FrancophonIA/ELRC3.0 huggingface dataset:
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Croatian: Ispitivanje HS-I (PIONEER I) ocjenjivalo je 307 bolesnika tijekom 2 razdoblja liječenja.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Croatian: Simptomi mogu uključivati nodule (kvržice) koji su bolni na dodir i apscese (čireve) iz kojih može istjecati gnoj.
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Croatian: Važno je da liječniku kažete jeste li ikada bolovali od tuberkuloze,
English: • skin cancer;
Croatian: • rak kože,
English: 40 mg every other week
Croatian: 40 mg svaki drugi tjedan
English: Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab ***,**,* statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
Croatian: i n=84 za placebo i adalimumab j n=82 za placebo i n=85 za adalimumab ***, **, * statistički značajno kod p<0,001, p<0,01 odnosno p<0,05 za sve usporedbe adalimumaba s placebom.
English: phase OL-LI 16 weeks ped ACR 30 response (n/N)
Croatian: bez MTX-a faza otvorena uvodna16 tjedana pedijatrijski odgovor ACR 30 (n/N)
English: Scarring may also occur in affected areas.
Croatian: Na zahvaćenim mjestima mogu nastati i ožiljci.
English: Figure A: Hefiya SensoReady pen parts
Croatian: Slika A: Dijelovi brizgalice SensoReady s lijekom Hefiya
English: ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
Croatian: ASDASc neaktivna bolest djelomična egzacerbacijad a Međunarodno društvo za ocjenu spondiloartritisa b Početna vrijednost definirala se kao vrijednost na početku razdoblja otvorenog liječenja kada bolesnici imaju aktivnu bolest.
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Croatian: Neki od tih hepatospleničnih T-staničnih limfoma povezanih s primjenom adalimumaba javili su se u mladih odraslih bolesnika koji su istodobno bili liječeni azatioprinom ili 6-merkaptopurinom zbog upalne bolesti crijeva.
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Croatian: Prijavljene stope nemelanomskih tumora kože i limfoma bile su oko 0,2 odnosno 0,3 na 1000 bolesnik-godina liječenja (vidjeti dio 4.4).
English: placebo adalimumab 40 mg weekly placebo adalimumab 40 mg weekly hidradenitis suppurativa clinical response (HiSCR)a
Croatian: placebo adalimumab 40 mg svaki tjedan placebo adalimumab 40 mg svaki tjedan klinički odgovor gnojnog hidradenitisa (HiSCR)a
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 0,5 ili manje.
English: Immune system disorders*
Croatian: Poremećaji imunološkog sustava*
English: Figure G: hold your pen
Croatian: Slika G: držite brizgalicu
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab / methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Croatian: Od 342 ispitanika izvorno randomizirana za monoterapiju adalimumabom ili liječenje kombinacijom adalimumaba i metotreksata koji su ušli u otvoreni produžetak ispitivanja, 171 ispitanik završio je godina liječenja adalimumabom.
English: • inflammation of the pancreas which causes severe pain in the abdomen and back;
Croatian: • upala gušterače, koja uzrokuje jaku bol u trbuhu i leđima,
English: Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration.
Croatian: Bolesnici u ne-MTX skupini ili nikad nisu uzimali metotreksat ili su ga prestali uzimati bar dva tjedna prije uzimanja ispitivanog lijeka.
English: Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Croatian: Nekim bolesnicima koji ne odgovore na terapiju do 4. tjedna mogao bi koristiti nastavak terapije održavanja do 12. tjedna.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Croatian: Nakon stavljanja lijeka u promet zabilježene su zloćudne bolesti, neke sa smrtnim ishodom, u djece, adolescenata i mlađih odraslih osoba (u dobi do 22 godine) liječenih antagonistima TNF-a (početak terapije u 18. godini života ili ranije), uključujući adalimumab.
English: HS study II
Croatian: ispitivanje HS II
English: Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Croatian: Stvaranje protutijela na adalimumab povezano je s bržim klirensom i smanjenom djelotvornošću adalimumaba.
English: • It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
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 Hefiya (za više informacija o cjepivima vidjeti dio „Upozorenja i mjere opreza“).
English: The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the known safety profile of adalimumab.
Croatian: Sigurnosni profil adalimumaba u bolesnika s uveitisom liječenih svaki drugi tjedan bio je u skladu s poznatim sigurnosnim profilom adalimumaba.
