FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
Slovenian: Ena 26 ml viala zdravila STELARA vsebuje 130 mg ustekinumaba.
English: Do not use if visibly opaque particles, discoloration or foreign particles are observed.
Slovenian: Raztopine ne smete uporabiti, če vsebuje vidne neprozorne ali tuje delce ali če je spremenjene barve.
English: • If you are 65 years of age or over - you may be more likely to get infections.
Slovenian: • če ste stari 65 let ali več.
English: The solution is clear, colourless to light yellow.
Slovenian: Raztopina je bistra, brezbarvna do svetlo rumena.
English: Any unused product remaining in the vial and the syringe should be thrown away.
Slovenian: Neuporabljeno zdravilo, ki ostane v viali in brizgi je treba zavreči.
English: Patients receiving ustekinumab at the recommended dose showed significant improvements on the histo endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to theplacebo group (9%).
Slovenian: Pri bolnikih, ki so prejemali ustekinumab v priporočenem odmerku, se je v 8. tednu pokazalo statistično značilno večje izboljšanje glede cilja opazovanja histološko endoskopske zacelitve sluznice v skupini z ustekinumabom (18%) v primerjavi s skupino s placebom (9%).
English: A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose.
Slovenian: Za pediatrične bolnike, ki potrebujejo odmerek, manjši od 45 mg, je na voljo 45 mg viala.
English: Only use complete vials of STELARA.
Slovenian: Vedno uporabite celo vialo zdravila STELARA.
English: • Pick up the pre-filled syringe, hold the body of the syringe with one hand
Slovenian: • Telo brizge držite z eno roko.
English: ** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
Slovenian: **Klinična remisija je definirana kot ocena Mayo ≤2, pri čemer nobena od podocen ni >1.
English: 26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper.
Slovenian: 26 ml raztopine v 30 ml viali (steklo tipa I), zaprti z obloženo zaporko iz butilirane gume.
English: • the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles
Slovenian: • da raztopina v napolnjeni injekcijski brizgi ni spremenila barve ali je motna, da ne vsebuje tujih delcev in
English: No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
Slovenian: V kliničnih študijah odobrenih indikacij pri bolnikih, starih 65 let in več, ki so prejemali zdravilo STELARA, niso opazili nobenih razlik v celokupni učinkovitosti ali varnosti v primerjavi z mlajšimi bolniki.
English: In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up).
Slovenian: V obdobju s placebom nadzorovanih, kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa je znašala incidenca malignomov z izjemo nemelanomskega kožnega raka 0,11 na 100 bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom (1 bolnik na 929 bolnikov-let spremljanja), v primerjavi z 0,23 za bolnike, ki so prejemali placebo (1 bolnik na 434 bolnikov-let spremljanja).
English: • the vial is not damaged and the seal is not broken
Slovenian: • da viala ni poškodovana in da je neprodušno zaprta,
English: • Press an antiseptic wipe over the injection site for a few seconds after the injection.
Slovenian: • Na mesto injiciranja za nekaj sekund pritisnite antiseptični zloženec.
English: The effect is considered demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 (integrated analysis) and 100 (PsA Study 1).
Slovenian: Ta učinek se je pokazal v 1. študiji PsA. Ohranil se je do 52. tedna (sestavljena analiza) in do 100. tedna (1.
English: Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in children under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis because it has not been studied in this age group.
Slovenian: Zdravilo Stelara ni priporočljivo za otroke s psoriazo, mlajše od 6 let, ali za otroke, mlajše od 18 let s psoriatičnim artritisom, Crohnovo boleznijo ali ulceroznim kolitisom, ker ga pri teh starostnih skupinah še niso preučili.
English: Caution should be exercised when considering concomitant use of other immunosuppressants and STELARA or when transitioning from other immunosuppressive biologics (see section 4.5).
Slovenian: Če razmišljate o sočasni uporabi drugih imunosupresivov in zdravila STELARA ali če želite preiti z uporabe drugih imunosupresivnih bioloških zdravil na uporabo zdravila STELARA, je potrebna previdnost (glejte poglavje 4.5).
