FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži adalimumab u jednoj ili više podskupina pedijatrijske populacije u indikaciji ulceroznog kolitisa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Continue to hold
Croatian: Nastavite držati u tom položaju
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51 %) were in remission at week 52.
Croatian: U ispitivanju UC-II, među onima koji su uz adalimumab bili u remisiji u osmom tjednu, njih 21/41 (51 %) bilo je u remisiji u 52. tjednu.
English: If you receive Imraldi while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Croatian: Ako lijek Imraldi primate tijekom trudnoće, Vaše dijete može biti pod povećanim rizikom od dobivanja infekcije i do pet mjeseci nakon što ste primili posljednju dozu u trudnoći.
English: If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Imraldi provider for a replacement.
Croatian: Ako ste bijeli klip štrcaljke sasvim izvukli iz štrcaljke, bacite štrcaljku i obratite se dobavljaču lijeka Imraldi radi zamjene.
English: DO NOT rub the injection site.
Croatian: Mjesto ubrizgavanja NE trljajte.
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Croatian: Učestalost ozbiljnih infekcija među bolesnicima liječenima adalimumabom veća je u osoba starijih od 65 godina (3,7 %) nego u osoba mlađih od 65 godina (1,5 %).
English: Treatment with Imraldi should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Croatian: Liječenje lijekom Imraldi ne smije se započeti u bolesnika s aktivnim infekcijama, uključujući kronične ili lokalizirane infekcije, sve dok se te infekcije ne stave pod kontrolu.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Imraldi.
Croatian: Doza istodobno primijenjenih kortikosteroida može se postupno smanjivati u skladu s kliničkom praksom, počevši dva tjedna nakon započinjanja liječenja lijekom Imraldi.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Croatian: • autoimuni hepatitis (upala jetre uzrokovana vlastitim tjelesnim imunološkim sustavom);
English: After injecting Imraldi, confirm that the entire medication window is yellow.
Croatian: Nakon ubrizgavanja lijeka Imraldi, provjerite je li cijeli prozorčić za prikaz lijeka žut.
English: The needle is now attached to the syringe.
Croatian: Sada je igla pričvršćena za štrcaljku.
English: Week 16 Placebo-Controlled
Croatian: 16. tjedan Placebom kontrolirano
English: • neuropathy (nerve damage);
Croatian: • neuropatija (oštećenje živca);
English: Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis.
Croatian: Tuberkuloza se može razviti tijekom liječenja čak i ako je dijete primilo preventivnu terapiju za tuberkulozu.
English: Imraldi contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Croatian: Imraldi sadrži djelatnu tvar adalimumab, lijek koji djeluje na imunološki (obrambeni) sustav organizma.
English: DO NOT push the white plunger rod past the dose position.
Croatian: NE gurajte bijeli klip štrcaljke preko položaja doze.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section
Croatian: Produljenje terapije na dulje od 12 tjedana ne daje bitno veći postotak odgovora (vidjeti dio 4.2).
English: Week 26 Placebo-Controlled
Croatian: 26. tjedan Placebom kontrolirano
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Imraldi (see section 4.4).
Croatian: Oftalmolozima se preporučuje da se posavjetuju s odgovarajućim specijalistom prije nego što započnu liječenje lijekom Imraldi (vidjeti dio 4.4).
English: Excess liquid may come out of the needle while the white plunger rod is being pushed.
Croatian: Višak tekućine može izaći kroz iglu za vrijeme pritiskanja bijelog klipa štrcaljke.
English: Thus additional caution should be exercised in considering adalimumab treatment of these patients (see section 4.8).
Croatian: Zbog toga je potreban dodatan oprez prilikom razmatranja liječenja adalimumabom u takvih bolesnika (vidjeti dio 4.8).
English: • Certain vaccines contain weakened but live forms of disease-causing bacteria or viruses, and these vaccines should not be given while receiving Imraldi.
Croatian: • Određena cjepiva sadrže oslabljene ali žive uzročnike bolesti, bakterije ili viruse, pa se ta cjepiva nesmiju primati tijekom liječenja lijekom Imraldi.
English: • shortness of breath with exertion or upon lying down or swelling of the feet.
Croatian: • nedostatak zraka u naporu ili nakon lijeganja ili oticanje stopala.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Paediatric ACR 50 response, and Paediatric ACR 70 response.
Croatian: Iako nije statistički značajno, većina bolesnika pokazala je kliničko poboljšanje sekundarnih mjera ishoda kao što su broj mjesta s entezitisom, broj osjetljivih zglobova, broj otečenih zglobova, pedijatrijski odgovor ACR 50 i pedijatrijski odgovor ACR 70.
