FrancophonIA/ELRC3.0 huggingface dataset:
English: 95% confidence intervals for the differences in change scores between methotrexate and Humira.
Danish: JSNd score amethotrexat b95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og Humira.
English: Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Danish: Humira 40 mg hver anden uge blev undersøgt hos patienter med moderat til alvorlig aktiv psoriasisartrit i to placebokontrollerede studier, PsA-I og PsA-II.
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira versus methotrexate and placebo in 271 patients.
Danish: I Psoriasis-studie II (CHAMPION) blev Humiras virkning og sikkerhed sammenlignet med methotrexat og placebo hos 271 patienter.
English: By Week 68, patients receiving continuous Humira treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Danish: Ved uge 68, viste patienter, som fik forsat behandling med Humira statistisk signifikant større forbedring af tegn og symptomer på aktiv nr-axSpA sammenlignet med patienter, som blev allokeret til seponering af behandling i studiets dobbeltblindede periode (Tabel 15).
English: Your child's doctor should test your child for HBV. Humira can cause reactivation of HBV in people who carry this virus.
Danish: Lægen vil teste dit barn for HBV. Humira kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus.
English: This risk may increase if you have problems with your lungs.
Danish: Risikoen kan stige, hvis du har problemer med lungerne.
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during Humira trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Danish: Der blev ikke observeret nogen maligniteter hos 249 pædiatriske patienter med en samlet eksposition på 655,6 patientår i Humira-studier hos patienter med juvenil idiopatisk artrit (polyartikulær juvenil idiopatiske artrit og entesopatirelateret artrit).
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received Humira 40 mg eow for 28 weeks.
Danish: 673 patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [BASDAI] var 7,0), som havde utilstrækkeligt respons på ≥ 2 NSAIDs, eller var intolerante over for eller havde en kontraindikation mod NSAIDs deltog i den åbne periode af studie nr-axSpA II, hvor de fik Humira 40 mg hver anden uge i 28 uger.
English: Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Danish: Humira er vurderet hos mere end 3.000 patienter i de kliniske reumatoid artrit-studier.
English: Set up the following items on a clean surface.
Danish: Læg følgende ting på et rent underlag.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between Humira and placebo.
Danish: ***, ** Statistisk signifikant ved p < 0,001 og < 0,01, henholdvis, ved alle sammenligninger af Humira og placebo.
English: Disease flares at the end of 32 weeks a (n/N)
Danish: Opblussen af sygdom i slutningen af de 32 ugera (n/N)
English: Slowly push the plunger in to push the air out through the needle.
Danish: Pres langsomt stemplet ind for at presse luften ud af kanylen.
English: • Prepare the syringe by partially peeling the package open from the end closest to white plunger rod.
Danish: • Forbered sprøjten ved at åbne pakningen halvt fra enden nærmest den hvide stempelstang.
English: The Humira pre-filled pen is available in packs containing:
Danish: Humira fyldt pen findes i pakninger indeholdende;
English: Assessment of SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score mean change from baseline n=91 placebo and n=87 Humira high sensitivity C-Reactive Protein (mg/L) n=73 placebo and n=70 Humira Spondyloarthritis Research Consortium of Canada n=84 placebo and Humira n=82 placebo and n=85 Humira ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between Humira and placebo.
Danish: SPARCC MRI rygsøjlend,j a Assessments of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 Humira f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo and n=70 Humira h Spondyloarthritis Research Consortium of Canada i n=84 placebo og Humira j n=82 placebo og n=85 Humira ***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem Humira og placebo.
English: This risk may increase if your child has problems with his/her lungs.
Danish: Risikoen kan stige, hvis dit barn har problemer med lungerne.
English: Antibiotics may be continued during treatment with Humira if necessary.
Danish: Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under Humira-behandlingen.
English: Placebo/MTXHumira/MTX (95% Confidence Interval p-value
Danish: Placebo/MTXHumira/MTX (95% konfidensintervalb)
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during Humira trials in paediatric patients with Crohn's disease.
Danish: Desuden blev der ikke observeret maligniteter hos 192 pædiatriske patienter med en eksponering på 498,1 patientår i Humira-studier med pædiatriske patienter med Crohns sygdom.
English: The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.
Danish: Ovennævnte symptomer kan være tegn på følgende bivirkninger, som er observeret ved brug af Humira:
English: • swollen face, hands, feet
Danish: • hævelser i ansigt, hænder eller fødder
English: The safety profile for patients with HS treated with Humira weekly was consistent with the known safety profile of Humira.
Danish: Sikkerhedsprofilen for patienter med HS, som fik ugentlig behandling med Humira var i overenstemmelse med Humiras kendte sikkerhedsprofil.
English: Clinical remission Clinical response (CR
Danish: Klinisk remission Klinisk respons (CR
English: If your child has active tuberculosis, do not use Humira.
Danish: Hvis dit barn har aktiv tuberkulose, må barnet ikke tage Humira.
English: • Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira.
Danish: • Dit barn og barnets læge bør være særligt opmærksomme på tegn på infektion, mens dit barn er i behandling med Humira.
