FrancophonIA/ELRC3.0 huggingface dataset:
English: Hospitalizations and ulcerative colitis (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.
Croatian: Hospitalizacija i kirurški zahvati povezani s ulceroznim kolitisom Tijekom 8 tjedana ispitivanja UNIFI-I udio ispitanika hospitaliziranih zbog razloga povezanih s ulceroznim kolitisom bio je značajno manji među ispitanicima koji su primili preporučenu dozu ustekinumaba (1,6%; 5/322) nego među onima koji su primili placebo (4,4%; 14/319).
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).
Croatian: Značajno veći udio bolesnika održao je kliničku remisiju i odgovor u skupinama liječenim ustekinumabom u usporedbi s placebo skupinom u 44. tjednu (vidjeti tablicu 4).
English: Keep the vial or pre-filled syringe in the outer carton in order to protect from light.
Croatian: Bočicu ili napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
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.
Croatian: U oba ispitivanja, bolesnici su bili randomizirani na jednu intravensku primjenu, bilo preporučene doze određene prema tjelesnoj težini (od engl. tiered dose) od otprilike 6 mg/kg (vidjeti dio 4.2 sažetka za STELARU 130 mg koncentrat za otopinu za infuziju), bilo fiksne doze od 130 mg ustekinumaba ili placeba u 0. tjednu.
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.
Croatian: Functional Assessment of Chronic Illness TherapyFatigue) u skupinama koje su primale ustekinumab kada se uspoređuje s placebom u 24. tjednu.
English: STELARA 45 mg solution for injection in pre-filled syringe 3 years
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
English: Your doctor will check how well you are before each treatment.
Croatian: Vam je zdravstveno stanje prije svake primjene lijeka.
English: Improvement in HAQ-DI score from baseline was maintained through Weeks 52 and 100.
Croatian: Poboljšanje HAQ-DI bodova u odnosu na početne, održalo se kroz 52 i 100 tjedana.
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).
Croatian: Bolesnici su bili randomizirani u skupine koje su primale supkutani režim održavanja od bilo 90 mg ustekinumaba svakih 8 tjedana, 90 mg ustekinumaba svakih 12 tjedana ili placebo tijekom 44 tjedna (za preporučeno doziranje održavanja, vidjeti dio 4.2 sažetka opisa svojstava lijeka STELARA otopine za injekciju (bočica) i otopine za injekciju u napunjenoj štrcaljki).
English: Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: saharoza, L-histidin, L-histidinklorid hidrat, polisorbat 80, voda za injekcije.
English: How Stelara is given
Croatian: Kako se primjenjuje Stelara
English: STELARA 90 mg solution for injection EU/1/08/494/002
Croatian: STELARA 90 mg otopina za injekciju EU/1/08/494/002
English: STELARA 45 mg solution for injection EU/1/08/494/001
Croatian: STELARA 45 mg otopina za injekciju EU/1/08/494/001
English: How much Stelara is given Your doctor will decide how much Stelara you need to receive and for how long.
Croatian: Liječnik će odrediti koju dozu Stelare trebate primiti, te trajanje liječenja.
English: STELARA 90 mg solution for injection in pre-filled syringe 3 years
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
English: Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Croatian: Simptomatska remisija definirana je kao Mayo podrezultat za učestalost pražnjenja crijeva 0 ili 1 i podrezultat za rektalno krvarenje 0.
English: This effect was driven by PsA Study 1.
Croatian: Ovaj učinak bio je potaknut PsA Ispitivanjem
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.
Croatian: U bolesnika kod kojih se 16 tjedana nakon primjene intravenske uvodne doze ili 16 tjedana nakon prelaska na terapiju održavanja primijenjenu svakih 8 tjedana ne pokaže terapijska korist, treba razmotriti prekid liječenja.
English: PRE-FILLED SYRINGE LABEL TEXT (45 mg)
Croatian: TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (45 mg)
English: Any unused product remaining in the vial and the syringe should be thrown away.
Croatian: Sav neiskorišteni lijek koji je preostao u bočici i štrcaljki potrebno je primjereno zbrinuti.
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%).
Croatian: Histološko cijeljenje (koje se definiralo kao infiltracija neutrofila u < 5% kripti, izostanak oštećenja kripti te izostanak erozija, ulceracija i granuloma) ocjenjivalo se u 8. tjednu ispitivanja UNIFI-I i 44. tjednu ispitivanja UNIFI-M.
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.
