FrancophonIA/ELRC3.0 huggingface dataset:
English: 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Croatian: 14 tjedana a Pedijatrijski odgovori ACR 30/50/70 nakon 48 tjedana terapije bili su značajno veći nego u skupini koja je uzimala placebo p = 0,015 cp = 0,031
English: 104 Week 28.4% 28.1% 46.6% <0.001 <0.001 0.864 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Croatian: 104 tjedna 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 ap-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa cp-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U testa
English: Should treatment be interrupted, Imraldi may be re-introduced as appropriate.
Croatian: Ako se liječenje mora prekinuti, ponovno uvođenje lijeka Imraldi moguće je prema potrebi.
English: In RA studies I-IV, adalimumab -treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Croatian: U ispitivanjima RA I - IV, bolesnici liječeni adalimumabom postigli su statistički značajno bolje odgovore ACR 20 i 50 u usporedbi s placebom već jedan do dva tjedna nakon početka liječenja.
English: Hidradenitis suppurativa in adults and adolescents
Croatian: Gnojni hidradenitis u odraslih i adolescenata
English: If you use less Imradi than you should
Croatian: Ako primijenite manje lijeka Imraldi nego što ste trebali
English: Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Croatian: Tablica 28 Odgovor, remisija i cijeljenje sluznice u Ispitivanju UC-II (postotak bolesnika)
English: Always make sure your medicine is clear, free of particles, and has not expired.
Croatian: Uvijek provjerite je li lijek bistar, bez čestica i je li mu istekao rok trajanja.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p <0.001) and adalimumab monotherapy (p <0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Croatian: Kombinirana terapija adalimumaba i metotreksata pokazala se klinički i statistički superiornom monoterapiji metotreksatom (p < 0,001) i adalimumabom (p < 0,001) u postizanju niske aktivnosti bolesti u bolesnika s nedavno dijagnosticiranim umjerenim do teškim reumatoidnim artritisom.
English: - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati lijek Imraldi - Ako je Vaše dijete alergično na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years.
Croatian: Kada se objedine rezultati kontroliranih dijelova tih ispitivanja te otvorenih produžetaka ispitivanja koji su u tijeku ili dovršeni, s ukupno 6427 bolesnika i više od 26 439 bolesnik-godina terapije te medijanom trajanja od 3,3 godine, primijećena stopa zloćudnih bolesti, isključujući limfome i nemelanomske vrste raka kože, iznosi približno 8,5 na 1000 bolesnik-godina.
English: EU/1/17/1216/001 1 pre-filled syringe EU/1/17/1216/002 2 pre-filled syringes EU/1/17/1216/003 4 pre-filled syringes EU/1/17/1216/004 6 pre-filled syringes
Croatian: EU/1/17/1216/001 1 napunjena štrcaljka EU/1/17/1216/002 2 napunjene štrcaljke EU/1/17/1216/003 4 napunjene štrcaljke EU/1/17/1216/004 6 napunjenih štrcaljki
English: Prescribers should exercise caution in considering the use of Imraldi in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Imraldi should be considered if any of these disorders develop.
Croatian: Propisivači moraju biti oprezni prilikom razmatranja liječenja lijekom Imraldi u bolesnika s otprije postojećim ili nedavno nastalim demijelinizirajućim poremećajima središnjeg ili perifernog živčanog sustava; ako se razvije bilo koji od tih poremećaja, treba razmotriti prekid liječenja lijekom Imraldi.
English: Surgery or dental procedure
Croatian: Kirurški ili stomatološki zahvati
English: If your medication is not clear, free of particles, or expired, do not use it.
Croatian: Ako lijek nije bistar, nije bez čestica ili mu je rok trajanja istekao, nemojte ga primijeniti.
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Croatian: Prijavljene stope nemelanomskih vrsta raka kože i limfoma bile su oko 0,2 odnosno 0,3 na 1000 bolesnik-godina liječenja (vidjeti dio 4.4).
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Imraldi should be promptly discontinued.
Croatian: Ako se u bolesnika pojave znakovi i simptomi kao što su vrućica, malaksalost, gubitak težine, znojenje, kašalj, dispneja i/ili plućni infiltrati ili druge ozbiljne sistemske bolesti s istodobnim šokom ili bez njega, treba posumnjati na invazivnu gljivičnu infekciju te odmah prekinuti primjenu lijeka Imraldi.
English: DO NOT wipe off the needle or the syringe.
