FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hulio.
Croatian: Bolesnike se mora upozoriti da se obrate liječniku ako se za vrijeme ili nakon liječenja lijekom Hulio pojave znakovi/simptomi koji upućuju na tuberkuloznu infekciju (npr. perzistirajući kašalj, progresivno propadanje/gubljenje težine, blago povišena tjelesna temperatura, bezvoljnost).
English: • If your child has or develops demyelinating disease (a disease that affects the insulating layer around the nerves), such as multiple sclerosis, your child's doctor will decide if he/she should receive or continue to receive Hulio.
Croatian: • Ako Vaše dijete boluje ili oboli od demijelinizirajuće bolesti (bolesti koja zahvaća ovojnicu živaca), poput multiple skleroze, odluku o tome smije li početi ili nastaviti primati lijek Hulio donijet će liječnik Vašeg djeteta.
English: Table 16: Ps Study IV Efficacy Results at 16, 26 and 52 weeks Endpoint
Croatian: Rezultati djelotvornosti u 16., 26. i 52. tjednu
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/ml for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 μg/ml for patients < 40 kg (80/40 mg).
Croatian: Srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u serumu u 4. tjednu bile su 15,7 ± 6,6 µg/ml u bolesnika tjelesne težine ≥ 40 kg (160/80 mg) i 10,6 ± 6,1 µg/ml u bolesnika tjelesne težine < 40 kg (80/40 mg).
English: The recommended dose of Hulio for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Croatian: Preporučena doza lijeka Hulio za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 4).
English: Hulio is also available as a pre-filled syringe or a pre-filled pen.
Croatian: Hulio je dostupan i u obliku napunjene štrcaljke ili napunjene brizgalice.
English: Hulio is for subcutaneous injection.
Croatian: Hulio se primjenjuje supkutanom injekcijom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Hulio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Hulio 40 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: Table 21: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Croatian: Tablica 21: Ispitivanje kod Crohnove bolesti u djecePrestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula
English: Hulio is used to treat: - adults with non-infectious uveitis with inflammation affecting the back of the eye. - 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 za liječenje: - odraslih osoba s nezaraznim uveitisom kod kojeg upala zahvaća stražnji dio oka - djece i adolescenata u dobi od 2 do 17 godina s kroničnim nezaraznim uveitisom kod kojeg upala zahvaća prednji dio oka.
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Croatian: Nakon drugog tjedna bolesnici u obje skupine liječene adalimumabom primali su 40 mg svaki drugi tjedan.
English: Patients demonstrating a Pediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Croatian: Bolesnici koji su u 16. tjednu pokazali pedijatrijski odgovor ACR 30 (American College of Rheumatology 30) mogli su biti randomizirani u dvostruko slijepu fazu ispitivanja i primiti ili 24 mg/m² adalimumaba, do maksimalne doze od 40 mg, ili placebo, svaki drugi tjedan kroz 32 tjedna ili do egzacerbacije bolesti.
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 80 mg u nultom tjednu, nakon kojih slijede doze od 40 mg svaki drugi tjedan, počevši od 1. tjedna) u odraslih bolesnika s uveitisom u trajanju do 80 tjedana, uz medijan izloženosti od 166,5 dana u bolesnika liječenih adalimumabom te 105,0 dana u bolesnika iz kontrolne skupine, povišenja razine ALT-a ≥ 3 × GGN zabilježena su u 2,4% bolesnika liječenih adalimumabom i 2,4% bolesnika iz kontrolne skupine.
English: For storage information, see the package leaflet.
Croatian: Za informacije o čuvanju, pogledajte uputu o lijeku.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hulio.
Croatian: Preporučuje se da bolesnik tijekom liječenja lijekom Hulio svakodnevno koristi topikalnu antiseptičku tekućinu za ispiranje lezija uzrokovanih gnojnim hidradenitisom.
English: Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Croatian: Hulio je indiciran za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalnu terapiju (vidjeti dio 5.1).
