 years
Slovenian: STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 3 leta
English: STELARA 45 mg solution for injection Each vial contains 45 mg ustekinumab in 0.5 mL.
Slovenian: STELARA 45 mg raztopina za injiciranje Ena viala vsebuje 45 mg ustekinumaba v 0,5 ml raztopine.
English: The solution should be visually inspected for particulate matter or discoloration prior to administration.
Slovenian: Pred injiciranjem jo morate vizualno pregledati, ali vsebuje delce in ali je obarvana.
English: For patients with enthesitis and/or dactylitis at baseline, in PsA Study 1 significant improvement in enthesitis and dactylitis score was observed in the ustekinumab groups compared with placebo at week 24.
Slovenian: Pri bolnikih z entezitisom in daktilitisom na začetku zdravljenja z ustekinumabom so v 1. študiji PsA po 24 tednih zdravljenja opazili pomembno izboljšanje ocene entezitisa in daktilitisa v primerjavi z bolniki, ki so prejemali placebo.
English: Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells.
Slovenian: Ustekinumab preprečuje vezavo p40 na receptorski protein IL-12R1, ki se nahaja na površini imunskih celic in na ta način zavira biološko aktivnost človeških interlevkinov IL-12 in IL-23.
English: In patients who failed biological therapy In patients who failed both a TNF and vedolizumab Clinical Response
Slovenian: pri bolnikih z neuspešnim zdravljenjem z biološkim zdravilom pri bolnikih z neuspešnim zdravljenjem z zaviralcem TNF in vedolizumabom Zacelitev sluznice
English: In patients who failed conventional therapy, but not a biologic c77% (78/102)
Slovenian: pri bolnikih z neuspešnim zdravljenjem z biološkim zdravilom pri bolnikih z neuspešnim zdravljenjem z zaviralcem TNF in vedolizumabom Ohranjen klinični odziv do 44. tedna pri bolnikih z neuspešnim konvencionalnim zdravljenjem, ne pa neuspešnim zdravljenjem z biološkim zdravilom c 77% (78/102)
English: STELARA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STELARA is indicated.
Slovenian: Zdravilo STELARA je namenjeno za uporabo pod vodstvom in nadzorom zdravnikov z izkušnjami z diagnostiko in zdravljenjem bolezni, za katere je indicirano.
English: Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)
Slovenian: Klinični odziv (100 točk), 8. teden Klinični odziv (70 točk), 3. teden
English: Patients were randomised to receive treatment with ustekinumab 45 mg, 90 mg, or placebo subcutaneously at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing.
Slovenian: Bolnike so randomizirali, da so subkutano prejemali ustekinumab v odmerkih po 45 mg, 90 mg ali placebo v tednu 0 in 4 in nato na vsakih 12 tednov.
English: Let the pre-filled syringe stand outside the box for about half an hour.
Slovenian: • Napolnjeno injekcijsko brizgo vzemite iz hladilnika in iz škatle ter jo pustite na sobni temperaturi približno pol ure.
English: In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab treated group compared to placebo at week 8 (Table 11).
Slovenian: V študiji UNIFI-I je bil v skupini, ki je prejemala ustekinumab, statistično značilno večji delež bolnikov po 8 tednih v klinični remisiji v primerjavi s skupino, ki je prejemala placebo (Preglednica 11).
English: STELARA 90 mg solution for injection in pre-filled syringe 3 years
Slovenian: STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 3 leta
English: In both studies, 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: V obeh študijah so bili bolniki randomizirani in so v tednu 0 prejeli enkratni intravenski odmerek približno 6 mg/kg ustekinumaba glede na telesno maso (glejte Preglednico 1, poglavje 4.2), fiksni odmerek 130 mg ustekinumaba ali placebo.
English: The efficacy of ustekinumab was studied in 110 paediatric patients aged 12 to 17 years with moderate to severe plaque psoriasis in a multicenter, phase 3, randomised, double blind, placebo controlled study (CADMUS).
Slovenian: Učinkovitost ustekinumaba so preučevali v multicentrični, randomizirani, dvojno slepi s placebom nadzorovani študiji faze 3 (CADMUS) pri 110 pediatričnih bolnikih z zmerno do hudo psoriazo s plaki, starih 12 do 17 let.
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 1.0 years for ulcerative colitis studies.
Slovenian: V nadzorovanih in nenadzorovanih obdobjih kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa pri 6.709 bolnikih, izpostavljenih 11.561 bolnikov-let, je bila mediana časa spremljanja 1,0 leto; 1,1 leto za študije psoriatičnih bolezni, 0,6 let za študije Crohnove bolezni in 1,0 leto za študije ulceroznega kolitisa.
English: This includes antiseptic wipes, a cotton ball or gauze, and a sharps container.
Slovenian: Pripomočke, to je brizgo, iglo in antiseptične zložence, vato ali gazo ter vsebnik za odlaganje igel položite na čisto površino.
English: STELARA 45 mg solution for injection EU/1/08/494/001
Slovenian: STELARA 45 mg raztopina za injiciranje EU/1/08/494/001
English: Each vial contains 45 mg ustekinumab in 0.5 mL.
