FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Imraldi.
Croatian: Sve bolesnike, a posebno one koji u anamnezi imaju dugotrajno korištenje imunosupresivne terapije ili bolesnike s psorijazom i PUVA liječenjem u anamnezi, potrebno je prije i za vrijeme liječenja lijekom Imraldi pregledavati u svrhu otkrivanja nemelanomskog karcinoma kože.
English: Maintenance of remission and response rates are presented in Table 24.
Croatian: Održavanje remisije i stope kliničkog odgovora nalaze se u Tablici 24.
English: Imraldi should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Zato se bolesnicima s blagim zatajenjem srca (NYHA razred I/II) Imraldi mora davati oprezno.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated patients.
Croatian: U dvostruko slijepim, kontroliranim dijelovima pivotalnih ispitivanja, liječenje je zbog štetnih događaja prekinuto u 5,9 % bolesnika koji su dobivali adalimumab, odnosno 5,4 % bolesnika iz kontrolne skupine.
English: Hypersensitivity, allergies (including seasonal allergy) Uncommon Sarcoidosis1),
Croatian: često preosjetljivost, alergije (uključujući sezonske alergije) manje često sarkoidoza vaskulitis rijetko anafilaksija
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Croatian: Klinička remisija Klinički odgovor (CR-100) Bolesnici u remisiji bez primjene steroida >= 90 danaa 56. tjedan
English: • Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid.
Croatian: • Gurajte bijeli klip štrcaljke pažljivo u štrcaljku sve dok u štrcaljki ne preostane propisana količina otopine lijeka.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Croatian: Adolescenti s gnojnim hidradenitisom u dobi od 12 do 17 godina, tjelesne težine 30 kg ili više
English: Rare
Croatian: divertikulitis
English: Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Croatian: Tablica 21 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula
English: Skin Pain b
Croatian: Smanjenje kožne boli za b
English: • When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.
Croatian: • Kada ste sigurni da ste pričvrstili nastavak na bočicu, maknite pakiranje s nastavka.
English: • stroke;
Croatian: • trnce;
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥40 kg, and 80 mg and 40 mg, respectively, for subjects <40 kg.
Croatian: Svi ispitanici su primali otvorenu indukcijsku terapiju u dozi određenoj prema njihovoj početnoj tjelesnoj težini: 160 mg u nultom tjednu i 80 mg u drugom tjednu za ispitanike tjelesne težine ≥ 40 kg, odnosno 80 mg i 40 mg za ispitanike tjelesne težine < 40 kg.
English: • You will need a special container for waste, such as a sharps container or as instructed by your nurse, doctor or pharmacist.
Croatian: • Potreban Vam je poseban spremnik za otpad, kao što je spremnik za oštre predmete ili prema preporuci medicinske sestre, liječnika ili ljekarnika.
English: • Push the white plunger rod all the way back in to push the liquid medication back into the vial.
Croatian: • Pritisnite bijeli klip štrcaljke sasvim do kraja da se tekućina vrati natrag u bočicu.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Croatian: Od tih vrsta raka kože, karcinom skvamoznih stanica javljao se (interval pouzdanosti 95 %) u stopi od 2,7 (1,4; 5,4) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom i u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.
English: • Use one of the alcohol pads to wipe the vial stopper.
Croatian: • Upotrijebite jedan od jastučića natopljenih alkoholom za brisanje čepa bočice.
English: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Croatian: Stopa nemelanomskih vrsta raka kože (interval pouzdanosti 95 %) bila je 8,8 (6,0; 13,0) na 1000 bolesnik-godina u bolesnika liječenih adalimumabom, odnosno 3,2 (1,3; 7,6) na 1000 bolesnik-godina u kontrolnoj skupini bolesnika.
English: • enthesitis-related arthritis,
Croatian: • artritisa povezanog s entezitisom,
English: Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Croatian: Tablica 16 ACR odgovor u placebom kontroliranim ispitivanjima kod psorijatičnog artritisa (postotak bolesnika)
English: • arm or leg weakness;
Croatian: • slabost u rukama ili nogama;
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Croatian: A primali adalimumab ponovno su randomizirani u razdoblju B u jednu od 3 terapijske skupine (adalimumab u dozi od 40 mg svaki tjedan, adalimumab u dozi od 40 mg svaki drugi tjedan ili placebo od 12. do 35. tjedna).
English: Table 20 Paediatric CD Study PCDAI Clinical Remission and Response
Croatian: Tablica 20 Ispitivanje kod Crohnove bolesti u djece PCDAI klinička remisija i odgovor
English: Imraldi is used to treat rheumatoid arthritis in adults.
Croatian: Imraldi je namijenjen liječenju reumatoidnog artritisa u odraslih.
English: Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Imraldi je indiciran za liječenje umjerenog do teškog oblika aktivnog ulceroznog kolitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), ili koji ne podnose ili kod kojih postoje medicinske kontraindikacije za takve terapije.
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 Imraldi.
