FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus additional caution should be exercised in considering Hefiya treatment of these patients (see section 4.8).
Croatian: Zbog toga je potreban dodatan oprez prilikom razmatranja liječenja lijekom Hefiya u takvih bolesnika (vidjeti dio 4.8).
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Croatian: • Stevens-Johnsonov sindrom (po život opasna reakcija sa simptomima nalik gripi i osip s mjehurićima),
English: Before your injection Preparing the pen
Croatian: Prije primjene injekcije Priprema brizgalice
English: Patients taking TNF-antagonists are more susceptible to serious infections.
Croatian: Za vrijeme terapije antagonistima TNF-a bolesnici su podložniji ozbiljnim infekcijama.
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Croatian: • pleuralna efuzija (abnormalno nakupljanje tekućine u pleuralnom prostoru),
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Croatian: U prospektivan kohortni registar uključeno je 257 žena s reumatoidnim artritisom ili Crohnovom bolešću koje su se liječile adalimumabom najmanje tijekom prvog tromjesečja te 120 žena s reumatoidnim artritisom ili Crohnovom bolešću koje se nisu liječile adalimumabom.
English: Patients who develop a new infection while undergoing treatment with Hefiya should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike u kojih se za vrijeme liječenja lijekom Hefiya razviju nove infekcije potrebno je pozorno pratiti i podvrgnuti kompletnoj dijagnostičkoj procjeni.
English: Table 9 radiographic mean changes over 12 months in RA study III
Croatian: Tablica 9 Srednje vrijednosti promjena radiografskih nalaza tijekom 12 mjeseci u ispitivanju RA III
English: Cancer
Croatian: Rak
English: MTX n = 257
Croatian: odgovor MTX n=257
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Croatian: Ako je potrebna drukčija doza, treba primijeniti druge lijekove koji sadrže adalimumab i koji nude tu mogućnost.
English: Most ALT elevations occurred with concomitant methotrexate use.
Croatian: Većinom je povišenje ALT-a zabilježeno pri istodobnoj primjeni s metotreksatom.
English: Nervous system disorders*
Croatian: Poremećaji živčanog sustava*
English: • children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Croatian: • djece u dobi od 2 i više godina s kroničnim nezaraznim uveitisom kod kojega upala zahvaća prednji dio oka
English: • sensation of heart beating irregularly such as skipped beats;
Croatian: • osjećaj da srce kuca nepravilno, primjerice, preskakanje otkucaja,
English: In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
Croatian: U otvorenom razdoblju ispitivanja, odgovor PASI 75 i PGA rezultat 'bez bolesti' ili 'minimalno' održali su se tijekom dodatna 52 tjedna, bez novih nalaza povezanih sa sigurnošću.
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Croatian: Ukupno je 19 ispitanika, od kojih 11 iz skupine koja je na početku ispitivanja bila u dobi od 4 do 12 godina i 8 iz skupine koja je na početku ispitivanja bila u dobi od 13 do 17 godina, liječeno 6 ili više godina.
English: During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
Croatian: Tijekom 52 tjedna ispitivanja UC-I i UC-II, zamijećene su niže stope hospitalizacija zbog bilo kojeg uzroka i hospitalizacija povezanih s UC-om u skupini liječenoj adalimumabom u odnosu na skupinu koja je primala placebo.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije živim cjepivima u bolesnika liječenih adalimumabom
English: How should you store your pen?
Croatian: Kako čuvati brizgalicu?
English: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Croatian: U ispitivanju Psoriasis Study I (REVEAL) evaluirano je 1212 bolesnika u tri razdoblja terapije.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Croatian: Od zdravstvenih radnika traži se da prijave svaku sumnju na nuspojavu za ovaj lijek.
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Croatian: Nakon supkutane primjene jednokratne doze od 40 mg, adalimumab se sporo apsorbira i raspodjeljuje, a vršne koncentracije u serumu postižu se približno 5 dana nakon primjene.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hefiya and is positive for antibodies against double-stranded DNA, further treatment with Hefiya should not be given (see section 4.8).
Croatian: Ako bolesnik nakon primjene lijeka Hefiya razvije simptome koji upućuju na sindrom nalik lupusu i pozitivan je na protutijela usmjerena protiv dvolančane DNK, terapija lijekom Hefiya ne smije se nastaviti (vidjeti dio 4.8).
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II).