Croatian: NE brišite iglu niti štrcaljku.
English: EU/1/17/1216/005 1 pre-filled pen EU/1/17/1216/006 2 pre-filled pens EU/1/17/1216/007 4 pre-filled pens EU/1/17/1216/008 6 pre-filled pens
Croatian: EU/1/17/1216/005 1 napunjena brizgalica EU/1/17/1216/006 2 napunjene brizgalice EU/1/17/1216/007 4 napunjene brizgalice EU/1/17/1216/008 6 napunjenih brizgalica
English: • Before you inject, ask your doctor or nurse to show you how to use your pre-filled pen.
Croatian: • Prije ubrizgavanje upitajte liječnika ili medicinsku sestru neka Vam pokaže kako koristiti napunjenu brizgalicu.
English: The Imraldi vial is a glass vial containing a solution of adalimumab.
Croatian: Bočica lijeka Imraldi je staklena bočica koja sadrži otopinu adalimumaba.
English: After injecting Imraldi, confirm that the needle has retracted and immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Croatian: Nakon injiciranja lijeka Imraldi, provjerite je li igla uvučena i odmah bacite iskorištenu štrcaljku u za to namijenjeni spremnik prema uputama liječnika, medicinske sestre ili ljekarnika.
English: Patient Weight
Croatian: Tjelesna težina bolesnika
English: When needed (for example when you are travelling), a single Imraldi pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 28 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), pojedinačna napunjena brizgalica lijeka Imraldi može se čuvati na sobnoj temperaturi (do 25°C) najviše do 28 dana - pazite da je zaštitite od svjetlosti.
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Croatian: U ispitivanju nr-axSpA II ocjenjivalo se ukidanje terapije u bolesnika s aktivnim nr-axSpA koji su postigli remisiju tijekom otvorenog liječenja lijekom adalimumab.
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako dobijete vrućicu koja ne prolazi, modrice ili ako jako lako krvarite ili izgledate jako blijedo, odmah nazovite Vašeg liječnika.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Croatian: Stope kliničke remisije i kliničkog odgovora (definirano kao smanjenje PCDAI rezultata za barem 15 bodova od početne vrijednosti) prikazane su u Tablici 26.
English: If you forget to give yourself an injection, you should inject the next dose of Imraldi as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju, sljedeću dozu lijeka Imraldi morate primijeniti čim to primijetite.
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Croatian: • Nemojte koristiti 40 mg napunjene štrcaljke ako je preporučena doza različita od 40 mg.
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNF-antagonists.
Croatian: 48 % bolesnika koji su imali klinički odgovor u 4. tjednu već je prije koristilo neki drugi antagonist TNF-a.
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Croatian: 673 bolesnika s aktivnim nr-axSpA (srednja početna vrijednost aktivnosti bolesti [BASDAI)] iznosila je 7,0) koja nisu imala zadovoljavajući odgovor na ≥ 2 NSAIL-a, nisu podnosila NSAIL-ove ili su imala kontraindikaciju za primjenu NSAIL-ova uključena su u otvoreno razdoblje ispitivanja nr-axSpA II, u kojem su primali lijek adalimumab u dozi od 40 mg svaka dva tjedna tijekom 28 tjedana.
English: The conduct and results of these tests should be recorded on your Patient Reminder Card.
Croatian: Provođenje i rezultati ovih testova moraju se zabilježiti na Vašoj kartici s podsjetnikom za bolesnika.
English: Talk to your child's doctor or pharmacist before using Imraldi.
Croatian: Obratite se djetetovom liječniku ili ljekarniku prije nego primijenite lijek Imraldi.
English: It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis.
Croatian: Važno je da liječniku kažete je li dijete ikada bolovalo od tuberkuloze, ili je li bilo u bliskom doticaju s nekim tko je od nje bolovao.
English: If your child develops a fever that does not go away, or he/she bruises or bleeds very easily or looks very pale, call your doctor right away.
Croatian: Ako Vaše dijete dobije vrućicu koja ne prolazi, modrice ili ako jako lako krvari ili izgleda jako blijedo, odmah nazovite svog liječnika.
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Croatian: Uvijek primijenite ovaj lijek svome djetetu točno onako kako Vam je rekao djetetov liječnik ili ljekarnik.
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).
Croatian: Koristi i rizike od produljenog liječenja potrebno je povremeno provjeravati (vidjeti podatke za odrasle u dijelu 5.1).
