FrancophonIA/ELRC3.0 huggingface dataset:
English: Adalimumab-treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Estonian: Adalimumabiga ravitud patsientidel esines, võrreldes platseeboga 24. ravinädalal, statistiliselt oluline paranemine füüsilises funktsioonis, hinnatuna HAQ ja tervise lühiküsimustiku (SF 36) alusel.
English: Serious adverse reactions have been reported for adalimumab.
Estonian: Adalimumabi kasutamisel on teatatud tõsistest kõrvaltoimetest.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Estonian: Adalimumabi kasutamisel on samuti teatatud surmaga lõppevatest ja eluohtlikest infektsioonidest (sh sepsis, oportunistlikud infektsioonid ja tuberkuloos), HBV reaktivatsioonist ja mitmesugustest vähkkasvajatest (sh leukeemia, lümfoom ja hepatospleeniline T-rakuline lümfoom).
English: SC
Estonian: NEc
English: • Merkel cell carcinoma (a type of skin cancer);
Estonian: • merkelirakk-kartsinoom (nahavähi tüüp);
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.
Estonian: Adalimumabi kontrolliga kliinilistes uuringutes (algannus 0-nädalal 160 mg ja 2. nädalal 80 mg, järgnevalt 40 mg igal nädalal, alates 4. nädalast) mädase hidradeniidiga patsientidel, kontrollperioodi kestusega 12...16 nädalani esines ALAT aktiivsuse suurenemine ≥ 3 korda üle normi ülemise piiri 0,3%-l adalimumabiga ja 0,6%-l kontrollravimiga ravitud patsientidel.
English: Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Estonian: Hefiya on näidustatud raske aktiivse anküloseeriva spondüliidi raviks täiskasvanutel, kelle ravivastus konventsionaalsele ravile on olnud ebapiisav.
English: There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Estonian: Adalimumabil puudub asjakohane kasutus alla 2-aastastel patsientidel antud näidustusel.
English: • Keep the syringes in the original carton until ready to use to protect from light.
Estonian: • Hoidke süstlaid originaalpakendis kuni kasutamiseni, valguse eest kaitstult.
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes
Estonian: süstelahus Mitmikpakend: 6 (3 kahest pakki) eeltäidetud süstalt
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Estonian: Kliinilistes uuringutes esines adalimumabi kasutamisega seotud tõsiseid allergilisi reaktsioone harva.
English: EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
Estonian: EU/1/18/1287/006 6 pensüstlit (3 kahest pakki)
English: Doses of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Estonian: Igal teisel nädalal manustati naha alla 20 või 40 mg adalimumabi, platseebot manustati vahepealsetel nädalatel või igal nädalal 26 nädala jooksul; platseebot manustati kord nädalas sama kaua.
English: Axial spondyloarthritis without radiographic evidence of AS
Estonian: Aksiaalne spondüloartriit ilma AS radioloogilise leiuta
English: Hefiya is indicated for treatment of moderately to severely active Crohn's disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Estonian: Hefiya on näidustatud mõõduka kuni raske aktiivse Crohni tõve raviks täiskasvanud patsientidel, kellel puudus ravivastus, vaatamata täielikule ja adekvaatsele ravikuurile kortikosteroidi ja/või immunosupressandiga või kes ei talu või kellel on meditsiinilised vastunäidustused selliste ravikuuride suhtes.
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.
Estonian: Hefiya 40 mg süstelahus üheannuselises eeltäidetud süstlas (I tüüpi klaas), millel on kummistopper ja roostevabast terasest nõel automaatse nõelakaitsega koos sõrmeääriku, kummist nõelakorgi ja plastist kolviga, sisaldab 0,8 ml lahust.
English: Hefiya is only available as 40 mg pre-filled syringe / pre-filled pen.
Estonian: Hefiya on saadaval ainult 40 mg eeltäidetud süstla / pensüstlina.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Estonian: Neist 37 patsienti (56,9%) saavutasid taas remissiooni (ASDAS < 1,3) 12 nädalat pärast avatud ravi taasalustamist.
English: It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Estonian: Tähtis on arsti informeerida sellest, kui teil tekivad infektsiooni sümptomid, näiteks palavik, haavad, väsimus või hambaprobleemid.
English: Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Estonian: Abiained: adipiinhape, sidrunhappe monohüdraat, naatriumkloriid, mannitool, polüsorbaat 80, vesinikkloriidhape, naatriumhüdroksiid ja süstevesi.
English: solution for injection 1 pre-filled syringe 2 pre-filled syringes
Estonian: süstelahus 1 eeltäidetud süstal 2 eeltäidetud süstalt
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Estonian: Kaplan-Meieri kõverad, mis võtavad kokku ravi ebaõnnestumiseni kulunud aja laste uveiidi uuringus
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.
