FrancophonIA/ELRC3.0 huggingface dataset:
English: o DO NOT use other heat sources such as a microwave oven or hot water to warm the vial.
Croatian: ◦ NEMOJTE upotrebljavati druge izvore topline, kao što je mikrovalna pećnica ili vruća voda, za zagrijavanje štrcaljke.
English: Hulio is used to treat rheumatoid arthritis in adults.
Croatian: Hulio je namijenjen liječenju reumatoidnog artritisa u odraslih.
English: • vertigo (sensation of the room spinning);
Croatian: • vrtoglavica (osjećaj da se prostorija vrti),
English: Hulio packs should be stored in the fridge (between 2 to 8°C) until needed for use.
Croatian: Pakiranja lijeka Hulio treba čuvati u hladnjaku (na temperaturi od 2 do 8 °C) do primjene.
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: After the needle is completely inserted, let go of the site you are squeezing.
Croatian: Nakon što ste do kraja umetnuli iglu, pustite mjesto ubrizgavanja koje držite.
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: 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: b p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa. c p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U testa.
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 Hulio.
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 Hulio pregledavati u svrhu otkrivanja nemelanomskog karcinoma kože.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON - VIAL MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA - VIŠESTRUKO PAKIRANJE BOČICA (BEZ PLAVOG OKVIRA)
English: Results from the Short Form Health Survey (SF 36) for all doses/schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Croatian: Short Form Health Survey, SF-36) podupiru te nalaze za sve doze/režime davanja adalimumaba u sva četiri ispitivanja, sa statistički značajnim rezultatom za cjelokupnu fizičku komponentu (engl.
English: Table 14: Efficacy Response in Placebo-Controlled Study nr-axSpA I
Croatian: Tablica 14: Djelotvornost u placebom kontroliranom ispitivanju nr-axSpA I
English: The recommended Hulio 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 Hulio 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: In CD Study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Croatian: U ispitivanju CD III 854 bolesnika primila su 80 mg adalimumaba u nultom tjednu i 40 mg dva tjedna kasnije.
English: • DO NOT move, twist, or rotate the pen during injection.
Croatian: • NE pomičite i ne zaokrećite brizgalicu tijekom ubrizgavanja.
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: • DO NOT shake the syringe.
Croatian: • NE tresite štrcaljku.
English: If you have mild heart failure and you are being treated with Hulio your heart failure status must be closely monitored by your doctor.
Croatian: Bolujete li od blagog zatajenja srca, a liječite se lijekom Hulio, liječnik mora pomno nadzirati status zatajenja srca.
English: 40 mg Adalimumab every other week
Croatian: 40 mg adalimumaba svaki drugi tjedan
English: Patients should be tested for HBV infection before initiating treatment with Hulio.
Croatian: Bolesnike je potrebno prije početka terapije lijekom Hulio testirati na HBV infekciju.
English: • DO NOT throw the sharps container in your household bin.
Croatian: • NE bacajte spremnik za zbrinjavanje oštrih predmeta u kućanski otpad.
English: • DO NOT re-use the pen.
Croatian: • NEMOJTE ponovno upotrebljavati brizgalicu.
English: Hulio is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Croatian: Hulio se koristi za liječenje teške plak psorijaze u djece i adolescenata u dobi od 4 do 17 godina u kojih lijekovi koji se primjenjuju na kožu i terapija UV zračenjem nisu djelovale jako dobro ili nisu bile prikladne.
English: o DO NOT use other heat sources such as a microwave oven or hot water to warm the pen.
Croatian: ◦ NEMOJTE upotrebljavati druge izvore topline, kao što je mikrovalna pećnica ili vruća voda, za zagrijavanje brizgalice.
English: Step 10 - Flip down pink needle cover and remove needle cap Hold the syringe with the needle pointing up.
Croatian: Korak 10 - Okrenite ružičasti pokrov igle prema dolje i uklonite kapicu igle
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja, provedena u bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a (nr axSpA).
English: Hulio 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: Hulio 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: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab /methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Croatian: U ispitivanju RA V poboljšanje indeksa onesposobljenosti HAQ i fizičke komponente SF-36 nakon 52 tjedna bilo je veće u bolesnika liječenih kombinacijom adalimumaba i metotreksata (p<0,001) u usporedbi s bolesnicima koji su dobivali monoterapiju metotreksatom, odnosno adalimumabom, i to se poboljšanje održalo tijekom 104 tjedna liječenja.