Slovenian: Ena viala vsebuje 45 mg ustekinumaba v 0,5 ml.
English: STELARA 45 mg injection ustekinumab
Slovenian: STELARA 45 mg injekcija ustekinumab s.c.
English: STELARA 90 mg injection ustekinumab
Slovenian: STELARA 90 mg injekcija ustekinumab s.c.
English: What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion.
Slovenian: Zdravilo Stelara je bister, brezbarven do svetlo rumen koncentrat za raztopino za infundiranje.
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,581 patient-years of exposure in 6,709 patients, the median follow up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 1.0 years for ulcerative colitis studies.
Slovenian: V nadzorovanih in nenadzorovanih obdobjih kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa pri 6.709 bolnikih, izpostavljenih 11.581 bolnikov-let, je bila mediana časa spremljanja 1,0 leto; 1,1 leto za študije psoriatičnih bolezni, 0,6 let za študije Crohnove bolezni in 1,0 leto za študije ulceroznega kolitisa.
English: • it has not passed its expiry date
Slovenian: • da rok uporabnosti ni pretečen,
English: It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe.
Slovenian: Pakirana je v kartonsko škatlico z 1 ml stekleno napolnjeno injekcijsko brizgo z 1 odmerkom.
English: In UNIFI-I a significantly greater proportion of patients were in clinical remission in the ustekinumab treated group compared to placebo at week 8 (Table 5).
Slovenian: V študiji UNIFI-I je bil v skupini, ki je prejemala ustekinumab, statistično značilno večji delež bolnikov po 8 tednih v klinični remisiji v primerjavi s skupino, ki je prejemala placebo (Preglednica 5).
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 4).
Slovenian: Po 44 tednih so bili deleži bolnikov, ki so vzdrževali klinično remisijo in odziv na zdravljenje, statistično značilno večji v skupinah, ki sta prejemali ustekinumab, v primerjavi s placebom (glejte Preglednico 4).
English: • the number of pre-filled syringes and strength is correct o If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara o If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will need to give yourself two injections.
Slovenian: o Če je vaš odmerek 90 mg, boste prejeli dve 45 mg napolnjeni injekcijski brizgi zdravila Stelara in si boste morali dati dve injekciji.
English: During the 12-week active-controlled portion of the study, patients were randomised to receive etanercept (50 mg twice a week), ustekinumab 45 mg at Weeks 0 and 4, or ustekinumab 90 mg at Weeks 0 and 4.
Slovenian: (50 mg dvakrat na teden), 45 mg ustekinumaba v 0. in 4. tednu ali 90 mg ustekinumaba v 0. in 4. tednu.
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 10).
Slovenian: Po 44 tednih so bili deleži bolnikov, ki so vzdrževali klinično remisijo in odziv na zdravljenje, statistično značilno večji v skupinah, ki sta prejemali ustekinumab, v primerjavi s placebom (glejte Preglednico 10).
English: STELARA 130 mg concentrate for solution for infusion
Slovenian: STELARA 130 mg koncentrat za raztopino za infundiranje
English: • A 45 mg vial is available if you need to receive less than the full 45 mg dose.
Slovenian: • Za otroke, ki morajo prejeti odmerek, manjši od 45 mg je na voljo 45 mg viala.
English: • the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
Slovenian: • da je raztopina v napolnjeni injekcijski brizgi bistra do rahlo opalescentna (ima biserni sijaj) in brezbarvna do rumenkasta,
English: Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 12).
Slovenian: Po 44 tednih so bili deleži bolnikov, ki so bili v klinični remisiji, v obeh skupinah, ki sta prejemali ustekinumab statistično značilno večji kot v skupini, ki je prejemala placebo (glejte Preglednico 12).
English: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL of solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 90 mg ustekinumaba v 1 ml raztopine za injiciranje.
English: Each vial contains 90 mg ustekinumab in 1 mL of solution for injection.
Slovenian: Ena viala vsebuje 90 mg ustekinumaba v 1 ml raztopine za injiciranje.
English: How to store Stelara
Slovenian: Shranjevanje zdravila Stelara
English: L-histidine monohydrochloride monohydrate Polysorbate 80
Slovenian: L-histidinijev klorid monohidrat L-metionin polisorbat 80 saharoza voda za injekcije
English: Talk to your doctor or pharmacist before using Stelara.
Slovenian: Pred začetkom uporabe zdravila Stelara se posvetujte z zdravnikom ali farmacevtom.
English: Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Slovenian: Ena viala vsebuje 45 mg ustekinumaba v 0,5 ml raztopine za injiciranje.
English: STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003
Slovenian: STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/08/494/003
English: Number of patients randomised
Slovenian: Posebne skupine bolnikov
English: • the number of vials and strength is correct o If your dose is 45 mg or less, you will get one 45 mg vial of Stelara o If your dose is 90 mg you will get two 45 mg vials of Stelara and you will need to give yourself two injections.