Estonian: Kõik uuritavad said avatud induktsioonravi annuses, mis põhines nende ravi alguse kehamassil: 160 mg 0-nädalal ja 80 mg 2. nädalal uuritavatel kehamassiga ≥ 40 kg, ja vastavalt 80 mg ja 40 mg uuritavatel kehamassiga < 40 kg.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Estonian: Reumatoidartriidi, polüartikulaarse juveniilse idiopaatilise artriidi ja psoriaatilise artriidiga patsientidel on uuritud adalimumabi kasutamist nii monoteraapiana kui koos metotreksaadiga.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Estonian: Aktiivse anküloseeriva spondüliidiga 393 patsiendil, kelle vastus konventsionaalsele ravile oli olnud ebapiisav, hinnati adalimumabi toimet (40 mg igal teisel nädalal) kahes randomiseeritud, 24-nädalases topeltpimedas, platseebokontrolliga uuringus [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) oli kõikides gruppides 6,3].
English: The recommended dose of Hefiya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Estonian: Soovitatav adalimumabi annus Crohni tõvega patsientidele vanuses 6 kuni 17 aastat põhineb kehakaalul (tabel 4).
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Estonian: • turse(vedeliku kogunemine kehas, mis põhjustad mõjutatud koe paistetust);
English: • Keep your pen in the original carton until ready to use to protect from light.
Estonian: • Hoidke pensüstleid originaalpakendis kuni kasutamiseni, valguse eest kaitstult.
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Estonian: 79 patsienti 207-st, keda raviti 40 mg adalimumabiga igal teisel nädalal, hinnati radioloogiliselt 10. aastal.
English: Hefiya 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1287/001
Estonian: Hefiya 40 mg süstelahus nõelkaitsega eeltäidetud süstlas EU/1/18/1287/001
English: Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Estonian: Anakinra ja teise TNF-antagonisti, etanertsepti, samaaegsel kasutamisel täheldati kliinilistes uuringutes raskekujulisi infektsioone; täiendavat kliinilist kasu võrreldes etanertsepti eraldi manustamisega ei ilmnenud.
English: A similar safety profile was observed during retreatment as before withdrawal.
Estonian: Kordusravi ajal täheldati mitteravi eelsele perioodile sarnast ohutusprofiili.
English: Hefiya 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.
Estonian: Hefiya on näidustatud raske aksiaalse spondüloartriidi raviks täiskasvanutel, kellel ei ole AS-i radioloogilist leidu, kuid esinevad objektiivsed põletikuleiud (CRV tõus ja/või MRI leid) ja kellel mittesteroidsete põletikuvastaste ravimitega ei saavutata piisavat ravivastust või kellel esineb talumatus nende ravimite suhtes.
English: Thirty-three (18 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79 %) patients with NSAIDs at baseline.
Estonian: Uuringu alustamisel sai 33 patsienti (18%) samaaegset ravi haigust moduleerivate antireumaatiliste ravimitega ja 146 patsienti (79%) said MSPVA-sid.
English: Elderly
Estonian: Eakad
English: • inflammation of the skin (such as eczema);
Estonian: • nahapõletik (nagu ekseem);
English: Patients on Hefiya may receive concurrent vaccinations, except for live vaccines.
Estonian: Patsientidele, kes kasutavad Hefiya'i, võib samaaegselt manustada ka vaktsiine (v.a elusvaktsiine).
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Estonian: Reumatoidartriidi, psoriaatilise artriidi, anküloseeriva spondüliidi või anküloseeriva spondüliidi radioloogilise leiuta aksiaalse spondüloartriidiga täiskasvanud Tavaline annus reumatoidartriidi, anküloseeriva spondüliidi ja anküloseeriva spondüliidi radioloogilise leiuta aksiaalse spondüloartriidiga täiskasvanutele ja psoriaatilise artriidiga patsientidele on 40 mg adalimumabi, mis manustatakse ühekordse annusena iga kahe nädala järel.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Estonian: CRV sisalduse kiiret langust pärast adalimumabiga ravi täheldati ka polüartikulaarse juveniilse idiopaatilise artriidi, Crohni tõve, haavandilise koliidi ja mädase hidradeniidiga patsientidel.
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Estonian: Pärast 2. nädalat said mõlema adalimumabi grupi patsiendid 40 mg adalimumabi igal teisel nädalal.
English: Mean steady-state trough levels of approximately 8 µg / ml were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week.
Estonian: Keskmist tasakaalukontsentratsiooni minimaalset taset ligikaudu 8 μg/ml täheldati haavandilise koliidiga patsientidel, kes said säilitusannust 40 mg adalimumabi igal teisel nädalal.
English: Pharmacodynamic effects
Estonian: Farmakodünaamilised omadused
English: Cartons contain 1 and 2 pre-filled pens of Hefiya.
Estonian: Pakendid sisaldavad 1 ja 2 eeltäidetud Hefiya'i pensüstlit.
English: Your Hefiya single-use pre-filled SensoReady pen
Estonian: Teie Hefiya'i ühekordne SensoReady pensüstel
English: Children and adolescents from 2 years of age weighing less than 30 kg
Estonian: Lapsed ja noorukid alates vanusest 2 aastat, kehakaaluga alla 30 kg
English: Hefiya is used to treat psoriatic arthritis in adults.
Estonian: Hefiya'i kasutatakse psoriaatilise artriidi raviks täiskasvanutel.
English: Immunogenicity
Estonian: Immunogeensus
English: At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Estonian: 81 patsienti 207-st, keda raviti 40 mg adalimumabiga igal teisel nädalal, hinnati radioloogiliselt 8. aastal.
English: Placebo
Estonian: Platseebo
English: adalimumab 40 mg weekly N = 70
Estonian: adalimumab 40 mg igal nädalal N = 70
English: • intestinal perforation (hole in the wall of the gut);
Estonian: • soolemulgustus (auk soole seinas);
English: Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Estonian: Pärast Hefiya'i manustamist võib tekkida peapööritus ja nägemine halveneda (vt lõik 4.8).
English: If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.
Estonian: Kui on tarvis kiiremat ravivastust, võib teie arst määrata annuse 80 mg ravi alguses (kahe 40 mg süstena ühel päeval), millele järgneb 40 mg kahe nädala pärast.
English: How to store Hefiya
Estonian: Kuidas Hefiya'i säilitada
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Estonian: Lümfoomide esinemissagedus (95% usaldusvahemik) oli 0,7 juhtu (0,2; 2,7) 1000 patsientaasta kohta adalimumabi saanud patsientidel ja 0,6 juhtu (0,1; 4,5) 1000 patsientaasta kohta kontrollgrupi patsientidel.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hefiya.
Estonian: Mitmikpakendid sisaldavad 6 (3 kahest pakki) Hefiya'i pensüstlit.
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).
Estonian: Soovitatav on kord aastas hinnata jätkuva pikaajalise ravi kasu/riski suhet (vt lõik 5.1).
English: Night sweats, scar
Estonian: Öine higistamine, armid
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.
Estonian: Nendest nahavähkidest täheldati lamerakulisi kartsinoome esinemissagedusega (95% usaldusvahemik) 2,7 juhtu (1,4; 5,4) 1000 patsientaasta kohta adalimumabi saanud patsientidel ja 0,6 juhtu (0,1; 4,5) 1000 patsientaasta kohta kontrollgrupi patsientidel.
English: Hefiya 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.
Estonian: Hefiya on näidustatud mõõduka kuni raske aktiivse Crohni tõve raviks lastel (alates 6 aasta vanusest), kelle ravivastus konventsionaalsele ravile, sh esmasele toitumisteraapiale ning kortikosteroididele ja/või immunomodulaatoritele on ebapiisav või kes ei talu või kellel on vastunäidustus selliste ravikuuride suhtes.
English: Correct
Estonian: Õige
English: Hypertension, flushing, haematoma
Estonian: Hüpertensioon, õhetus, hematoom
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Estonian: Reumatoidartriit on liigeste põletikuline haigus.
English: 6.6 Special precautions for disposal
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2-< 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Estonian: Adalimumabi ohutust ja efektiivsust hinnati avatud mitmekeskuselises uuringus 32-l mõõduka kuni raske aktiivse polüartikulaarse JIA diagnoosiga lapsel (vanuses 2 kuni < 4 eluaastat või 4 eluaastat ja vanemad, kehakaaluga < 15 kg).
English: In these trials, 11.9 % of patients treated with adalimumab and 8.1 % of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Estonian: Nendes uuringutes täheldati 24. nädalal antinukleaarsete antikehade positiivseid tiitreid 11,9% adalimumabi saanud ja 8,1% platseebot ja kontrollravimit saanud patsientidest, kellel antikehad enne uuringut puudusid.
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Estonian: Adalimumabi kontrolliga III faasi uuringutes reumatoidartriidi ja psoriaatilise artriidiga patsientidel, mille kontrollperioodi kestus oli vahemikus 4…104 nädalat, esines ALAT aktiivsuse suurenemine ≥ 3 korda üle normi ülemise piiri 3,7% adalimumabiga ja 1,6% kontrollravimiga ravitud patsientidel.