Croatian: • da je količina bočica i jačina lijeka ispravna o Ako je Vaša doza 90 mg, dobit ćete jednu bočicu Stelare od 90 mg.
English: In Psoriasis Study 2, the Hospital Anxiety and Depression Scale (HADS) and Work Limitations Questionnaire (WLQ) were also significantly improved in each ustekinumab treatment group compared with placebo.
Croatian: Work Limitations Questionnaire, WLQ) također su se značajno poboljšali u svakoj grupi liječenoj ustekinumabom u usporedbi s placebom.
English: The solution is clear to slightly opalescent, colourless to light yellow.
Croatian: Otopina je bistra do blago opalescentna, bezbojna do svijetložuta.
English: PRE-FILLED SYRINGE LABEL TEXT (90 mg)
Croatian: TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (90 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 Table 1, section 4.2), a fixed dose of 130 mg ustekinumab, or placebo at week 0.
Croatian: U oba ispitivanja, bolesnici su bili randomizirani na jednu intravensku primjenu, bilo preporučene doze određene prema tjelesnoj težini (od engl. tiered dose) od otprilike 6 mg/kg (vidjeti Tablicu 1, dio 4.2), bilo fiksne doze od 130 mg ustekinumaba ili placeba u 0. tjednu.
English: Solution for injection 90 mg/1 mL 1 vial
Croatian: Otopina za injekciju 90 mg/1 ml 1 bočica
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.
Croatian: Nail Psoriasis Severity Index), sažetih rezultata fizičkih i mentalnih komponenti SF-36 i vizualno analognoj skali (eng.
English: Renal and hepatic impairment STELARA has not been studied in these patient populations.
Croatian: Ispitivanja sa STELAROM u toj populaciji bolesnika nisu provedena.
English: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL of solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
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).
Croatian: Sigurnost i djelotvornost ustekinumaba bila je ocijenjena u tri randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja u odraslih bolesnika s umjerenim do teškim oblikom aktivne Crohnove bolesti (Indeks aktivnosti Crohnove bolesti od engl.
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%).
Croatian: U 8. tjednu zabilježeno je značajno poboljšanje histo-endoskopskog cijeljenja sluznice u bolesnika koji su primili ustekinumab u preporučenoj dozi (18%) u usporedbi s onima koji su primili placebo (9%).
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.
Croatian: U 44. tjednu ispitivanja UNIFI-M normalizaciju je postiglo 24% bolesnika liječenih ustekinumabom svakih 12 tjedana, 29% bolesnika liječenih ustekinumabom svakih 8 tjedana te 18% bolesnika koji su primali placebo.
English: a 41 (19.6%) 84 (40.2%)
Croatian: Klinička remisija, 8. tjedan a 41 (19,6%) 84 (40,2%)
English: Dosing frequency adjustment
Croatian: Prilagodba učestalosti primjene lijeka
English: The clinical development program consisted of one intravenous induction study (referred to as UNIFI-I) with treatment of up to 16 weeks followed by a
Croatian: Klinički razvojni program sastojao se od jednog ispitivanja intravenske primjene uvodnog liječenja (UNIFI-I) u trajanju do 16 tjedana, nakon čega je uslijedilo randomizirano ispitivanje supkutane primjene terapije održavanja u trajanju od 44 tjedna (UNIFI-M), što je činilo najmanje 52 tjedna liječenja.
English: Each vial contains 130 mg of ustekinumab in 26 mL.
Croatian: Jedna bočica sadrži 130 mg ustekinumaba u 26 ml otopine.
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.
Croatian: Bolesnici su bili randomizirani u skupine liječene ustekinumabom od 45 mg, 90 mg ili placebom, primijenjenim supkutano u 0. i 4. tjednu, a potom svakih 12 tjedana.
English: How much Stelara is given Your doctor will decide how much Stelara you need to use and for how long.
Croatian: Liječnik će odrediti koju Vam je dozu Stelare potrebno primijeniti, te trajanje liječenja.
English: STELARA 90 mg solution for injection Each vial contains 90 mg ustekinumab in 1 mL.
Croatian: STELARA 90 mg otopina za injekciju Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine.
English: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
English: L-histidine monohydrochloride monohydrate Polysorbate 80
Croatian: L-histidinklorid hidrat polisorbat 80 saharoza voda za injekcije
English: VIAL LABEL TEXT (45 mg)
Croatian: TEKST NA NALJEPNICI BOČICE (45 mg)
English: As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis.
Croatian: Liječnici moraju budno pratiti simptome eritrodermne psorijaze ili eksfolijativnog dermatitisa, kao dio postupka nadzora psorijaze u bolesnika.