English: Stelara is used to treat the following inflammatory diseases:
Slovenian: Zakaj se uporablja zdravilo Stelara Zdravilo Stelara se uporablja za zdravljenje naslednjih vnetnih bolezni:
English: Intravenous use after dilution.
Slovenian: Intravenska uporaba po redčenju.
English: Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 (PSUMMIT I) and Study 2 (PSUMMIT II) at week 24
Slovenian: Preglednica 6 Število bolnikov, ki so v 1. študiji psoriatičnega artritisa (PSUMMIT I) in v 2. študiji psoriatičnega artritisa (PSUMMIT II) po 24 tednih dosegli klinični odziv 1. študija psoriatičnega artritisa
English: Your doctor will examine you and do a test for tuberculosis, before you have Stelara.
Slovenian: Zdravnik vas bo pred začetkom zdravljenja z zdravilom Stelara pregledal in opravil preiskave za tuberkulozo.
English: In PsA Study 1, ACR 20 responses at week 100 were achieved by 57% and 64%, for 45 mg and 90 mg, respectively.
Slovenian: V 1. študiji PsA je v 100. tednu odziv ACR 20 doseglo 57% bolnikov, ki so prejemali 45 mg in 64% bolnikov, ki so prejemali 90 mg.
English: Improvements in enthesitis score and dactylitis score were maintained through weeks 52 and 100.
Slovenian: Izboljšanje ocene entezitisa in daktilitisa se je ohranilo do 52. in do 100. tedna.
English: • If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
Slovenian: • Če tehtate več kot 100 kg, je priporočeni odmerek zdravila Stelara 90 mg.
English: Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab.
Slovenian: V obdobju po odobritvi ustekinumaba so poročali o primerih alergijskega alveolitisa, eozinofilne pljučnice in neinfekcijske organizirajoče pljučnice.
English: Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Slovenian: V Preglednici 2 je podan seznam neželenih učinkov iz kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa pri odraslih ter neželenih učinkov, poročanih v obdobju trženja zdravila.
English: VIAL LABEL TEXT (130 mg)
Slovenian: BESEDILO NA NALEPKI VIALE (130 mg)
English: Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select endpoints, and tiered dosing is therefore the recommended intravenous induction dose.
Slovenian: Pri določenih ciljih opazovanja je bila učinkovitost zdravljenja večja v skupini s prirejenim odmerjanjem (6 mg/kg) kot v skupini z odmerkom 130 mg, zato je za intravenski indukcijski odmerek priporočeno prirejeno odmerjanje.
English: In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
Slovenian: V 2. študiji PsA je v 52. tednu odziv ACR 20 doseglo 47% bolnikov, ki so prejemali 45 mg in 48% bolnikov, ki so prejemali 90 mg.
English: Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection (vial) and Solution for injection in pre filled syringe SmPC).
Slovenian: Bolniki so bili randomizirani v skupine, v katerih so 44 tednov prejemali subkutani vzdrževalni odmerek 90 mg ustekinumaba na 8 tednov, 90 mg ustekinumaba na 12 tednov ali placebo (za priporočeno vzdrževalno odmerjanje glejte poglavje 4.2 v SmPC zdravila STELARA raztopina za injiciranje (viala) in STELARA raztopina za injiciranje v napolnjeni injekcijski brizgi).
English: • Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger.
Slovenian: Palec položite na vrh glave bata, z drugo roko nežno stisnite kožo v gubo na predelu, ki ste ga pred tem očistili.
English: • Drooping eyelid and sagging muscles on one side of the face (‘facial palsy' or ‘Bell's palsy'), which is usually temporary
Slovenian: • povešena veka in mlahave mišice na eni strani obraza (‘paraliza obraznega živca' ali
English: In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo.
