FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks, ALT elevations ≥ 3 x ULN occurred in 0.9 % of adalimumabtreated patients and 0.9 % of controlled-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s Crohnovom bolešću i ulceroznim kolitisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 52 tjedna, povišenje razine ALT-a ≥ 3 x GGN zabilježeno je u 0,9% bolesnika liječenih adalimumabom i 0,9% bolesnika iz kontrolne skupine.
English: RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks 40 mg adalimumab administered every other week
Croatian: Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon 24 tjedna i nakon 52 tjedna 40 mg adalimumaba primijenjenog svaki drugi tjedan **p < 0,01, adalimumab u usporedbi s placebom
English: Inflammation
Croatian: Infekcije
English: Cyltezo dose for patients with polyarticular juvenile idiopathic arthritis
Croatian: Tablica 1: Doza lijeka Cyltezo za bolesnike s poliartikularnim juvenilnim idiopatskim
English: Cyltezo dose for paediatric patients with plaque psoriasis
Croatian: Tablica 3: Doza lijeka Cyltezo za pedijatrijske bolesnike s plak psorijazom
English: Note: P = Placebo (Number at Risk (flared)); A = adalimumab (Number at Risk (flared)).
Croatian: Napomena: P = Placebo (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]); A = adalimumab (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]).
English: • vasculitis (inflammation of blood vessels);
Croatian: • vaskulitis (upala krvnih žila)
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your
Croatian: Jave li se za trajanja ili nakon liječenja simptomi tuberkuloze (uporan kašalj, gubitak tjelesne težine, bezvoljnost, blaga vrućica) ili neke druge infekcije, javite odmah svom liječniku.
English: Full instructions for use are provided in the package A paediatric presentation is not available for patients who need to administer less than the full 40 mg dose.
Croatian: Cjelovite upute za primjenu nalaze se u uputi o Za bolesnike u kojih treba primijeniti manju od pune doze od 40 mg nije dostupan oblik za
English: ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
Croatian: ACR odgovori bolesnika u ispitivanju PsA I su bili slični, neovisno o tome jesu li istodobno dobivali metotreksat ili nisu.
English: If these medicines do not work well enough, patients will be given Cyltezo to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related
Croatian: Ako ti lijekovi neće dovoljno dobro djelovati, u svrhu liječenja poliartikularnog juvenilnog idiopatskog artritisa ili artritisa povezanog s entezitisom bolesnicima će biti propisan
English: Cyltezo is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Croatian: Cyltezo je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u pedijatrijskih bolesnika (u dobi od 6 godina i starijih) u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući primarnu nutritivnu terapiju i liječenje kortikosteroidom i/ili imunomodulatorom, ili u onih koji ne podnose ili u kojih su takve vrste liječenja kontraindicirane.
English: The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients
Croatian: Srednje vrijednosti (± SD) najnižih koncentracija adalimumaba u serumu u 4. tjednu bile su 15,7 ± 6,6 µg/ml u bolesnika tjelesne težine ≥ 40 kg (160/80 mg) i 10,6 ± 6,1 µg/ml u bolesnika tjelesne težine < 40 kg (80/40 mg).
English: Cyltezo 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 nonsteroidal anti-inflammatory drugs.
Croatian: Cyltezo je indiciran za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza ASa u odraslih osoba, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MRI), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with
Croatian: Bolesnike se mora upozoriti da se obrate liječniku ako se za vrijeme ili nakon liječenja lijekom Cyltezo pojave znakovi/simptomi koji upućuju na tuberkuloznu infekciju (npr. perzistirajući kašalj, progresivno propadanje/gubljenje težine, blago povišena tjelesna temperatura, bezvoljnost).
English: EU/1/17/1240/007
Croatian: EU/1/17/1240/001 1 napunjena štrcaljka EU/1/17/1240/002 2 napunjene štrcaljke EU/1/17/1240/003 4 napunjene štrcaljke EU/1/17/1240/004 6 napunjenih štrcaljki
English: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Croatian: Dermatology Life Quality Index, DLQI), u usporedbi s placebom (ispitivanja I i II) i u usporedbi s MTX-om (ispitivanje II).
English: Cyltezo is used to treat rheumatoid arthritis in adults.
Croatian: Cyltezo je namijenjen liječenju reumatoidnog artritisa u odraslih.
English: Adalimumab 40 mg every other week N = 70
Croatian: Adalimumab 40 mg svaki drugi tjedan N = 70
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with
Croatian: U ispitivanjima kod Crohnove bolesti u odraslih, u kombinaciji adalimumaba i azatioprina/6-merkaptopurina primijećene su veće incidencije nuspojava povezanih sa zloćudnim bolestima i ozbiljnim infekcijama nego u monoterapiji adalimumabom.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3 % of adalimumab-treated patients
Croatian: U kontroliranim ispitivanjima adalimumaba (početna doza od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim 40 mg svaki tjedan, počevši od 4. tjedna) u bolesnika s gnojnim hidradenitisom, uz kontrolno razdoblje u trajanju od 12 do 16 tjedana, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 0,3% bolesnika liječenih adalimumabom i 0,6% bolesnika iz kontrolne skupine.