English: Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Croatian: Hulio se koristi za liječenje gnojnog hidradenitisa u adolescenata u dobi od 12 godina i starijih.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Croatian: Ispitivanje nr-axSpA I bilo je dvostruko slijepo, placebom kontrolirano ispitivanje u kojem se kroz 12 tjedana ispitivalo djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna u 185 bolesnika s aktivnim nr-axSpA (srednja početna vrijednost aktivnost bolesti [engl.Bath Ankylosing Spondilitis Disease Activity Index, BASDAI)] bila je 6,4 u skupini bolesnika koji su primali adalimumab i 6,5 u skupini koja je primala placebo) koji nisu imali zadovoljavajući odgovor na ≥ 1 NSAIL-a ili ga nisu podnosili, ili su imali kontraindikaciju za primjenu NSAIL-a.
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 bolesnikgodina u bolesnika liječenih adalimumabom i u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.
English: • inflammatory skin rash;
Croatian: • upalni kožni osip,
English: Each pre-filled syringe or pre-filled pen contains 38.2 mg sorbitol (E420).
Croatian: Jedna napunjena štrcaljka ili napunjena brizgalica sadrži 38,2 mg sorbitola (E420).
English: Gently place the syringe on a clean, flat surface.
Croatian: Pažljivo odložite štrcaljku na čistu i ravnu površinu.
English: On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
Croatian: U rijetkim je slučajevima u nekih bolesnika koji su uzimali adalimumab opažen specifičan i težak oblik limfoma.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 μg/ml for the Standard Dose group and 3.5 ± 2.2 μg/ml for the Low Dose group.
Croatian: U bolesnika koji su nastavili terapiju na koju su randomizirani, srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u 52. tjednu bile su 9,5 ± 5,6 µg/ml za skupinu koja je primala standardnu dozu i 3,5 ± 2,2 µg/ml za skupinu koja je primala nisku dozu.
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: Hulio Dose for Paediatric Patients with Crohn's disease
Croatian: Tablica 4: Doza lijeka Hulio za pedijatrijske bolesnike s Crohnovom bolešću
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim 40 mg svaki tjedan, počevši od 4. tjedna) u bolesnika s gnojnim hidradenitisom, uz kontrolno razdoblje u trajanju od 12 do 16 tjedana, povišenja razine ALT-a ≥ 3 × GGN zabilježena su u 0,3% bolesnika liječenih adalimumabom i 0,6% bolesnika iz kontrolne skupine.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hulio treatment.
Croatian: Žene reproduktivne dobi trebaju razmotriti korištenje odgovarajuće kontracepcije kako bi spriječile trudnoću i trebale bi je nastaviti koristiti još najmanje pet mjeseci nakon posljednje doze lijeka Hulio.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Hulio.
Croatian: Bolesnici kojima je potrebna doza manja od 40 mg trebaju upotrebljavati pakiranje lijeka Hulio u bočici od 40 mg.
English: Hulio is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Croatian: Hulio je namijenjen liječenju ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza AS-a u odraslih.
English: • Take a single vial box out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
Croatian: • Izvadite kutiju s jednom bočicom iz hladnjaka najmanje 30 minuta prije namjeravane primjene da bi sadržaj mogao postići sobnu temperaturu.
English: The recommended dose of Hulio for patients with ankylosing spondylitis axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U bolesnika s ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza AS-a te u bolesnika sa psorijatičnim artritisom preporučena doza lijeka Hulio iznosi 40 mg adalimumaba, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: Table 18: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Croatian: Tablica 18: Udio bolesnikaa koji su postigli HiSCRb u 24. i 36. tjednu nakon preraspodjele liječenja u 12. tjednu, do kada su primali adalimumab svaki tjedan
English: Your doctor will test you for HBV. Hulio can reactivate HBV infection in people who carry this virus.
Croatian: Hulio može ponovno aktivirati infekciju HBV-om u nositelja virusa.
English: Pull the needle cover straight off the syringe.
Croatian: Povucite pokrov igle ravno sa štrcaljke.
English: Table 15: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II Double-Blind
Croatian: Tablica 15: Djelotvornost u placebom kontroliranom razdoblju ispitivanja nr axSpA II
English: TIME (WEEKS) Treatment
Croatian: VRIJEME (TJEDNI)
English: Table 22: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Croatian: Tablica 22: Udio bolesnikaa koji su postigli HiSCRb u 24. i 36. tjednu nakon preraspodjele liječenja u 12. tjednu, do kada su primali adalimumab svaki tjedan
English: With the vial adapter still in the clear package, attach it to the vial stopper by pushing the adapter over the vial until it snaps in place.
Croatian: Dok je nastavak za bočicu još u prozirnom pakiranju, pričvrstite ga za čep bočice tako da ga pritisnete na bočicu sve dok ne sjedne na svoje mjesto.