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Croatian: U ispitivanju UC-II 248 bolesnika primalo je adalimumab u dozi od 160 mg u nultom tjednu, 80 mg u drugom tjednu i zatim 40 mg svaka dva tjedna, a 246 bolesnika primalo je placebo.
English: Adalimumab 40 mg every other week N = 70
Croatian: Adalimumab 40 mg svaki drugi tjedan N=70
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007 2 vials (2 packs of 1)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1319/007 2 bočice (pakiranje s dva puta po jednom bočicom)
English: Table 8: ACR Responses in RA Study V (percent of patients)
Croatian: Tablica 8: ACR odgovori u ispitivanju RA V (postotak bolesnika) Odgovor
English: • inflammation of the liver;
Croatian: • zatajenje jetre,
English: • Take a single pre-filled syringe out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
Croatian: • Izvadite napunjenu štrcaljku iz hladnjaka najmanje 30 minuta prije namjeravane primjene da bi sadržaj mogao postići sobnu temperaturu.
English: • DO NOT put the clear needle cap back on the needle.
Croatian: • NE vraćajte prozirnu kapicu na iglu.
English: Each vial contains one 40 mg dose of adalimumab.
Croatian: Jedna bočica sadrži jednu dozu od 40 mg adalimumaba.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hulio injection.
Croatian: • Trebate razmotriti primjenu odgovarajuće kontracepcije kako biste spriječili trudnoću te biste je trebali nastaviti primjenjivati najmanje 5 mjeseci nakon zadnje injekcije lijeka Hulio.
English: The patients received 24 mg/m 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: The Hulio vial is a glass vial with a rubber stopper.
Croatian: Bočica lijeka Hulio staklena je bočica s gumenim čepom.
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Croatian: često astma, dispneja, kašalj manje često plućna emobolija1), intersticijska bolest pluća, kronična opstruktivna plućna bolest, pneumonitis, pleuralna efuzija1)
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Croatian: Tijekom liječenja adalimumabom može doći do stvaranja protutijela na adalimumab.
English: Follow the steps below carefully each time you inject Hulio:
Croatian: Pažljivo slijedite korake u nastavku pri svakom ubrizgavanju lijeka Hulio:
English: Time to Treatment Failure in Studies UV I and UV II
Croatian: Tablica 24: Vrijeme do neuspjeha liječenja u ispitivanjima UV I i UV II
English: Hulio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Croatian: Aksijalni spondiloartritis bez radiološkog dokaza AS-a Hulio je indiciran za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MRI), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: Put the used syringe, needle, vial and vial adapter in a sharps disposal container after use.
Croatian: Iskorištenu štrcaljku, iglu, bočicu i nastavak za bočicu stavite u spremnik za zbrinjavanje oštrih predmeta.
English: • Check the expiry date printed on the syringe.
Croatian: • Provjerite rok valjanosti otisnut na brizgalici.
English: a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Croatian: 36. tjedan a Bolesnici koji su ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan nakon 12 tjedana liječenja.
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your child's doctor.
Croatian: Ako se za vrijeme liječenja ili nakon njega na koži jave nova oštećenja kože ili ako se postojeća oštećenja kože promijene, obavijestite o tome liječnika svog djeteta.
English: For patients who are prescribed a full 40 mg dose of Hulio, a 40 mg pre-filled pen and a 40 mg prefilled syringe are also available from your pharmacist.
Croatian: Bolesnicima kojima je propisana puna doza lijeka Hulio od 40 mg u ljekarni je dostupna napunjena brizgalica od 40 mg i napunjena štrcaljka od 40 mg.
English: Hulio is used to treat moderate to severe plaque psoriasis in adults.
Croatian: Hulio je namijenjen liječenju umjerene do teške plak psorijaze u odraslih.
English: Step 15 - End of injection, remove syringe, engage needle cover When the syringe is empty, remove syringe and needle from the skin.
Croatian: Korak 15 - Završite s ubrizgavanjem, uklonite štrcaljku, vratite pokrov igle na mjesto
English: • Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after their last Hulio injection.