English: 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 %).
Croatian: Physician's Global Assessment, PGA), kretao u rasponu od „umjerenog“ (53% uključenih ispitanika) do „teškog“ (41%) i „vrlo teškog“ (6%).
English: Tachycardia
Croatian: Psorijaza
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 TNFα blocker.
Croatian: • U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNFα blokatore, zabilježeni su i drugačiji oblici tumora osim limfoma.
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Croatian: Merkelovih stanica (neuroendokrini karcinom kože)
English: • Inspect Cyltezo pre-filled syringe, medication, and expiration date.
Croatian: • Pregledajte napunjenu štrcaljku lijeka Cyltezo, lijek u njoj, i rok valjanosti.
English: Treatment with Cyltezo may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka Cyltezo mogu se razviti autoimuna protutijela.
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ta doza neće dovoljno dobro djelovati, Vaš liječnik Vam može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: The recommended dose of Cyltezo for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Croatian: Preporučena doza lijeka Cyltezo za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
English: Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Croatian: Cyltezo je dostupan samo u obliku napunjene štrcaljke i napunjene brizgalice od 40 mg.
English: The recommended dose of Cyltezo is an initial dose of 40 mg, followed by 40 mg one week later.
Croatian: Preporučeno doziranje lijeka Cyltezo je početna doza od 40 mg, a zatim 40 mg nakon tjedan dana.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified
Croatian: U ispitivanju RA V, strukturno oštećenje zglobova procjenjivalo se radiološki, a izraženo je promjenom ukupnog zbroja bodova prema Sharpu (vidjeti Tablicu 10).
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients
Croatian: Zloćudne bolesti nisu primijećene u 60 pedijatrijskih bolesnika s izloženošću od 58,4 bolesnik-godina u ispitivanju adalimumaba provedenom u pedijatrijskih bolesnika s uveitisom.
English: 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.
Croatian: 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
English: Radiographic Mean Changes Over 12 Months in RA Study III
Croatian: Tablica 9: Srednje vrijednosti promjena radioloških nalaza tijekom 12 mjeseci u ispitivanju
English: Improvement in health-related quality of life and physical function was maintained during the open-label
Croatian: Poboljšanje kvalitete života vezane uz zdravlje i fizičke funkcije održalo se tijekom otvorenog nastavka ispitivanja do 156. tjedna.
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment.
Croatian: U odraslih bolesnika sa psorijazom, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže bila je 5 μg/ml tijekom primjene monoterapije dozom adalimumaba od 40 mg svaki drugi
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of
Croatian: U primjeni adalimumaba također su prijavljene infekcije sa smrtnim ishodom i po život opasne infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), reaktivacija HBV-a i razne zloćudne bolesti (uključujući leukemiju, limfom i hepatosplenični T-stanični limfom).
English: Cyltezo is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Croatian: Cyltezo je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Croatian: Ankilozantni spondilitis, aksijalni spondiloartritis bez radiološkog dokaza AS-a te psorijatični artritis U bolesnika s ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza ASa te u bolesnika s psorijatičnim artritisom preporučena doza lijeka Cyltezo iznosi 40 mg, a daje se u obliku jednokratne doze svaka dva tjedna putem supkutane injekcije.
English: If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi neće dovoljno dobro djelovati, dobit ćete lijek Cyltezo kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing
Croatian: Psorijatični artritis i aksijalni spondiloartritis, uključujući ankilozantni spondilitis Nema relevantne primjene adalimumaba u pedijatrijskoj populaciji za indikacije ankilozantnog spondilitisa i psorijatičnog artritisa.
English: Adalimumab 40 mg weekly N = 70
Croatian: Adalimumab 40 mg svaki tjedan N = 70
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions
Croatian: * p < 0,001 za adalimumab naspram placeba, sparena usporedba udjela ** p < 0,02 za adalimumab naspram placeba, sparena usporedba udjela
English: Cyltezo is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and
Croatian: Cyltezo je indiciran za liječenje teške kronične plak psorijaze u djece i adolescenata u dobi od 4 ili više godina u kojih nije postignut zadovoljavajući odgovor ili koji nisu prikladni kandidati za topikalnu terapiju i fototerapije.
English: 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
English: Radiographic Mean Changes at Week 52 in RA Study V MTX n=257 confidence interval)
Croatian: Tablica 8: ACR odgovori u ispitivanju RA V (postotak bolesnika) Odgovor MTX n = 257
English: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric
Croatian: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha lije6enja u ispitivanju lije6enja uveitisa u djece
English: The double-blind period is followed by an open-label (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: Call your
Croatian: I DOHVATA
English: • Vaccinations: if possible children should be up to date with all vaccinations before using Cyltezo.
