natgillin/translations-raw huggingface dataset:
26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper.
26 ml otopine u bočici od 30 ml, izrađenoj od stakla tipa
Combined Symptomatic Remission and Mucosal Healing
Kombinacija simptomatske remisije i cijeljenja sluznice
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
Kombinacija simptomatske remisijei cijeljenjasluznicedefiniranaje kao podrezultat za učestalost pražnjenja crijeva0 ili 1, podrezultat za rektalno krvarenje 0 i endoskopski podrezultat 0 ili 1. p < 0,001 p < 0,05
PASI 90 response N (%)
PASI 90 odgovor N (%)
A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose.
Za pedijatrijske bolesnike koji trebaju primiti manje od pune doze od 45 mg dostupna je bočica od 45 mg.
Psoriatic arthritis (PsA) (Adults)
Psorijatični artritis (PsA) (Odrasli bolesnici)
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).
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).
Disposal:
Odlaganje:
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.
U kontroliranim i nekontroliranim razdobljima kliničkih ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa, koje je predstavilo izloženost od 11 581 bolesnik-godine u 6709 bolesnika, medijan praćenja bio je 1,0 godina; 1,1 godinu za ispitivanja psorijatične bolesti, 0,6 godina za ispitivanja Crohnove bolesti i 1,0 godina za ispitivanja ulceroznog kolitisa.
STELARA 45 mg solution for injection 2 years
STELARA 45 mg otopina za injekciju 2 godine
• Do not remove the needle cover from the pre-filled syringe until instructed to do so
• Ne uklanjajte zaštitnu kapicu s igle napunjene štrcaljke dok ne dođete do koraka u uputi kada je vrijeme za njeno uklanjanje
STELARA 90 mg solution for injection 2 years
STELARA 90 mg otopina za injekciju 2 godine
• Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in
• herpes zoster (vrsta bolnog osipa s mjehurićima) je manje čest (može se pojaviti u do 1 na
Any unused product remaining in the syringe should be thrown away.
Sav neiskorišteni lijek koji je preostao u štrcaljki potrebno je primjereno zbrinuti.
It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial.
Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj bočici od 30 ml.
What Stelara looks like and contents of the pack Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection.
Stelara je bistra do blago opalescentna (ima biserni sjaj), bezbojna do svijetložuta otopina za injekciju.
• burning when passing water
• žarenje pri mokrenju
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).
Tijekom 44 tjedna ispitivanja UNIFI-M udio ispitanika hospitaliziranih zbog razloga povezanih s ulceroznim kolitisom bio je značajno niži među ispitanicima iz obje skupine liječene ustekinumabom (2,0%; 7/348) nego među onima koji su primali placebo (5,7%; 10/175).
STELARA 130 mg concentrate for solution for infusion
STELARA 130 mg koncentrat za otopinu za infuziju
Excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Pomoćne tvari: EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinklorid hidrat, L-metionin, polisorbat 80, saharoza, voda za injekcije.
Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)
Klinički odgovor (100 bodova), 8. tjedan a 67 (32,1%) 121 (57,9%)
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.
STELARA je namijenjena za primjenu pod vodstvom i nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju stanja za koja je STELARA indicirana.
• the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
• da je otopina u napunjenoj štrcaljki bistra do blago opalescentna (biserno sjajna) i bezbojna do svijetložuta
b 60 (28.7%) 116 (55.5%) Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)
Klinički odgovor (100 bodova), 6. tjedan b 60 (28,7%) 116 (55,5%)
At the start of your treatment,
Dok to radite,
• the number of pre-filled syringes and strength is correct o If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
• da je količina napunjenih štrcaljki i jačina lijeka ispravna o Ako je Vaša doza 90 mg, dobit ćete jednu napunjenu štrcaljku Stelare od 90 mg.
It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe.
Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj napunjenoj štrcaljki od 1 ml.
STELARA 90 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine.
How to store Stelara
Kako čuvati Stelaru
Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline
Broj bolesnika sa zahvaćenošću kože psorijazom ≥ 3% površine tijela (BSA, engl. body surface area) na početku liječenja
Water for injection
Upute za primjenu injekcije
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).