English: You will see the liquid medication from the vial go into the syringe.
Croatian: Vidjet ćete kako tekućina ide iz bočice u štrcaljku.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Croatian: • hepatosplenični T-stanični limfom (rijetki rak krvi često sa smrtnim ishodom);
English: Your doctor will decide if you should receive Imraldi.
Croatian: Liječnik će odlučiti trebate li primiti lijek Imraldi.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Croatian: • poremećaji živaca (kao upala očnog živca i Guillain-Barréov sindrom, stanje koje može uzrokovati slabost mišića, abnormalne osjete, trnce u rukama i gornjem dijelu tijela);
English: Following 3 years of adalimumab therapy, 75 % (301/402) continued to be in clinical remission per partial Mayo score.
Croatian: Nakon 3 godine terapije adalimumabom, 75 % (301/402) je i dalje bilo u kliničkoj remisiji prema djelomičnom Mayo rezultatu.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Croatian: Koncentracije adalimumaba u sinovijalnoj tekućini nekolicine bolesnika s reumatoidnim artritisom iznosile su 31-96 % koncentracija u serumu.
English: Your child's symptoms may return upon stopping treatment.
Croatian: Simptomi se Vašem djetetu mogu vratiti nakon prekida liječenja.
English: Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek svome djetetu jer sadrži važne podatke.
English: Of the 417 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Croatian: Od ukupno 417 ispitanika uključenih u nekontrolirani dugoročni produžetak ispitivanja UV I i UV II, 46 ispitanika nije zadovoljavalo kriterije (npr. kod njih su se razvile komplikacije kao posljedica dijabetičke retinopatije, zbog operacije katarakte ili vitrektomije) i stoga nisu bili uključeni u primarnu analizu djelotvornosti.
English: Fatty areas are good for inserting the needle correctly.
Croatian: Mjesta s potkožnom masti su dobra za ispravno ubadanje igle.
English: Disease flares at the end of 32 weeksa (n/N)
Croatian: Egzacerbacija bolesti pri kraju razdoblja od 32 tjednaa (n/N)
English: • sensation of heart beating rapidly;
Croatian: • osjećaj brzog kucanja srca;
English: After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI.
Croatian: Nakon 5 godina terapije adalimumabom, 74,0 % (37/50) od 50 bolesnika koji su ostali u ispitivanju i dalje su bili u kliničkoj remisiji dok je 92,0 % (46/50) bolesnika nastavilo imati klinički odgovor prema PCDAI.
English: DO NOT touch the area again before injecting.
Croatian: To područje više nemojte dodirivati prije ubrizgavanja.
English: You might accidentally stick yourself or waste medication.
Croatian: Možete se nehotice ubosti ili uzalud potrošiti lijek.
English: DO NOT set the syringe down at any time.
Croatian: Ni u kojem trenutku NEMOJTE odložiti štrcaljku.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Croatian: Kvaliteta života vezana uz zdravlje i fizička funkcija ocjenjivale su se uz pomoć upitnika HAQ-S i SF 36.
English: • When the syringe is empty, remove the needle from skin, being careful to pull it out at the same angle as when it was inserted.
Croatian: • Kada se štrcaljka isprazni, izvadite iglu iz kože, pazeći pri tom da je zadržite pod istim kutom pod kojim ste je i uveli.
English: Imraldi is a biosimilar medicinal product.
Croatian: Imraldi je biosličan lijek.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Croatian: Slični trendovi (ne svi statistički značajni) viđeni su i u manjem, randomiziranom, dvostruko slijepom ispitivanju kontroliranom placebom AS II, u kojem su sudjelovala 82 odrasla bolesnika s aktivnim ankilozantnim spondilitisom.
English: Fistula remission3
Croatian: Remisija fistula3
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Croatian: Bolesnicima koji su primali MTX i koji su u 8. i/ili 12. tjednu postigli odgovor ≥ PASI 50 doza se nije dalje povećavala.
English: • To reduce the chance of infection, wipe the injection site with the other alcohol pad.
Croatian: • Radi smanjenja mogućnosti infekcije, mjesto na kojem ćete ubrizgati injekciju prebrišite drugim jastučićem natopljenim alkoholom.
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 upalne su bolesti zglobova koje se prvi puta javljaju obično u djetinjstvu.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite djetetovog liječnika ili ljekarnika ako Važe dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove.
English: • Recheck the prescribed medication amount.
Croatian: • Ponovno provjerite koja je propisana količina lijeka.
English: Do not remove the needle cap before you are ready to inject.
Croatian: Nemojte skidati štitnik za iglu prije nego budete spremni za injiciranje.
English: • asthma;
Croatian: • astma;
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78.