Slovenian: V 1. študiji psoriaze so bila tudi izboljšanja psoriaze na nohtih (indeks jakosti psoriaze na nohtih - Nail Psoriasis Severity Index), skupni oceni telesnega in duševnega stanja z vprašalnikom SF-36 in vizualni analogni lestvici (Visual Analogue Scale - VAS) statistično značilna v obeh terapevtskih skupinah z ustekinumabom v primerjavi s placebom.
English: • If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe (see
Slovenian: • Če so v brizgi vidni zračni mehurčki, nežno potrkajte po njej od strani, da bodo zračni mehurčki splavali na vrh (glejte Sliko 5).
English: • If you have recently had or are going to have a vaccination.
Slovenian: • če ste bili pred kratkim cepljeni oziroma boste cepljeni.
English: Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and etanercept.
Slovenian: V 3. študiji psoriaze (ACCEPT) so ocenjevali 903 bolnike z zmerno do hudo psoriazo, ki se na druge sistemske terapije niso odzvali v zadostni meri, jih niso prenašali ali so bile le-te kontraindicirane.
English: Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses.
Slovenian: Po enem do treh odmerkih je klinična slika vključevala kašelj, dispnejo in intersticijske infiltrate.
English: 70 Point Response, week 6
Slovenian: Klinični odziv (70 točk), 6. teden
English: During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in < 1% of patients (see section 4.4).
Slovenian: Med nadzorovanim obdobjem kliničnih študij psoriaze in psoriatičnega artritisa z ustekinumabom so izpuščaje in urtikarijo opazili pri < 1% bolnikov.
English: The first subcutaneous administration of 90 mg STELARA should take place at week 8 after the intravenous dose.
Slovenian: Prvi subkutani 90 mg odmerek zdravila STELARA je treba injicirati 8 tednov po intravenskem odmerku.
English: Solution for injection 45 mg/0.5 mL 1 vial
Slovenian: raztopina za injiciranje 45 mg/0,5 ml 1 viala
English: Solution for injection 90 mg/1 mL 1 vial
Slovenian: raztopina za injiciranje 90 mg/1 ml 1 viala
English: • Stelara is given as an injection under the skin (‘subcutaneously').
Slovenian: • Zdravilo Stelara dajemo s podkožno injekcijo (‘subkutano').
English: PASI 90 response N (%)
Slovenian: odziv PASI 90 N (%)
English: The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2.
Slovenian: V študijo, ki je ocenjevala vzdrževalno obdobje zdravljenja (IM-UNITI), je bilo vključenih 388 bolnikov, ki so v študijah UNITI-1 in UNITI-2 dosegli klinični odziv na ustekinumab (izboljšanje indeksa CDAI za vsaj 100 točk ) po 8 tednih.
English: Improvement in HAQ-DI score from baseline was maintained through Weeks 52 and 100.
Slovenian: Izboljšanje od izhodiščne ocene HAQ-DI se je ohranilo do 52. in do 100. tedna.
English: In patients with Crohn's disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 or 12 weeks.
Slovenian: Bolniki s Crohnovo boleznijo in ulceroznim kolitisom so od 8. tedna po intravenskemu odmerku približno 6 mg/kg ustekinumaba prejemali 90 mg vzdrževalni odmerek ustekinumaba na 8 ali 12 tednov.
English: In patients with ulcerative colitis, median steady-state trough concentrations ranged from 2.69 μg/mL to 3.09 μg/mL and from 0.92 μg/mL to 1.19 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks.
Slovenian: Pri bolnikih z ulceroznim kolitisom se je mediana vrednost najmanjše koncentracije v stanju dinamičnega ravnovesja pri 90 mg odmerku ustekinumaba gibala od 2,69 μg/ml do 3,09 μg/ml (ob injiciranju na 8 tednov) in od 0,92 μg/ml do 1,19 μg/ml (ob injiciranju na 12 tednov).
English: • However, you and your doctor may decide that you may inject Stelara yourself.
Slovenian: • Z zdravnikom se lahko dogovorite, da si boste zdravilo Stelara injicirali sami.
English: * Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
Slovenian: *Klinična remisija je definirana kot ocenaMayo ≤2, pri čemer nobena od podocen ni >1.
