FrancophonIA/ELRC3.0 huggingface dataset:
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 Humira 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 Humira hver anden uge eller placebo i yderligere 19 uger.
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Danish: I kliniske studier er der set andre alvorlige infektioner inklusive pneumoni, pyelonephritis, septisk artritis og sepsis.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Danish: • autoimmun hepatit (leverbetændelse forårsaget af kroppens eget immunsystem);
English: Patients who had been randomised to placebo in Period A were assigned to receive Humira 40 mg every week in Period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt Humira 40 mg hver uge i periode B.
English: • moderate to severe chronic plaque psoriasis in adults and
Danish: • moderat til alvorlig kronisk plaque-psoriasis hos voksne og
English: • moderate to severe Crohn's disease in adults and
Danish: • moderat til alvorlig Crohns sygdom hos voksne og
English: Doses of 20 or 40 mg of Humira 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 Humira 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: Among patients who were not in response at Week 4, 43% of Humira maintenance patients responded by Week 12 compared to 30% of placebo maintenance patients.
Danish: Blandt de patienter, som ikke havde respons i uge 4, responderede 43 % af patienterne i Humiravedligeholdelsesbehandling ved uge 12 sammenlignet med 30 % af patienter i placebogruppen.
English: Your child may first be given other medicines.
Danish: Dit barn kan først behandles med andre lægemidler.
English: • Use your other hand to flip the pink needle cover down toward the syringe.
Danish: • Brug din anden hånd til at presse det lyserøde kanylehus ned mod sprøjten
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by Week 8 and adverse events were more frequently noted in the 160/80 mg group.
Danish: Der sås sammenlignelige remissions-rater ved uge 8 for 160/80 mg og 80/40 mg induktionsregimerne, men bivirkninger var hyppigere i gruppen med 160/80 mg.
English: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Danish: • behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responsen på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig.
English: Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2%) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 216 (80,3%) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis ≤ 7,5 mg pr. dag og 178 (66,2% ) var både steroidfri og inaktive.
English: ASDAS Inactive Disease hs-CRP
Danish: ASDAS inaktiv sygdom hs-CRPd,f,g
English: AbbVie AB
Danish: AbbVie SA
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: Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding in place without moving).
Danish: Hold på beholderen med den fyldte pen, og tryk let ned mod injektionsstedet (hold den på plads uden at bevæge den).
English: Your symptoms may return if you stop using Humira.
Danish: Dine symptomer kan komme igen, hvis du stopper med at tage Humira..
English: DO NOT touch the vial stopper after wiping with the alcohol pad.
Danish: Rør IKKE ved hætteglassets prop efter den er tørret af med alkoholservietten.
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: • moderate to severe hidradenitis suppurativa in adults and
Danish: • moderat til alvorlig hidrosadenitis suppurativa hos voksne og
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Danish: I de pivotale kontrollerede studier med voksne og børn havde 12,9% af de patienter, som blev behandlet med Humira, reaktioner ved injektionsstedet (erythem og/eller kløe, blødning, smerter eller hævelse) sammenlignet med 7,2% af de patienter, som fik placebo eller aktiv kontrol.
English: Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Humira kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: All doses/schedules of Humira 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 Humira 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: Patients treated with Humira should be given the Patient Reminder Card.
Danish: Patienter i Humira-behandling bør få udleveret et særligt patientkort.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Humira i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa , se pkt.
English: Hidradenitis Suppurativa Clinical Response (HiSCR)
Danish: Hidradenitis Suppurativa Clinical Respons (HiSCR)a
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
Danish: • autoimmun hepatit (leverbetændelse forårsaget af kroppens eget immunsystem)
English: Among patients who were at least partial responders at Week 12, and who received continuous weekly Humira therapy, the HiSCR rate at Week 48 was 68.3% and at Week 96 was 65.1%.
Danish: Blandt patienter, der som minimum var delvise respondere ved uge 12, og som fik fortsat ugentlig Humira-behandling, var HiSCR-raten ved uge 48; 68,3 % og ved uge 96; 65,1 %.
English: Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.
Danish: Entesopatirelateret artrit er en inflammatorisk sygdom i leddene og de steder, hvor senerne hæfter på knoglen.
English: If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Danish: Hvis du har KOL, eller ryger meget, bør du diskutere med din læge, om behandling med en TNF-hæmmer er passende for dig.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Danish: • forværring af en tilstand, som kaldes dermatomyositis (ses som hududslæt ledsaget af muskelsvaghed)
English: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Humira er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: Prescribers should exercise caution in considering the use of Humira in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Humira should be considered if any of these disorders develop.
Danish: Lægen bør udvise forsigtighed, når behandling med Humira overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet eller det perifere nervesystem, og seponering skal overvejes, hvis nogle af disse sygdomme forværres.