Croatian: U 78. tjednu BCVA se ili poboljšao ili održao na istoj razini (pogoršanje za < 5 slova) u 88,4 % očiju.
English: • If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip.
Croatian: • Ako blizu vrha štrcaljke vidite veliki mjehurić zraka ili zračnu prazninu, POLAKO pritisnite bijeli klip štrcaljke u štrcaljku tako da tekućina počne ulaziti u vrh štrcaljke.
English: Treatment with Imraldi can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Croatian: Liječenje lijekom Imraldi može se započeti u kombinaciji s kortikosteroidima i/ili drugim nebiološkim imunomodultorima.
English: • If you received Imraldi during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako primate lijek Imraldi tijekom trudnoće, Vaše dijete može imati povećan rizik od dobivanja infekcije.
English: DO NOT try to reinsert the white plunger rod.
Croatian: NE pokušavajte ponovno umetnuti bijeli klip štrcaljke.
English: At week 12 and week 24, PaedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Croatian: U 12. i 24. tjednu, pedijatrijski odgovor ACR 30 bio je 93,5 %, odnosno 90,0 %, što je utvrđeno na temelju zabilježenih podataka.
English: The proportions of subjects with PaedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Croatian: Udio ispitanika s pedijatrijskim odgovorom ACR 50/70/90 u 12. i 24. tjednu bio je 90,3 %/61,3 %/38,7 %, odnosno 83,3 %/73,3 %/36,7 %.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Imraldi should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako se pojavi anafilaktička reakcija ili kakva druga ozbiljna alergijska reakcija, primjenu lijeka Imraldi treba odmah obustaviti i započeti odgovarajuću terapiju.
English: Before initiation of therapy with Imraldi, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Croatian: Prije početka liječenja lijekom Imraldi sve bolesnike se mora podvrgnuti pretragama za otkrivanje i aktivnog i neaktivnog (“latentnog“) oblika tuberkuloze.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Croatian: • Stevens-Johnsonov sindrom (rani simptomi uključuju malaksalost, vrućicu, glavobolju i osip);
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Croatian: Bolesnici su i dalje uzimali stabilne doze NSAIL-a i/ili prednizona (≤ 0,2 mg/kg/dan ili najviše 10 mg/dan).
English: Imraldi is intended for treatment of:
Croatian: Imraldi je namijenjen za liječenje:
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Croatian: Provjerite s djetetovim liječnikom ili ljekarnikom ako niste sigurni, trebate dodatne informacije ili imate dodatna pitanja.
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Croatian: • sistemski eritemski lupus (uključujući upalu kože, srca, pluća, zglobova i drugih organskih sustava);
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Croatian: PGA-F: bez bolesti/minimalno i poboljšanje za ≥ 2 stupnja
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Croatian: Ciljna tvar za koju se vezuje adalimumab je protein koji se naziva faktor tumorske nekroze (TNFα), čije su razine povišene pri ranije navedenim upalnim bolestima.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Imraldi in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu profilakse tuberkuloze također treba razmotriti prije početka liječenja lijekom Imraldi u bolesnika s nekoliko faktora rizika ili sa značajnim faktorima rizika od tuberkuloze unatoč negativnom nalazu na tuberkulozu i u bolesnika s latentnom ili aktivnom tuberkulozom u anamnezi u kojih se ne može utvrditi adekvatan tijek liječenja.
English: If you take off the needle cap before you are ready to inject, do not put the needle cap back on.
Croatian: Ako štitnik s igle skinete prije nego ste spremni za ubrizgavanje, nemojte ga vraćati na iglu.
English: Administration of Imraldi should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Primjena lijeka Imraldi mora se obustaviti ako bolesnik razvije novu ozbiljnu infekciju ili sepsu te je potrebno započeti odgovarajuću antimikrobnu ili antifungalnu terapiju sve dok se infekcija ne stavi pod kontrolu.
English: Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Croatian: Neki od tih bolesnika su također uzimali lijek azatioprin ili merkaptopurin.
English: • Place the syringe on your clean work surface.
Croatian: • Postavite štrcaljku na Vašu čistu radnu površinu.
English: Imraldi can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Croatian: Imraldi može smanjiti broj nodula i apscesa koje imate te ublažiti bol koja često prati ovu bolest.
English: • DO NOT touch the needle.
Croatian: • NE dirajte iglu.
English: Fever, bruising, bleeding or looking pale
Croatian: Vrućica, stvaranje modrica, krvarenje ili bljedilo
English: • heart problems that can cause shortness of breath or ankle swelling;
Croatian: • problemi sa srcem koji mogu uzrokovati nedostatak zraka ili oticanje zglobova;
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and not known (cannot be estimated from the available data).
