FrancophonIA/ELRC3.0 huggingface dataset:
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg every other week thereafter, and 246 patients received placebo.
Croatian: U ispitivanju UC-II, 248 bolesnika primalo je adalimumab u dozi od 160 mg u nultom tjednu, 80 mg u drugom tjednu i zatim 40 mg svaka dva tjedna, a 246 bolesnika primalo je placebo.
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Croatian: Stopa nemelanomskih tumora kože (interval pouzdanosti 95%) bila je 8,8 (6,0; 13,0) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom, odnosno 3,2 (1,3; 7,6) na 1000 bolesnikgodina u kontrolnoj skupini bolesnika.
English: Adalimumab 160/80 mg N = 76
Croatian: 160/80 mg N = 76
English: ACR 50 6 months 12 months
Croatian: ACR 50 6 mjeseci 12 mjeseci
English: AMGEVITA is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Croatian: AMGEVITA je indicirana za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalnu terapiju (vidjeti dio 5.1).
English: AMGEVITA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: AMGEVITA je indicirana za liječenje umjerenog do teškog oblika aktivnog ulceroznog kolitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), ili koji ne podnose ili kod kojih postoje medicinske kontraindikacije za takve terapije.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Croatian: Od tih tumora kože, karcinom skvamoznih stanica javljao se (interval pouzdanosti 95%) u stopi od 2,7 (1,4; 5,4) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom i u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.
English: Table 24.
Croatian: Tablica 24.
English: 2 pre-filled syringes.
Croatian: 2 napunjene štrcaljke.
English: AMGEVITA 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection (injection).
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici (SureClick) Otopina za injekciju (injekcija).
English: 2 SureClick pre-filled pens.
Croatian: 2 SureClick napunjene brizgalice.
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to month 6 compared to placebo and in RA study III the same was seen at week 52.
Croatian: Nakon 6 mjeseci praćenja, u sva četiri ispitivanja zabilježeno je statistički značajno veće poboljšanje indeksa onesposobljenosti HAQ s obzirom na početne vrijednosti pri svim dozama/režimima davanja adalimumaba nego kod placeba, a identičan je nalaz primijećen i nakon 52 tjedna u ispitivanju RA III.
English: Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Croatian: Bolesnici koji su u 16. tjednu pokazali pedijatrijski odgovor ACR 30 (American College of Rheumatology 30) mogli su biti randomizirani u dvostruko slijepu fazu ispitivanja i primiti ili 24 mg/m2 adalimumaba, do maksimalne doze od 40 mg, ili placebo, svaki drugi tjedan kroz 32 tjedna ili do ponovne reaktivacije bolesti.
English: Rare (may affect up to 1 in 1,000 people) • low blood measurements for white blood cells, red blood cells and platelet count.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) • niska razina leukocita, eritrocita i trombocita.
English: Clear and colourless to slightly yellow solution.
Croatian: Bistra i bezbojna do blago žuta otopina.
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to AMGEVITA in utero is not recommended for 5 months following the mother's last AMGEVITA injection during pregnancy.
Croatian: Djeci koja su u maternici bila izložena lijeku AMGEVITA ne preporučuje se davati živa cjepiva (npr. cjepivo BCG) najmanje 5 mjeseci otkad je majka u trudnoći primila zadnju injekciju lijeka AMGEVITA.
English: - The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Croatian: Drugi sastojci su ledena acetatna kiselina, saharoza, polisorbat 80, natrijev hidroksid i voda za injekcije.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with AMGEVITA.
Croatian: Preporučuje se da bolesnik tijekom liječenja lijekom AMGEVITA svakodnevno koristi topikalnu antiseptičku tekućinu za ispiranje lezija uzrokovanih gnojnim hidradenitisom.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week (eow).
Croatian: Nakon završetka oba ispitivanja, 383 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem su dobivali 40 mg adalimumaba svaki drugi tjedan.
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Croatian: Ispitanicima kojima se stanje pogoršalo tijekom dvostruko slijepog razdoblja, bilo je dozvoljeno liječene s adalimumabom 40 mg svaki drugi tjedan, kao terapijom spasa, kroz najmanje 12 tjedana.
English: Table 26.
Croatian: Tablica 26.
English: The combination of AMGEVITA and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirana terapija lijekom AMGEVITA i abataceptom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početna doza od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim 40 mg svaki tjedan, počevši od 4. tjedna) u bolesnika s gnojnim hidradenitisom, uz kontrolno razdoblje u trajanju od 12 do 16 tjedana, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 0,3% bolesnika liječenih adalimumabom i 0,6% bolesnika iz kontrolne skupine.
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Croatian: U ovoj otvorenoj uvodnoj fazi ispitivanja svi bolesnici su primali 24 mg/m2 adalimumaba do maksimalne doze od 40 mg adalimumaba, svaki drugi tjedan kroz 16 tjedana.
English: 1 SureClick pre-filled pen.
Croatian: 1 SureClick napunjena brizgalica.
English: Table 12.
Croatian: Tablica 12.
English: Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines.