English: In patients who develop HBV reactivation, Hefiya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika u kojih se javi reaktivacija HBV infekcije mora se prekinuti terapija lijekom Hefiya i započeti učinkovita antivirusna terapija uz odgovarajuće potporne mjere.
English: • If you are over 65 years you may be more susceptible to infections while taking Hefiya.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Croatian: Pokazalo se da adalimumab smanjuje brzinu progresije oštećenja perifernih zglobova mjerene radiografski u bolesnika s poliartikularnim simetričnim podtipovima bolesti (vidjeti dio 5.1) te da popravlja funkciju zglobova.
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see tables 17 and 18).
Croatian: U ispitivanjima Psoriasis Study I i II primarni ishod bio je udio bolesnika u kojih je od početka ispitivanja do 16. tjedna postignut odgovor PASI 75 (vidjeti tablice 17 i 18).
English: Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy.
Croatian: Stvaranje protutijela bilo je manje kada se adalimumab davao zajedno s metotreksatom nego kada se primjenjivao kao monoterapija.
English: Hefiya is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Croatian: Hefiya se koristi za liječenje gnojnog hidradenitisa u odraslih i adolescenata u dobi od 12 godina i starijih.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Reakcije na mjestu primjene
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Croatian: Većina podrezultata brojčano je išla u prilog adalimumabu, a srednje vrijednosti razlike bile su statistički značajne za opći vid, bol u oku, vid na blizinu, mentalno zdravlje i ukupan rezultat u ispitivanju UV I te za opći vid i mentalno zdravlje u ispitivanju UV II.
English: After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Croatian: Nakon indukcije, preporučena doza je 40 mg svaki drugi tjedan supkutanom injekcijom.
English: Prescribers should exercise caution in considering the use of Hefiya in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Hefiya should be considered if any of these disorders develop.
Croatian: Propisivači moraju biti oprezni prilikom razmatranja liječenja lijekom Hefiya u bolesnika s otprije postojećim ili nedavno nastalim demijelinizirajućim poremećajima središnjeg ili perifernog živčanog sustava; ako se razvije bilo koji od tih poremećaja, treba razmotriti prekid liječenja lijekom Hefiya.
English: PGA: clear/minimal
Croatian: PGA: bez bolesti/minimalno
English: Concurrent treatment with azathioprine/6-mercaptopurine
Croatian: Istodobna primjena azatioprina/6-merkaptopurina
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and / or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Hefiya should be promptly discontinued.
Croatian: Ako se u bolesnika pojave znakovi i simptomi kao što su vrućica, malaksalost, gubitak težine, znojenje, kašalj, dispneja i/ili plućni infiltrati ili druge ozbiljne sistemske bolesti s istodobnim šokom ili bez njega, treba posumnjati na invazivnu gljivičnu infekciju te odmah prekinuti primjenu lijeka
English: • if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
Croatian: • ako Vam štrcaljka padne, ne koristite je ako izgleda oštećena, ili ako Vam je pala nakon što ste skinuli zatvarač igle.
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Croatian: Manje često Neurološke infekcije (uključujući virusni meningitis), oportunističke infekcije i tuberkuloza (uključujući kokcidioidomikozu, histoplazmozu i infekciju kompleksom mycobacterium avium), bakterijske infekcije, infekcije oka, divertikulitis1)
English: Leukaemia1)
Croatian: Leukemija1)
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 64.3 % and at week 96 was 65.1 %.
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor i koji su nastavili terapiju adalimumabom svaki tjedan, stopa HiSCR-a u 48. tjednu iznosila je 68,3%, a u 96. tjednu 65,1%.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Croatian: U ispitivanju RA IV, ACR 20 odgovor u bolesnika liječenih adalimumabom uz standardnu skrb bio je statistički značajno bolji nego u bolesnika koji su primali placebo uz standardnu skrb (p<0,001).
English: week 24 week 36 a patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Croatian: 24. tjedan 36. tjedan a bolesnici koji su ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan nakon 12 tjedana liječenja.
English: Should treatment be interrupted, Hefiya 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Croatian: Ako liječenje treba privremeno prekinuti, Hefiya se kasnije može ponovno uvesti u dozi od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan (vidjeti dio 5.1).
English: Psoriasis
Croatian: Psorijaza
English: • high blood sugar;
Croatian: • visoke razine šećera u krvi,
English: Hefiya contains sodium
Croatian: Hefiya sadrži natrij
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Croatian: U ispitivanju nr-axSpA II ocjenjivalo se ukidanje terapije u bolesnika s aktivnim nr-axSpA koji su postigli remisiju tijekom otvorenog liječenja adalimumabom.
