natgillin/translations-raw huggingface dataset:
Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines. 
Bolesnici koji primaju lijek AMGEVITA mogu istodobno primiti cjepiva, ali ne živa cjepiva.
ACR 20 6 months 12 months 
ACR 20 6 mjeseci 12 mjeseci
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 
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
Consequently, AMGEVITA can be used during breastfeeding. 
Stoga se AMGEVITA može primjenjivati tijekom dojenja.
LIST OF EXCIPIENTS Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection. 
POPIS POMOĆNIH TVARI Ledena acetatna kiselina, saharoza, polisorbat 80, natrijev hidroksid i voda za injekciju.
Inspect the AMGEVITA pre-filled syringe. 
Pregledaite AMGEVITA napunjenu štrcaljku.
4 SureClick pre-filled pens. 
4 SureClick napunjene brizgalice.
AMGEVITA is administered by subcutaneous injection. 
AMGEVITA se primjenjuje supkutanom injekcijom.
AMGEVITA is a clear and colourless to slightly yellow solution. 
AMGEVITA je bistra i bezbojna do blago žuta otopina.
AMGEVITA is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. 
AMGEVITA je namijenjena liječenju ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa u odraslih.
AMGEVITA is used to treat rheumatoid arthritis in adults. 
AMGEVITA je namijenjena liječenju reumatoidnog artritisa u odraslih.
A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken. 
Bolesnike kojima je za vrijeme liječenja lijekom AMGEVITA potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis, 
često astma, dispneja, kašalj manje često plućna embolija1), intersticijska plućna bolest, kronična opstruktivna plućna bolest, pneumonitis pleuralna efuzija1)
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). 
Preporučena doza lijeka AMGEVITA za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
● Do not remove the yellow cap from the pre-filled pen until you are ready to inject. 
Nemojte uklanjati žuti zatvarač s napunjene brizgalice sve dok niste spremni injicirati.
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). 
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
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. 
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.
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. 
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.
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%). 
Physician's Global Assessment, PGA) kretao se u rasponu od „umjerenog“ (53% uključenih ispitanika) do „teškog“ (41%) i „vrlo teškog“ (6%).
If you do not respond well enough to these medicines, you will be given AMGEVITA. 
Ako na njih ne reagirate dovoljno dobro, bit će Vam propisan lijek AMGEVITA.
Paediatric plaque psoriasis efficacy results at 16 weeks 
Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your rheumatoid arthritis. 
Ukoliko na njih ne reagirate dovoljno dobro, u svrhu liječenja Vašeg reumatoidnog artritisa bit će Vam propisan lijek AMGEVITA.
Induction of clinical remission and response (percent of patients) 
Tablica 23. Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes. 
Pakiranje od jedne, dvije, četriri ili višestruko pakiranje od šest (3x2) napunjenih brizgalica.
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). 
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).
Full instructions for use are provided in the package leaflet. 
Cjelovite upute za primjenu nalaze se u uputi o lijeku.
How to use AMGEVITA 
Kako primjenjivati lijek AMGEVITA
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. 
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.
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. 
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).
Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphatemia, Dehydration 
Poremećaji metabolizma i prehrane vrlo često povišena razina lipida često hipokalijemija, povišene razine mokraćne kiseline, abnormalna razina natrija u krvi, hipokalcijemija, hiperglikemija, hipofosfatemija, dehidracija
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. 
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.
● Do not remove the needle cap until you are ready to inject. 
Nemojte uklanjati zatvarač igle saštrcaljke sve dok niste spremni injicirati.
If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase. 
Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako primjenjujete lijek AMGEVITA.
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 
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.
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. 
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
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. 
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.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment. 
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.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA. 
Kod nezaraznog uveitisa se uz lijek AMGEVITA mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.4 mL 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
The recommended AMGEVITA dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3). 
Preporučena doza lijeka AMGEVITA za bolesnike s plak psorijaom od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
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. 
Ako na njih ne reagirate dovoljno dobro, u svrhu smanjenja znakova i simptoma Crohnove bolesti bit će Vam propisan lijek AMGEVITA.
AMGEVITA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. 
AMGEVITA je indicirana za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
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. 
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.
Total sharp score 
Ukupan zbroj bodova prema Sharpu
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. 
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.
Use a new AMGEVITA pre-filled pen. 
Primijenite novu AMGEVITA napunjenu brizgalicu.
Name and address of the manufacturers of the biological active substance Amgen Inc 
Naziv i adresa proizvođača biološke djelatne tvari
Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased 
vrlo često povišenijetrenienzimi manje često kolecistitis i kolelitijaza, steatoza jetre, povišen bilirubin rijetko
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). 
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).
• Enthesitis-related arthritis 
• artritisa povezanim s entezitisom
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). 
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).
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. 
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.
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. 
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.
Ps study I (REVEAL) - efficacy results at 16 weeks 
Ispitivanje Ps II (CHAMPION) rezultati djelotvornosti nakon 16 tjedana
AMGEVITA is used to treat psoriatic arthritis in adults. 
AMGEVITA je namijenjena liječenju psorijatičnog artritisa u odraslih.
AMGEVITA Dose for Patients with Enthesitis-Related Arthritis Patient Weight 
Tablica 2. Doza lijeka AMGEVITA za bolesnike s artritisom povezanim s entezitisom Tjelesna težina bolesnika
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. 
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.
AMGEVITA is used to treat moderate to severe plaque psoriasis in adults. 
AMGEVITA je namijenjena liječenju umjerene do teške plak psorijaze u odraslih.
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). 
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).
AMGEVITA is used to treat ulcerative colitis in adults. 
AMGEVITA je namijenjena liječenju ulceroznog kolitisa u odraslih.
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. 
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.
A. Remove one AMGEVITA pre-filled pen from the package. 
Izvadite jednu AMGEVITA napunjenu brizgalicu iz pakiranja.
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. 
U odraslih bolesnika s reumatoidnim artritisom preporučena doza adalimumaba iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
p-valuea p-valueb p-valuec 
pvrijednos ta pvrijednos tb pvrijednos tc
Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)). 
Napomena: P = Placebo (broj bolesnika pod rizikom (pogoršanje)); A = Adalimumab (broj bolesnika pod rizikom (pogoršanje)).
Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less. 
Njih 48 nije imalo znakove progresije strukturnog oštećenja, definirane kao promjena početne vrijednosti mTSS za
AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. 
U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, AMGEVITA se može primijeniti i bez prethodnog liječenja metotreksatom.
There is little experience from re-administration after more than 8 weeks since the previous dose. 
Postoji malo podataka o ponovnoj primjeni lijeka AMGEVITA kad je prekid terapije trajao duže od 8 tjedana.
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. 
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.
AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight 
Tablica 3. Doza lijeka AMGEVITA za pedijatrijske bolesnike s plak psorijazom Tjelesna težina bolesnika
Finger flange Label and expiration date 
Naljepnica i rok valjanosti
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. 
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.
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. 
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.
Your doctor should test you for HBV. AMGEVITA can cause reactivation of HBV in people who carry this virus. 
AMGEVITA može u nositelja virusa uzrokovati reaktivaciju HBV-a.
AMGEVITA Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight 
Doza lijeka AMGEVITA za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom
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. 
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.
AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab 
AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
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. 
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.