Croatian: Bolesnike se mora upozoriti da se obrate liječniku ako se za vrijeme ili nakon liječenja lijekom Imraldi pojave znakovi/simptomi koji upućuju na tuberkuloznu infekciju (npr. perzistirajući kašalj, progresivno propadanje/gubljenje težine, blaga vrućica, bezvoljnost).
English: Imraldi 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: Imraldi je indiciran za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza ASa kod odraslih, 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: Tell your doctor if your child is taking azathioprine or mercaptopurine with Imraldi.
Croatian: Obavijestite liječnika ako istodobno uz lijek Imraldi Vaše dijete uzima azatioprin ili merkaptopurin.
English: If these medicines do not work well enough, patients will be given Imraldi to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Croatian: Ukoliko ovi lijekovi ne djeluju dovoljno dobro, u svrhu liječenja poliartikularnog juvenilnog idiopatskog artritisa ili artritisa povezanog s entezitisom bolesnicima će biti propisan lijek Imraldi.
English: Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Croatian: Tablica 27 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula
English: c Based on rank analysis d Joint Space Narrowing
Croatian: Joint Space Narrowing)
English: Polyarticular juvenile idiopathic arthritis from 2 years of age
Croatian: Poliartikularni juvenilni idiopatski artritis u bolesnika u dobi od 2 i više godina
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Croatian: Srednja početna vrijednost PASI rezultata u svih ispitanih skupina iznosila je 19,7 a početni PGA rezultat kretao se u rasponu od „blagog“ (< 1 %), preko „umjerenog“ (48 %) do „teškog“ (46 %) i „vrlo teškog“ (6 %).
English: 0.8 ml solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Croatian: 0,8 ml otopine za injekciju u napunjenoj brizgalici za samoinjiciranje za jednokratnu primjenu koja sadrži napunjenu štrcaljku.
English: • serious infections
Croatian: • teške infekcije
English: Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a pre-filled syringe (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger for patient use and 2, 2, 4 or 6 alcohol pads are enclosed in packs respectively.
Croatian: Imraldi je dostupan u pakiranjima koja sadrže 1, 2, 4 ili 6 napunjenih brizgalica koje sadrže napunjenu štrcaljku (staklo tipa I) s iglom od nehrđajućeg čelika, čvrstim štitnikom za iglu i gumenim klipom za uporabu od strane bolesnika te s 2, 2, 4 odnosno 6 alkoholnih tupfera priloženih u pakiranju.
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 14 and 15).
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 14 i 15).
English: • With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
Croatian: • Dok je nastavak još u prozirnom pakiranju, pričvrstite ga na čep bočice tako da ga pritisnete prema dolje sve dok nastavak ne sjedne na svoje mjesto.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 29).
Croatian: Rezultati iz obaju ispitivanja pokazali su statistički značajno smanjenje rizika od neuspjeha liječenja u bolesnika liječenih adalimumabom u odnosu na one koji su primali placebo (vidjeti Tablicu 29).
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Croatian: • kožni vaskulitis (upala krvnih žila u koži);
English: • In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi.
Croatian: • Uz to su u bolesnika koji primjenjuju lijek Imraldi opaženi su slučajevi nemelanomskog raka kože.
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (<40 kg or ≥40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score >30.
Croatian: Djelotvornost i sigurnost adalimumaba ispitivane su u multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju indukcijske terapije i terapije održavanja dozama ovisnim o tjelesnoj težini (< 40 kg ili ≥ 40 kg) u 192 pedijatrijska ispitanika u dobi između (i uključujući) 6 i 17 godina s umjerenom do teškom Crohnovom bolešću (engl.
English: There is little experience from re-administration after more than 8 weeks since the previous dose.
Croatian: Postoji malo podataka o ponovnoj primjeni lijeka Imraldi kad je prekid terapije trajao duže od 8 tjedana.
English: Steroid-free remission for ≥ 90 daysa
Croatian: Bolesnici u remisiji bez primjene steroida ≥ 90 danaa
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
Croatian: Obavijestite liječnika ako istodobno uz lijek Imraldi uzimate azatioprin ili merkaptopurin.
English: Imraldi is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Croatian: Imraldi se koristi za liječenje gnojnog hidradenitisa u odraslih i adolescenata u dobi od 12 godina.
English: 104 Week 56.0% 49.3% 69.4% 0.002 <0.001 0.140
Croatian: 52 tjedna 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043 104 tjedna 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
English: 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 eow or MTX.
Croatian: U 16. tjednu veći broj bolesnika randomiziranih za liječenje adalimumabom u dozi od 0,8 mg/kg imalo je pozitivan odgovor s obzirom na djelotvornost (npr. PASI 75) nego onih randomiziranih za primanje doze od 0,4 mg/kg svaki drugi tjedan ili za liječenje MTX-om.
English: I − V. In these trials, 11.9 % of patients treated with adalimumab and 8.1% of placebo and active control treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Croatian: U tim ispitivanjima, u 11,9 % bolesnika liječenih adalimumabom i 8,1 % bolesnika koji su primali placebo i aktivni kontrolni lijek i koji su prije početka liječenja imali negativan titar antinuklearnih protutijela zabilježen je pozitivan titar nakon 24 tjedna primjene lijeka.