English: 70 Point Response, week 3
Slovenian: Klinični odziv (70 točk), 3. teden
English: Significant differences in partial Mayo score and symptomatic remission were observed between ustekinumab and placebo as early as Week 2.
Slovenian: Glede parcialne ocene Mayo in simptomatske remisije so statistično značilne razlike med skupino, ki je prejemala ustekinumab in skupino, ki je prejemala placebo, opazili že po 2 tednih.
English: Stelara is for single use only.
Slovenian: Ena viala je namenjena le za enkratno uporabo.
English: Plaque psoriasis (Adults)
Slovenian: Psoriaza s plaki (odrasli bolniki)
English: Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in the placebo group (5.7%, 10/175).
Slovenian: Do 44. tedna v študiji UNIFI-M je bilo število bolnikov, ki so bili hospitalizirani zaradi ulceroznega kolitisa, statistično značilno manjše v kombinirani skupini, ki je prejemala ustekinumab (2,0%, 7/348) kot med bolniki v skupini, ki je prejemala placebo (5,7%, 10/175).
English: • Do not touch the needle or allow it to touch any surface
Slovenian: • Ne dotikajte se igle in pazite, da se z njo ničesar ne dotaknete.
English: The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo-controlled, multicenter studies in adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450).
Slovenian: Varnost in učinkovitost ustekinumaba so ocenjevali v treh randomiziranih, dvojno slepih, s placebom nadzorovanih, multicentričnih študijah pri odraslih bolnikih z zmerno do močno aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450).
English: • Pick up the syringe and remove the needle cover
Slovenian: • Vzemite brizgo in snemite pokrovček z igle.
English: If you forget a dose, contact your doctor or pharmacist.
Slovenian: Če pozabite vzeti odmerek zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Solution for injection in pre-filled syringe 90 mg/1 mL
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 90 mg/1 ml
English: Improvements in FACIT scores were maintained through week 52.
Slovenian: Izboljšanje v FACIT-F se je ohranilo do 52. tedna.
English: At week 8, patients receiving ustekinumab showed statistically significantly greater and clinically meaningful improvements on IBDQ total score and SF-36 Mental Component Summary Score in both UNITI-1 and UNITI-2, and SF-36 Physical Component Summary Score in UNITI-2, when compared to placebo.
Slovenian: Pri bolnikih, zdravljenih z ustekinumabom, je bilo v študijah UNITI-1 in UNITI-2 po 8 tednih statistično značilno večje in klinično pomembno izboljšanje po vprašalniku IBDQ in SF-36 povzetek ocene duševnih komponent (SF-36 Mental Component Summary Score); ter SF-36 povzetek ocene telesnih komponent (SF-36 Physical Component Summary Score) v študiji UNITI-2, v primerjavi s placebom.
English: Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Slovenian: Simptomatska remisija je definirana kot podocena frekvence odvajanja blata Mayo 0 ali 1 in podocena krvavitve iz danke 0.
English: Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in monkeys that were more than 100-fold higher than observed in humans.
Slovenian: V študijah na živalih so bili odmerki do približno 45-krat večji kot so največji ekvivalentni odmerki namenjeni injiciranju bolnikom s psoriazo.
English: For further instructions on preparation and special precautions for handling, see section 6.6.
Slovenian: Za dodatne previdnostne ukrepe pri ravnanju z zdravilom glejte poglavje 6.6.
English: • the solution is not discoloured or cloudy and does not contain any foreign particles
Slovenian: • da raztopina ni spremenila barve ali je motna, da ne vsebuje tujih delcev in
English: Uncommon: Hypersensitivity reactions (including rash, urticaria) Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Slovenian: Redki: hude preobčutljivostne reakcije (vključno z anafilaksijo in angioedemom)
English: STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Slovenian: Zdravilo STELARA je indicirano za zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, ki se niso ustrezno odzvali, so izgubili odziv na zdravljenje, ali niso prenašali konvencionalnega zdravljenja ali zdravljenja z zaviralci faktorja tumorske nekroze alfa (TNFα) oziroma je takšno zdravljenje kontraindicirano.