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u odraslih bolesnika s neinfektivnim intermedijarnim, posteriornim i panuveitisom, isključujući bolesnike s izoliranim anteriornim uveitisom, u dvama randomiziranim, dvostruko maskiranim, placebom kontroliranim ispitivanjima (UV I i II).
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Croatian: Djelotvornost adalimumaba je u tih bolesnika smanjena u odnosu na bolesnike koji nisu prethodno liječeni antagonistima TNF-a.
English: Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab.
Croatian: Slučajevi pogoršanja kongestivnog zatajenja srca također su prijavljeni i u bolesnika liječenih adalimumabom
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Croatian: Djeci koja su in utero bila izložena adalimumabu ne preporučuje se davati živa cjepiva (npr. cjepivo BCG) najmanje 5 mjeseci otkad je majka u trudnoći primila zadnju injekciju adalimumaba.
English: Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Croatian: Smanjenje kožne boli uzrokovane gnojnim hidradenitisom ocjenjivalo se uz pomoć brojčane ocjenske ljestvice u bolesnika koji su pri uključivanju u ispitivanje imali početni rezultat od 3 ili više na ljestvici od 11 bodova.
English: Holding the pen:
Croatian: Držanje brizgalice:
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Croatian: • imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće kao bolest koja se naziva sarkoidoza),
English: Hefiya may have a minor influence on your ability to drive, cycle or use machines.
Croatian: Hefiya može imati manji utjecaj na sposobnost upravljanja vozilima, biciklom i strojevima.
English: • low blood measurements for white blood cells, red blood cells and platelet count.
Croatian: • niska razina bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica.
English: • reduction in blood platelets which increases risk of bleeding or bruising;
Croatian: • smanjen broj trombocita, što povećava rizik od krvarenja i stvaranja modrica,
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Croatian: Nisu provedena ispitivanja kancerogenog potencijala ni standardna procjena toksičnosti za plodnost i postnatalne toksičnosti adalimumaba zbog nepostojanja odgovarajućih modela za protutijelo s ograničenom križnom reaktivnošću s TNF-om glodavaca, odnosno stvaranjem neutralizirajućih protutijela u glodavaca.
English: 14 weeks a ped ACR 30/50/70 responses week 48 significantly greater than those of placebo-treated patients b p = 0.015
Croatian: 14 tjedana a pedijatrijski odgovori ACR 30/50/70 nakon 48 tjedana terapije bili su značajno veći nego u skupini koja je uzimala placebo b p=0,015
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hefiya and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Croatian: • Ako imate alergijske reakcije sa simptomima poput stezanja u prsnom košu, ''piskanja pri disanju'', omaglice, oticanja ili osipa, prestanite ubrizgavati lijek Hefiya i odmah se javite liječniku, jer te reakcije u rijetkim slučajevima mogu biti opasne po život.
English: 25, 40 and 40 mg
Croatian: 25, 40 i 40 mg
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Croatian: Adalimumab nije ispitivan u bolesnika s artritisom povezanim s entezitisom mlađih od 6 godina.
English: Adults with ulcerative colitis
Croatian: Odrasli s ulceroznim kolitisom
English: Figure K: slowly release the plunger
Croatian: Slika K: polako otpustite klip
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Croatian: Nakon 16 tjedana terapije, bolesnici u kojih je postignut barem odgovor PASI 75 (poboljšanje PASI rezultata za barem 75% u odnosu na početak terapije) ušli su u razdoblje B (otvoreni dio ispitivanja) i primali po 40 mg adalimumaba svaki drugi tjedan.
English: Cook Pharmica LLC 1300 S. Patterson Drive Bloomington Indiana
Croatian: Patterson Drive Bloomington Indiana
English: The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.
Croatian: Kriteriji koji su određivali neuspjeh liječenja bili su pogoršanje ili dugotrajan izostanak poboljšanja upale oka, djelomično poboljšanje uz razvoj dugotrajnih popratnih očnih bolesti ili pogoršanje popratnih očnih bolesti, nedopuštena istodobna primjena drugih lijekova te prekid liječenja na dulje razdoblje.
English: • hepatitis (liver inflammation);
Croatian: • hepatitis (upala jetre),
English: No patients developed lupus nephritis or central nervous system symptoms.
Croatian: Ni u jednog bolesnika nije se razvio lupusni nefritis niti su se pojavili simptomi u središnjem živčanom sustavu.