Značajno veći udio bolesnika održao je kliničku remisiju i odgovor u skupinama liječenim ustekinumabom u usporedbi s placebo skupinom u 44. tjednu (vidjeti tablicu 10).
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.
Bolesnici randomizirani u placebo grupu, primali su placebo u tjednima 0 i 4, potom su u tjednima 12 i 16, prešli na dobivanje ustekinumaba (od 45 mg ili 90 mg), nakon čega je slijedilo doziranje svakih 12 tjedana.
Solution for injection 45 mg/0.5 mL 1 vial
Otopina za injekciju 45 mg/0,5 ml 1 bočica
Ustekinumab-treated patients showed significant improvement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24.
Disability Index of the Health Assessment Questionnaire) u 24. tjednu.
STELARA 45 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine.
STELARA 130 mg concentrate for solution for infusion ustekinumab
STELARA 130 mg koncentrat za otopinu za infuziju ustekinumab
• Turn the vial and the syringe upside down
• Okrenite bočicu i štrcaljku naopako.
• Clean the stopper with an antiseptic swab
• Očistite čep antiseptičkom maramicom.
It is supplied as a carton pack containing 1 single-dose, glass 2 mL vial.
Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj bočici od 2 ml.
A beneficial effect was also observed in induction in patients who failed at least one prior TNFα antagonist therapy and vedolizumab, however the number of patients in this subgroup was too small to draw definitive conclusions about the beneficial effect in this group during maintenance.
Međutim, broj bolesnika u toj podskupini bio je premalen da bi se mogli donijeti konačni zaključci o korisnom učinku u toj skupini tijekom terapije održavanja.
Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Kod bolesnika s anamnezom latentne tuberkuloze ili aktivne tuberkuloze kod kojih se ne može utvrditi odgovarajući tijek liječenja, također se mora razmotriti antituberkulozno liječenje prije početka primjene STELARE.
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.
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).
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).
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).
Keep the vial or pre-filled syringe in the outer carton in order to protect from light.
Bočicu ili napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
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.
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.
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.
Functional Assessment of Chronic Illness TherapyFatigue) u skupinama koje su primale ustekinumab kada se uspoređuje s placebom u 24. tjednu.
STELARA 45 mg solution for injection in pre-filled syringe 3 years
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
Your doctor will check how well you are before each treatment.
Vam je zdravstveno stanje prije svake primjene lijeka.
Improvement in HAQ-DI score from baseline was maintained through Weeks 52 and 100.
Poboljšanje HAQ-DI bodova u odnosu na početne, održalo se kroz 52 i 100 tjedana.
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).
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).
Excipients: Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Pomoćne tvari: saharoza, L-histidin, L-histidinklorid hidrat, polisorbat 80, voda za injekcije.
How Stelara is given
Kako se primjenjuje Stelara
STELARA 90 mg solution for injection EU/1/08/494/002
STELARA 90 mg otopina za injekciju EU/1/08/494/002
STELARA 45 mg solution for injection EU/1/08/494/001
STELARA 45 mg otopina za injekciju EU/1/08/494/001
How much Stelara is given Your doctor will decide how much Stelara you need to receive and for how long.
Liječnik će odrediti koju dozu Stelare trebate primiti, te trajanje liječenja.
STELARA 90 mg solution for injection in pre-filled syringe 3 years
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki 3 godine
Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Simptomatska remisija definirana je kao Mayo podrezultat za učestalost pražnjenja crijeva 0 ili 1 i podrezultat za rektalno krvarenje 0.
This effect was driven by PsA Study 1.
Ovaj učinak bio je potaknut PsA Ispitivanjem
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.
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.
PRE-FILLED SYRINGE LABEL TEXT (45 mg)
TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (45 mg)
Any unused product remaining in the vial and the syringe should be thrown away.
Sav neiskorišteni lijek koji je preostao u bočici i štrcaljki potrebno je primjereno zbrinuti.
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%).
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.
• the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of Stelara.
• da je količina bočica i jačina lijeka ispravna o Ako je Vaša doza 90 mg, dobit ćete jednu bočicu Stelare od 90 mg.
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.
Work Limitations Questionnaire, WLQ) također su se značajno poboljšali u svakoj grupi liječenoj ustekinumabom u usporedbi s placebom.
The solution is clear to slightly opalescent, colourless to light yellow.
Otopina je bistra do blago opalescentna, bezbojna do svijetložuta.
PRE-FILLED SYRINGE LABEL TEXT (90 mg)
TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE (90 mg)
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.
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.
Solution for injection 90 mg/1 mL 1 vial
Otopina za injekciju 90 mg/1 ml 1 bočica
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.
Nail Psoriasis Severity Index), sažetih rezultata fizičkih i mentalnih komponenti SF-36 i vizualno analognoj skali (eng.
Renal and hepatic impairment STELARA has not been studied in these patient populations.
Ispitivanja sa STELAROM u toj populaciji bolesnika nisu provedena.
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL of solution for injection.
Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
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).
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.
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%).
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%).
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.
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.
a 41 (19.6%) 84 (40.2%)
Klinička remisija, 8. tjedan a 41 (19,6%) 84 (40,2%)
Dosing frequency adjustment
Prilagodba učestalosti primjene lijeka
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
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.
Each vial contains 130 mg of ustekinumab in 26 mL.
Jedna bočica sadrži 130 mg ustekinumaba u 26 ml otopine.
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.
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.
How much Stelara is given Your doctor will decide how much Stelara you need to use and for how long.
Liječnik će odrediti koju Vam je dozu Stelare potrebno primijeniti, te trajanje liječenja.
STELARA 90 mg solution for injection Each vial contains 90 mg ustekinumab in 1 mL.
STELARA 90 mg otopina za injekciju Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
L-histidine monohydrochloride monohydrate Polysorbate 80
L-histidinklorid hidrat polisorbat 80 saharoza voda za injekcije
VIAL LABEL TEXT (45 mg)
TEKST NA NALJEPNICI BOČICE (45 mg)
As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis.
Liječnici moraju budno pratiti simptome eritrodermne psorijaze ili eksfolijativnog dermatitisa, kao dio postupka nadzora psorijaze u bolesnika.
• Keep the pre-filled syringe in the outer carton in order to protect from light.
• Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
• the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
• da je otopina u bočici bistra do blago opalescentna (biserno sjajna) i bezbojna do svijetložuta
STELARA 90 mg injection ustekinumab
STELARA 90 mg otopina za injekciju ustekinumab
At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders.
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
What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion.
Stelara je bistri, bezbojni do svijetložuti koncentrat za otopinu za infuziju.
STELARA 45 mg injection ustekinumab
STELARA 45 mg otopina za injekciju ustekinumab
STELARA 45 mg solution for injection Each vial contains 45 mg ustekinumab in 0.5 mL.
STELARA 45 mg otopina za injekciju Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine.
If this happens, please contact your doctor or pharmacist
kontaktirajte svog liječnika ili ljekarnika
VIAL LABEL TEXT (90 mg)
TEKST NA NALJEPNICI BOČICE (90 mg)
Each vial contains 90 mg ustekinumab in 1 mL of solution for injection.
Jedna bočica sadrži 90 mg ustekinumaba u 1 ml otopine za injekciju.
Your doctor will check how well you are before treatment.
Vam je zdravstveno stanje prije primjene lijeka.
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.
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.
STELARA 90 mg solution for injection in pre-filled syringe EU/1/08/494/004
STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/004
Preparing for use of the pre-filled syringe
Priprema za primjenu napunjene štrcaljke
STELARA 45 mg solution for injection in pre-filled syringe EU/1/08/494/003
STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki EU/1/08/494/003
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.
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).
Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine.
Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Jedna bočica sadrži 45 mg ustekinumaba u 0,5 ml otopine za injekciju.
STELARA 90 mg solution for injection Solution for injection.
STELARA 90 mg otopina za injekciju Otopina za injekciju.
• it has not passed its expiry date
• da lijeku nije istekao rok valjanosti
Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine.
• 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').
(pogledajte dio 6 ‘Kako Stelara izgleda i sadržaj pakiranja').
In patients who failed biological therapy In patients who failed both a TNF and vedolizumab Clinical Response
U bolesnika neuspješno liječenih antagonistima TNFα i vedolizumabom Održan klinički odgovor tijekom 44 tjedna