English: Your doctor or nurse should make sure you can use your pen correctly.
Croatian: Liječnik ili medicinska sestra moraju se uvjeriti da ste sposobni koristiti napunjenu brizgalicu na ispravni način.
English: • Use your other hand to flip the pink needle cover down toward the syringe.
Croatian: • Drugom rukom okrenite ružičasti pokrov igle dolje prema štrcaljki.
English: Imraldi can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Imraldi se može primjenjivati istodobno s metotreksatom ili nekim antireumaticima koji mijenjaju tijek bolesti (sulfasalazinom, hidroksiklorokinom, leflunomidom i injekcijskim pripravcima zlata), kortikosteroidima ili lijekovima za ublažavanje boli, uključujući i nesteroidne protuupalne lijekove (NSAIL).
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤18 years of age), including adalimumab in the post marketing setting.
Croatian: Nakon stavljanja lijeka u promet zabilježene su zloćudne bolesti, neke sa smrtnim ishodom, u djece, adolescenata i mlađih odraslih osoba (u dobi do 22 godine) liječenih antagonistima TNF-a (početak terapije u 18. godini života ili ranije), uključujući adalimumab.
English: Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Imraldi se može davati i kao monoterapija ako bolesnik ne podnosi metotreksat ili kada kontinuirana primjena metotreksata nije prikladna.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Imraldi.
Croatian: Karticu s podsjetnikom za bolesnika držite kod sebe sve vrijeme dok traje liječenje i još 4 mjeseca nakon što ste Vi (ili Vaše dijete) primili posljednju injekciju lijeka Imraldi.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Croatian: Odmah recite svom liječniku ako osjetite simptome kao što su promjene vida, slabost u rukama ili nogama ili utrnulost ili trnci u bilo kojem dijelu tijela.
English: • DO NOT use the white plunger rod to remove the syringe from the package.
Croatian: • NE koristite bijeli klip štrcaljke za vađenje štrcaljke iz pakiranja.
English: Table 15 Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Croatian: Tablica 15 Djelotvornost u placebom kontroliranom razdoblju ispitivanja nr-axSpA II
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Croatian: Ako bolujete od teške infekcije, uključujući tuberkulozu (pogledajte dio „Upozorenja i mjere opreza“).
English: • Pull the needle package off, but DO NOT remove the clear needle cap.
Croatian: • Sada maknite pakiranje igle, ali NE skidajte prozirnu kapicu igle.
English: • paediatric uveitis.
Croatian: • nezaraznog uveitisa.
English: Patients participating in studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima HS-I i HS-II mogli su sudjelovati u otvorenom produžetku ispitivanja u kojem se adalimumab primjenjivao svaki tjedan u dozi od 40 mg.
English: If you forget to give your child an injection, you should inject the Imraldi dose as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju svome djetetu, sljedeću dozu lijeka Imraldi morate primijeniti čim to primijetite.
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Croatian: Većina podrezultata brojčano je išla u prilog adalimumaba, a srednje vrijednosti razlike bile su statistički značajne za opći vid, bol u oku, vid na blizinu, mentalno zdravlje i ukupan rezultat u ispitivanju UV I te za opći vid i mentalno zdravlje u ispitivanju UV II.
English: Should treatment be interrupted, Imraldi 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Croatian: Ako liječenje treba privremeno prekinuti, Imraldi se kasnije može ponovno uvesti u dozi od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan (vidjeti dio 5.1).
English: Place your pre-filled syringe and alcohol pads on a clean, dry surface.
Croatian: Napunjenu brizgalicu i alkoholne tupfere stavite na čistu, suhu površinu.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p <0.001).
Croatian: U ispitivanju RA IV, ACR 20 odgovor u bolesnika liječenih adalimumabom uz standardnu skrb bio je statistički značajno bolji nego u bolesnika koji su primali placebo uz standardnu skrb (p < 0,001).
English: ASDAS Inactive Disease hs-CRPd,f,g
Croatian: ASDAS neaktivna bolest hs-CRP
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Croatian: Klinička remisija Klinički odgovor (CR-100) Bolesnici u remisiji bez primjene steroida >= 90 dana a
English: • inflammation of the pancreas which causes severe pain in the abdomen and back;
Croatian: • upala gušterače, koja uzrokuje jaku bol u trbuhu i leđima;
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at Week 96 was 65.1%.