Croatian: Bolesnici koji primaju lijek AMGEVITA mogu istodobno primiti cjepiva, ali ne živa cjepiva.
English: ACR 20 6 months 12 months
Croatian: ACR 20 6 mjeseci 12 mjeseci
English: a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Croatian: ND ND 4,5% 23,2% a Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon 24 tjedna i nakon 52 tjedna b 40 mg adalimumaba primijenjenog svaki drugi tjedan c MTX = metotreksat ** p < 0,01, adalimumab u usporedbi s placebom
English: Consequently, AMGEVITA can be used during breastfeeding.
Croatian: Stoga se AMGEVITA može primjenjivati tijekom dojenja.
English: LIST OF EXCIPIENTS Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Croatian: POPIS POMOĆNIH TVARI Ledena acetatna kiselina, saharoza, polisorbat 80, natrijev hidroksid i voda za injekciju.
English: Inspect the AMGEVITA pre-filled syringe.
Croatian: Pregledaite AMGEVITA napunjenu štrcaljku.
English: 4 SureClick pre-filled pens.
Croatian: 4 SureClick napunjene brizgalice.
English: AMGEVITA is administered by subcutaneous injection.
Croatian: AMGEVITA se primjenjuje supkutanom injekcijom.
English: AMGEVITA is a clear and colourless to slightly yellow solution.
Croatian: AMGEVITA je bistra i bezbojna do blago žuta otopina.
English: AMGEVITA is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Croatian: AMGEVITA je namijenjena liječenju ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa u odraslih.
English: AMGEVITA is used to treat rheumatoid arthritis in adults.
Croatian: AMGEVITA je namijenjena liječenju reumatoidnog artritisa u odraslih.
English: A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom AMGEVITA potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Croatian: često astma, dispneja, kašalj manje često plućna embolija1), intersticijska plućna bolest, kronična opstruktivna plućna bolest, pneumonitis pleuralna efuzija1)
English: The recommended dose of AMGEVITA for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Croatian: Preporučena doza lijeka AMGEVITA za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
English: ● Do not remove the yellow cap from the pre-filled pen until you are ready to inject.
Croatian: Nemojte uklanjati žuti zatvarač s napunjene brizgalice sve dok niste spremni injicirati.
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Croatian: Stopa trudnoća koje su završile najmanje jednim živorođenim djetetom s velikom urođenom manom iznosila je 6/69 (8,7%) među ženama liječenima adalimumabom koje su imale reumatoidni artritis i 5/74 (6,8%) među ženama s reumatoidnim artritisom koje nisu primale liječenje (neprilagođen OR: 1,31; 95% CI: 0,38 - 4,52) te
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 80 mg u nultom tjednu, nakon kojih slijede doze od 40 mg svaki drugi tjedan, počevši od 1. tjedna) u odraslih bolesnika s uveitisom u trajanju do 80 tjedana, uz medijan izloženosti od 166,5 dana u bolesnika liječenih adalimumabom te 105,0 dana u bolesnika iz kontrolne skupine, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 2,4% bolesnika liječenih adalimumabom i 2,4% bolesnika iz kontrolne skupine.
English: AMGEVITA is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Croatian: AMGEVITA je indicirana za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u pedijatrijskih bolesnika (u dobi od 6 godina i starijih) u kojih nije postignut zadovoljavajući odgovor na konvencionalnu terapiju, uključujući primarnu nutritivnu terapiju i liječenje kortikosteroidom i/ili imunomodulatorom ili u onih koji ne podnose ili u kojih su takve vrste terapija kontraindicirane.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Croatian: Physician's Global Assessment, PGA) kretao se u rasponu od „umjerenog“ (53% uključenih ispitanika) do „teškog“ (41%) i „vrlo teškog“ (6%).
English: If you do not respond well enough to these medicines, you will be given AMGEVITA.
Croatian: Ako na njih ne reagirate dovoljno dobro, bit će Vam propisan lijek AMGEVITA.
English: Paediatric plaque psoriasis efficacy results at 16 weeks
Croatian: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your rheumatoid arthritis.
Croatian: Ukoliko na njih ne reagirate dovoljno dobro, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek AMGEVITA.
English: Induction of clinical remission and response (percent of patients)
Croatian: Tablica 23. Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes.
Croatian: Pakiranje od jedne, dvije, četriri ili višestruko pakiranje od šest (3x2) napunjenih brizgalica.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79% CV).
Croatian: Nakon supkutano primijenjene doze od 0,8 mg/kg (do maksimalno 40 mg) svaki drugi tjedan u pedijatrijskih bolesnika s kroničnom plak psorijazom, srednja vrijednost ± SD najniže koncentracije adalimumaba u stanju dinamičke ravnoteže iznosila je približno 7,4 ± 5,8 µg/ml (79% CV).
English: Full instructions for use are provided in the package leaflet.
Croatian: Cjelovite upute za primjenu nalaze se u uputi o lijeku.
English: How to use AMGEVITA
Croatian: Kako primjenjivati lijek AMGEVITA
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Croatian: Bolesnici su bili randomizirani i primali su ili 24 mg/m2 tjelesne površine adalimumaba do maksimalne doze od 40 mg ili placebo svaki drugi tjedan tijekom 12 tjedana.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION AMGEVITA 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki Jedna jednodozna napunjena štrcaljka sadrži 20 mg adalimumaba u 0,4 ml otopine (50 mg/ml).
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphatemia, Dehydration
Croatian: Poremećaji metabolizma i prehrane vrlo često povišena razina lipida često hipokalijemija, povišene razine mokraćne kiseline, abnormalna razina natrija u krvi, hipokalcijemija, hiperglikemija, hipofosfatemija, dehidracija
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m2 (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s artritisom povezanim s entezitisom u dobi od 6 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene u 24. tjednu) bila je 8,8 ± 6,6 µg/ml za adalimumab bez istodobne primjene metotreksata i 11,8 ± 4,3 µg/ml uz istodobnu primjenu metotreksata.
English: ● Do not remove the needle cap until you are ready to inject.
Croatian: Nemojte uklanjati zatvarač igle saštrcaljke sve dok niste spremni injicirati.
English: If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako primjenjujete lijek AMGEVITA.
English: SPARCC MRI Spined,j a Assessment of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Croatian: Ankylosing Spondylitis Disease Activity Score) d Srednja promjena od početne vrijednosti e n = 91 za placebo i n = 87 za adalimumab f C-reaktivni protein visoke osjetljivosti (engl. high sensitivity C-Reactive Protein) (mg/l) g n = 73 za placebo i n = 70 za adalimumab h Kanadski konzorcij za istraživanje spondiloartritisa (engl.
English: In the open-label extension of RA study V, the mean change from baseline at year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Croatian: U otvorenom produžetku ispitivanja RA V, srednja vrijednost promjene ukupnog zbroja bodova prema modificiranoj Sharpovoj ljestvici od početka ispitivanja do 10. godine iznosila je 10,8 u bolesnika izvorno randomiziranih za monoterapiju metotreksatom, 9,2 u bolesnika izvorno randomiziranih za monoterapiju adalimumabom te 3,9 u bolesnika izvorno randomiziranih za liječenje kombinacijom
English: In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg/m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/mL (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/mL (71.2% CV) with concomitant methotrexate.
Croatian: U bolesnika s poliartikularnim JIA u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i starijih i tjelesne težine manje od 15 kg, nakon primjene 24 mg/m2 adalimumaba srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže bila je 6,0 ± 6,1 µg/ml (101% CV) za adalimumab bez istodobne primjene metotreksata i 7,9 ± 5,6 µg/ml (71,2% CV) uz istodobnu primjenu metotreksata.
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment.
Croatian: U odraslih bolesnika sa psorijazom, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže bila je 5 μg/ml tijekom primjene monoterapije dozom adalimumaba od 40 mg svaki drugi tjedan.
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA.
Croatian: Kod nezaraznog uveitisa se uz lijek AMGEVITA mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.4 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: The recommended AMGEVITA dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Croatian: Preporučena doza lijeka AMGEVITA za bolesnike s plak psorijaom od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ako na njih ne reagirate dovoljno dobro, u svrhu smanjenja znakova i simptoma Crohnove bolesti bit će Vam propisan lijek AMGEVITA.
English: AMGEVITA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Croatian: AMGEVITA je indicirana za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more The recommended dose of AMGEVITA is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Croatian: Adolescenti s gnojnim hidradenitisom u dobi od 12 do 17 godina tjelesne težine 30 kg ili više Preporučeno doziranje lijeka AMGEVITA je početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), a zatim 40 mg svaki drugi tjedan, počevši tjedan dana kasnije.
English: Total sharp score
Croatian: Ukupan zbroj bodova prema Sharpu
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg every other week or MTX.
Croatian: U 16. tjednu, pozitivan odgovor s obzirom na djelotvornost (npr. PASI 75) postigao je veći broj bolesnika randomiziranih za liječenje adalimumabom u dozi od 0,8 mg/kg nego onih randomiziranih za primanje doze od 0,4 mg/kg svaki drugi tjedan ili za liječenje MTX-om.
English: Use a new AMGEVITA pre-filled pen.
Croatian: Primijenite novu AMGEVITA napunjenu brizgalicu.
English: Name and address of the manufacturers of the biological active substance Amgen Inc
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased
Croatian: vrlo često povišenijetrenienzimi manje često kolecistitis i kolelitijaza, steatoza jetre, povišen bilirubin rijetko
English: AMGEVITA 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki 0,4 ml otopine u napunjenoj štrcaljki (staklo tipa I), s čepom klipa (bromobutilna guma) i iglom od nehrđajućeg čelika sa zaštitom za iglu (termoplastični elastomer).
English: • Enthesitis-related arthritis
Croatian: • artritisa povezanim s entezitisom
English: AMGEVITA 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki 0,8 ml otopine u napunjenoj štrcaljki (staklo tipa I), s čepom klipa (bromobutilna guma) i iglom od nehrđajućeg čelika sa zaštitom za iglu (termoplastični elastomer).