English: If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Danish: Hvis lægen har ordineret en dosis på 0,5 ml skal du trække stempelstangen ud til 0,6 ml.
English: Humira is intended for the treatment of the inflammatory diseases described below:
Danish: Humira er beregnet til behandlingen af de inflammatoriske sygdomme beskrevet nedenfor:
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: Among patients who had failed prior anti-TNF treatment, Week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Danish: Blandt de patienter, som tidligere havde haft mislykket anti-TNF-behandling, opnåede 3 % på placebo og 10 % på Humira remission i uge 52.
English: Humira 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: Humira kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtmæssig (for effektivitet ved monoterapi se pkt 5.1).
English: Österreich AbbVie GmbH Tel: +43 1 20589-0
Danish: AbbVie GmbH Tel: +43 1 20589-0
English: In study UC-II, among those treated with Humira who were in remission at Week 8, 21/41 (51%) were in remission at Week 52.
Danish: I studie UC-II var 21/41 (51%) af de Humira-behandlede patienter, der var i remission i uge 8, også i remission i uge 52.
English: You can press a cotton ball or a piece of gauze over the injection site for 10 seconds.
Danish: De kan presse et stykke vat eller et plaster over injektionsstedet i 10 sekunder.
English: Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) Placebo Humira 40 mg eow
Danish: Tabel 28 Respons, remission og slimhindeheling i studie UC-II (Procent patienter) Placebo Humira 40 mg hver anden uge
English: Doses of 20, 40 or 80 mg of Humira or placebo were given every other week for 24 weeks.
Danish: Doser på 20, 40 eller 80 mg Humira eller placebo blev givet hver anden uge i 24 uger.
English: MTX = methotrexate P=0.027, Humira 0.8 mg/kg versus MTX P=0.083, Humira 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc a MTX = methotrexat b P=0,027, Humira 0,8 mg/kg versus MTX c P=0,083, Humira 0,8 mg/kg versus MTX
English: Of 342 subjects originally randomized to Humira monotherapy or Humira/methotrexate combination therapy who entered the openlabel extension study, 171 subjects completed 10 years of Humira treatment.
Danish: Ud af 342 patienter som startede i det åbne forlængelsesstudie og blev randomiseret til Humira monoterapi eller Humira/methotrexat kombinationsterapi, afsluttede 171 patienter 10 års behandling med Humira.
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which Humira 40mg was administered every week.
Danish: Patienter, som deltog i HS-studie I og II, var kvalificerede til inklusion i et åbent forlængelsesstudie, hvor Humira 40 mg blev givet hver uge.
English: • Humira should only be used during a pregnancy if needed.
Danish: • Humira bør kun anvendes under graviditet, hvis det tydeligvis er nødvendigt.
English: Choose a site on your thigh or stomach
Danish: Vælg et injektionssted på låret eller maven
English: • hepatitis
Danish: • hepatit
English: If your child stops using Humira
Danish: Hvis dit barn holder op med at tage Humira
English: In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
Danish: I de pivotale studier blev der identificeret anti-adalimumabantistoffer hos 5,5% (58/1.053) af de patienter, der blev behandlet med adalimumab, sammenlignet med 0,5% (2/370) af de patienter, der fik placebo.
English: Of 542 patients who were randomised to Humira 40 mg every other week, 170 patients continued on Humira 40 mg every other week for 10 years.
Danish: Ud af 542 patienter, som blev randomiseret til Humira 40 mg hver anden uge, fortsatte 170 patienter på Humira 40 mg hver anden uge i 10 år.
English: Your doctor may prescribe another strength of Humira if your child needs a different dose.
Danish: Din læge kan have udskrevet Humira i en anden styrke, hvis dit barn har behov for en anden dosis.
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the jointsthat usually first appears in childhood.
Danish: Polyartikulær juvenil idiopatisk artrit er en inflammatorisk sygdom i leddene som sædvanligvis først ses i barndommen.
English: Wipe your skin by using the enclosed alcohol pad, using a circular motion.
Danish: Tør din hud af med den medfølgende alkoholserviet ved hjælp af cirklende bevægelser.
English: • pre-filled pen has been dropped or crushed
Danish: • den fyldte pen har været tabt eller knust
English: p-value p-value b p-value
Danish: p-værdia p-værdib p-værdic
English: • feeling weak or tired
Danish: • følelse af svaghed eller træthed
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: Humira is injected under the skin (subcutaneous use).
Danish: Humira injiceres under huden (subkutan anvendelse).
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 Binfektion.
English: For the pooled crossover RA studies VI and VII, a statistically significant difference for injection site pain immediately after dosing was observed between Humira 40 mg/0.8 ml and Humira 40 mg/0.4 ml (mean VAS of 3.7 cm versus 1.2 cm, scale of 0-10 cm, P < 0.001).