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja i nakon stavljanja lijeka u promet, a prikazane su dolje u Tablici 6 prema klasifikaciji organskih sustava i učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • psoriasis,
Croatian: • psorijaze,
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Croatian: Tijekom ispitivanja, 19,3 % bolesnika nastavilo je terapiju oralnim antibioticima koje su uzimali pri uključivanju u ispitivanje.
English: If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Croatian: Ako je propisana doza 0,5 ml, izvucite bijeli klip štrcaljke do 0,6 ml.
English: • sicca syndrome (including dry eyes and dry mouth);
Croatian: • sicca (suhi) sindrom (uključujući suhoću očiju i suhoću usta);
English: • mood swings (including depression);
Croatian: • promjene raspoloženja (uključujući depresiju);
English: If new areas of damaged skin appear during or after therapy or if existing marks or areas of damage change appearance, tell your doctor.
Croatian: Ako se za vrijeme terapije ili nakon nje na koži jave nova područja oštećene kože ili ako postojeće tvorbe ili područja oštećene kože promijene izgled, javite se svom liječniku.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Croatian: Među bolesnicima koji su prekinuli sudjelovanje u ispitivanju prije 78. tjedna, njih 11 % to je učinilo zbog nuspojava, a njih 5 % zbog nedovoljno dobrog odgovora na liječenje adalimumabom.
English: A single Imraldi pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 28 days.
Croatian: Jedna napunjena štrcaljka ili napunjena brizgalica lijeka Imraldi može se čuvati na temperaturama do maksimalno 25 °C u trajanju do 28 dana.
English: If you use more Imraldi than you should
Croatian: Ako primijenite više lijeka Imraldi nego što ste trebali
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Croatian: Farmakoterapijska skupina: Imunosupresivi, Inhibitori faktora tumorske nekroze alfa (TNF-α).
English: • For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Croatian: • Na primjer, ako je propisana doza 0,5 ml, NE gurajte bijeli klip štrcaljke preko položaja od 0,5 ml.
English: Fatty areas are easier to pinch and are good for inserting the needle correctly.
Croatian: Na njima se najlakše može učiniti kožni nabor i dobra su za ispravno ubadanje igle.
English: 5) Injecting Imraldi
Croatian: 5) Ubrizgavanje lijeka Imraldi
English: Your doctor may recommend temporary discontinuation of Imraldi.
Croatian: Liječnik može preporučiti privremeni prekid terapije lijekom Imraldi.
English: Table 13 Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Croatian: Tablica 13 Djelotvornost u placebom kontroliranom ispitivanju kod AS-a - ispitivanje I Smanjenje znakova i simptoma
English: • DO NOT pull the white plunger rod completely out of the syringe.
Croatian: • NE izvlačite bijeli klip štrcaljke u potpunosti van iz štrcaljke.
English: • nausea and vomiting;
Croatian: • mučnina i povraćanje;
English: Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Croatian: Imraldi se može davati kao monoterapija u slučajevima nepodnošenja metotreksata ili kada nastavak terapije metotreksatom nije prikladan (za djelotvornost monoterapije vidjeti dio 5.1).
English: If you have ulcerative colitis you will first be given other medicines.
Croatian: Ukoliko bolujete od ulceroznog kolitisa, prvo će Vam biti propisani drugi lijekovi.
English: Improvement in health-related quality of life and physical function was maintained during the openlabel extension through week 156.
Croatian: Poboljšanje kvalitete života vezane uz zdravlje i fizičke funkcije održalo se tijekom otvorenog produžetka ispitivanja do 156. tjedna.
English: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Croatian: Sigurnost preporučene doze adalimumaba u adolescentnoj populaciji s gnojnim hidradenitisom temelji se na sigurnosnom profilu adalimumaba u drugim indikacijama i u odraslih i u pedijatrijskih bolesnika pri sličnoj ili većoj učestalosti doziranja (vidjeti dio 5.2).
English: • Use each syringe only once.
Croatian: • Svaku štrcaljku upotrijebite samo jedanput.
English: This medicinal product contains 20.0 mg sorbitol.
Croatian: Lijek sadrži 20,0 mg sorbitola.
English: • Imraldi is a liquid that is clear and colourless.
Croatian: Imraldi je bistra i bezbojna tekućina.
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where adalimumab was given for at least an additional 108 weeks.
Croatian: Bolesnici koji su sudjelovali u svim ispitivanjima faze II i III kod psorijaze ispunili su kriterije za uključivanje u otvoreni produžetak ispitivanja, gdje se adalimumab primjenjivao još najmanje dodatnih 108 tjedana.