Croatian: • Vaše dijete treba razmotriti primjenu odgovarajuće kontracepcije kako bi spriječilo trudnoću te bi je trebalo nastaviti primjenjivati najmanje 5 mjeseci nakon zadnje injekcije lijeka Hulio.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/ml (79% CV).
Croatian: Nakon supkutano primijenjene doze od 0,8 mg/kg (do maksimalno 40 mg) svaki drugi tjedan u pedijatrijskih bolesnika s kroničnom plak psorijazom, srednja vrijednost ± SD najniže koncentracije adalimumaba u stanju dinamičke ravnoteže iznosila je približno 7,4 ± 5,8 µg/ml (79% CV).
English: Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Croatian: Bolesnici su bili randomizirani i primali su ili 24 mg/m² tjelesne površine adalimumaba do maksimalne doze od 40 mg ili placebo svaki drugi tjedan tijekom 12 tjedana.
English: Chest pain, oedema, pyrexia1)
Croatian: često bol u prsištu, edem, pireksija1
English: Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 weeks
Croatian: Tablica 13: Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and PASI ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Sigurnost i djelotvornost adalimumaba ispitivala se u odraslih bolesnika s kroničnom plak psorijazom (zahvaćeno ≥ 10% površine tijela i PASI rezultat ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
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: Preparing the pre-filled syringe
Croatian: Priprema napunjene brizgalice
English: Hulio can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Croatian: U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa lijek Hulio se može primijeniti i bez prethodnog liječenja metotreksatom.
English: Your doctor may prescribe another strength of Hulio if your child needs a different dose.
Croatian: Ako je Vašem djetetu potrebna drugačija doza, liječnik mu može propisati drugu jačinu lijeka Hulio.
English: Step 14 - Push plunger to inject solution Let go of the squeezed skin.
Croatian: Korak 14 - Pritisnite klip da biste ubrizgali otopinu Pustite kožu.
English: Place the Orange Activator end of the pen onto the injection site.
Croatian: Postavite kraj brizgalice s narančastom tipkom za aktivaciju na mjesto ubrizgavanja.
English: Hulio 40 mg/0.8 ml solution for injection adalimumab
Croatian: Hulio 40 mg/0,8 ml otopina za injekciju adalimumab
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Hulio je indiciran za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u adolescenata u dobi od 12 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa (vidjeti dijelove 5.1 i 5.2).
English: Hulio is used to treat ulcerative colitis in adults.
Croatian: Hulio je namijenjen liječenju ulceroznog kolitisa u odraslih.
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: o DO NOT put the pen back in the fridge after it has reached room temperature.
Croatian: ◦ NEMOJTE stavljati brizgalicu natrag u hladnjak nakon što dosegne sobnu temperaturu.
English: The recommended Hulio dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Croatian: Preporučena doza lijeka Hulio za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Hulio je indiciran za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u odraslih i adolescenata u dobi od 12 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa (vidjeti dijelove 5.1 i 5.2).
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Croatian: U ispitivanju CD II, 325 bolesnika koji su izgubili odgovor ili nisu podnosili terapiju infliksimabom randomizirani su u dvije skupine: jedna je primila 160 mg adalimumaba u nultom tjednu i 80 mg adalimumaba dva tjedna kasnije, a druga skupina je primila placebo u nultom tjednu i 2. tjednu.
English: • blockage in an artery of the lung;
Croatian: • blokada u plućnoj arteriji,
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: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Croatian: U ovoj otvorenoj uvodnoj fazi ispitivanja svi bolesnici su primali 24 mg/m² adalimumaba do maksimalne doze od 40 mg adalimumaba svaki drugi tjedan kroz 16 tjedana.
English: Hulio is used to treat psoriatic arthritis in adults.
Croatian: Hulio je namijenjen liječenju psorijatičnog artritisa u odraslih.
English: • There have been cases of cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Croatian: • U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNFα blokatore, prijavljeni su i drugačiji oblici tumora osim limfoma.
