FrancophonIA/ELRC3.0 huggingface dataset:
English: For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution for injection (vial) and solution for injection in pre-filled syringe SmPC.
Croatian: Za doziranje naknadnih supkutanih režima doziranja, vidjeti dio 4.2 sažetka opisa svojstava lijeka za STELARA otopinu za injekciju (bočica) i otopinu za injekciju u napunjenoj štrcaljki.
English: In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
Croatian: U PsA Ispitivanju 2, ACR 20 odgovori u 52. tjednu postignuti su za 47% uz 45 mg odnosno 48% uz 90 mg.
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.
Croatian: Bolesnici koji nisu postigli klinički odgovor na uvodno liječenje ustekinumabom do 8. tjedna ispitivanja UNFI-I, ali su postigli odgovor do 16. tjedna (157 bolesnika), uključeni su u nerandomizirani dio ispitivanja UNIFI-M tijekom kojega su nastavili primati terapiju održavanja svakih 8 tjedana; među tim je bolesnicima većina (62%) imala održan odgovor, a njih 30% postiglo je remisiju u 44. tjednu.
English: 90mg ustekinumab every 12 Weeks N = 172
Croatian: 90 mg ustekinumaba svakih 12 tjedana N = 172
English: Do not squeeze it tightly
Croatian: Nemojte jako stisnuti
English: • If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site.
Croatian: • Ako će Vam injekciju dati netko drugi, onda mjesto primjene može biti i nadlaktica.
English: In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
Croatian: U placebom kontroliranim ispitivanjima bolesnika s psorijazom, psorijatičnim artritisom, Crohnovom bolesti i ulceroznim kolitisom, stope infekcije ili ozbiljne infekcije bile su istovjetne kod bolesnika liječenih ustekinumabom i onih u placebo grupi.
English: Uncommon: Hypersensitivity reactions (including rash, urticaria) Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Croatian: Rijetko: ozbiljne reakcije preosjetljivosti (uključujući anafilaksiju, angioedem)
English: Do not touch the plunger while you do this
Croatian: nemojte dirati klip štrcaljke
English: Children and adolescents aged 6 years or older
Croatian: Djeca i adolescenti u dobi od 6 godina ili stariji Psorijaza
English: In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment (see section 4.8).
Croatian: Nakon liječenja ustekinumabom, u bolesnika s psorijazom bio je prijavljen eksfolijativni dermatitis (vidjeti dio 4.8).
English: • the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles
Croatian: • da otopina u napunjenoj štrcaljki nije promijenila boju, nije zamućena ili ne sadrži strane čestice
English: 51% of patients had failed or were intolerant to a biologic.
Croatian: Pedeset i jedan posto (51%) bolesnika bilo je neuspješno liječeno biološkom terapijom ili je nije podnosilo.
English: The solution in the STELARA vial or pre-filled syringe should not be shaken.
Croatian: Otopina STELARE u bočici ili napunjenoj štrcaljki ne smije se tresti.
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.
Croatian: Najniže razine ustekinumaba u stanju dinamičke ravnoteže koje su rezultat 90 mg ustekinumaba svakih 8 tjedana bile su povezane s višim stopama kliničke remisije u usporedbi s najnižim razinama u stanju dinamičke ravnoteže nakon 90 mg svakih 12 tjedana.
English: PGA of cleared (0) or minimal (1)
Croatian: PGA čist (0) ili minimalan (1) PGA čist (0)
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.
Croatian: U bolesnika s ulceroznim kolitisom medijan najnižih koncentracija u stanju dinamičke ravnoteže bio je u rasponu od 2,69 μg/ml do 3,09 μg/ml i od 0,92 μg/ml do 1,19 μg/ml za 90 mg ustekinumaba svakih 8 tjedana odnosno svakih 12 tjedana.
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 questionnaires.
Croatian: Inflammatory Bowel Disease Questionnaire, IBDQ) i SF-36 upitnika za procjenu zdravlja.
English: Table 8 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS Jr.) (Age 6-11) Week 12
Croatian: Tablica 8: Sažetak primarnih i sekundarnih mjera ishoda u 12. tjednu i 52. tjednu Ispitivanje kod pedijatrijske psorijaze (CADMUS Jr.) (dob od 6 do 11 godina) 12. tjedan
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).
Croatian: STELARA je indicirana za liječenje odraslih bolesnika s umjerenom do teškom plak psorijazom koji nisu reagirali, imaju kontraindikaciju ili ne podnose drugu sustavnu terapiju uključujući ciklosporin, metotreksat (MTX) ili PUVA (psoralen i UVA zračenje) (vidjeti dio 5.1).
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).
Croatian: U placebom kontroliranom razdoblju kliničkih ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa incidencija malignih bolesti isključujući nemelanomski rak kože bila je 0,11 na 100 bolesnik-godina praćenja bolesnika liječenih ustekinumabom (1 bolesnik na 929 bolesnikgodina praćenja) u usporedbi s 0,23 bolesnika u placebo grupi (1 bolesnik na 434 bolesnik-godine praćenja).
English: After the starting dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an injection under the skin (‘subcutaneously').
Croatian: Nakon početne doze, sljedeću dozu od 90 mg Stelare primit ćete nakon 8 tjedana, a nakon toga svakih 12 tjedna injekcijom pod kožu ('supkutano').
English: However, before Stelara is given to you, it is mixed with a solution that contains sodium.
Croatian: Vam se primijeni, Stelara se miješa s otopinom koja sadrži natrij.
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.
Croatian: Sigurnost i djelotvornost ustekinumaba procijenjena je kod 972 bolesnika u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s aktivnim PsA (≥ 5 otečeni zglobovi i ≥ 5 bolni zglobovi) usprkos nesteroidnoj protuupalnoj (NSAIL) terapiji ili antireumatskoj terapiji koja modificira tijek bolesti (DMARD).
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).
Croatian: Djelotvornost ustekinumaba ispitivana je u 110 pedijatrijskih bolesnika s umjerenom do teškom plak psorijazom u dobi od 12 do 17 godina u multicentričnom, randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju faze 3 (CADMUS).
English: Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: STELARA sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarivu količinu natrija.
English: In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab.
Croatian: U rijetkim su slučajevima u bolesnika liječenih ustekinumabom prijavljene plućne alergijske reakcije i upala pluća.
English: At week 8 of UNIFI-I, patients receiving ustekinumab showed significantly greater and clinically meaningful improvements on IBDQ total score, EQ-5D and EQ-5D VAS, and SF-36 Mental Component Summary Score and SF-36 Physical Component Summary Score when compared to placebo.
Croatian: U 8. tjednu ispitivanja UNIFI-I u bolesnika koji su primili ustekinumab zabilježena su značajno veća i klinički važna poboljšanja ukupnog IBDQ rezultata te rezultata upitnika EQ-5D i EQ-5D VAS, kao i zbirnog rezultata za mentalnu i fizičku komponentu upitnika SF-36 u odnosu na bolesnike koji su primili placebo.
English: • Push the needle into the pinched skin
Croatian: • Uvucite iglu u/pod uhvaćeni nabor kože.
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.
Croatian: U bolesnika s Crohnovom bolesti medijan najnižih koncentracija u stanju dinamičke ravnoteže bio je u rasponu od 1,97 μg/ml do 2,24 μg/ml i od 0,61 μg/ml do 0,76 μg/ml za 90 mg ustekinumaba svakih 8 tjedana odnosno svakih 12 tjedana.
English: Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Croatian: Stelara se primjenjuje kod odraslih bolesnika s umjerenom do teškom plak psorijazom, koji ne mogu koristiti ciklosporin, metotreksat ili fototerapiju ili kada navedeno liječenje nije pokazalo rezultate.
English: In PsA Study 1, ACR 20 responses at week 100 were achieved by 57% and 64%, for 45 mg and 90 mg, respectively.
Croatian: U PsA Ispitivanju 1, odgovor ACR 20 u 100. tjednu postignuti su za 57% uz 45 mg odnosno 64% uz 90 mg.
English: STELARA 45 mg solution for injection STELARA 90 mg solution for injection STELARA 45 mg solution for injection in pre-filled syringe STELARA 90 mg solution for injection in pre-filled syringe
Croatian: STELARA 45 mg otopina za injekciju STELARA 90 mg otopina za injekciju STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki
English: STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Croatian: STELARA koncentrat za otopinu za infuziju je namijenjen za primjenu pod vodstvom i nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju Crohnove bolesti ili ulceroznog kolitisa.
English: Table 3 List of adverse reactions System Organ Class
Croatian: Tablica 3. Popis nuspojava Klasifikacija organskih sustava
English: Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with ulcerative colitis, Crohn's disease, psoriasis and/or psoriatic arthritis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Croatian: Medijan poluvijeka (t1/2) ustekinumaba bio je približno 3 tjedna kod bolesnika s ulceroznim kolitisom, Crohnovom bolesti, psorijazom i/ili psorijatičnim artritisom i kretao se u rasponu od 15 do 32 dana u svim ispitivanjima psorijaze i psorijatičnog artritisa.
English: Improvements in PGA, PASI, and CDLQI were maintained through week 52 (Table 8).
Croatian: Poboljšanja PGA, PASI i CDLQI rezultata održala su se do 52. tjedna (Tablica 8).
English: STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
Croatian: STELARA se treba razrijediti jedino s 9 mg/ml (0,9%-tnom) otopinom natrijevog klorida.
English: Number of patients ≤ 100 kg ACR 20 response, N (%)
Croatian: Broj randomiziranih bolesnika ACR 20 odgovor, N (%)
English: How Stelara will be given
Croatian: Kako će Vam Stelara biti primijenjena
English: These improvements were maintained in ustekinumab-treated patients in UNIFI-M through week 44.
Croatian: Ta su se poboljšanja u bolesnika liječenih ustekinumabom održala do 44. tjedna ispitivanja UNIFI-M.
English: Table 2 List of adverse reactions System Organ Class
Croatian: Tablica 2. Popis nuspojava Klasifikacija organskih sustava
English: Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Croatian: Medijan poluvijeka (t1/2) ustekinumaba bio je približno 3 tjedna kod bolesnika s psorijazom, psorijatičnim artritisom, Crohnovom bolesti ili ulceroznim kolitisom i kretao se u rasponu od 15 do 32 dana u svim ispitivanjima psorijaze i psorijatičnog artritisa.
English: You should tell your doctor straight away if you notice any of these signs.
Croatian: Morate odmah reći svom liječniku ako primijetite bilo koji od tih znakova.
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.
Croatian: Bolesnici randomizirani u placebo grupu po primitku placeba u tjednima 0 i 4, prešli su na primanje ustekinumaba (od 45 mg ili 90 mg) u tjednima 12 i 16.
English: • If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
Croatian: • Ukoliko je Vaša tjelesna težina veća od 100 kg, preporučena doza je 90 mg Stelare.
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).
Croatian: Incidencija nemelanomskog raka kože bila je 0,49 na 100 bolesnik-godina praćenja u bolesnika liječenih ustekinumabom (56 bolesnika na 11 545 bolesnik-godina praćenja).
English: Plaque psoriasis (Adults)
Croatian: Plak psorijaza (Odrasli bolesnici)
English: Significant differences in partial Mayo score and symptomatic remission were observed between ustekinumab and placebo as early as Week 2.
Croatian: Značajne razlike između liječenja ustekinumabom i placeba s obzirom na djelomičan Mayo rezultat i simptomatsku remisiju opažene su već u 2. tjednu.
English: Improvements in enthesitis score and dactylitis score were maintained through weeks 52 and 100.
Croatian: Poboljšanja bodova entezitisa i daktilitisa održali su se kroz 52 i 100 tjedana.
English: Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Croatian: Kod bolesnika koji nisu imali odgovor na liječenje u trajanju do 28 tjedana, mora se razmotriti prekid liječenja.
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).
Croatian: STELARA je indicirana za liječenje odraslih bolesnika s umjerenim do teškim oblikom aktivnog ulceroznog kolitisa, koji su imali neadekvatan odgovor ili su izgubili odgovor ili nisu podnosili bilo konvencionalnu terapiju ili biološku terapiju ili koji imaju medicinske kontraindikacije za takve terapije (vidjeti dio 5.1).
English: Week 16 Responders to Ustekinumab Induction Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients).
Croatian: Bolesnici koji su do 16. tjedna odgovorili na uvodno liječenje ustekinumabom Bolesnici liječeni ustekinumabom koji nisu postigli odgovor do 8. tjedna ispitivanja UNIFI-I primili su supkutanu dozu od 90 mg ustekinumaba u 8. tjednu (36% bolesnika).
English: If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away.
Croatian: Ako ste primijenili ili dobili veću dozu Stelare od propisane, odmah kontaktirajte svog liječnika ili ljekarnika.
English: Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy.
Croatian: U bolesnika u UNITI-1 ispitivanju, prethodna anti-TNFα terapija je bila neuspješna ili je bolesnici nisu podnosili.
English: Psoriasis Study 2
Croatian: Ispitivanje psorijaze 2
English: • Do not pull back on the plunger at any time
Croatian: • Nikada ne povlačite klip prema natrag
English: Traceability:
Croatian: Sljedivost:
English: Inject the dose:
Croatian: Primijenite dozu:
English: Detailed instructions for use are provided in the package leaflet.
Croatian: Detaljne upute za korištenje dane su u Uputi o lijeku.
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).
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljku 0,5 ml otopine u štrcaljki od 1 ml, izrađenoj od stakla tipa I, s pričvršćenom iglom od nehrđajućeg čelika i pokrovom igle koji sadrži suhu prirodnu gumu (derivat lateksa).
English: In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).
Croatian: U kliničkim ispitivanjima, kod bolesnika koji su primali STELARU primijećene su ozbiljne bakterijske, gljivične i virusne infekcije (vidjeti dio 4.8).
English: Common: Diarrhoea, nausea, vomiting
Croatian: Poremećaji probavnog sustava Često: proljev, mučnina, povraćanje
English: Solution for injection in pre-filled syringe 90 mg/1 mL
Croatian: Otopina za injekciju u napunjenoj štrcaljki 90 mg/1 ml
English: UNIFI-M, evaluated 523 patients who achieved clinical response with single IV administration of ustekinumab in UNIFI-I.
Croatian: U ispitivanju UNIFI-M ocjenjivala su se 523 bolesnika koja su u ispitivanju UNIFI-I postigla klinički odgovor nakon primjene jedne intravenske doze ustekinumaba.
English: • Vaginal yeast infection
Croatian: • gljivična infekcija rodnice
English: These include:
Croatian: Ti znakovi uključuju:
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).
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljku 1 mL otopine u štrcaljki od 1 ml, izrađenoj od stakla tipa 1, s pričvršćenom iglom od nehrđajućeg čelika i pokrovom igle koji sadrži suhu prirodnu gumu (derivat lateksa).
English: After proper training in subcutaneous injection technique, patients or their caregivers may inject STELARA if a physician determines that it is appropriate.
Croatian: U slučaju kada liječnik odredi da je primjereno, bolesnici ili njihovi njegovatelji mogu sami injicirati STELARU nakon što su prošli primjerenu obuku o tehnici primjene supkutane injekcije.
English: In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA.
Croatian: U ispitivanjima Crohnove bolesti i ulceroznog kolitisa nije zabilježeno da istodobna primjena imunosupresiva ili kortikosteroida utječe na sigurnost ili djelotvornost STELARE.
English: Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
Croatian: Jedna bočica STELARE od 26 ml sadrži 130 mg ustekinumaba.
English: In Psoriasis Study 1, at week 2 and week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
Croatian: Ispitivanju psorijaze 1, u tjednu 2 i tjednu 12, pokazano je značajno veće poboljšanje u odnosu na početne vrijednosti dermatološkog indeksa kvalitete života (DLQI) u svim grupama liječenim ustekinumabom u usporedbi s placebom.
English: Solution for injection in pre-filled syringe 45 mg/0.5 mL
Croatian: Otopina za injekciju u napunjenoj štrcaljki 45 mg/0,5 ml
English: The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
Croatian: Incidencija nemelanomskog raka kože bila je 0,43 na 100 bolesnik-godina praćenja u bolesnika liječenih ustekinumabom (4 bolesnika u 929 bolesnik-godina praćenja) u usporedbi s 0,46 kod bolesnika u placebo grupi (2 bolesnika u 433 bolesnik-godine praćenja).
English: STELARA is supplied as a sterile, single-use vial or singleuse pre-filled syringe.
Croatian: STELARA se isporučuje u obliku sterilne bočice za jednokratnu upotrebu ili napunjene štrcaljke za jednokratnu upotrebu.
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).
Croatian: Sigurnost i djelotvornost ustekinumaba ocjenjivale su se u dva randomizirana, dvostruko slijepa, placebom kontrolirana multicentrična ispitivanja u odraslih bolesnika s umjerenim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo rezultat 6 - 12; endoskopski podrezultat ≥ 2).
English: Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.
Croatian: Kao dio prirodnog tijeka bolesti, u bolesnika s plak psorijazom može se razviti eritrodermna psorijaza, čiji simptomi mogu biti klinički nerazlučivi od onih eksfolijativnog dermatitisa.
English: • Press an antiseptic wipe over the injection site for a few seconds after the injection.
Croatian: • Pritisnite antiseptičku maramicu na mjesto primjene injekcije i držite tako nekoliko sekundi.
English: The efficacy of ustekinumab was studied in 44 paediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis in an open label, single-arm, multicenter, phase 3, study (CADMUS Jr.).
Croatian: Djelotvornost ustekinumaba ispitivala se u 44 pedijatrijska bolesnika s umjerenom do teškom plak psorijazom u dobi od 6 do 11 godina u sklopu otvorenog, neusporednog, multicentričnog ispitivanja faze 3 (CADMUS Jr.).
English: Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.
Croatian: Jedna bočica je samo za jednokratnu upotrebu i sav preostali lijek mora se zbrinuti sukladno nacionalnim propisima.
English: Recommended dose of ustekinumab N = 209
Croatian: Preporučena doza ustekinumaba N = 209
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.
Croatian: Bolesnici randomizirani na ustekinumab dobili su doze od 45 mg ili 90 mg u tjednima 0 i 4 nakon čega je slijedila dodatna doza u 16. tjednu.
English: Change from baseline Mean (SD)
Croatian: Promjena u odnosu na početnu vrijednost Srednja vrijednost (SD)
English: In patients who failed both a TNF and vedolizumab
Croatian: U bolesnika neuspješno liječenih antagonistima TNFα i vedolizumabom
English: Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion.
Croatian: Jedna bočica sadrži 130 mg ustekinumaba u 26 ml koncentrata za otopinu za infuziju.