English: • Push the white plunger rod to inject the liquid medication until the syringe is empty.
Danish: • Pres den hvide stempelstang ned for at injicere den flydende medicin indtil sprøjten er tom.
English: Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Danish: Tryk ikke på den blommefarvede aktiveringsknap, før pennen er korrekt placeret på huden, idet det vil resultere i udløsning af lægemidlet.
English: Do not use the pre-filled pen if expiry (EXP) date has passed.
Danish: Brug ikke den fyldte pen, hvis udløbsdatoen (EXP) er passeret.
English: In adult plaque psoriasis patients on long term adalimumab monotherapy who participated in a withdrawal and retreatment study, the rate of antibodies to adalimumab after retreatment (11 of 482 subjects, 2.3%) was similar to the rate observed prior to withdrawal (11 of 590 subjects, 1.9%).
Danish: Hos voksne plaque-psoriasis-patienter i langtidsbehandling med adalimumab som monoterapi, som deltog i et studie med behandlingsafbrydelse og genbehandling, var andelen af antistoffer over for adalimumab efter genbehandling (11 ud af 482 patienter, 2,3 %) sammenlignelig med den andel, som blev set inden behandlingsafbrydelse (11 ud af 590 patienter, 1,9 %).
English: There are no data available comparing Humira and MTX beyond 16 weeks of therapy.
Danish: Der er ingen tilgængelige data, som sammenligner behandling med Humira versus methotrexat i mere end 16 uger.
English: • There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Danish: • Der har været tilfælde af kræft, der er forskellig fra lymfom hos patienter med en specifik lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNF-hæmmer.
English: In RA study III, where Humira treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Danish: I RA-studie III, hvor de Humira-behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (TSS) og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
English: Your doctor should test you for HBV. Humira can cause reactivation of HBV in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Humira kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus.
English: Check the expiry (EXP) date.
Danish: Kontrollér udløbsdatoen (EXP).
English: • severe allergic reaction with shock
Danish: • alvorlig allergisk reaktion med shock
English: • On the front of your thighs or
Danish: • På forsiden af dine lår eller
English: Enrolled patients were either current users of Humira 40 mg/0.8 ml and rated their average injection site pain as at least 3 cm (on a 0-10 cm VAS) or were biologic-naïve subjects who were starting Humira 40 mg/0.8 ml.
Danish: De inkluderede patienter var enten nuværende brugere af Humira 40 mg/0,8 ml, der bedømte deres gennemsnitlige smerter ved injektionsstedet som mindst 3 cm (på en 0-10 cm VAS (visual analog skala)) eller biologisk naive patienter, der påbegyndte Humira 40 mg/0,8 ml.
English: Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Humira har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at forbedre den fysiske funktion, når det gives i kombination med methotrexat.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Humira.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med Humira.
English: Greater improvements at Week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Danish: Sammenlignet med placebo blev der ved uge 12 påvist større forbedringer i forhold til baseline i hudspecifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af Humira-behandling.
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of Humira and azathioprine/6-mercaptopurine compared with Humira alone.
Danish: I studier hos voksne med Crohns sygdom blev der set en højere forekomst af maligne og alvorlige infektionsrelaterede bivirkninger ved kombination af Humira og azathioprin/6-mercaptopurin end med Humira alene.
English: For storage information, see package leaflet.
Danish: For information vedrørende opbevaring, se indlægssedlen.
English: ASAS Partial Remission BASDAI
Danish: ASAS delvis remission BASDAIb 50
English: • cancer that affects the lymph system
Danish: • kræft, der rammer lymfesystemet
English: Humira 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.
Danish: Patienter, der blev behandlet med Humira, viste en statistisk signifikant forbedring i den fysiske funktion, målt ved hjælp af HAQ og Short Form Health Survey (SF 36), sammenlignet med placebo ved uge 24.
English: o One vial adapter (2) o One vial for paediatric use of Humira for injection (3) o Two alcohol pads (4) o One needle (5)
Danish: o En 1 ml sprøjte (1) o En hætteglasadapter (2) o Et hætteglas Humira til injektion til pædiatrisk brug (behandling af børn) (3) o 2 alkoholservietter (4) o 1 kanyle (5)
English: The syringe or pen must be protected from light, and discarded if not used within the 14-day period.
Danish: Injektionssprøjten eller pennen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques
Danish: • Injicer ikke i et område, hvor huden er øm, forslået, rød, hård, arret eller har mærker eller områder med plaque-psoriasis
English: Disease flare criteria were defined as a worsening of  30% from baseline in  3 of 6 Pediatric ACR core criteria,  2 active joints, and improvement of  30% in no more than 1 of the 6 criteria.
Danish: Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACRhovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: 3) Choosing and preparing an injection site
Danish: 3) Valg og forberedelse af et injektionssted .
English: АбВи ЕООД Тел.