English: Figure E: choose your injection site
Estonian: Joonis E: valige süstekoht
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.
Estonian: Psoriaasiga täiskasvanud patsientidel oli keskmine madalaim tasakaalukontsentratsioon 5 μg/ml adalimumab monoteraapia 40 mg igal teisel nädalal ravikuuri ajal.
English: Hefiya 40 mg / 0.8 ml injection adalimumab SC
Estonian: Hefiya 40 mg / 0,8 ml süstelahus adalimumab s.c.
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg / ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg / ml with concomitant methotrexate.
Estonian: Pärast igal teisel nädalal subkutaanse 24 mg/m2 (kuni maksimaalselt 40 mg) manustamise järgselt mõõdeti entesiidiga seotud artriidiga 6...17-aastastel patsientide adalimumabi keskmised minimaalsed tasakaalukontsentratsioonid seerumis (määratuna 24. nädalal), mis olid ilma samaaegse metotreksaadita adalimumab-ravi korral 8,8 ± 6,6 μg/ml ja samaaegse metotreksaatravi korral 11,8 ± 4,3 μg/ml.
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.
Estonian: Entesiidiga seotud artriidiga lapsed, noorukid ja täiskasvanud Lapsed, noorukid ja täiskasvanud alates vanusest 6 aastat, kehakaaluga 30 kg või rohkem Soovitatav Hefiya'i annus on 40 mg igal teisel nädalal.
English: In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumabtreated patients and 1.8 % of control-treated patients.
Estonian: Adalimumabi kontrolliga III faasi uuringutes naastulise psoriaasiga patsientidel, mille kontrollperioodi kestus oli vahemikus 12…24 nädalat, esines ALAT aktiivsuse suurenemine ≥ 3 korda üle normi ülemise piiri 1,8% adalimumabiga ja 1,8% kontrollravimiga ravitud patsientidest.
English: Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Estonian: Adalimumabi manustamise järgselt on teatatud tõsistest allergilistest reaktsioonidest, sh anafülaksiast.
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Hefiya.
Estonian: Enne Hefiya'i süstimist lugege, mõistke ja järgige antud juhiseid.
English: Hefiya 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.
Estonian: Hefiya on näidustatud kroonilise mitteinfektsioosse anterioorse uveiidi raviks lastel alates 2 aasta vanusest, kelle ravivastus konventsionaalsele ravile on ebapiisav, kes ei ole talunud konventsionaalset ravi või kellele konventsionaalne ravi ei sobi.
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Estonian: 12. ravinädalal saavutas platseeboga võrreldes oluliselt suurem hulk adalimumabiga ravitud patsiente HiSCR-i.
English: You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds.
Estonian: Suruge vatitups või marli süstekohale ja hoidke 10 sekundit.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Estonian: Bioloogilis(t)e toimeaine(te) tootja(te) nimi (nimed) ja aadress(id)
English: week 24 week 36 a patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Estonian: 24. nädal 36. nädal a Patsiendid, kellel esines pärast 12 ravinädalat vähemalt osaline ravivastus raviskeemile adalimumab 40 mg igal nädalal.
English: clinical remission clinical response week 52
Estonian: 26. nädal kliiniline paranemine kliiniline ravivastus
English: Hefiya is administered by injection under the skin (by subcutaneous injection).
Estonian: Hefiya'i manustatakse süstena naha alla (subkutaanse süstena).
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Estonian: Patsientidel, keda ravitakse TNFantagonistidega, sh adalimumabiga, on teatatud ka melanoomist ja merkelirakk-kartsinoomist (vt lõik 4.8).
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.
Estonian: Adalimumabi III faasi kontrolliga uuringutes juveniilse polüartikulaarse idiopaatilise artriidiga 4...17-aastastel patsientidel ja entesiidiga seotud artriidiga 6...17-aastastel patsientidel esines ALAT aktiivsuse suurenemine ≥ 3 korda üle normi ülemise piiri 6,1% adalimumabiga ravi saanutest ja 1,3% kontrollrühma patsientidest.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hefiya (see section 4.4).
Estonian: Enne Hefiya'iga ravi alustamist soovitatakse silmaarstidel nõu pidada vastava eriarstiga (vt lõik 4.4).
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Estonian: Anküloseeriv spondüliit, radioloogilise AS leiuta aksiaalne spondüloartriit ja psoriaatiline artriit
English: adalimumab 40 mg every other week N = 70
Estonian: adalimumab 40 mg igal teisel nädalal N = 70