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Croatian: • Nemojte koristiti napunjenu brizgalicu od 40 mg ako se preporučuju doze drukčije od 40 mg.
English: Patient weight
Croatian: Tjelesna težina bolesnika
English: Disposing of used syringes” at the end of these Instructions for Use.
Croatian: Zbrinjavanje korištenih štrcaljki” na kraju ovih Uputa za uporabu.
English: • bacterial infections;
Croatian: • bakterijske infekcije,
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Croatian: Potrebno je pažljivo ponovno procijeniti koristi i rizike kontinuiranog liječenja lijekom u dozi od 40 mg jednom tjedno ili 80 mg svaki drugi tjedan u bolesnika u kojih nije postignut zadovoljavajući odgovor nakon povećanja doziranja (vidjeti dio 5.1).
English: Infection
Croatian: Infekcije
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Croatian: Djelotvornost adalimumaba u liječenju adolescentnih bolesnika s gnojnim hidradenitisom predviđa se na temelju dokazane djelotvornosti i povezanosti izloženosti i odgovora u odraslih bolesnika s gnojnim hidradenitisom kao i vjerojatnosti da su tijek bolesti, patofiziologija i učinici lijeka u suštini slični kao u odraslih osoba pri istim razinama izloženosti.
English: • Do not store your pen in extreme heat or cold.
Croatian: • Ne čuvati brizgalicu na krajnje toplom ili hladnom.
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Croatian: Ako se za vrijeme terapije ili nakon nje na koži jave nova područja oštećene kože ili ako se postojeći znakovi ili područja oštećenja promijene, javite se svom liječniku.
English: Usually, Hefiya is used with methotrexate.
Croatian: Hefiya se obično primjenjuje u kombinaciji s metotreksatom.
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Croatian: Među onima koji su odgovorili na terapiju (pedijatrijski odgovor ACR 30) u 24. tjednu (n=27 od 30 bolesnika), pedijatrijski odgovori ACR 30 održali su se do 60 tjedana u otvorenom produžetku ispitivanja u bolesnika koji su primali adalimumab kroz ovo vremensko razdoblje.
English: Hefiya is intended for the treatment of the following inflammatory diseases:
Croatian: Hefiya je namijenjen liječenju upalnih bolesti opisanih u nastavku:
English: Hypersensitivity, allergies (including seasonal allergy)
Croatian: alergije (uključujući sezonske alergije)
English: Your symptoms may return upon stopping treatment.
Croatian: Simptomi se mogu vratiti nakon prestanka uzimanja lijeka.
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Croatian: Napomena: P# = Placebo (broj događaja/broj bolesnika pod rizikom); A# = Adalimumab (broj događaja/broj bolesnika pod rizikom).
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Croatian: Sve bolesnike s ulceroznim kolitisom u kojih je povećan rizik od displazije ili karcinoma debelog crijeva (na primjer, bolesnici s dugotrajnim ulceroznim kolitisom ili primarnim sklerozirajućim kolangitisom) ili bolesnike koji su imali displaziju ili karcinom debelog crijeva treba kontrolirati zbog mogućeg razvoja displazije u redovitim intervalima prije početka liječenja i tijekom čitavog trajanja bolesti.
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Croatian: Populacijske farmakokinetičke analize na temelju podataka dobivenih u više od 1300 bolesnika s reumatoidnim artritisom pokazale su tendenciju da se prividni klirens adalimumaba povećava s bolesnikovom tjelesnom težinom.
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNF-antagonists.
Croatian: 48% bolesnika koji su imali klinički odgovor u 4. tjednu već je prije koristilo neki drugi antagonist TNF-a.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Croatian: većina bolesnika pokazala je kliničko poboljšanje sekundarnih mjera ishoda kao što su broj mjesta s entezitisom, broj osjetljivih zglobova, broj otečenih zglobova, pedijatrijski odgovor ACR 50 i pedijatrijski odgovor ACR 70.
English: a adalimumab / MTX 40 mg every other week placebo / MTXadalimumab / MTX (95 % confidence interval b)
Croatian: placebo/ MTXa adalimumab/MTX 40 mg svaka dva tjedna placebo/MTXadalimumab/MTX (95% interval pouzdanostib)
English: Rare
Croatian: Rijetko
English: Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Croatian: Kombinirana primjena adalimumaba i metotreksata pokazala se klinički i statistički superiornom monoterapiji metotreksatom (p <0,001) i adalimumabom (p <0,001) u postizanju niske aktivnosti bolesti u bolesnika s nedavno dijagnosticiranim umjerenim do teškim reumatoidnim artritisom.