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: If you have any further questions on the use of this medicine, ask your child's doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku svog djeteta ili ljekarniku.
English: EU/1/18/1319/001 1 pack EU/1/18/1319/002 2 pack EU/1/18/1319/003 6 pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1319/001 pakiranje s jednom napunjenom štrcaljkom EU/1/18/1319/002 pakiranje s dvije napunjene štrcaljke EU/1/18/1319/003 pakiranje sa šest napunjenih štrcaljki
English: • It is important that you tell her baby's doctors and other health care professionals about her Hulio's use during her pregnancy before the baby receives any vaccine.
Croatian: • Važno je da liječnika njezina djeteta i druge zdravstvene radnike obavijestite o tome da je Vaša kći primjenjivala lijek Hulio u trudnoći prije nego što njezino dijete primi bilo kakvo cjepivo.
English: Abdomen or Thighs
Croatian: Trbuh (abdomen) ili bedra
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
Croatian: U odraslih bolesnika sa psorijazom, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže bila je 5 µg/ml tijekom primjene monoterapije dozom adalimumaba od 40 mg svaki drugi tjedan.
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika u dobi od 4 do 17 godina s poliartikularnim juvenilnim idiopatskim artritisom i u bolesnika u dobi od 6 do 17 godina s artritisom povezanim s entezitisom, povišenje ALT-a ≥ 3 × GGN zabilježeno je u 6,1% bolesnika liječenih adalimumabom i 1,3% bolesnika iz kontrolne skupine.
English: The usual dose regimen is 40 mg initially, followed by 20 mg two weeks later.
Croatian: Uobičajena početna doza je 40 mg, a zatim 20 mg nakon dva tjedna.
English: b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale
Croatian: b Među bolesnicima s procijenjenom početnom kožnom boli uzrokovanom gnojnim hidradenitisom
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hulio.
Croatian: Kod nezaraznog uveitisa se uz lijek Hulio mogu nastaviti primjenjivati kortikosteroidi ili drugi lijekovi koji utječu na imunološki sustav.
English: Viewing Window Fill Marker
Croatian: Prozorčić Oznaka napunjenosti
English: Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Croatian: Hulio je indiciran za liječenje kroničnog neinfektivnog anteriornog uveitisa u djece u dobi od 2 godine i starije u koje nije postignut zadovoljavajući odgovor na konvencionalno liječenje, koji ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno.
English: Solution for injection 1 pre-filled pen, 2 alcohol pads 2 pre-filled pens, 2 alcohol pads 6 pre-filled pens, 6 alcohol pads
Croatian: 1 napunjena štrcaljka, 2 jastučića natopljena alkoholom 2 napunjene štrcaljke, 2 jastučića natopljena alkoholom 6 napunjenih štrcaljki, 6 jastučića natopljenih alkoholom
English: At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Croatian: U četvrtom tjednu bolesnici su randomizirani u skupine koje su primale 40 mg svaki drugi tjedan, 40 mg svaki tjedan ili placebo kroz ukupno razdoblje ispitivanja od 56 tjedana.
English: • DO NOT inject into scars or stretch marks.
Croatian: • NEMOJTE ubrizgavati u područja na kojima ima ožiljaka i strija.
English: Table 9: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Croatian: Tablica 9: ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika)
English: Sustained Remission
Croatian: Održana remisija
English: 4.5 Interaction with other medicinal products and other forms of interaction Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Croatian: Djelovanje adalimumaba ispitivano je u bolesnika s reumatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom i psorijatičnim artritisom koji su dobivali adalimumab kao monoterapiju i u onih koji su istodobno uzimali i metotreksat.
English: Adalimumab 40 mg weekly N = 70
Croatian: Adalimumab 40 mg svaki tjedan N=70
English: At a 45° angle to the injection site, use a quick dart-like motion to insert the needle into the site.
Croatian: Držeći štrcaljku pod kutom od 45°, brzim kratkim pokretom gurnite iglu do kraja u mjesto ubrizgavanja.