English: Table 26 Paediatric CD Study PCDAI Clinical Remission and Response
Croatian: Tablica 26 Ispitivanje kod Crohnove bolesti u djece PCDAI klinička remisija i odgovor
English: Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Croatian: Tablica 15 Ispitivanje Ps II (CHAMPION) - Rezultati djelotvornosti nakon 16 tjedana
English: Table 4 Imraldi Dose for Paediatric Patients with Crohn's disease
Croatian: Tablica 4 Doza lijeka Imraldi za pedijatrijske bolesnike s Crohnovom bolešću
English: This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Croatian: Tijekom 104 tjedna uspoređivana je djelotvornost kombiniranog liječenja (40 mg adalimumaba svaka dva tjedna/metotreksat), monoterapije adalumambom (40 mg svaka dva tjedna) te monoterapije metotreksatom na smanjenje simptoma i znakova te brzinu progresije oštećenja zglobova kod reumatoidnog artritisa.
English: 36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare >32 weeks
Croatian: 43,3 % (13/30) 71,4 % (20/28)c
English: Imraldi 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 phototherapies.
Croatian: Imraldi 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: CD study I and CD study II induction of remission and response rates are presented in Table 22.
Croatian: Indukcija remisije i stopa kliničkog odgovora u ispitivanjima CD I i II nalaze se u Tablici 22.
English: Solution for injection.
Croatian: otopina za injekciju
English: 104 Week 42.8% 36.9% 59.0% <0.001 <0.001 0.162
Croatian: 52 tjedna 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104 tjedna 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162
English: Adalimumab 160/80 mg N=76
Croatian: Adalimumab 160/80 mg
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 and18).
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: 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: Srednja početna vrijednost PASI rezultata u svih ispitivanih skupina iznosila je 18,9, a rezultat prema općoj procjeni liječnika PGA kretao se u rasponu od „umjerenog“ (53 % uključenih ispitanika) do „teškog“ (41 %) i „vrlo teškog“ (6 %).
English: Imraldi 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: Imraldi 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 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.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Croatian: U bolesnika koji su primali adalimumab zabilježene su ozbiljne infekcije, uključujući sepsu, uzrokovane bakterijama, mikobakterijama, invazivnim gljivicama, parazitima, virusima, ili druge oportunističke infekcije poput listerioze, legioneloze i pneumocistisa.
English: A patient who requires surgery while on Imraldi should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom Imraldi potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: 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).
Croatian: 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).
English: Use a plaster if you want to.
Croatian: Ako želite, prekrijte ga flasterom.
English: • elevated bilirubin measurement (liver blood test).
Croatian: • povišena razina bilirubina (vidljivo u nalazima krvne pretrage kojom se provjerava rad jetre)
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 24).
Croatian: Rezultati iz obaju ispitivanja pokazali su statistički značajno smanjenje rizika od neuspjeha liječenja u bolesnika liječenih adalimumabom u odnosu na one koji su primali placebo (vidjeti Tablicu 24).
English: CD Study II: Infliximab Experienced Patients
Croatian: Ispitivanje CD II: bolesnici koji su uzimali infliksimab
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Croatian: Juvenilni idiopatski artritis (JIA) Poliartikularni juvenilni idiopatski artritis (pJIA)
English: The recommended dose of Imraldi for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Croatian: Preporučena doza lijeka Imraldi za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
English: Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Croatian: Pomoćne tvari: natrijev citrat, citratna kiselina hidrat, histidin, histidinklorid hidrat, sorbitol, polisorbat 20 i voda za injekciju.
English: • eye infections;
Croatian: • infekcije oka;
English: Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Croatian: Produljenje terapije nakon 12. tjedna u bolesnika u kojih u ovom razdoblju nije došlo do poboljšanja, potrebno je pažljivo razmotriti.
English: • breaking of finger nails and toe nails;
Croatian: • lomljenje noktiju na rukama i nogama;
English: Week 2 Week 12 Week 24
Croatian: 2. tjedan 12. tjedan 24. tjedan
English: • It is important that you tell your baby's doctors and other health care professionals about your Imraldi 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 Imraldi (za više informacija o cjepivima pogledajte dio „Upozorenja i mjere opreza“).
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Imraldi.
Croatian: Kod nezaraznog uveitisa se uz lijek Imraldi mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, and uveitis patients.
Croatian: Ispitivanjima su obuhvaćeni bolesnici s nedavnom pojavom reumatoidnog artritisa i oni s dugotrajnom bolešću te bolesnici s juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), kao i oni s aksijalnim spondiloartritisom (ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza AS-a), psorijatičnim artritisom, Crohnovom bolešću, ulceroznim kolitisom, psorijazom, gnojnim hidradenitisom i uveitisom.
English: Imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Croatian: Imraldi je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.
English: Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Croatian: Imraldi je namijenjen liječenju ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa u odraslih.
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.