FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika u dobi od 4 do 17 godina s poliartikularnim juvenilnim idiopatskim artritisom i u bolesnika u dobi od 6 do 17 godina s artritisom povezanim s entezitisom, povišenje ALT-a ≥ 3 x GGN zabilježeno je u 6,1% bolesnika liječenih adalimumabom i 1,3% bolesnika iz kontrolne skupine.
English: The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Croatian: Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje tijekom kojeg su bolesnici primali 24 mg/m2 tjelesne površine adalimumaba do maksimalne doze od 40 mg svaki drugi tjedan supkutano tijekom najviše 192 dodatna tjedna.
English: Ps study I (REVEAL) - efficacy results at 16 weeks
Croatian: Ispitivanje Ps II (CHAMPION) rezultati djelotvornosti nakon 16 tjedana
English: AMGEVITA is used to treat psoriatic arthritis in adults.
Croatian: AMGEVITA je namijenjena liječenju psorijatičnog artritisa u odraslih.
English: AMGEVITA Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Croatian: Tablica 2. Doza lijeka AMGEVITA za bolesnike s artritisom povezanim s entezitisom Tjelesna težina bolesnika
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/mL (47.7% CV) with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m2 (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom (JIA) u dobi od 4 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene od 20. do 48. tjedna) bila je 5,6 ± 5,6 µg/ml (102% CV) za adalimumab bez istodobne primjene metotreksata i 10,9 ± 5,2 µg/ml (47,7% CV) uz istodobnu primjenu metotreksata.
English: AMGEVITA is used to treat moderate to severe plaque psoriasis in adults.
Croatian: AMGEVITA je namijenjena liječenju umjerene do teške plak psorijaze u odraslih.
English: AMGEVITA 40 mg solution for injection in pre-filled pen 0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I glass).
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici 0,8 ml otopine za injekciju u napunjenoj brizgalici za upotrebu bolesnika koja sadrži napunjenu štrcaljku (staklo tipa I).
English: AMGEVITA is used to treat ulcerative colitis in adults.
Croatian: AMGEVITA je namijenjena liječenju ulceroznog kolitisa u odraslih.
English: AMGEVITA is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Croatian: AMGEVITA je indicirana za liječenje kroničnog neinfektivnog anteriornog uveitisa u djece u dobi od 2 godine i starije u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, koji ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno.
English: A. Remove one AMGEVITA pre-filled pen from the package.
Croatian: Izvadite jednu AMGEVITA napunjenu brizgalicu iz pakiranja.
English: The recommended dose of AMGEVITA for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U odraslih bolesnika s reumatoidnim artritisom preporučena doza adalimumaba iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: p-valuea p-valueb p-valuec
Croatian: pvrijednos ta pvrijednos tb pvrijednos tc
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Croatian: Napomena: P = Placebo (broj bolesnika pod rizikom (pogoršanje)); A = Adalimumab (broj bolesnika pod rizikom (pogoršanje)).
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Croatian: Njih 48 nije imalo znakove progresije strukturnog oštećenja, definirane kao promjena početne vrijednosti mTSS za
English: AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Croatian: U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, AMGEVITA se može primijeniti i bez prethodnog liječenja metotreksatom.
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 AMGEVITA kad je prekid terapije trajao duže od 8 tjedana.
English: AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Croatian: Aksijalni spondiloartritis bez radiološkog dokaza AS-a AMGEVITA je indicirana za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MR), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Croatian: Tablica 3. Doza lijeka AMGEVITA za pedijatrijske bolesnike s plak psorijazom Tjelesna težina bolesnika
English: Finger flange Label and expiration date
Croatian: Naljepnica i rok valjanosti
English: In CD study I, 299 TNF-antagonist naïve patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Croatian: U ispitivanju CD I, 299 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su u jednu od 4 terapijske skupine: placebo u nultom tjednu i nakon 2 tjedna, 160 mg adalimumaba u nultom tjednu i 80 mg nakon 2 tjedna, 80 mg adalimumaba u nultom tjednu i 40 mg nakon 2 tjedna, 40 mg adalimumaba u nultom tjednu i 20 mg nakon 2 tjedna.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) 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: Limfomi su se javljali u stopi (interval pouzdanosti 95%) od 0,7 (0,2; 2,7) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom, odnosno u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.
English: Your doctor should test you for HBV. AMGEVITA can cause reactivation of HBV in people who carry this virus.
Croatian: AMGEVITA može u nositelja virusa uzrokovati reaktivaciju HBV-a.
English: AMGEVITA Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Croatian: Doza lijeka AMGEVITA za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom
English: vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Croatian: Učinci povezani s vidom koji nisu brojčano išli u prilog adalimumabu bili su učinci na vid u boji u ispitivanju UV I, odnosno učinci na vid u boji, periferni vid i vid na blizinu u ispitivanju UV II.