English: The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 11,545 patient-years of follow-up).
Slovenian: Pogostnost nemelanomskega kožnega raka za bolnike, zdravljene z ustekinumabom, je bila 0,49 na 100 bolnikov-let spremljanja (56 bolnikov na 11.545 bolnikov-let spremljanja).
English: Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
Slovenian: Zacelitev sluznice je definirana kot endoskopska podocena Mayo 0 ali 1.
English: Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
Slovenian: Kombinacija simptomatske remisije in zacelitve sluznice infuzijski odmerek ustekinumaba v skladu z režimom odmerjanja glede na telesno maso, opisanem v Preglednici 1.
English: Immunogenicity
Slovenian: Imunoterapija
English: • A 45 mg vial is available for children who 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: Common: Diarrhoea, nausea, vomiting
Slovenian: Pogosti: driska, navzea, bruhanje
English: Stelara is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis because it has not been studied in this age group.
Slovenian: Zdravilo Stelara ni priporočljivo za otroke s Crohnovo boleznijo ali ulceroznim kolitisom, mlajše od 18 let, ker ga pri tej starostni skupini še niso preučili.
English: 90 mg ustekinumab every 12 weeks N = 129
Slovenian: 90 mg ustekinumaba na 12 tednov n = 129†
English: PGA of Cleared (0) PASI
Slovenian: PGA čisto (0) PASI
English: In PsA Study 2 there was a significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores in the ustekinumab groups when compared with placebo at week 24.
Slovenian: V 2. študiji PsA so v skupini, ki je 24 tednov prejemala ustekinumab, dokazali značilno izboljšanje funkcijske ocene zdravljenja kronične bolezni - utrujenosti (FACIT-FFunctional Assessment of Chronic Illness Therapy - Fatigue) v primerjavi s skupino, ki je prejemala placebo.
English: The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebocontrolled, multicenter studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2).
Slovenian: Varnost in učinkovitost ustekinumaba so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih, multicentričnih študijah pri odraslih bolnikih z zmerno do močno aktivnim ulceroznim kolitisom (z oceno Mayo od 6 do 12 in endoskopsko podoceno ≥ 2).
English: There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Slovenian: Pri subkutani uporabi ustekinumaba na 12 tednov ni bilo opaznega povečevanja njegove serumske koncentracije s časom.
English: • Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
Slovenian: • Potem potisnite bat noter, da boste iz brizge iztisnili ves zrak (ampak nič tekočine).
English: Solution for injection in pre-filled syringe 45 mg/0.5 mL
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 45 mg/0,5 ml
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).
Slovenian: Zdravilo STELARA je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki se niso odzvali na drugo sistemsko zdravljenje, vključno z zdravljenjem s ciklosporinom, metotreksatom (MTX) ali PUVA (psoralen in obsevanje z UVA svetlobo), pri katerih je drugo sistemsko zdravljenje kontraindicirano ali ga ne prenašajo (glejte poglavje 5.1).
English: In patients with Crohn's disease, median steady-state trough concentrations ranged from 1.97 μg/mL to 2.24 μg/mL and from 0.61 μg/mL to 0.76 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks respectively.
Slovenian: Pri bolnikih s Crohnovo boleznijo se je mediana vrednost najmanjše koncentracije v stanju dinamičnega ravnovesja pri 90 mg odmerku ustekinumaba gibala od 1,97 μg/ml do 2,24 μg/ml (ob injiciranju na 8 tednov) in od 0,61 μg/ml do 0,76 μg/ml (ob injiciranju na 12 tednov).
English: Infuse the diluted solution over a period of at least one hour.
Slovenian: Razredčeno raztopino infundirajte bolniku v času, ki naj ne bo krajši od ene ure.
English: Psoriatic arthritis (PsA) (Adults)
Slovenian: Psoriatični artritis (PsA) (odrasli bolniki)