FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Hefiya Lijek čuvajte izvan pogleda i dohvata djece.
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Croatian: Nakon drugog tjedna, bolesnici u obje skupine liječene adalimumabom primali su 40 mg svaki drugi tjedan.
English: ACR 70 6 months
Croatian: ACR 70
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes
Croatian: Otopina za injekciju Višestruko pakiranje: 6 (3 pakiranja po 2) napunjenih štrcaljki
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Croatian: Izloženost adalimumabu u pedijatrijskih bolesnika s uveitisom predviđena je uz pomoć populacijskog farmakokinetičkog modeliranja i simulacije na temelju farmakokinetike u ostalim indikacijama u drugih pedijatrijskih bolesnika (psorijaza u djece, juvenilni idiopatski artritis, Crohnova bolest u djece i artritis povezan s entezitisom).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ŠTRCALJKI
English: 15 kg to < 30 kg ≥ 30 kg
Croatian: 15 kg do < 30 kg ≥ 30 kg
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: The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1).
Croatian: Potrebno je periodički ocjenjivati koristi i rizike kontinuiranog dugotrajnog liječenja (vidjeti dio 5.1).
English: Solution for injection.
Croatian: Otopina za injekciju
English: Do not re-use a syringe.
Croatian: Nemojte ponovno koristiti istu štrcaljku.
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: Table 11 distribution of patients by age and adalimumab dose received during the OL LI phase age group number of patients at baseline n (%) Minimum, median and maximum dose
Croatian: Tablica 11 Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja dobne skupine početni broj bolesnika n (%)
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: Figure G: pull the needle cap off
Croatian: Slika G: povucite zatvarač igle
English: • mouth infections (including tooth infections and cold sores);
Croatian: • infekcije usta (uključujući infekcije zuba i herpes),
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Croatian: Ispitanici su bili pogodni ako je ranije konvencionalno liječenje Crohnove bolesti bilo neuspješno (uključujući kortikosteroid i/ili imunomodulator).
English: This study evaluated the efficacy of adalimumab 40 mg every other week / methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Croatian: Tijekom 104 tjedna uspoređivana je djelotvornost kombiniranog liječenja (40 mg adalimumaba svaka dva tjedna/metotreksat), monoterapije adalimumabom (40 mg svaka dva tjedna) te monoterapije metotreksatom na smanjenje simptoma i znakova te brzinu progresije oštećenja zglobova kod reumatoidnog artritisa.
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: response placebo N=162
Croatian: odgovor placebo N=162
English: Each syringe contains 40 mg/0.8 ml of Hefiya.
Croatian: Jedna brizgalica sadrži 40 mg/0,8 ml lijeka Hefiya.
English: Heart failure
Croatian: STOPA NEUSPJEHA
English: Table 3.
Croatian: PRILOG III.
English: adalimumab 40 mg every other week N = 70
Croatian: adalimumab 40 mg svaki drugi tjedan N = 70
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: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Croatian: Bolesnici su primili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) ili placebo tijekom 26 tjedana, nakon čega je slijedilo otvoreno liječenje adalimumabom tijekom dodatnih 26 tjedana.
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: Erectile dysfunction
Croatian: Manje često Erektilna disfunkcija
English: Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Croatian: Plak psorijaza u djece Hefiya je indiciran za liječenje teške kronične plak psorijaze u djece i adolescenata u dobi od 4 ili više godina u kojih nije postignut zadovoljavajući odgovor ili koji nisu prikladni kandidati za topikalnu terapiju i fototerapije.
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled pens (SensoReady)
Croatian: Otopina za injekciju Višestruko pakiranje: 6 (3 pakiranja po 2) napunjenih brizgalica (SensoReady)
English: Do not rub the injection site.
Croatian: Ne trljajte mjesto primjene.
English: • Store your outer carton of syringes in a refrigerator, between 2°C to 8°C.
Croatian: • Čuvajte kutiju sa štrcaljkama u hladnjaku na temperaturi od 2°C do 8°C.