English: AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: In controlled phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s plak psorijazom, s kontrolnim razdobljem koje je trajalo u rasponu od 12 do 24 tjedna, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 1,8% bolesnika liječenih adalimumabom i 1,8% bolesnika iz kontrolne skupine.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/mL (without concomitant methotrexate) and 8 to 9 μg/mL (with concomitant methotrexate), respectively.
Croatian: Nakon supkutane primjene adalimumaba u dozi od 40 mg svaka dva tjedna u odraslih bolesnika s reumatoidnim artritisom srednje vrijednosti najniže koncentracije lijeka u stanju dinamičke ravnoteže bile su približno 5 μg/ml (bez istodobne primjene metotreksata), odnosno 8 do 9 μg/ml (uz metotreksat).
English: ● Do not twist or bend the needle cap.
Croatian: Nemojte okretati ili savijati zatvarač igle.
English: SPARCCh MRI Sacroiliac Jointsd,i
Croatian: SPARCCh MR sakroilijakalnih zglobovad,i
English: INFORMATION IN BRAILLE AMGEVITA 40 mg pen
Croatian: 16. PODACI NA BRAILLEOVOM PISMU AMGEVITA 40 mg brizgalica
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p < 0.001) in the adalimumab group (at week 48).
Croatian: Bolesnici koji su primali placebo imali su promjenu mTSS-a u odnosu na početnu vrijednost (srednja vrijednost ± standardno odstupanje) od 0,8 ± 2,5 (24. tjedan), a bolesnici liječeni adalimumabom 0,0 ± 1,9 (p < 0,001) (48. tjedan).
English: AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe Solution for injection (injection).
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki Otopina za injekciju (injekcija).
English: Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of AMGEVITA is 40 mg every other week with methotrexate.
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine 30 kg ili više Uobičajena doza lijeka AMGEVITA je 40 mg svaki drugi tjedan s metotreksatom.
English: • It is important that you tell your baby's doctors and other health care professionals about your AMGEVITA use during your pregnancy before the baby receives any vaccine.
Croatian: • Važno je da prije bilo kakvog cijepljenja djeteta obavijestite liječnika svog djeteta i druge zdravstvene radnike o tome da ste u trudnoći primali lijek AMGEVITA (za više informacija o cjepivima pogledajte dio „Upozorenja i mjere opreza“).
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/mL.
Croatian: U odraslih bolesnika s uveitisom, udarna doza adalimumaba od 80 mg u nultom tjednu i zatim 40 mg svaki drugi tjedan, počevši od 1. tjedna, dovela je do srednje vrijednosti koncentracija u stanju dinamičke ravnoteže od približno 8 - 10 µg/ml.
English: Step 3: Inject G. Hold the stretch or pinch.
Croatian: Korak 3: Injiciranje G.
English: The recommended dose of AMGEVITA for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Croatian: Preporučena doza lijeka AMGEVITA za bolesnike s artritisom povezanim s entezitisom u dobi od 6 godina i starije određuje se na temelju tjelesne težine (Tablica 2).
English: INFORMATION IN BRAILLE AMGEVITA 20 mg syringe
Croatian: 16. PODACI NA BRAILLEOVOM PISMU AMGEVITA 20 mg štrcaljka
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg The recommended dose of AMGEVITA is an initial dose of 20 mg, followed by 20 mg one week later.
Croatian: Djeca i adolescenti u dobi od 4 do 17 godina, tjelesne težine od 15 kg do manje od 30 kg Preporučeno doziranje lijeka AMGEVITA je početna doza od 20 mg, a zatim 20 mg nakon tjedan dana.
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion
Croatian: 26. tjedan 52. tjedan 1 p vrijednost za standardnu dozu u usporedbi s niskom dozom 2 Imunosupresivna terapija mogla se obustaviti samo u 26. tjednu ili kasnije, prema slobodnoj procjeni ispitivača ako je ispitanik ispunio kriterije kliničkog odgovora 3 definirano kao zatvaranje svih fistula iz kojih se na početku cijedio sadržaj, održano kroz barem 2 uzastopna posjeta nakon početka liječenja
English: There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Croatian: • U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNF blokatore, zabilježeni su i drugačiji oblici tumora osim limfoma.
English: Use a new AMGEVITA pre-filled syringe.
Croatian: Primijenite novu AMGEVITA napunjenu štrcaljku.
English: if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating AMGEVITA therapy.
Croatian: Ako je moguće, preporučuje se da djeca obave sva cijepljenja prema važećim smjernicama prije započinjanja terapije lijekom AMGEVITA.