English: If these medicines do not work well enough, your child will be given Hulio to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Croatian: Ako ti lijekovi ne budu dovoljno djelotvorni, Vašem će djetetu za liječenje poliartikularnog juvenilnog idiopatskog artritisa ili artritisa povezanog s entezitisom biti propisan lijek Hulio.
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: Hulio is used to treat children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
Croatian: Hulio je namijenjen liječenju djece i adolescenata u dobi od 2 do 17 godina s kroničnim nezaraznim uveitisom kod kojeg upala zahvaća prednji dio oka.
English: Insert the syringe tip into the vial adapter and twist it clockwise until firmly attached.
Croatian: Umetnite vrh štrcaljke u nastavak za bočicu i zakrenite ga u smjeru kazaljke na satu dok ne bude dobro pričvršćen.
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/ml (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Croatian: S povećanjem koncentracija adalimumaba povećavale su se i stope odgovora PASI 75 i PGA rezultata „bez bolesti” ili „minimalno”, u oba slučaja uz sličan prividan EC50 od približno 4,5 µg/ml (95% CI: 0,4 - 47,6 odnosno 1,9 - 10,5).
English: Treatment with Hulio may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka Hulio mogu se razviti autoimuna protutijela.
English: What you need to know before you use Hulio
Croatian: Što morate znati prije nego
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: Hulio 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: Hulio 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: Table 10: ACR Responses in RA Study V (percent of patients)
Croatian: Tablica 10: ACR odgovori u ispitivanju RA V (postotak bolesnika)
English: Note: P = Placebo (Number at Risk); H = adalimumab (Number at Risk).
Croatian: - Adalimumab Napomena: P = Placebo (broj bolesnika pod rizikom); H = Adalimumab (broj bolesnika pod rizikom)
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Hulio.
Croatian: Obavijestite liječnika ako istodobno uz lijek Hulio uzimate azatioprin ili merkaptopurin.
English: Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.
Croatian: Jedna napunjena brizgalica namijenjena je samo za jednokratnu uporabu i sadrži dozu od 40 mg adalimumaba.
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Croatian: Istodobna primjena adalimumaba i drugih bioloških antireumatika koji modificiraju tijek bolesti (npr. anakinra i abatacept) ili drugih antagonista TNF-a se ne preporučuje zbog mogućeg povećanog rizika od razvoja infekcija, uključujući ozbiljne infekcije, i drugih potencijalnih farmakoloških interakcija (vidjeti dio 4.5).
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Croatian: * p<0,001 za adalimumab naspram placeba, sparena usporedba udjela ** p<0,02 za adalimumab naspram placeba, sparena usporedba udjela a onih koji su na početku uzimali kortikosteroide
English: Injecting Hulio
Croatian: Ubrizgavanje lijeka Hulio
English: Dose Preparation
Croatian: Priprema doze
English: It is also normal to see air bubble(s).
Croatian: Uobičajeni su i mjehurići zraka.
English: HS Study I
Croatian: Ispitivanje HS I
English: • Take a single pen out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
Croatian: • Izvadite jednu brizgalicu iz hladnjaka najmanje 30 minuta prije namjeravane primjene da bi sadržaj mogao postići sobnu temperaturu.
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 adalimumaba (40 mg svaka dva tjedna) te monoterapije metotreksatom na smanjenje simptoma i znakova te brzinu progresije oštećenja zglobova kod reumatoidnog artritisa.
English: • 1 gauze pad or cotton ball (not included in Hulio pack)
Croatian: • 1 tupfer ili vatica (nije priloženo u pakiranju lijeka Hulio)
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Croatian: Ako se za vrijeme liječenja ili nakon njega na koži jave nova oštećenja kože ili ako se postojeća oštećenja kože promijene, javite se svom liječniku.
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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL MULTIPACK (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - VIŠESTRUKO PAKIRANJE BOČICA (S PLAVIM OKVIROM)
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3±11.4 μg/ml (40/20 mg, weekly) and 6.7±3.5 μg/ml (20/10 mg, weekly).
Croatian: U bolesnika čija je učestalost doziranja povišena sa svaka dva tjedna na svaki tjedan, srednje vrijednosti (±SD) koncentracija adalimumaba u serumu u 52. tjednu bile su 15,3 ± 11,4 µg/ml (40/20 mg, tjedno) i 6,7 ± 3,5 µg/ml (20/10 mg, tjedno).
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 Hulio.
Croatian: • Ako bolujete ili obolite od demijelinizirajuće bolesti (bolesti koja zahvaća ovojnicu živaca), poput multiple skleroze, odluku o tome smijete li početi ili nastaviti primati lijek Hulio donijet će Vaš liječnik.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hulio.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom Hulio zbog moguće pojave infekcija, uključujući tuberkulozu.
English: Hulio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Croatian: Hulio je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih osoba u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje.