FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Hefiya.
Croatian: Kirurški ili stomatološki zahvati • Ako se spremate podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, molimo da svog liječnika obavijestite o tome da primjenjujete lijek Hefiya.
English: Disposing of used pens:
Croatian: Zbrinjavanje korištenih brizgalica:
English: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Croatian: Vrlo često Infekcije dišnih putova (uključujući infekcije donjih i gornjih dišnih putova, pneumoniju, sinusitis, faringitis, nazofaringitis i pneumoniju uzrokovanu virusom herpesa)
English: It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Pritom liječnici koji propisuju lijek trebaju imati na umu da tuberkulinski kožni test može dati lažno negativne rezultate, pogotovo u teško bolesnih ili imunokompromitiranih bolesnika.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for controltreated patients.
Croatian: U dvostruko slijepim, kontroliranim dijelovima pivotalnih ispitivanja, liječenje je zbog štetnih događaja prekinuto u 5,9% bolesnika koji su dobivali adalimumab, odnosno 5,4% bolesnika iz kontrolne skupine.
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli s poliartikularnim juvenilnim idiopatskim artritisom Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Hefiya je 40 mg svaki drugi tjedan.
English: • inflammation of the eye lid and eye swelling;
Croatian: • upala očnog kapka i oticanje oka,
English: Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Croatian: U obje skupine su zabilježena statistički značajna povećanja (poboljšanja) indeksa tjelesne mase i brzine rasta u 26. i 52. tjednu u odnosu na početne vrijednosti.
English: Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki za jednokratnu primjenu Hefiya se isporučuje u prozirnoj napunjenoj štrcaljki za jednokratnu primjenu (staklo tipa I), s gumenim čepom i iglom od nehrđajućeg čelika s automatskim štitnikom za iglu s hvatištem za prste, gumenim zatvaračem igle i plastičnim klipom, a koja sadrži 0,8 ml otopine.
English: ACR 50 6 months
Croatian: ACR 50
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Croatian: Prijavljeni su i rijetki slučajevi hepatospleničnog T-staničnog limfoma u bolesnika liječenih adalimumabom nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: The patients received 24 mg / m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Croatian: Bolesnici su primali 24 mg/m2 tjelesne površine adalimumaba, do maksimalne doze od 20 mg, svaki drugi tjedan kao pojedinačnu dozu s.c. injekcijom kroz najmanje 24 tjedna.
English: week 4 clinical remission clinical response (CR
Croatian: 4. tjedan klinička remisija klinički odgovor (CR-100)
English: Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Croatian: uzrokovane bakterijama, mikobakterijama, invazivnim gljivicama, parazitima, virusima, ili druge oportunističke infekcije poput listerioze, legioneloze i pneumocistisa.
English: • shortness of breath with exertion or upon lying down or swelling of the feet.
Croatian: • otežano disanje, gutanje, • nedostatak zraka u naporu ili nakon lijeganja ili oticanje stopala.
English: Your Hefiya single-use pre-filled syringe with needle guard and add-on finger flange
Croatian: Vaša jednokratna napunjena štrcaljka lijeka Hefiya sa štitnikom igle i dodatnim hvatištem za prste
English: 40 mg adalimumab every week week 26
Croatian: 40 mg adalimumaba svaki tjedan
English: Crohn's disease is an inflammatory disease of the gut.
Croatian: Crohnova bolest je upalna bolest crijeva.
English: • Keep the syringes in the original carton until ready to use to protect from light.
Croatian: • Štrcaljke čuvati u originalnoj kutiji dok niste spremni za primjenu radi zaštite od svjetlosti.
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Croatian: *** p < 0,001 za sve usporedbe adalimumaba s placebom * p < 0,05 za sve usporedbe adalimumaba s placebom N/P nije primjenjivo
English: • pulmonary embolism (blockage in an artery of the lung);
Croatian: • plućna embolija (blokada u plućnoj arteriji),
English: Psoriatic arthritis
Croatian: Psorijatični artritis
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Croatian: • simptomi problema sa živcima kao što su trnci, utrnulost, dvoslike ili slabost u rukama ili nogama,
English: Sodium content
Croatian: Sadržaj natrija
English: It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Croatian: Važno je da liječnika obavijestite ako razvijete simptome infekcije, kao što su vrućica, rane, osjećaj umora i problemi sa zubima.
English: Hypertension, flushing, haematoma
Croatian: Hipertenzija, navale crvenila, hematomi
English: Ulcerative colitis
Croatian: Ulcerozni kolitis
English: • ulcerative colitis and
Croatian: • ulceroznog kolitisa i
English: Ulcerative colitis is an inflammatory disease of the bowel.
Croatian: Ulcerozni kolitis je upalna bolest crijeva.
English: System Organ Class
Croatian: Organski sustav
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: • Hefiya pre-filled SensoReady pen/s (see Figure A).
Croatian: • Napunjena/e brizgalica/e SensoReady s lijekom Hefiya (vidjeti Sliku A).
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Croatian: Aktivna tuberkuloza ili druge teške infekcije, poput sepse, i oportunističke infekcije (vidjeti dio 4.4).
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Croatian: Jave li se za trajanja ili nakon liječenja simptomi tuberkuloze (uporan kašalj, gubitak tjelesne težine, bezvoljnost, blaga vrućica) ili neke druge infekcije, javite odmah svom liječniku.
English: Adalimumab / methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 9).
Croatian: Radiografski nalazi u bolesnika liječenih kombinacijom adalimumaba i metotreksata pokazali su znatno sporiju progresiju strukturnih oštećenja zglobova nego u bolesnika liječenih samo metotreksatom tijekom 6 i 12 mjeseci (vidjeti tablicu 9).
English: ASAS partial remission BASDAIb 50
Croatian: BASDAIb 50
English: • never leave the syringe unattended where others might tamper with it.
Croatian: • nikada ne ostavljajte brizgalicu bez nadzora radi zaštite od nestručnog rukovanja.
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Croatian: Napomena: P = Placebo (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]); A = Adalimumab (Broj bolesnika pod rizikom [bolesnici s egzacerbacijom]).
English: • haematoma (a solid swelling with clotted blood);
Croatian: • hematomi (tvrdo oteknuće sa zgrušanom krvi),
English: Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was administered every other week up to 10 years.
Croatian: Po završetku prva 104 tjedna, 497 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem adalimumab u dozi od 40 mg primjenjivala svaka dva tjedna tijekom razdoblja do 10 godina.
English: Hefiya 40 mg solution for injection in single-use pre-filled SensoReady pen Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj SensoReady brizgalici za jednokratnu primjenu Hefiya se isporučuje u napunjenoj štrcaljki za jednokratnu primjenu uloženoj u brizgalicu trokutastog oblika s prozirnim prozorčićem i naljepnicom (SensoReady brizgalica).
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Croatian: Poboljšanje rezultata u broju aktivnih zglobova s artritisom održalo se tijekom otvorenog razdoblja do 156. tjedna ispitivanja za 26 od 31 (84%)
English: No other disease-modifying anti-rheumatic drugs were allowed.
Croatian: Bolesnici nisu smjeli uzimati nikakve druge antireumatske lijekove koji modificiraju tijek bolesti.
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn's disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Croatian: Djelotvornost i sigurnost adalimumaba ispitivane su u multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju indukcijske terapije i terapije održavanja dozama ovisnim o tjelesnoj težini (< 40 kg ili ≥ 40 kg) u 192 pedijatrijska ispitanika u dobi između (i uključujući) 6 i 17 godina s umjerenom do teškom Crohnovom bolešću (engl.
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab / methotrexate combination therapy, respectively.
Croatian: U otvorenom produžetku ispitivanja RA V, srednja vrijednost promjene ukupnog zbroja bodova prema modificiranoj Sharpovoj ljestvici od početka ispitivanja do 10. godine iznosila je 10,8 u bolesnika izvorno randomiziranih za monoterapiju metotreksatom, 9,2 u bolesnika izvorno randomiziranih za monoterapiju adalimumabom te 3,9 u bolesnika izvorno randomiziranih za liječenje kombinacijom adalimumaba i metotreksata.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during an 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: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Croatian: Svi ispitanici su primali otvorenu indukcijsku terapiju u dozi određenoj prema njihovoj početnoj tjelesnoj težini: 160 mg u nultom tjednu i 80 mg u drugom tjednu za ispitanike tjelesne težine ≥ 40 kg, odnosno 80 mg i 40 mg za ispitanike tjelesne težine < 40 kg.
English: • Keep your pen in the original carton until ready to use to protect from light.
Croatian: • Brizgalicu čuvati u originalnoj kutiji dok niste spremni za primjenu radi zaštite od svjetlosti.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Croatian: Reumatoidni artritis je upalna bolest zglobova.
English: Hefiya is administered by subcutaneous injection.
Croatian: Hefiya se primjenjuje supkutanom injekcijom.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Croatian: pozitivan nalaz testa na autoprotutijela (uključujući protutijela na dvolančanu DNK), povišena laktat dehidrogenaza u krvi
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Croatian: što pokazuje omjer hazarda (HR = 0,25 [95% CI: 0,12; 0,49]).
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: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte / macrophages, and neutrophils.
Croatian: U ispitivanju 64 bolesnika s reumatoidnim artritisom liječena adalimumabom nije zabilježeno smanjenje odgođene preosjetljivosti, sniženje razina imunoglobulina niti promjene broja efektorskih T
English: HS study I
Croatian: ispitivanje HS I
English: The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned.
Croatian: Pri planiranju operacija treba voditi računa o dugom poluvijeku adalimumaba.
English: 12 months
Croatian: 6 mjeseci 12 mjeseci
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Croatian: Procjenu rizika otežava i inače povećani rizik od razvoja limfoma i leukemije u bolesnika s reumatoidnim artritisom s dugotrajnom, izrazito aktivnom upalnom bolešću.
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year vs. 0.22 per patient year.
Croatian: Broj hospitalizacija zbog bilo kojeg uzroka u skupini liječenoj adalimumabom bio je 0,18 po bolesnik-godini u odnosu na 0,26 po bolesnik-godini u skupini koja je primala placebo,
English: Figure I: hold the syringe
Croatian: Slika I: držite štrcaljku
English: Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg / m2 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/m2 adalimumaba, do maksimalne doze od 40 mg, ili placebo, svaki drugi tjedan kroz 32 tjedna ili do ponovne reaktivacije bolesti.
English: Patients on Hefiya may receive concurrent vaccinations, except for live vaccines.
Croatian: Bolesnici koji primaju lijek Hefiya mogu istodobno primiti cjepiva, ali ne živa cjepiva.
English: If these medicines do not work well enough, patients will be given Hefiya to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, u svrhu liječenja poliartikularnog juvenilnog idiopatskog artritisa ili artritisa povezanog s entezitisom bolesnicima će biti propisan lijek Hefiya.
English: d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
Croatian: <0,001c rezultat za eroziju JSNd rezultat a metotreksat b razlike između metotreksata i adalimumaba s obzirom na promjene ukupnog zbroja bodova na razini intervala pouzdanosti od 95%
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Croatian: Preporučuje se svake godine ocijeniti omjer koristi i rizika kontinuiranog dugotrajnog liječenja (vidjeti dio 5.1).
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Croatian: Slika 3: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u ispitivanju liječenja uveitisa u djece
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: Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli s artritisom povezanim s entezitisom Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Hefiya je 40 mg svaki drugi tjedan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: • Store your pen within the carton in a refrigerator, between 2°C to 8°C.
Croatian: • Čuvajte brizgalicu u kutiji u hladnjaku na temperaturi od 2°C do 8°C.
English: • Do not give Hefiya to children with polyarticular juvenile idiopathic arthritis below the age of
Croatian: • Nemojte davati Hefiya djeci s poliartikularnim juvenilnim idiopatskim artritisom mlađoj od 2 godine.
English: • Press your pen firmly against the skin to start the injection (see
Croatian: • Pritisnite brizgalicu čvrsto na kožu da biste započeli injekciju (vidjeti Sliku H).
English: Sarcoidosis1), vasculitis
Croatian: Manje često Sarkoidoza1), vaskulitis
English: Women of child bearing potential
Croatian: Žene reproduktivne dobi
English: Chest pain, oedema, pyrexia1)
Croatian: Bol u prsištu, edem pireksija1)
English: ***, ** statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Croatian: ***, ** Statistički značajno kod p < 0,001 odnosno p < 0,01 za sve usporedbe adalimumaba s placebom.
English: 10 kg to < 30 kg ≥ 30 kg
Croatian: 10 kg do < 30 kg ≥ 30 kg
English: Figure D: choose your injection site
Croatian: Slika D: odaberite mjesto primjene injekcije
English: It is only available as 40 mg pre-filled syringe and / or as 40 mg pre-filled pen.
Croatian: Dostupan je samo kao napunjena štrcaljka od 40 mg ili kao napunjena brizgalica od 40 mg.
English: The rate (95 % confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient years among control patients.
Croatian: Stopa nemelanomskih 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: Your Hefiya single-use pre-filled SensoReady pen
Croatian: Vaša jednokratna napunjena brizgalica SensoReady s lijekom Hefiya
English: Hefiya 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 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Hefiya je indiciran za liječenje umjerenog do teškog oblika aktivnog ulceroznog kolitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), ili koji ne podnose ili kod kojih postoje medicinske kontraindikacije za takve terapije.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hefiya.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom Hefiya zbog moguće pojave infekcija, uključujući tuberkulozu.
English: Children and adolescents from 6 to 17 years of age weighing less than 40 kg
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine manje od 40 kg
English: Figure E: choose your injection site
Croatian: Slika E: odaberite mjesto primjene injekcije
English: Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Croatian: Izloženost adalimumabu u adolescentnih bolesnika s gnojnim hidradenitisom predviđena je uz pomoć populacijskog farmakokinetičkog modeliranja i simulacije na temelju farmakokinetike u ostalim indikacijama u drugih pedijatrijskih bolesnika (psorijaza u djece, juvenilni idiopatski artritis, Crohnova bolest u djece i artritis povezan s entezitisom).
English: • breaking of finger nails and toe nails;
Croatian: • lomljenje noktiju,
English: If these medicines do not work well enough, you will be given Hefiya to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete lijek Hefiya kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: • eye infections;
Croatian: • infekcije oka,
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 adalimumabtreated 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 x GGN zabilježena su u 0,3% bolesnika liječenih adalimumabom i 0,6% bolesnika iz kontrolne skupine.
English: Treatment with Hefiya may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka Hefiya mogu se razviti autoimuna protutijela.