Danish: I de puljede data fra RA-overkrydsnings-studier VI og VII sås umiddelbart efter dosering en statistisk signifikant forskel i smerter ved injektionsstedet mellem Humira 40 mg/0,8 ml og Humira 40 mg/0,4 ml (gennemsnitlig 3,7 cm versus 1,2 cm på en visuel analog skala (VAS) fra 0 til10 cm, p < 0,001).
English: • allergic reactions (including seasonal allergy)
Danish: • allergiske reaktioner (inklusive sæsonbestemt allergi)
English: • Do not rub • Slight bleeding at the injection site is normal
Danish: • Gnid ikke på injektionsstedet • Lidt blod på injektionsstedet er normalt
English: • Do not remove the needle cover while allowing Humira to reach room temperature
Danish: • Fjern ikke beskyttelseshætten, imens Humira opnår stuetemperatur
English: Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9; (p< 0.001) in the Humira group (at Week 48).
Danish: Sammenlignet med placebo reducerede Humira progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ±1,9 i Humira-gruppen (ved uge 48) (p<0,001).
English: The safety and efficacy of Humira was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Danish: Humiras 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: Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Danish: Når injektionssprøjten er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal injektionssprøjten bruges indenfor 14 dage eller kasseres, også selv om den lægges tilbage i køleskab.
English: Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week.
Danish: To uger senere (Dag 29) fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge.
English: Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Humira bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg Humira was administered every other week.
Danish: Efter afslutningen af begge studier blev 383 patienter inkluderet i et åbent forlængelsesstudie, hvor 40 mg Humira blev administreret hver anden uge.
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with Humira compared to placebo (Table 14).
Danish: Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med Humira sammenlignet med placebo (Tabel 14).
English: After treatment with Humira, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Danish: Efter behandling med Humira blev der hos patienter med reumatoid artrit observeret et hurtigt fald i niveauet af inflammatoriske akutfasereaktanter (C-reaktivt protein (CRP) og erytrocytsænkningshastighed (ESR)) og serumcytokiner (IL-6) sammenholdt med baseline.
English: There is limited safety experience in patients undergoing arthroplasty while receiving Humira.
Danish: Der er begrænset erfaring med sikkerhed for patienter, som får artroplastik under behandling med Humira.
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Danish: I alt 76,5 % (218/285) af de patienter, som fik genbehandling, havde et PGA-respons på ”clear” eller “minimal” efter 16 ugers genbehandling, uanset om de fik tilbagefald i den behandlingsfri periode (69,1 % [123/178] for patienter, som fik tilbagefald, og 88,8 % [95/107] for patienter, som ikke fik tilbagefald).
English: • Merkel cell carcinoma (a type of skin cancer)
Danish: • Merkelcelle karcinom (en type hudkræft)
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: • behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere er blevet behandlet med methotrexat.
English: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: Humira er i kombination med methotrexat indiceret til behandling af aktiv polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år, som har haft et utilstrækkeligt respons på en eller flere sygdomsmodificerende anti-reumatiske lægemidler (DMARDs).
English: The caps, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.
Danish: Beskyttelseshætten, alkoholservietten, vatkugle eller gazeserviet, blisterpakning og pakning kan smides ud med husholdningsaffald.
English: • SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose.
Danish: • Træk LANGSOMT stempletstangen ud til 0,1 ml mere end den ordinerede dosis.
English: • Ulcerative colitis and
Danish: • Colitis ulcerosa og
English: Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Danish: Antistofdannelsen var lavere ved Humira i kombination med methotrexat i forhold til ved behandling med Humira alene.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, who are chronic carriers of this virus (i.e. surface antigen positive).
Danish: Der er forekommet reaktivering af hepatitis B hos kroniske bærere af denne virus, som fik en TNFantagonist herunder Humira (dvs. overflade-antigen-positive-patienter).
English: The active substance is adalimumab.
Danish: Aktivt stof: adalimumab.
English: Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Humira kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), steroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler(NSAIDs).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Danish: Hudkræft eksklusive melanom (inklusive basal cellekarcinom og spinocellulært karcinom), benign neoplasmer
English: Table 18 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Danish: Tabel 18 Respons, remission og slimhindeheling i studie UC-II (Procent patienter)
English: • inflammations
Danish: • inflammationer
English: Children, adolescents and adults with enthesitis-related arthritis
Danish: Børn, unge og voksne med entesopatirelateret artrit
English: In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.
Danish: Der er ingen erfaring ved behandling med Humira uden samtidig behandling med methotrexat i pædiatrisk uveitis.
English: • severe rash, hives or other signs of allergic reaction;
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion;