FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Croatian: • Recite svom liječniku ako ste ranije bolovali od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: Warning: Keep your sharps disposal container out of the reach of children.
Croatian: Upozorenje: Držite spremnik za odlaganje oštrih predmeta izvan dohvata djece.
English: If these medicines do not work well enough, you will be given Kromeya to reduce the signs and symptoms of your disease.
Croatian: Ako ti drugi lijekovi ne djeluju dovoljno dobro, bit će Vam propisan lijek Kromeya kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Table 16 Ps study IV efficacy results at 16, 26 and 52 weeks
Croatian: Rezultati djelotvornosti u 16., 26. i 52. tjednu
English: Ulcerative colitis Age or body weight
Croatian: Ulcerozni kolitis Dob ili tjelesna težina
English: Syringe plunger final position
Croatian: Konačna pozicija klipa štrcaljke
English: • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Croatian: • aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Croatian: Primijetite li bilo koji od dolje navedenih znakova alergijske reakcije ili zatajenja srca, hitno potražite medicinsku pomoć:
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Croatian: Bolesnici su primali adalimumab u dozi od 0,8 mg/kg svaki drugi tjedan (do najviše 40 mg), 0,4 mg/kg svaki drugi tjedan (do najviše 20 mg) ili metotreksat u dozi od 0,1 - 0,4 mg/kg jednom tjedno (do najviše 25 mg).
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 22).
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 22).
English: Each box of Kromeya pre-filled syringe comes with two or six syringes.
Croatian: Svaka kutija Kromeya napunjenih štrcaljki sadrži dvije ili šest štrcaljki.
English: Table 14 Efficacy response in placebo-controlled study nr-axSpA I
Croatian: Tablica 14 Djelotvornost u placebom kontroliranom ispitivanju nr-axSpA I
English: • Keep all components of the Kromeya Vial Kit and the sharps disposal container out of reach and sight of children.
Croatian: • Čuvajte sve komponente Kromeya seta s bočicom i spremnik za odlaganje oštrih predmeta izvan dohvata i pogleda djece.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Croatian: - Drugi sastojci su: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, manitol, natrijev klorid, citratna kiselina hidrat, natrijev citrat, polisorbat 80, natrijev hidroksid i voda za injekcije.
English: a p Value b
Croatian: P-vrijednost b
English: Kromeya 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: Kromeya je indicirana 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: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Croatian: Paediatric CD Study) nastavilo je otvoreni dugotrajni produžetak ispitivanja.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a adalimumab trial in paediatric patients with chronic plaque psoriasis.
Croatian: Zloćudne bolesti nisu primijećene ni u 77 pedijatrijskih bolesnika s izloženošću od 80,0 bolesnik-godina u ispitivanju adalimumaba provedenom u pedijatrijskih bolesnika s kroničnom plak psorijazom.
English: • pull the pre-filled pen straight up and out of the packaging (Figure D).
Croatian: • podižući brizgalicu ravno prema gore izvadite je van iz pakiranja (slika D).
English: 3.7 Place the syringe on a clean, flat surface.
Croatian: 3.7 Stavite štrcaljku na čistu i ravnu površinu.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use in single-use vial 0.8 mL solution in vial (type I glass) with a rubber stopper (synthetic rubber) and aluminium crimp seal.
Croatian: Kromeya 40 mg/0,8 ml otopina za injekciju za pedijatrijsku uporabu u bočici za jednokratnu primjenu 0,8 ml otopine u bočici (staklo tipa I) s gumenim čepom (sintetička guma) i aluminijskim prstenom.
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Croatian: • Recite liječniku ako je Vaše dijete ranije bolovalo od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Kromeya.
Croatian: • Ako bolujete ili obolite od demijelinizirajuće bolesti (bolest koja zahvaća izolirajući sloj oko živaca, poput multiple skleroze), odluku o tome smijete li početi ili nastaviti primati lijek Kromeya donijet će Vaš liječnik.
English: Put it on a clean flat surface.
Croatian: Stavite brizgalicu na čistu ravnu površinu.
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Croatian: Bolesnici su primali placebo ili MTX u početnoj dozi od 7,5 mg, nakon čega se ona povećavala do 12. tjedna do maksimalne doze od 25 mg, ili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) tijekom 16 tjedana.
English: Warning: Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where there are stretch marks.
Croatian: Upozorenje: Nemojte injicirati u područje koje je bolno (na dodir), na kojem su prisutne modrice, koje je crveno, tvrdo ili na kojem su prisutni ožiljci ili strije.
English: Kromeya is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Croatian: Kromeya se koristi za liječenje teške plak psorijaze u djece i adolescenata u dobi od 4 do 17 godina u kojih lijekovi koji se nanose na kožu i terapije s UV svjetlom nisu djelovale jako dobro ili nisu prikladne.
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: • The expiration date on the pre-filled pen has not passed (Figure I).
Croatian: • rok valjanosti napunjene brizgalice nije prošao (slika I).
English: Patients demonstrating a Pediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Croatian: Bolesnici koji su u 16. tjednu pokazali pedijatrijski odgovor ACR 30 (American College of Rheumatology 30) mogli su biti randomizirani u dvostruko slijepu fazu ispitivanja i primiti ili 24 mg/m adalimumaba, do maksimalne doze od 40 mg, ili placebo, svaki drugi tjedan kroz 32 tjedna ili do egzacerbacije bolesti.
English: • Do not insert your fingers into the opening of the safety guard.
Croatian: • Nemojte stavljati prste u otvor štitnika za iglu.
English: Kromeya is used in adults to treat these conditions.
Croatian: Kromeya je namijenjena liječenju ovih stanja u odraslih.
English: Label area (Kromeya, dose, expiration date)
Croatian: Dio s naljepnicom (Kromeya, doza, rok valjanosti) Gumb za injektiranje
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 tumora 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: 3.5 Slowly push the plunger rod all the way in to push the medicine back into the vial.
Croatian: Polako potisnite štapić klipa do kraja unutra da biste istisnuli lijek natrag u bočicu.
English: • The expiration date on syringe has not passed (Figure K).
Croatian: • nije istekao rok valjanosti na štrcaljki (slika K).
English: CD study II: Infliximab experienced patients
Croatian: Ispitivanje CD II: bolesnici koji su uzimali infliksimab
English: Clinical remission
Croatian: Klinička remisija
English: ▪ the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Croatian: ▪ liječenje umjereno teškog do teškog oblika reumatoidnog artritisa u aktivnoj fazi u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti, uključujući metotreksat, nije postignut zadovoljavajući odgovor.
English: • Only use Kromeya Vial Kit if your healthcare professional has trained you how to use it correctly.
Croatian: • Primjenjujte Kromeya set s bočicom samo ako vas je zdravstveni radnik osposobio za njezinu pravilnu upotrebu.
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: Table 10 ACR responses in RA study V (percent of patients)
Croatian: Tablica 10 ACR odgovori u ispitivanju RA V (postotak bolesnika)
English: Axial spondyloarthritis without radiographic evidence of AS
Croatian: Aksijalni spondiloartritis bez radiološkog dokaza AS-a
English: Kromeya dose for paediatric patients with Crohn's disease
Croatian: Tablica 4. Doza lijeka Kromeya za pedijatrijske bolesnike s Crohnovom bolešću
English: • Keep Kromeya pre-filled syringe and the sharps disposal container out of reach and sight of children.
Croatian: • Čuvajte Kromeya napunjenu štrcaljku i spremnik za odlaganje oštrih predmeta izvan dohvata i pogleda djece.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Croatian: U nekih bolesnika koji su bili uspješno liječeni zbog aktivne tuberkuloze, za vrijeme liječenja adalimumabom ponovno se razvila tuberkuloza.
English: • Store the Kromeya Vial Kit in its original box to protect it from light.
Croatian: • Čuvajte Kromeya set s bočicom u originalnoj kutiji radi zaštite od svjetla
English: The recommended Kromeya induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Croatian: Preporučena indukcijska doza lijeka Kromeya u odraslih bolesnika s umjerenom do teškom aktivnom Crohnovom bolešću je 80 mg u nultom tjednu, praćena dozom od 40 mg u drugom tjednu.
English: • If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Kromeya.
Croatian: • Ako se Vaše dijete sprema podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, recite svom liječniku da primjenjuje lijek Kromeya.
English: • The name on the pre-filled pen says Kromeya (Figure I).
Croatian: • ime lijeka na napunjenoj brizgalici je Kromeya (slika I).
English: Kromeya is used to treat rheumatoid arthritis in adults.
Croatian: Kromeya je namijenjena liječenju reumatoidnog artritisa u odraslih.
English: The rate (95% confidence interval) of nonmelanoma 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 tumora 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: Warning: Do not warm the syringe any other way, such as in a microwave, hot water, or direct sunlight.
Croatian: Upozorenje: Nemojte zagrijavati štrcaljku ni na koji drugi način, kao npr. u mikrovalnoj pećnici, u vrućoj vodi ili na izravnoj sunčevoj svjetlosti.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Croatian: U kontroliranim i otvorenim ispitivanjima adalimumaba u odraslih i djece zabilježene su ozbiljne infekcije (u rijetkim slučajevima i sa smrtnim ishodom), među kojima i tuberkuloza (uključujući njezin milijarni oblik i izvanplućne lokalizacije) te invazivne oportunističke infekcije (npr. diseminirana ili ekstrapulmonalna histoplazmoza, blastomikoza, kokcidioidomikoza, pneumocistis, kandidijaza, aspergiloza i listerioza).
English: Nervous system disorders* Very common
Croatian: Poremećaji živčanog sustava*
English: Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Croatian: Vaše dijete počne primjenjivati ovaj lijek jer sadrži važne podatke.
English: Percent of patients achieving PASI75 response was calculated as centeradjusted rate b p<0.001, adalimumab vs. placebo
Croatian: Postotak bolesnika s rezultatom PASI 75 izražen kao stopa prilagođena istraživačkom centru b p<0,001, adalimumab naspram placeba
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
Croatian: Nakon 6 mjeseci praćenja, u sva četiri ispitivanja zabilježeno je statistički značajno veće poboljšanje indeksa onesposobljenosti HAQ s obzirom na početne vrijednosti pri svim dozama/režimima davanja adalimumaba nego kod placeba, a identičan je nalaz primijećen i nakon 52 tjedna u ispitivanju RA III.
English: Table 15 Ps study II (CHAMPION) efficacy results at 16 weeks
Croatian: Tablica 15 Ispitivanje Ps II (CHAMPION) Rezultati djelotvornosti u 16. tjednu
English: 3.3 Check the label to make sure that:
Croatian: 3.3 Provjerite da na naljepnici:
English: The results for the 40 mg every other week dose are summarised in Table 9.
Croatian: Rezultati zabilježeni u skupini koja je dobivala 40 mg svaka dva tjedna prikazani su u Tablici 9.
English: A 40 mg pre-filled syringe and a 40 mg prefilled pen are also available for use.
Croatian: Dostupne su i napunjena štrcaljka od 40 mg i napunjena brizgalica od 40 mg.
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the openlabel extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Croatian: Među bolesnicima u kojih je nastupio gubitak primjerenog odgovora nakon ponovne randomizacije u skupinu koja je primala placebo, a koji su potom uključeni u otvoreni produžetak ispitivanja, odgovor PASI 75 ponovno je postignut u 38% (25/66) bolesnika nakon 12 tjedana terapije, odnosno u 55% (36/66) bolesnika nakon 24 tjedna terapije.
English: 2.7 With the vial adapter still in its packaging, push the vial adapter onto the vial top until it snaps in place.
Croatian: 2.7 Dok je nastavak za bočicu još u svom podlošku, nataknite nastavak za bočicu na vrh bočice tako da zvučno sjedne na svoje mjesto.
English: P=0.083, adalimumab 0.8 mg/kg versus MTX
Croatian: P=0,083, adalimumab 0,8 mg/kg naspram MTX-a
English: Assessments in Ankylosing Spondylitis b
Croatian: Rezultat za aktivnost ankilozantnog spondilitisa d
English: 5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K).
Croatian: 5.1 Da biste očistili mjesto injiciranja, kožu prebrišite jastučićem s alkoholom (slika K).
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Kromeya.
Croatian: • Ako Vaše dijete boluje ili oboli od demijelinizirajuće bolesti (bolest koja zahvaća izolirajući sloj oko živaca, poput multiple skleroze), odluku o tome smije li Vaše dijete početi ili nastaviti primati lijek Kromeya donijet će Vaš liječnik.
English: Low dose
Croatian: Niska doza Standardna doza
English: CD study I and CD study II induction of remission and response rates are presented in Table 20.
Croatian: Indukcija remisije i stopa kliničkog odgovora u ispitivanjima CD I i II nalaze se u Tablici 20.
English: Notes
Croatian: Bilješke
English: Warning: Do not throw away the syringe in your household trash.
Croatian: Upozorenje: Nemojte bacati štrcaljku u kućni otpad.
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Croatian: * p < 0,001 za adalimumab naspram placeba, sparena usporedba udjela ** p < 0,02 za adalimumab naspram placeba, sparena usporedba udjela a
English: If so, throw away the syringe in a sharps disposal container and contact your healthcare professional or pharmacist.
Croatian: U tom slučaju, bacite brizgalicu u spremnik za oštre predmete i javite se svom liječniku ili ljekarniku.
English: Step 4 Choose the injection Site
Croatian: 4. korak Odaberite mjesto injiciranja
English: Warning: Do not warm the kit any other way, such as in a microwave, hot water, or direct sunlight.
Croatian: Upozorenje: Nemojte zagrijavati set ni na koji drugi način, kao npr. u mikrovalnoj pećnici, u vrućoj vodi ili na izravnoj sunčevoj svjetlosti.
English: Adalimumab was assessed in a multicenter, 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: Kromeya 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: Kromeya je indicirana za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MRI), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: CD study I and CD study II induction of remission and response rates are presented in Table 21.
Croatian: Indukcija remisije i stopa kliničkog odgovora u ispitivanjima CD I i II nalaze se u Tablici 21.
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 adalimumabom (40 mg svaka dva tjedna) te monoterapije metotreksatom na smanjenje simptoma i znakova te brzinu progresije oštećenja zglobova kod reumatoidnog artritisa.
English: Kromeya 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: Kromeya je indicirana 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: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Croatian: U analizi u kojoj su se svi bolesnici koji su izašli iz ispitivanja zbog štetnih događaja ili nedostatka djelotvornosti ili kojima je doza povećavana smatrali bolesnicima bez odgovora na terapiju, stopa odgovora PASI 75 i PGA rezultata “bez bolesti” ili “minimalno” nakon dodatnih 108 tjedana otvorene terapije (ukupno 160 tjedana) iznosila je 69,6%, odnosno 55,7%.
English: Treatment with Kromeya may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka Kromeya mogu se razviti autoimuna protutijela.
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Croatian: U ovoj otvorenoj uvodnoj fazi ispitivanja svi bolesnici su primali 24 mg/m adalimumaba do maksimalne doze od 40 mg adalimumaba, svaki drugi tjedan kroz 16 tjedana.