English: • Keep the pre-filled syringe in the outer carton in order to protect from light.
Croatian: • Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: • the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
Croatian: • da je otopina u bočici bistra do blago opalescentna (biserno sjajna) i bezbojna do svijetložuta
English: STELARA 90 mg injection ustekinumab
Croatian: STELARA 90 mg otopina za injekciju ustekinumab
English: At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders.
Croatian: U 3. godini (148. tjedan), 82% bolesnika koji su ponovno randomizirani na održavanje liječenja, imalo je odgovor PASI 75. U 5. godini (244. tjedan), 80% bolesnika koji su ponovno randomizirani na održavanje liječenja imalo je PASI odgovor
English: What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion.
Croatian: Stelara je bistri, bezbojni do svijetložuti koncentrat za otopinu za infuziju.
English: STELARA 45 mg injection ustekinumab
Croatian: STELARA 45 mg otopina za injekciju ustekinumab
English: STELARA 45 mg solution for injection Each vial contains 45 mg ustekinumab in 0.5 mL.
Croatian: STELARA 45 mg otopina za injekciju Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine.
English: If this happens, please contact your doctor or pharmacist
Croatian: kontaktirajte svog liječnika ili ljekarnika
English: VIAL LABEL TEXT (90 mg)
Croatian: TEKST NA NALJEPNICI BOČICE (90 mg)
English: Each vial contains 90 mg ustekinumab in 1 mL of solution for injection.
Croatian: Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
English: Your doctor will check how well you are before treatment.
Croatian: Vam je zdravstveno stanje prije primjene lijeka.
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.
Croatian: Bolesnici su bili randomizirani na jednokratnu intravensku primjenu ustekinumaba, bilo u preporučenoj dozi određenoj na temelju tjelesne težine koja je iznosila približno 6 mg/kg (vidjeti Tablicu 1, dio 4.2), bilo u fiksnoj dozi od 130 mg, ili na primanje placeba u 0. tjednu.
English: STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/004
English: Preparing for use of the pre-filled syringe
Croatian: Priprema za primjenu napunjene štrcaljke
English: STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/003
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.
Croatian: Tijekom 44 tjedna kirurškom zahvatu povezanom s ulceroznim kolitisom bilo je podvrgnut manji broj ispitanika u skupini liječenoj ustekinumabom (0,6%; 2/348) nego u onoj koja je primala placebo (1,7%; 3/175).
English: Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
Croatian: Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine.
English: Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Croatian: Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
English: STELARA 90 mg solution for injection Solution for injection.
Croatian: STELARA 90 mg otopina za injekciju Otopina za injekciju.
English: • it has not passed its expiry date
Croatian: • da lijeku nije istekao rok valjanosti
English: Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
Croatian: Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine.
English: • If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack').
Croatian: (pogledajte dio 6 ‘Kako Stelara izgleda i sadržaj pakiranja').
English: In patients who failed biological therapy In patients who failed both a TNF and vedolizumab Clinical Response
Croatian: U bolesnika neuspješno liječenih antagonistima TNFα i vedolizumabom Održan klinički odgovor tijekom 44 tjedna
English: Table 12: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Croatian: Tablica 12: Sažetak ključnih mjera ishoda za djelotvornost u ispitivanju UNIFI-M (44. tjedan; 52 tjedna od početka primjene uvodne doze) Placebo* N = 175
English: Maintenance of Clinical Response through week 44
Croatian: Održan klinički odgovor tijekom 44 tjedna Klinička remisija bez kortikosteroida Dugotrajna remisija
English: STELARA 45 mg solution for injection Solution for injection.
Croatian: STELARA 45 mg otopina za injekciju Otopina za injekciju.
English: The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response from baseline at week 12 (see Tables 4 and 5).
Croatian: PASI 75 u odnosu na početnu vrijednost (vidjeti Tablicu 4 i 5).
English: The solution should be visually inspected for particulate matter or discoloration prior to administration.
Croatian: Prije primjene otopinu treba vizualno pregledati radi prisutnosti čestica ili promjene boje.
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.
Croatian: o Ako je Vaša doza 90 mg, dobit ćete dvije bočice Stelare od 45 mg i trebat ćete si dati dvije injekcije.
English: Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Croatian: Tablica 6: Sažetak ključnih mjera ishoda za djelotvornost u ispitivanju UNIFI-M (44. tjedan; 52 tjedna od početka primjene uvodne doze) Placebo* N = 175
English: PASI 50 response N (%)
Croatian: ACR 50 odgovor, N (%)
English: Children weighing less than 60 kg need a dose lower than 45 mg. Make sure you know the proper amount (volume) to remove from the vial and type of syringe needed for dosing.
Croatian: Budite sigurni da znate odgovarajuću količinu (volumen) koju treba izvaditi iz bočice i tip štrcaljke potreban za doziranje.
English: The proportion of patients achieving a modified PsA response criteria (PsARC) response was also significantly greater in the ustekinumab groups compared to placebo at week 24.
Croatian: PsA response criteria) bio je značajno veći u skupinama liječenim ustekinumabom u odnosu na placebo u 24. tjednu
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.
Croatian: o Ako je Vaša doza 90 mg, dobit ćete dvije napunjene štrcaljke Stelare od 45 mg i trebat ćete si dati dvije injekcije.
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
Croatian: Kombinacija simptomatske remisije i cijeljenjasluznicedefiniranaje kao podrezultat za učestalost pražnjenja crijeva 0 ili 1, podrezultat za rektalno krvarenje 0 i endoskopski podrezultat 0 ili 1.
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).
Croatian: U ispitivanju UNIFI-I, u 8. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika liječenih ustekinumabom nego onih koji su primili placebo (Tablica 11).
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).
Croatian: U ispitivanju UNIFI-I, u 8. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika liječenih ustekinumabom nego onih koji su primili placebo (Tablica 5).
English: response, N (%)
Croatian: PASI 90 odgovor, N (%)
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).
Croatian: U 44. tjednu je u kliničkoj remisiji bio značajno veći udio bolesnika u obje skupine liječene ustekinumabom nego u onoj koja je primala placebo (vidjeti Tablicu 12).
English: CorticosteroidFree Clinical Remission Durable Remission
Croatian: Klinička remisija bez kortikosteroida Klinička remisija u bolesnika:
English: Each vial contains 90 mg ustekinumab in 1 mL.
Croatian: Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine.
English: Each vial contains 45 mg ustekinumab in 0.5 mL.
Croatian: Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine.
English: Secondary endpoints included PASI 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory) at week 12.
Croatian: Children's Dermatology Life Quality Index (CDLQI)), promjenu u odnosu na početnu vrijednost skale ukupnog rezultata PedsQL (engl.
English: In these patients, 45 mg was also shown to be efficacious.
Croatian: Kod tih bolesnika, doza od 45 mg također se pokazala djelotvornom, međutim, doza od 90 mg pokazala je veću djelotvornost (vidjeti dio 5.1, tablicu 4).
English: STELARA 90 mg solution for injection in pre-filled syringe Ustekinumab
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki ustekinumab
English: STELARA 45 mg solution for injection in pre-filled syringe Ustekinumab
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki ustekinumab
English: • The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate
Croatian: • Pomoćne tvari su: EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinklorid hidrat, L-metionin,
English: Patients who weigh more than 100 kilograms
Croatian: Broj bolesnika ≤ 100 kg
English: • If you have recently had or are going to have a vaccination.
Croatian: • ako ste se nedavno cijepili ili ćete se cijepiti.
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.
Croatian: 0,5 ml otopine u bočici od 2 ml, izrađenoj od stakla tipa
English: STELARA 90 mg solution for injection in pre-filled syringe Solution for injection.
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki.
English: Psoriasis
Croatian: • proljev
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
Croatian: Tablica 6 Broj bolesnika koji su dostigli klinički odgovor u ispitivanjima psorijatičnog artritisa 1 (PSUMMIT I) i 2 (PSUMMIT II) u 24. tjednu Ispitivanje psorijatičnog artritisa 1 Ispitivanje psorijatičnog artritisa 2 placebo 45 mg 90 mg placebo 45 mg 90 mg
English: Clinical Remission Clinical Response Corticosteroid-Free Clinical Remission Clinical Remission in patients: in remission at the start of maintenance therapy who entered from study CRD3002 who are Anti-TNFα naïve who entered from study CRD3001
Croatian: Koji su ušli iz ispitivanja CRD3002 Koji prethodno nisu primali anti-TNFα terapiju
English: The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration.
Croatian: Prije supkutane primjene otopinu treba vizualno pregledati radi prisutnosti čestica ili promjene boje.
English: Comprehensive instructions for administration are given in the package leaflet.
Croatian: Detaljne upute kako primijeniti lijek navedene su u Uputi o lijeku.