English: • ankylosing spondylitis,
Croatian: • ankilozantnog spondilitisa
English: Treatment
Croatian: Liječenje
English: There are no clinical trials with adalimumab in adolescent patients with HS.
Croatian: Adolescentni gnojni hidradenitis Nisu provedena klinička ispitivanja adalimumaba u adolescentnih bolesnika s gnojnim hidradenitisom.
English: Of the 417 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Croatian: II, 46 ispitanika nije zadovoljavalo kriterije (npr. kod njih su se razvile komplikacije kao posljedica dijabetičke retinopatije, zbog operacije katarakte ili vitrektomije) i stoga nisu bili uključeni u primarnu analizu djelotvornosti.
English: The recommended dose of Hefiya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Croatian: Preporučena doza lijeka Hefiya za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (tablica 4).
English: Hefiya 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: Hefiya je indiciran 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: Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Croatian: Djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna ispitivano je u bolesnika s umjereno teškim do teškim aktivnim psorijatičnim artritisom u dva placebom kontrolirana ispitivanja, ispitivanja
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Croatian: Primijetite li išta od dolje navedenih znakova alergijske reakcije ili zatajenja srca, hitno zatražite medicinsku pomoć:
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Croatian: (poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), kao i oni s aksijalnim spondiloartritisom (ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiografskog dokaza AS-a), psorijatičnim artritisom, Crohnovom bolešću, ulceroznim kolitisom, psorijazom, gnojnim hidradenitisom i uveitisom.
English: Incorrect
Croatian: Pravilno Nepravilno
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Croatian: • kožni vaskulitis (upala krvnih žila u koži),
English: MARKETING AUTHORISATION NUMBERS
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Croatian: MTX u početnoj dozi od 7,5 mg, nakon čega se ona povećavala do 12. tjedna do maksimalne doze od 25 mg, ili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) tijekom 16 tjedana.
English: Adults with hidradenitis suppurativa
Croatian: Odrasli s gnojnim hidradenitisom (Hidradenitis suppurativa)
English: Hefiya 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: Artritis povezan s entezitisom Hefiya je indiciran 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: Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Croatian: Obratite se liječniku ako primijetite simptome kao što su dugotrajan osip nepoznatog uzroka, vrućica, bol u zglobovima ili umor.
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Croatian: I i II) u djece s aktivnim poliartikularnim ili poliartikularnim tijekom juvenilnog idiopatskog artritisa i raznim vrstama početka JIA (najčešće negativni reumatoidni faktor ili pozitivni poliartritis i prošireni oligoartritis). pJIA-I
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Croatian: U 12. tjednu HiSCR je postigao značajno veći udio bolesnika liječenih adalimumabom naspram onih koji su primali placebo.
English: clinical response clinical remission mucosal healing steroid-free remission for ≥ 90 daysa
Croatian: klinički odgovor klinička remisija cijeljenje sluznice bolesnici u remisiji bez primjene steroida ≥ 90 danaa
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Croatian: Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a
English: • Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Croatian: • Ako ste boravili ili putovali u predjele u kojima su uobičajene gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza, recite to svom liječniku.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva
English: EU/1/18/1287/001 1 pre-filled syringe EU/1/18/1287/002 2 pre-filled syringes
Croatian: EU/1/18/1287/001 1 napunjena štrcaljka EU/1/18/1287/002 2 napunjene štrcaljke
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: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Croatian: [HiSCR]; smanjenje ukupnog broja apscesa i upalnih nodula za najmanje 50%, bez povećanja broja apscesa i bez povećanja broja drenirajućih fistula u odnosu na početnu vrijednost).