Slovenian: o Če je vaš odmerek 45 mg ali manjši, boste prejeli eno 45 mg vialo zdravila Stelara.
English: Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of patients in the recommended dose group achieved histologic healing (36%) compared with patients in the placebo group (22%).
Slovenian: Histološka in histološko endoskopska zacelitev sluznice Histološko zacelitev sluznice (ki je definirana kot prisotnost nevtrofilne infiltracije v < 5% kript, odsotnost uničenja strukture kript, odsotnost erozij, ulceracij ali granulacijskega tkiva) so ocenjevali v 8. tednu študije UNIFI-I in v 44. tednu študije UNIFI-M.
English: Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Slovenian: Preglednica12:Povzetek glavnih kazalcev učinkovitosti v študij UNIFI-M (po 44 tednih; 52tednov po začetnem indukcijskem odmerku) Placebo* N=175
English: STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004
Slovenian: STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/08/494/004
English: STELARA must not be given to patients with active tuberculosis (see section 4.3).
Slovenian: Pred začetkom zdravljenja z zdravilom STELARA je treba bolnike pregledati in opraviti preiskave na prisotnost tuberkuloze, ker se zdravila STELARA ne sme dajati bolnikom z aktivno tuberkulozo (glejte poglavje 4.3).
English: Endoscopic normalization was defined as a Mayo endoscopic subscore of 0 and was observed as early as week 8 of UNIFI-I. At week 44 of UNIFI-M, it was achieved in 24% and 29% of patients treated with ustekinumab every 12 or 8weeks, respectively,as compared to18% of patients in the placebo group.
Slovenian: V 44. tednu študije UNIFI-M jo je doseglo 24% bolnikov, ki so prejemali ustekinumab vsakih 12 tednov, in 29% tistih bolnikov, ki so prejemali ustekinumab vsakih 8 tednov, v primerjavi z 18% bolnikov iz skupine s placebom.
English: STELARA 90 mg solution for injection Solution for injection.
Slovenian: STELARA 90 mg raztopina za injiciranje Raztopina za injiciranje.
English: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 45 mg ustekinumaba v 0,5 ml raztopine za injiciranje.
English: • Infections of the chest are uncommon (may affect up to 1 in 100 people)
Slovenian: • Občasno se pojavijo okužbe spodnjih dihal (pojavijo se lahko pri največ 1 od
English: Fistula Response
Slovenian: Simptomatska remisija
English: What Stelara is
Slovenian: Kaj je zdravilo Stelara
English: • Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people)
Slovenian: • Občasno se pojavi pasavec (boleč izpuščaj v obliki mehurčkov - herpes zoster) (pojavi se lahko pri največ 1 od 100 bolnikov).
English: You must look out for signs of infection while you are using Stelara.
Slovenian: Med uporabo zdravila Stelara morate biti pozorni na znake okužbe, ki vključujejo:
English: STELARA 130 mg concentrate for solution for infusion Ustekinumab
Slovenian: STELARA 130 mg koncentrat za raztopino za injiciranje ustekinumab
English: A numerically lower number of subjects in the ustekinumab group (0.6%, 2/348) underwent UC disease related surgeries compared with subjects in the placebo group (1.7%, 3/175) through week 44.
Slovenian: Do 44. tedna je bilo absolutno število bolnikov, ki so potrebovali kirurški poseg zaradi ulceroznega kolitisa, manjše v skupini, ki je prejemala ustekinumab (0,6%, 2/348) kot v skupini, ki je prejemala placebo (1,7%, 3/175).
English: • the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of Stelara.
Slovenian: o Če je vaš odmerek 90 mg, boste prejeli eno 90 mg vialo zdravila Stelara.
English: Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 45 mg ustekinumaba v 0,5 ml.
English: STELARA 45 mg solution for injection in pre-filled syringe Solution for injection.
Slovenian: STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Raztopina za injiciranje.
English: Tell your doctor straight away if you notice any of these signs of infection.
Slovenian: Če opazite katerega teh znakov okužbe, to nemudoma povejte zdravniku.
English: • Vaginal yeast infection
Slovenian: • glivična okužba nožnice
English: This is because strong shaking may damage the medicine.
Slovenian: • Vial zdravila Stelara ne smete stresati, ker bi lahko močno stresanje poškodovalo zdravilo.
English: In patients with psoriasis, steady-state serum concentrations of ustekinumab were achieved by week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by doses every 12 weeks.
Slovenian: Po dajanju začetnih subkutanih odmerkov v 0. in 4. tednu in kasnejšem prejemanju odmerkov na 12 tednov so bile serumske koncentracije ustekinumaba v stanju dinamičnega ravnovesja, pri bolnikih s psoriazo, dosežene do 28. tedna.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.
Slovenian: Oznaka ATC: L04AC05
English: STELARA 45 mg solution for injection Solution for injection.
Slovenian: STELARA 45 mg raztopina za injiciranje Raztopina za injiciranje.
English: medical or nursing staff may inject Stelara.
Slovenian: Na začetku zdravljenja vam bo zdravilo Stelara lahko injiciralo medicinsko ali negovalno osebje.