English: Figure 1: Kaplan-Meier Curves summarizing time to flare in study nr-axSpA II
Croatian: Slika 1: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do egzacerbacije u ispitivanju nr-axSpA II
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Croatian: Rezultati u 12. tjednu pokazali su značajno poboljšanje znakova i simptoma aktivnog nr-axSpA u bolesnika koji su liječeni adalimumabom u odnosu na placebo (tablica 14).
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa week 56
Croatian: klinička remisija klinički odgovor (CR-100) bolesnici u remisiji bez primjene steroida >= 90 danaa
English: Inhibition of inflammation
Croatian: Inhibicija upale
English: What you need to know before you use Hefiya Do not use Hefiya
Croatian: Što morate znati prije nego počnete primjenjivati lijek Hefiya
English: Hefiya 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1287/001
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki sa štitnikom za iglu EU/1/18/1287/001
English: Radiographic changes were assessed in the psoriatic arthritis studies.
Croatian: U ispitivanjima kod psorijatičnog artritisa ocjenjivale su se radiografske promjene.
English: After single intravenous doses ranging from 0.25 to 10 mg / kg, concentrations were dose proportional.
Croatian: Nakon pojedinačnih intravenskih doza koje su se kretale od 0,25 do 10 mg/kg,
English: Hefiya 40 mg solution for injection in pre-filled pen EU/1/18/1287/004
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici EU/1/18/1287/004
English: Thereafter, the usual dose is 20 mg every other week.
Croatian: Nakon toga, uobičajena doza je 20 mg svaka dva tjedna.
English: Do not shake
Croatian: Ne tresti
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Croatian: Među bolesnicima kojima je liječenje adalimumabom ukinuto u12. tjednu u ispitivanjima HS-I i HSII, stopa HiSCR-a zabilježena 12 tjedana nakon ponovnog uvođenja adalimumaba u dozi od 40 mg svaki tjedan vratila se na razine slične onima prije prekida liječenja (56,0%).
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima HS-I i HS-II mogli su sudjelovati u otvorenom produžetku ispitivanja u kojem se adalimumab primjenjivao svaki tjedan u dozi od 40 mg.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hefiya cannot be excluded (see section 4.8).
Croatian: Rizik od pojave hepatospleničnog T-staničnog limfoma u bolesnika liječenih lijekom Hefiya ne može se isključiti (vidjeti dio 4.8).
English: Table 18 Ps study II (CHAMPION) efficacy results at 16 weeks placebo N = 53 n (%)
Croatian: Ps II (CHAMPION) - rezultati djelotvornosti nakon 16 tjedana placebo N=53 n (%)
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Croatian: Klinička remisija (definirana kao Mayo rezultat ≤ 2 bez podrezultata > 1)
English: • throw away the used pen right away after use.
Croatian: • bacite korištenu brizgalicu odmah nakon uporabe.
English: Disposing of used pens” at the end of these Instructions for Use.
Croatian: Zbrinjavanje korištenih brizgalica” na kraju ovih Uputa za uporabu.
English: Hefiya can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Hefiya se može primjenjivati istodobno s metotreksatom ili nekim antireumaticima koji mijenjaju tijek bolesti (sulfasalazinom, hidroksiklorokinom, leflunomidom i injekcijskim pripravcima zlata), kortikosteroidima ili lijekovima za ublažavanje boli, uključujući i nesteroidne protuupalne lijekove (NSAIL).
English: In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.
Croatian: Kod uveitisa u djece, nema iskustva s liječenjem adalimumabom bez istodobnog liječenja metotreksatom.
English: • There may be a small amount of blood at the injection site.
Croatian: • Na mjestu primjene moglo bi biti malo krvi.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Croatian: Indukcija kliničke remisije (definirana kao CDAI < 150) ispitivala se u dva ispitivanja, CD I
English: Table 29 time to treatment failure in studies UV I and UV II
Croatian: Vrijeme do neuspjeha liječenja u ispitivanjima UV I i UV II
English: Contact your pharmacist if the syringe fails any of the above mentioned checks.
Croatian: Obratite se ljekarniku ako štrcaljka ne prođe navedene provjere.