English: EU/1/16/1164/005 - 6 (3x2) multipack AMGEVITA 40 mg solution for injection in pre-filled pen EU/1/16/1164/006 - 1 pack
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1164/001 - 1 pakiranje AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1164/002 - 1 pakiranje EU/1/16/1164/003 - 2 pakiranja EU/1/16/1164/004 - 4 pakiranja EU/1/16/1164/005 - 6 (3x2) višestruko pakiranje AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici EU/1/16/1164/006 - 1 pakiranje EU/1/16/1164/007 - 2 pakiranja EU/1/16/1164/008 - 4 pakiranja EU/1/16/1164/009 - 6 (3x2) višestruko pakiranje
English: In controlled phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s reumatoidnim artritisom i psorijatičnim artritisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 104 tjedna, povišenje razine ALT-a ≥ 3 x GGN (gornja granica normalnog raspona) zabilježeno je u 3,7% bolesnika liječenih adalimumabom i 1,6% bolesnika iz kontrolne skupine.
English: If you have an inadequate response to AMGEVITA 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ne postignete zadovoljavajući odgovor na terapiju lijekom AMGEVITA u dozi od 40 mg svaki drugi tjedan, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ovisno o odgovoru na liječenje, liječnik Vam može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Treatment with AMGEVITA may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka AMGEVITA mogu se razviti autoimuna protutijela.
English: ● Cotton ball or gauze pad
Croatian: Pamučnu vatu ili komad gaze
English: Week 104 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Croatian: 104 tjedna 28,4% 28,1% 46,6% < 0,001 a p-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa b p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa c p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U testa
English: AMGEVITA works by reducing this inflammation.
Croatian: AMGEVITA djeluje tako da smanjuje tu upalu.
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitislike psoriatic arthropathy due to the small number of patients studied.
Croatian: Zbog premalog broja bolesnika uključenih u ispitivanje, nema dovoljno dokaza o djelotvornosti adalimumaba u liječenju bolesnika s psorijatičnom artropatijom sličnoj ankilozantnom spondilitisu.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom AMGEVITA zbog moguće pojave infekcija, uključujući tuberkulozu.
English: Adalimumab 40 mg eow N = 814 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan N = 814 n (%)
English: In adolescent patients with inadequate response to AMGEVITA 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Croatian: U adolescentnih bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek AMGEVITA u dozi od 40 mg svaki drugi tjedan, može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Keep AMGEVITA in the outer carton in order to protect from light.
Croatian: Lijek AMGEVITA čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Visual impairment, Conjunctivitis, Blepharitis, Eye swelling
Croatian: Poremećaji oka često oštećenje vida, konjunktivitis, blefaritis, oticanje očiju manje često diplopija
English: AMGEVITA is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: AMGEVITA je indicirana za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima nije postignut odgovor ili kod bolesnika koji ih ne podnose ili im je takva terapija kontraindicirana.
English: 4817 ZK Breda
Croatian: 4817 ZK Breda Nizozemska
English: AMGEVITA 40 mg solution for injection in pre-filled syringe.
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za potkožnu primjenu.
English: Adalimumab 40 mg eow N = 108 n (%)
Croatian: Adalimumab 40 mg svaki drugi tjedan N = 108 n (%)
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza ankilozantnog spondilitisa, upalne su bolesti kralježnice.
English: A single AMGEVITA pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Croatian: Pojedinačna napunjena štrcaljka lijeka AMGEVITA može se čuvati na temperaturi najviše do 25°C u razdoblju do 14 dana.
English: If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 80 mg (2 injekcije od 40 mg u jednom danu) i zatim 40 mg nakon dva tjedna.
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA.
Croatian: Za vrijeme liječenja lijekom AMGEVITA može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: • fungal infections;
Croatian: • gljivične infekcije,
English: ● Do not shake the pre-filled pen.
Croatian: Ne tresite napunjenu brizgalicu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED PEN
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU BRIZGALICU
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Psoriasis Area and Severity Index, PASI] ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: AMGEVITA is administered by injection under the skin (subcutaneous injection).
Croatian: AMGEVITA se primjenjuje potkožnom injekcijom (supkutana injekcija).
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by 40 mg one week later.
Croatian: Djeca i adolescenti u dobi od 4 do 17 godina, tjelesne težine od 30 kg ili više Preporučena doza lijeka AMGEVITA je početna doza od 40 mg, a zatim 40 mg nakon tjedan dana.
English: Distribution of patients by age and adalimumab dose received during the OL LI phase
Croatian: Tablica 11. Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I−V.
Croatian: U ispitivanjima (I - V) kod reumatoidnog artritisa, uzorci seruma bolesnika u više su vremenskih točaka testirani na prisutnost autoprotutijela.
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Croatian: Djelotvornost i sigurnost adalimumaba ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima u više od 1500 bolesnika s umjerenom do teškom aktivnom Crohnovom bolešću (indeks aktivnosti Chronove bolesti [engl.
English: ● Do not remove the needle cap from the syringe until you are ready to inject.
Croatian: Ne uklanjajte zatvarač igle s napunjene štrcaljke sve dok niste spremni injicirati.
English: Vertigo and visual impairment may occur following administration of AMGEVITA (see section 4.8).
Croatian: Nakon primjene lijeka AMGEVITA mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).