English: • intestinal infections (including gastroenteritis);
Croatian: • crijevne infekcije (uključujući gastroenteritis),
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Croatian: U ispitivanjima RA I - IV, bolesnici liječeni adalimumabom postigli su statistički značajno bolje odgovore ACR 20 i 50 u usporedbi s placebom već jedan do dva tjedna nakon početka liječenja.
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Croatian: Najčešće zahvaća specifične dijelove kože, poput područja ispod dojki i pazuha te područja na unutarnjem dijelu bedara, preponama i stražnjici.
English: If your doctor considers that methotrexate is inappropriate, Hefiya can be given alone.
Croatian: Smatra li Vaš liječnik da liječenje metotreksatom nije prikladno, Hefiya se može primijeniti sam.
English: • symptoms of nerve root compression (including low back pain and leg pain);
Croatian: • simptomi kompresije korijena živca (uključujući bolove u donjem dijelu leđa i nozi),
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Croatian: Tablica 7 ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika)
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Croatian: 673 bolesnika s aktivnim nr-axSpA (srednja početna vrijednost aktivnosti bolesti [BASDAI)] iznosila je 7,0) koja nisu imala zadovoljavajući odgovor na ≥ 2 NSAIL-a, nisu podnosila NSAIL-ove ili su imala kontraindikaciju za primjenu NSAIL-ova uključena su u otvoreno razdoblje ispitivanja nr-axSpA II, u kojem su primali adalimumab u dozi od 40 mg svaka dva tjedna tijekom 28 tjedana.
English: Hefiya is administered every other week via subcutaneous injection.
Croatian: Hefiya se primjenjuje svaki drugi tjedan supkutanom injekcijom.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Croatian: Rizik od pojave zloćudnih bolesti u djece i adolescenata liječenih antagonistima TNF-a ne može se isključiti.
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 0,8 ml, odnosno zanemarive količine natrija.
English: Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Croatian: S obzirom na prirodu štetnih događaja primijećenih pri istodobnoj primjeni anakinre i etanercepta, slične toksičnosti se također mogu pojaviti i za vrijeme liječenja anakinrom u kombinaciji s drugim antagonistima TNF-a.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Croatian: Približno dvostruko veći udio bolesnika u skupini koja je u prvih 12 tjedana ispitivanja HS-I i HS-II primala placebo, naspram onih koji su liječeni adalimumabom, doživio je pogoršanje apscesa (23,0% naspram 11,4%) i drenirajućih fistula (30,0% naspram 13,9%).
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Croatian: Unatoč profilaksi tuberkuloze, zabilježeni su slučajevi reaktivacije tuberkuloze u bolesnika liječenih adalimumabom.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Croatian: Kada se objedine rezultati kontroliranih dijelova tih ispitivanja te otvorenih produžetaka ispitivanja koji su u tijeku ili dovršeni, s ukupno 6427 bolesnika i više od 26 439 bolesnik-godina terapije te medijanom trajanja od 3,3 godine, primijećena stopa zloćudnih bolesti, isključujući limfome i nemelanomske tumore kože, iznosi približno 8,5 na 1000 bolesnik-godina.
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6 % (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6 % (median percent change -50.0 %) in patients in the placebo group.
Croatian: Primarna mjera ishoda bio je postotak promjene početne vrijednosti do 12. tjedna u broju aktivnih zglobova s artritisom (oticanje koje nije posljedica deformacije ili zglobovi s gubitkom pokretljivosti uz bol i/ili osjetljivost), koji je postignut uz srednji postotak smanjenja od -62,6% (medijan postotka promjene -88,9%) u bolesnika u skupini liječenoj adalimumabom u usporedbi s -11,6% (medijan postotka promjene -50,0%) u bolesnika u skupini koja je primala placebo.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: • Cotton ball or gauze
Croatian: • Pamučna vata ili gaza
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.
Croatian: Nije zabilježeno povišenje ALT-a ≥ 3 x GGN u ispitivanju faze III u kojem se adalimumab primjenjivao u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom u dobi od 2 do <4 godine.