FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2).
Danish: Der foreligger ingen kliniske data om brugen af en adalimumab-induktionsdosis til børn < 6 år (se pkt.
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.
Danish: Alle doser/skemaer for adalimumab i alle fire studier viste statistisk signifikant større forbedring ifølge HAQ's fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i RA-studie III blev det samme set efter 52 uger.
English: Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Danish: Nogle patienter, som ikke har responderet ved uge 4, kan have fordel af fortsat vedligeholdelsesbehandling i 12 uger.
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Danish: Figur 3: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis studie
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 %).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede fra “let” (<1 %) til “moderat” (48 %), “svær” (46 %) og “meget svær” (6 %).
English: There are no clinical trials with adalimumab in adolescent patients with HS.
Danish: Der er ikke udført kliniske studier med adalimumab hos unge patienter med HS.
English: Hefiya is intended for the treatment of the following inflammatory diseases:
Danish: Hefiya er beregnet til behandlingen af de inflammatoriske sygdomme beskrevet nedenfor:
English: Ulcerative colitis
Danish: Colitis ulcerosa
English: Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Danish: Sjældne post-marketing tilfælde af hepatosplenisk T-cellelymfom er blevet identificeret hos patienter, der blev behandlet med adalimumab.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hefiya.
Danish: Det anbefales, at patienten vasker sine HS-læsioner dagligt med topikal antiseptisk vask under Hefiya-behandlingen.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab / methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab monotherapy (50.7 %, p < 0.002 and 44.5 %, p < 0.001 respectively).
Danish: Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Total Sharp Score ≤ 0,5) signifikant højere med adalimumab/methotrexat-kombinationsterapi (henholdsvis 63,8 % og 61,2 %) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4 % og 33,5 %, p<0,001) og adalimumab-monoterapi (henholdsvis 50,7 %, p<0,002 og 44,5 %, p<0,001).
English: Preclinical data on postnatal toxicity of adalimumab are not available (see section 5.3).
Danish: Prækliniske data for adalimumab om postnatal toksicitet findes ikke (se pkt.
English: Patients were then re-treated with adalimumab 0.8 mg / kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Danish: Patienterne blev herefter genbehandlet med adalimumab 0,8 mg/kg hver anden uge i yderligere 16 uger, og responsraterne, som blev observeret under genbehandlingen, var sammenlignelige med responsraterne i den tidligere dobbeltblindede periode: PASI 75-respons på 78,9 % (15 ud af 19 forsøgspersoner) og PGA clear eller minimal på 52,6% (10 ud af 19 forsøgspersoner).
English: Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Danish: Patienter, der opretholdt ≥ PASI 75-respons ved uge 33, og som oprindeligt var randomiseret til aktiv behandling i periode A, blev randomiseret igen i periode C til at få enten 40 mg adalimumab hver anden uge eller placebo i yderligere 19 uger.
English: ***, ** statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Danish: ***, ** Statistisk signifikant ved henholdsvis p < 0,001 og < 0,01 ved alle sammenligninger af adalimumab og placebo.
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Danish: RA-studie IV vurderede primært sikkerheden hos 636 patienter, der var ≥18 år, med moderat til alvorlig aktiv reumatoid artrit.
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6 % (5 / 192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Danish: I fase 3-studiet med adalimumab hos patienter med pædiatrisk Crohns sygdom, der evaluerede effekten og sikkerheden af to vedligeholdelsesdosisregimer tilpasset legemsvægt (efter induktionsbehandling tilpasset legemsvægt) i op til 52 ugers behandling, forekom ALAT-stigninger ≥ 3 x ULN hos 2,6 % (5/192) af patienterne, hvoraf 4 havde fået samtidig behandling med immunsuppressiva ved baseline.
English: In Psoriasis Study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Danish: I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo i uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et <PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5%, som fortsatte på adalimumab (p< 0,001).
English: • systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
Danish: • systemisk lupus erythematosus (en immunforstyrrelse, der indbefatter betændelse i huden,
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
Danish: • sæklignende udposning på væggen af en større pulsåre (aneurisme), betændelse og blodprop i en blodåre, tilstopning af et blodkar
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et randomiseret, dobbeltblindet multicenterstudie med parallelgrupper med 171 børn (4-17 år) med polyartikulær JIA.
English: • sensation of heart beating rapidly;
Danish: • fornemmelse af hurtige hjerteslag
English: Patients induced with 160 / 80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 9 % respectively, p = 0.019).
Danish: I forhold til placebo opnåede en statistisk signifikant større procentdel af de patienter, der blev induceret med 160/80 mg adalimumab, klinisk remission i uge 8 (studie UC-I: henholdsvis 18 % og 9 %, p=0,031; studie UC-II: henholdsvis 17 % og 9 %, p=0,019).
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.
Danish: Ved uge 4 blev patienterne randomiseret til 40 mg hver anden uge, 40 mg hver uge eller placebo gennem hele studieforløbet på 56 uger.