Croatian: • Cijepljenje: ako je moguće, preporučuje se da djeca obave sva cijepljenja prema važećim smjernicama prije početka liječenja lijekom Cyltezo.
English: A patient who requires surgery while on Cyltezo should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom Cyltezo potreban operativni zahvat mora se pomno pratiti zbog moguće pojave infekcija te poduzeti odgovarajuće mjere.
English: Your doctor should test you for HBV. Cyltezo can reactivate HBV infection in people who carry this virus.
Croatian: Cyltezo može u nositelja virusa reaktivirati infekciju HBV-om.
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Croatian: U ispitivanju CD II, 325 bolesnika koji su izgubili odgovor ili nisu podnosili liječenje infliksimabom randomizirani su u dvije skupine: jedna je primila 160 mg adalimumaba u nultom tjednu i 80 mg adalimumaba dva tjedna kasnije, a druga skupina je primila placebo u u nultom tjednu i 2. tjednu.
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Croatian: I i II) u djece s aktivnim poliartikularnim ili poliartikularnim tijekom juvenilnog idiopatskog artritisa i raznim vrstama početka JIA (najčešće negativni reumatoidni faktor ili pozitivni poliartritis i prošireni
English: Very Common Uncommon
Croatian: Nuspojava manje često nokturija
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Croatian: *** p < 0,001 za sve usporedbe adalimumaba s placebom * p < 0,05 za sve usporedbe adalimumaba s placebom
English: Leukopenia (including neutropenia and agranulocytosis), anaemia
Croatian: vrlo često leukopenija (uključujući neutropeniju i agranulocitozu), anemija često leukocitoza, trombocitopenija
English: The safety profile for patients with HS treated with adalimumab weekly was consistent with the known
Croatian: Sigurnosni profil adalimumaba u bolesnika s gnojnim hidradenitisom liječenih jednom tjedno bio je u skladu s poznatim sigurnosnim profilom adalimumaba.
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg Cyltezo is only available as 40 mg pre-filled syringe and pre-filled pen.
Croatian: Djeca, adolescenti i odrasli s poliartikularnim juvenilnim idiopatskim artritisom Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine od 10 kg do manje od 30 kg Cyltezo je dostupan samo u obliku napunjene štrcaljke i napunjene brizgalice od 40 mg.
English: Adolescent hidradenitis suppurativa
Croatian: Adolescentni gnojni hidradenitis
English: Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose
Croatian: Početna doza od 40 mg, a zatim 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze - Nije primjenjivo.
English: The recommended Cyltezo dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Croatian: Preporučena doza lijeka Cyltezo za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
English: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Croatian: Tablica 7: ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika) Odgovor
English: • It is important that you tell your baby's doctors and other health care professionals about your Cyltezo 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 Cyltezo (za više informacija o cjepivima pogledajte dio „Upozorenja i mjere opreza“).
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: Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
Croatian: 2 (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
English: Paediatric CD Study PCDAI Clinical Remission and Response
Croatian: Tablica 26: Ispitivanje Crohnove bolesti u djece - klinička remisija i odgovori prema PCDAI
English: Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was administered
Croatian: Po završetku prva 104 tjedna, 497 bolesnika uključeno je u otvoreni nastavak ispitivanja u kojem se adalimumab u dozi od 40 mg primjenjivao svaka dva tjedna tijekom razdoblja do 10 godina.
English: What you need to know before you use Cyltezo
Croatian: Što morate znati prije nego počnete primjenjivati lijek Cyltezo Nemojte primjenjivati lijek Cyltezo
English: Adalimumab n = 113
Croatian: Adalimuma n = 113
English: o Expiration date on pen or carton has passed o Medication is cloudy, discoloured, frozen, or contains flakes or particles o Pen appears cracked, damaged, or leaking
Croatian: • NEMOJTE primijeniti brizgalicu lijeka Cyltezo ako: ○ istekao je rok valjanosti na brizgalici ili kutiji ○ lijek je zamućen, promijenjene boje, zamrznut ili sadrži pahulje ili čestice ○ brizgalica izgleda napuknuto, oštećeno ili propušta ○ brizgalica je već bila korištena
English: Concurrent administration of biologic DMARDS or TNF-antagonists Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Croatian: U kliničkim ispitivanjima istodobne primjene anakinre i drugog antagonista TNF-a, etanercepta, zabilježene su ozbiljne infekcije, a pritom nije bilo dodatne kliničke koristi u odnosu na monoterapiju etanerceptom.
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy
Croatian: Djelotvornost adalimumaba ocjenjivala se u randomiziranom, dvostruko slijepom, kontroliranom ispitivanju provedenom u 114 pedijatrijskih bolesnika u dobi od 4 ili više godina s teškom kroničnom plak psorijazom (koja se definirala kao PGA rezultat od ≥ 4 ili zahvaćenost površine tijela od > 20%