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor i koji su nastavili terapiju adalimumabom svaki tjedan, stopa HiSCR-a u 48. tjednu iznosila je 68,3 % a u 96. tjednu iznosila je 65,1 %.
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6% (median percent change -50.0 %) in patients in the placebo group.
Croatian: Primarna mjera ishoda bio je postotak promjene početne vrijednosti do 12. tjedna u broju aktivnih zglobova s artritisom (oticanje koje nije posljedica deformacije ili zglobovi s gubitkom pokretljivosti uz bol i/ili osjetljivost), koji je postignut uz srednji postotak smanjenja od -62,6 % (medijan postotka promjene -88,9 %) u bolesnika u skupini liječenoj adalimumabom u usporedbi s -11,6 % (medijan postotka promjene -50,0 %) u bolesnika u skupini koja je primala placebo.
English: There is limited experience in the initiation of treatment with Imraldi alone.
Croatian: Iskustvo sa započinjanjem liječenja samo lijekom Imraldi je ograničeno.
English: • Do not use a damaged syringe.
Croatian: • Oštećene štrcaljke nemojte koristiti.
English: • high blood sugar;
Croatian: • visoke razine šećera u krvi;
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
Croatian: • stvaranje komore u stijenci velike arterije, upala vena i stvaranje ugruška, začepljenje krvnih žila;
English: For single use.
Croatian: Za jednokratnu primjenu.
English: Place the container on your work surface.
Croatian: Postavite spremnik na radnu površinu.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Imraldi therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Croatian: Ako imate reumatoidni artritis i ne dobivate metotreksat zajedno s lijekom Imraldi, Vaš liječnik može odlučiti davati Vam 40 mg adalimumaba svaki tjedan ili 80 mg svaki drugi tjedan.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 25.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 25.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Croatian: Primijećena stopa nemelanomskih vrsta raka kože je približno 9,6 na 1000 bolesnik-godina, a limfoma 1,3 na 1000 bolesnik-godina.
English: Time to Treatment Failure At or After Week 6 in study UV I Primary analysis (ITT)
Croatian: Vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega u ispitivanju UV I Primarna analiza (ITT)
English: Patients who maintained ≥PASI 75 response at week 33
Croatian: Bolesnici u kojih se do 33. tjedna održao odgovor ≥ PASI 75, a koji su u razdoblju
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p=0.031) and study UC-II (17 % vs. 9 % respectively, p=0.019).
Croatian: Bolesnici koji su primili indukciju adalimumabom u dozi od 160/80 mg u osmom su tjednu postigli kliničku remisiju u značajno većem postotku u odnosu na placebo i u ispitivanju UC-I (18 %, odnosno 9 %, p = 0,031) i u ispitivanju UC-II (17 %, odnosno 9 %, p = 0,019).
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Croatian: 84 % ispitanika liječenih adalimumabom koji nisu imali radiološku progresiju od početka ispitivanja do 48. tjedna ispitivanja (n=102) nisu imali radiološku progresiju bolesti ni nakon 144 tjedna terapije.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 20.
Croatian: Stope kliničke remisije i kliničkog odgovora (definirano kao smanjenje PCDAI rezultata za barem 15 bodova od početne vrijednosti) prikazane su u Tablici 20.
English: In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Croatian: U nekim rijetkim slučajevima, osobito ako Vaše dijete uzima druge lijekove koji potiskuju imunološki sustav, reaktivacija infekcije HBV-om može biti opasna po život.
English: Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Croatian: Imraldi je indiciran za liječenje umjerene do teške kronične plak psorijaze u odraslih bolesnika koji su kandidati za sistemsko liječenje.
English: • vertigo (sensation of the room spinning);
Croatian: • vrtoglavica (osjećaj da se soba vrti);
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Croatian: Pokazalo se da adalimumab smanjuje brzinu progresije oštećenja perifernih zglobova mjerene radiološki u bolesnika s poliartikularnim simetričnim podtipovima bolesti (vidjeti dio 5.1) te da popravlja funkciju zglobova.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 19.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 19.
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 %[123/178] and 88.8 % [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Croatian: Ukupno je 76,5 % (218/285) bolesnika kojima je liječenje ponovno uvedeno imalo PGA odgovor “bez bolesti” ili “minimalno” nakon 16 tjedana liječenja, bez obzira jesu li doživjeli relaps u razdoblju kada je liječenje bilo ukinuto (69,1 % [123/178] za bolesnike s relapsom odnosno 88,8 % [95/107] za bolesnike bez relapsa).