English: • 160 mg at week 0 and 80 mg at week 2
Danish: • 160 mg i uge 0 og 80 mg i uge 2
English: Your healthcare provider should show you how to prepare and inject Hefiya properly using the pre-filled syringe before you use it for the first time.
Danish: Din læge viser dig, hvordan du skal forberede og injicere Hefiya korrekt med den fyldte injektionssprøjte, inden du bruger det for første gang.
English: • low blood measurements for white blood cells, red blood cells and platelet count.
Danish: • nedsat antal hvide blodlegemer, røde blodlegemer og blodplader.
English: 2 pre-filled pens (SensoReady) Component of a multipack, cannot be sold separately.
Danish: Injektionsvæske, opløsning 2 fyldte penne (SenseReady) Del af multipakning, kan ikke sælges separat.
English: Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy.
Danish: Antistofdannelsen var lavere ved adalimumab i kombination med methotrexat i forhold til ved behandling med adalimumab alene.
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab.
Danish: I sjældne tilfælde er der set en alvorlig type af lymfom hos patienter, som tog adalimumab.
English: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Danish: Meget almindelig Luftvejsinfektioner (inklusive nedre og øvre luftvejsinfektioner, pneumoni, sinuitis, pharyngitis, nasopharyngitis og viral herpespneumoni)
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.
Danish: Doser på 20 eller 40 mg adalimumab blev givet ved subkutan injektion hver anden uge med placebo i de øvrige uger eller hver uge i 26 uger; placebo blev givet hver uge i samme periode.
English: Table 23 induction of clinical remission and response (percent of patients) CD study I: infliximab-naive patients
Danish: Tabel 23 Induktion af klinisk remission og respons (procent af patienterne) CD-studie I: Infliximab-naive patienter CD-studie II: Infliximaberfarne patienter placebo N=74
English: The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks.
Danish: De gennemsnitlige dal-koncentrationer blev opretholdt hos patienter, som fortsatte med at få adalimumab-behandling hver anden uge i 52 uger.
English: Package leaflet: Information for the patient Hefiya 40 mg solution for injection in pre-filled syringe adalimumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Hefiya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte adalimumab Dette lægemiddel er underlagt supplerende overvågning.
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for bortskaffelse
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Danish: RA-studie III evaluerede 619 patienter, der var ≥18 år, med moderat til alvorlig aktiv reumatoid artrit, som havde haft et ikke-effektivt respons på methotrexat i doser på 12,5 til 25 mg eller som var intolerante over for 10 mg methotrexat hver uge.
English: Holding the pen:
Danish: Sådan holdes pennen:
English: The recommended adolescent HS dosing schedule is 40 mg every other week.
Danish: Det anbefalede HS-doseringsregime til unge er 40 mg hver anden uge.
English: • Keep your pen in the original carton until ready to use to protect from light.
Danish: • Opbevar din pen i den originale pakning, indtil du er klar til at bruge den, for at beskytte den mod lys.
English: Table 15 efficacy response in placebo-controlled period for study nr-axSpA II
Danish: Tabel 15 Effektrespons i den placebokontrollerede periode af Studie nr-axSpA II
English: Hefiya may have a minor influence on your ability to drive, cycle or use machines.
Danish: Hefiya kan i mindre grad påvirke din evne til at færdes i trafikken, cykle eller betjene maskiner.
English: • lung diseases causing shortness of breath (including inflammation);
Danish: • lungesygdom, som forårsager kortåndethed (inklusive inflammation)
English: Fertility Preclinical data on fertility effects of adalimumab are not available.
Danish: Der er ingen tilgængelige prækliniske data vedrørende adalimumabs effekt på fertilitet.
English: Included in your carton is:
Danish: I din pakning finder du:
English: HS study II
Danish: HS-studie II
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Danish: De hyppigst rapporterede bivirkninger er infektioner (såsom nasopharyngitis, øvre luftvejsinfektioner og sinuitis), reaktioner på injektionsstedet (erytem, kløe, blødning, smerter eller hævelse), hovedpine og muskuloskeletal smerte.
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.
Danish: Hos patienter, som blev på deres randomiserede behandling, var den gennemsnitlige laveste (±SD) adalimumab-koncentration 9,5±5,6 µg/ml for standarddosis-gruppen og 3,5±2,2 µg/ml for lavdoisgruppen ved uge 52.
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.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenterstudie med 32 børn (2<4 år gamle eller 4 år og derover med en vægt < 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
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 (see section 4.5).
Danish: Samtidig administration af adalimumab og andre biologiske DMARDs (f.eks., anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt.
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Danish: Ikke almindelig Aorta-anurisme, vaskulær arteriel okklusion, tromboflebit
English: • Do not freeze the syringes.
Danish: • Sprøjterne må ikke fryses.
English: Vaccinations
Danish: Vacciner
English: • Do not use the syringe if it is broken or the needle guard is activated.
Danish: • Brug ikke sprøjten, hvis den er itu eller hvis kanylebekyttelsen er aktiveret.
English: • increased uric acid in the blood;
Danish: • forhøjet urinsyre i blodet
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Danish: Den rapporterede hyppighed af ikke-melanom hudkræft og lymfomer er henholdsvis cirka 0,2 og 0,3 pr. 1.000 patient-behandlingsår (se pkt.
English: • do not remove the needle cap until just before you give the injection.
Danish: • ikke fjerner kanylehætten før umiddelbart inden, du giver injektionen.
English: • For a more comfortable injection, take your pen out of the refrigerator 15 to 30 minutes before injecting Hefiya to allow it to reach room temperature.
Danish: • For at få en mere behagelig injektion, kan du tage Hefiya ud af køleskabet 15-30 minutter før, du injicerer det, så det kan nå at få stuetemperatur.
English: Methotrexate should be continued during treatment with Hefiya.
Danish: Der fortsættes med methotrexat under behandling med Hefiya.
English: How should you store your pen?
Danish: Sådan skal du opbevare din pen:
English: • leukaemia (cancer affecting the blood and bone marrow);
Danish: • leukæmi (kræft, som påvirker blod og knoglemarv)
English: Figure F: remove the cap
Danish: Figur F: fjern hætten
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Danish: Blandt patienter, som fik afbrudt behandlingen med adalimumab ved uge 12 i HS-studie I og II, var HiSCR-raten 12 uger efter genoptagelse af behandling med adalimumab 40 mg ugentlig tilbage på samme niveau, som før behandlingsafbrydelsen (56,0 %).
English: Myocardial infarction1), arrhythmia, congestive heart failure
Danish: Ikke almindelig Myokardieinfarkt1), arytmi, kongestiv hjertesvigt
English: Your Hefiya single-use pre-filled SensoReady pen
Danish: Din Hefiya fyldte SensoReady pen til engangsbrug
English: Hefiya is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Hefiya kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Danish: To uger senere (Dag 29) fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge (givet som to injektioner af 40 mg på en dag).
English: Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Danish: ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Danish: Kanyler og sprøjter må aldrig genbruges af hensyn til sikkerheden for dig og andre.
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Danish: Din læge kan også ordinere en induktionsdosis på 80 mg, som kan administreres en uge før start af den sædvanlige dosis.
English: RA Study IIa**
Danish: RA-studie IIa**
English: Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: Hefiya kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig (for effektivitet ved monoterapi, se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PEN ETIKET
English: • When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: • Hvis det er nødvendigt (f.eks. når du rejser), kan Hefiya opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 14 dage - sørg for at beskytte den mod lys.
English: Leukaemia1)
Danish: Leukæmi1)
English: Figure 1: Kaplan-Meier Curves summarizing time to flare in study nr-axSpA II
Danish: Figur 1: Kaplan-Meier-kurver opsummerende tid til opblussen af sygdom i Studie nr-axSpA II
English: • Do not give Hefiya to children with paediatric Crohn's disease below the age of 6 years.
Danish: • Giv ikke Hefiya til børn under 6 år med pædiatrisk Crohns sygdom.
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated non-infectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Danish: Adalimumabs sikkerhed og virkning undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til < 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat.
English: * Note: Hefiya is currently only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Danish: *Bemærk: Hefiya er i øjeblikket kun tilgængelig som 40 mg fyldt injektionssprøjte og 40 mg fyldt pen.
English: week 24 week 36 a patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Danish: a patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling.
English: For the safety and health of you and others, the pens must never be re-used.
Danish: Pennene må aldrig genbruges af hensyn til sikkerheden for dig og andre.
English: Inhibition of inflammation
Danish: Hæmning af inflammation
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Danish: RA-studie II evaluerede 544 patienter, der var ≥18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel.
English: After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Danish: Efter yderligere 2 uger fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge, som foreskrevet af din læge.
English: 40 mg adalimumab every week week 26
Danish: 40 mg adalimumab hver uge
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Danish: Hos patienter i adalimumab-behandling blev signifikant forbedring af tegn på inflammation, målt ved hs-CRP og MRI af både sakroiliakaleddene og rygsøjlen, opretholdt frem til henholdsvis uge 156 og uge 104.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Danish: Efter afslutningen af begge studier blev 383 patienter inkluderet i et åbent forlængelsesstudie, hvor 40 mg adalimumab blev administreret hver anden uge.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: Konsultation hos en læge med erfaring i behandling af hepatitis B anbefales til patienter, der testes positive for hepatitis B- infektion.
English: Should treatment be interrupted, Hefiya may be re-introduced as appropriate.
Danish: Hvis behandlingen afbrydes, kan der startes op igen med Hefiya efter behov.
English: The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.
Danish: Behandlingssvigt blev defineret som en forværring eller vedvarende ikke-forbedret øjeninflammation eller delvis forbedret øjeninflammation med udvikling af vedvarende øjenkomorbiditeter eller forværring af øjenkomorbiditeter, uden anvendelse af samtidig medicinering og afbrydelse af behandling i en udvidet tidsperiode.