English: • intestinal perforation (hole in the wall of the gut);
Croatian: • proboj crijeva (rupa u stijenci crijeva),
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow 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: EU/1/18/1287/003 6 pre-filled syringes (3 packs of 2)
Croatian: EU/1/18/1287/003 6 napunjenih štrcaljki (3 pakiranja po 2)
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Croatian: Ispitivanje RA V obuhvatilo je 799 odraslih bolesnika s umjereno do teško aktivnim reumatoidnim artritisom (srednja vrijednost trajanja bolesti kraća od 9 mjeseci) koji do tada nisu bili liječeni metotreksatom.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Croatian: Primarni ishod ispitivanja RA V bio je postotak bolesnika u kojih je postignut terapijski odgovor
English: On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Croatian: (poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), utvrđena je veza između plazmatskih koncentracija i odgovora PedACR 50.
English: Hefiya 40 mg / 0.8 ml injection adalimumab
Croatian: Hefiya 40 mg / 0,8 ml injekcija adalimumab
English: • skin infections (including cellulitis and shingles);
Croatian: • kožne infekcije (uključujući celulitis i herpes zoster),
English: The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later.
Croatian: Uobičajena početna doza adalimumaba je 40 mg, nakon čega poslije dva tjedna slijedi doza od 20 mg.
English: Thus, it is not possible to use Hefiya for children who require less than a full 40 mg dose.
Croatian: Zato se Hefiya ne može koristiti u djece koja zahtijevaju manje od cijele doze od 40 mg.
English: For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly).
Croatian: (±SD) koncentracija adalimumaba u serumu u 52. tjednu bile su 15,3 ± 11,4 μg/ml (40/20 mg, tjedno) i 6,7 ± 3,5 μg/ml (20/10 mg, tjedno).
English: fistula remission3
Croatian: Tablica 6 Nuspojave
English: There is little experience from re-administration after more than 8 weeks since the previous dose.
Croatian: Postoji malo podataka o ponovnoj primjeni lijeka Hefiya kad je prekid terapije trajao duže od 8 tjedana.
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Croatian: Među njima je njih 86 (75,4%), 72 (63,2%) odnosno 41 (36%) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
English: EU/1/18/1287/004 1 pre-filled pen EU/1/18/1287/005 2 pre-filled pens
Croatian: EU/1/18/1287/004 1 napunjena brizgalica EU/1/18/1287/005 2 napunjene brizgalice
English: Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Croatian: Hefiya je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
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: Hefiya is used to treat rheumatoid arthritis in adults.
Croatian: Hefiya je namijenjen liječenju reumatoidnog artritisa u odraslih.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hefiya.
Croatian: Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih štrcaljki lijeka Hefiya.
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Croatian: Sigurnost i djelotvornost višestrukih doza adalimumaba ispitivane su u randomiziranim, dvostruko slijepim, placebom kontroliranim kliničkim ispitivanjima u odraslih bolesnika sa srednje teškim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo rezultat od 6 do 12 uz endoskopski podrezultat od 2 do 3).
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hefiya.
Croatian: Kod nezaraznog uveitisa se uz lijek Hefiya mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: • psoriatic arthritis,
Croatian: • psorijatičnog artritisa
English: A patient who requires surgery while on Hefiya should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom Hefiya potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: Do not use if any particulates and / or discolorations are observed.
Croatian: Lijek se ne smije koristiti ako su prisutne čestice i/ili promjena boje.
English: Hefiya is injected under the skin (subcutaneous use).
Croatian: Hefiya se ubrizgava pod kožu (supkutana primjena).
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Croatian: Vaš liječnik možda će propisati i početnu dozu od 80 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Croatian: Prividna plazmatska koncentracija adalimumaba uz koju se postiže polovica maksimalne vjerojatnosti za odgovor PedACR 50 (EC50)
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Croatian: U bolesnika s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovom bolešću, ulceroznim kolitisom i gnojnim hidradenitisom primijećeno je naglo smanjenje razina CRP-a nakon liječenja adalimumabom.
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Croatian: TNF-a, što je rezultiralo kašnjenjem s primjerenim liječenjem i ponekad dovelo do smrtnog ishoda.
English: • When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: • Kad je to potrebno (na primjer kad putujete), Hefiya se može čuvati na sobnoj temperaturi (do
English: • enthesitis-related arthritis,
Croatian: • artritisa povezanog s entezitisom