English: solution for injection 1 pre-filled syringe 2 pre-filled syringes
Croatian: Otopina za injekciju 1 napunjena štrcaljka 2 napunjene štrcaljke
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Croatian: Također su u obje skupine u odnosu na početne vrijednosti zabilježena statistički i klinički značajna poboljšanja parametara kvalitete života (uključujući IMPACT III).
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Croatian: U otvorenom produžetku ispitivanja ACR odgovor se održao do 136 tjedana.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
Croatian: Oba su ispitivanja pokazala rani i održan učinak adalimumaba na stopu neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 2).
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Croatian: Poliartikularni juvenilni idiopatski artritis i artritis povezan s entezitisom Poliartikularni juvenilni idiopatski artritis i artritis povezan s entezitisom upalne su bolesti zglobova koje se obično prvo javljaju u djetinjstvu.
English: All patients received a 2-week standardised dose of prednisone 60 mg / day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Croatian: Svi su bolesnici pri uključivanju u ispitivanje 2 tjedna primali standardiziranu dozu prednizona od 60 mg/dan, nakon čega je uslijedilo obavezno postupno smanjivanje doze, uz potpuni prestanak primjene kortikosteroida do 15. tjedna.
English: CD study I and CD study II induction of remission and response rates are presented in table 23.
Croatian: Indukcija remisije i stopa kliničkog odgovora u ispitivanjima CD I i II nalaze se u tablici 23.
English: • increased lipids in the blood;
Croatian: • povišena razina lipida u krvi,
English: Congestive heart failure
Croatian: Kongestivno zatajenje srca
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Croatian: Njih 40 nije imalo znakove progresije strukturnog oštećenja, definirane kao promjena početne vrijednosti mTSS za 0,5 ili manje.
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hefiya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (table 1).
Croatian: Poliartikularni juvenilni idiopatski artritis u dobi od 2 i više godina Preporučena doza lijeka Hefiya za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (tablica 1).
English: Table 10 radiographic mean changes at week 52 in RA study V
Croatian: Tablica 10 Srednje vrijednosti promjena radiografskih nalaza nakon 52 tjedna u ispitivanju RA V
English: There is a known association between intermediate uveitis and central demyelinating disorders.
Croatian: Poznato je da postoji povezanost između intermedijarnog uveitisa i demijelinizirajućih poremećaja središnjeg živčanog sustava.
English: Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19.
Croatian: Nakon toga je uslijedilo obavezno postupno smanjivanje doze i potpuni prestanak primjene kortikosteroida do 19. tjedna.
English: The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study.
Croatian: Primarna mjera ishoda za djelotvornost bio je udio bolesnika kod kojih nije došlo do egzacerbacije do 68. tjedna ispitivanja.
English: • lung diseases causing shortness of breath (including inflammation);
Croatian: • bolest pluća koja uzrokuje nedostatak zraka (uključujući upalu),
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84 % continued to show no radiographic progression through 144 weeks of treatment.
Croatian: 84% ispitanika liječenih adalimumabom koji nisu imali radiografsku progresiju od početka ispitivanja do 48. tjedna ispitivanja (n=102) nisu imali radiografsku progresiju bolesti ni nakon 144 tjedna terapije.
English: • Do not use if the safety seal has been broken
Croatian: • Ne upotrebljavajte ako je zaštitna naljepnica potrgana.
English: Myocardial infarction1), arrhythmia, congestive heart failure
Croatian: Manje često Infarkt miokarda1), aritmija, kongestivno zatajenje srca
English: Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Croatian: Radiografske su pretrage pokazale da adalimumab usporava brzinu progresije oštećenja zglobova i poboljšava fizičku funkciju kada se uzima u kombinaciji s metotreksatom.
English: Hefiya in combination with methotrexate, is indicated for:
Croatian: Reumatoidni artritis U kombinaciji s metotreksatom, Hefiya je indiciran za:
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Croatian: • edem (nakupljanje tekućine u tijelu koje uzrokuje oticanje zahvaćenog tkiva),
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Croatian: • znakove raka kože kao što su kvržica ili otvorena rana koja ne cijeli,
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Croatian: Dodatno, nisu primijećene zloćudne bolesti u 192 pedijatrijska bolesnika s izloženošću od 498,1 bolesnik-godina u ispitivanjima adalimumaba u pedijatrijskih bolesnika s Crohnovom bolešću.
English: • lupus-like syndrome;
Croatian: • sindrom sličan lupusu,