Danish: АбВи ЕООД
English: • Your child's belly (abdomen) at least 5 cm from his/her belly button (navel)
Danish: • På dit barns mave (abdomen) mindst 5 cm fra hans/hendes navle
English: The efficacy and safety of Humira were assessed in five randomised, double-blind and well-controlled studies.
Danish: Humiras virkning og bivirkningsprofil blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede studier.
English: * P < 0.05, ***P < 0.001, Humira versus placebo Among all randomised patients.
Danish: * p < 0,05, ***p < 0,001, Humira versus placebo c Blandt alle randomiserede patienter.
English: The safety and efficacy of Humira were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Danish: Humiras sikkerhed og virkning blev undersøgt i randomiserede, dobbeltblinde, placebokontrollerede studier og et åbent forlængelsesstudie hos voksne patienter med moderat til svær hidrosadenitis suppurativa (HS), som var intolerante, havde en kontraindikation eller et utilstrækkeligt respons på mindst 3 månders forsøg med systemisk antibiotikabehandling.
English: Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.
Danish: Når pennen er taget ud af køleskabet og opbevaret ved stuetemperatur, skal pennen bruges indenfor 14 dage eller kasseres, også selv om den lægges tilbage i køleskabet.
English: Patients induced with 160/80 mg Humira 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 Humira, 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: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Humira.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Humira, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: • neuropathy;
Danish: • neuropati;
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26.
Danish: Det primære endepunkt i RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non- MTX-treated.
Danish: I den åbne indkøringsfase blev patienterne stratificeret i to grupper - MTX-behandlede (methotrexat-behandlede) og ikke-MTXbehandlede.
English: 2 alcohol pads
Danish: 2 alkoholservietter
English: • facial oedema (swelling of the face) associated with allergic reactions
Danish: • ødem i ansigtet (hævelse i ansigtet) forbundet med allergiske reaktioner
English: Humira Dose for Paediatric Patients with Crohn's disease
Danish: Humira-dosis til pædiatriske patienter med Crohns sygdom
English: Usually, Humira is used with methotrexate.
Danish: Normalt gives Humira sammen med methotrexat.
English: Improvement in number of active joints with arthritis was maintained during the OL period through Week 156 for the 26 of 31 (84%) patients in the Humira group who remained in the study.
Danish: Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del i 156 uger for 26 ud af 31 (84%) patienter i Humiragruppen, som forblev i studiet.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Danish: Nioghalvfjerds (20,1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9,4 %) af patienterne med glukokortikoider.
English: Do not shake or drop the pre-filled pen.
Danish: Ryst eller tab ikke den fyldte pen
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Danish: Sygdommen påvirker oftest bestemte områder af huden, såsom under brystet, i armhulerne, på indersiden af lårerne, i lyskeområdet og på balderne.
English: • Cases of non-melanoma skin cancer have been observed in patients taking Humira.
Danish: • Tilfælde af ikke-melanom hudkræft er set hos patienter, der tager Humira.
English: Injection site pain of Humira 40 mg/0.4 ml was assessed in two randomised, active control, single-blind, two-period crossover studies.
Danish: Smerter ved injektionsstedet i forbindelse med Humira 40 mg/0,4 ml blev evalueret over 2 tidsperioder i to randomiserede, enkelt-blindede overkrydsningsstudier med aktiv kontrol.
English: • a bump or open sore that doesn't heal
Danish: • en bule eller åbent sår, som ikke vil hele
English: 2) Choosing and preparing an injection site
Danish: 2) Valg og forberedelse af injektionssted
English: • neurological infections (including viral meningitis)
Danish: • neurologiske infektioner (inklusive viral meningitis)
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: Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: Humira kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål til anvendelsen af dette lægemiddel, skal du spørge din læge eller apotekspersonalet.
English: Humira is available in other strengths and presentations.
Danish: Humira er tilgængelig i andre styrker og lægemiddelformer.
English: Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients p = 0.015 c p = 0.031
Danish: 14 uger a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Danish: Opportunistiske infektioner, inklusive invasive fungicide infektioner, er observeret hos patienter, som modtog Humira.
English: • It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
Danish: • Det anbefales, at børn om muligt får alle planlagte vaccinationer for deres alder, inden de begynder behandling med Humira.
English: In the Phase 3 trial of Humira 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 Humira 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: This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen kan føre til nedsat syn og/eller fluer i øjet (sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
English: Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Danish: Blandt patienter med HS-relateret evaluering af hudsmerte ≥ 3 ved baseline, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig.
English: Humira contains the active substance adalimumab.
Danish: Humira indeholder det aktive stof adalimumab.
English: Always take the outer carton or the vial of the medicine with you, even if it is empty.
Danish: Tag altid den ydre karton eller hætteglasset fra medicinen med, også selvom den er tom.
English: Water for injections.
Danish: Vand til injektionsvæsker.
English: Press the plum activator button and count slowly for 10 seconds.
Danish: Tryk på den blommefarvede aktiveringsknap og tæl langsomt i 10 sekunder.
English: • vertigo (feeling of dizziness or spinning)
Danish: • vertigo (fornemmelse af svimmelhed og at snurre rundt)