FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered.
Danish: Alternativt, kan Humira gen-administreres, hvis patienten er stoppet behandling med Humira, og tegn og symptomer på sygdommen kommer igen.
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 baselinePASI-score 19,7, og baseline-PGA-score varierede sig fra “let” (<1%) til “moderat” (48%), “alvorlig” (46%) og “meget alvorlig” (6%).
English: In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in 10.9% (5/46) of patients treated with adalimumab.
Danish: Hos patienter med entesopatirelateret artrit blev adalimumab-antistoffer påvist hos 10,9 % (5/46) af patienterne, der fik adalimumab.
English: For more information on vaccines, see the “Warnings and precautions” section.
Danish: For mere information om vacciner, se afsnittet vedrørende ”Advarsler og forsigtighedsregler”.
English: RA Study I a**
Danish: RA-studie Ia**
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Danish: Polyartikulær juvenil idiopatisk artrit er en inflammatorisk sygdom i leddene.
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
Danish: I CD-studie I blev 299 TNF-antagonist-naive patienter randomiseret til en af fire behandlingsgrupper: placebo i uge 0 og 2, 160 mg Humira i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
English: • Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton.
Danish: • Tag en boks indeholdende en sprøjte, en kanyle, en hætteglasadaptor, et hætteglas, og 2 alkoholservietter.
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; p < 0.05 for Humira vs. placebo pairwise comparison of proportions **p < 0.001 for Humira vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Danish: Klinisk respons er fald fra baseline i Mayo score på > 3 point og > 30 % samt et fald i rektal blødning-subscore [RBS] på > 1 eller en absolut RBS på 0 eller 1; *p<0,05 for Humira versus placebo ved parvis sammeligning af andelene **p<0,001 for Humira versus placebo ved parvis sammeligning af andelene a Af de patienter, der fik steroid ved baseline
English: Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.
Danish: Humira kan nedsætte hastigheden for ødelæggelse i leddene forårsaget af den inflammatoriske sygdom og kan hjælpe dem til at kunne bevæges mere frit.
English: In patients with psoriatic arthritis, anti-adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab.
Danish: Hos patienter med psoriasisartrit blev der påvist anti-adalimumab antistoffer hos 38/376 patienter (10 %) behandlet med adalimumab.
English: In patients with moderate to severe hidradenitis suppurativa, anti-adalimumab antibodies were identified in 10/99 subjects (10.1%) treated with adalimumab.
Danish: Hos adalimumabbehandlede patienter med moderat til svær hidrosadenitis suppurativa blev der fundet anti-adalimumab-antistoffer hos 10/99 forsøgspersoner (10,1%).
English: Patients received Humira 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Danish: Patienterne fik Humira 0,8 mg/kg hver anden uge (op til 40 mg), 0,4 mg/kg hver anden uge (op til 20 mg) eller methotrexat 0,1- 0,4 mg/kg ugentlig (op til 25 mg).
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table
Danish: I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med Humira og methotrexat til hurtigere og signifikant større ACRrespons end methotrexat-monoterapi og Humira-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 10).
English: Only remove both the grey cap and the plum cap immediately before injection
Danish: Fjern først den grå hætte og den blommefarvede hætte umiddelbart før injektion.
English: In controlled trials of Humira (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 Humira-treated patients and 0.6% of control-treated patients.
Danish: I kontrollerede studier med Humira (startdosis på 160 mg i uge 0 og 80 mg i uge 2, efterfulgt af 40 mg hver uge med start i uge 4) hos patienter med hidrosadenitis suppurativa med en kontrolperiode af 12 til 16 ugers varighed, forekom ALAT-stigning ≥ 3 x ULN hos 0,3% af patienterne i Humirabehandling og hos 0,6% af patienterne i kontrol-behandling.
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to Week 12, with a maximum dose of 25 mg or an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Danish: Patienterne fik placebo, en startdosis på 7,5 mg methotrexat og derefter dosisøgning op til uge 12 til en maksimum-dosis på 25 mg eller en startdosis på 80 mg Humira efterfulgt af 40 mg hver anden uge (med start en uge efter den første dosis) i 16 uger.
English: Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.
Danish: Humira kan være tilgængeligt i et hætteglas, en fyldt sprøjte og en og/eller fyldt pen.
English: Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label Humira treatment for an additional 26 weeks.
Danish: Patienterne fik en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis eller placebo i 26 uger efterfulgt af åben Humira behandling i yderligere 26 uger.
English: Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 2).
Danish: Begge studier viste en tidlig og vedvarende effekt af Humira på tid til behandlingssvigt versus placebo (se figur 2).
English: If a few small drops of liquid come out of the needle, that is okay.
Danish: Det er i orden, hvis der kommer nogle få små dråber væske ud af kanylen.
English: Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Danish: Humira bruges til at behandle hidrosadenitis suppurativa hos unge fra 12 år.
English: • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
Danish: • Pres tommelfingeren eller et stykke gazebind over injektionsstedet i 10 sekunder.
English: In rheumatoid arthritis, methotrexate is continued while using Humira.
Danish: Hvis du har reumatoid artrit, fortsættes med methotrexat under behandling med Humira.
English: • Ankylosing spondylitis
Danish: • Ankyloserende spondylitis
English: • Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector.
Danish: • Klargør kanylen ved at åbne emballagen halvt fra enden tættest på den gule vedhæftning til sprøjten, så den gule vedhæftning til sprøjten er tilgængelig.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 g/ml (without concomitant methotrexate) and 8 to 9 g/ml (with concomitant methotrexate), respectively.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med rheumatoid artrit (RA) var de gennemsnitlige dal-steady state-koncentrationer på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat).
English: • bacterial infections
Danish: • bakterieinfektioner
English: In patients with paediatric psoriasis, anti-adalimumab antibodies were identified in 5/38 subjects (13%) treated with 0.8 mg/kg adalimumab monotherapy.
Danish: Hos patienter med pædiatrisk psoriasis blev der fundet anti-adalimumab-antistoffer hos 5/38 forsøgspersoner (13%), som blev behandlet med 0,8 mg/kg adalimumab som monoterapi.
English: Table 3 Undesirable Effects
Danish: Tabel 3 Bivirkninger
English: For more information on vaccines see the “Warnings and precautions” section.
Danish: For mere information om vacciner se afsnittet vedrørende ”Advarsler og forsigtighedsregler”.
English: • signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
Danish: • tegn på infektion, såsom feber, følelse af sygdom, sår, tandproblemer eller smerter ved vandladning
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med Humira hos patienter med polyartikulær juvenile idiopatisk artrit, som var fra 2 til < 4 år.
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med Humira hos patienter med polyartikulær juvenile idiopatisk artrit, som var fra 2 til <4 år.
English: Humira 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.
Danish: Humira er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling og kortikosteroidbehandling og/eller immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: • sensation disorders such as tingling, prickling or numbness
Danish: • følelsesforstyrrelser såsom snurren, prikken eller følelsesløshed
English: If your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/ml (79% CV).
Danish: Efter subkutan administration af 0,8 mg/kg (op til maksimalt 40 mg) hver anden uge til pædiatriske patienter med kronisk plaque-psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 7,4 ± 5,8 µg/ml (± SD) (79% CV).
English: Hold the pre-filled pen with the grey cap (labelled ‘1') pointing up.
Danish: Hold den fyldte pen med den grå hætte (mærket '1') pegende opad.
English: The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Humira til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: • Do not hold or pull the plunger when removing the needle cover
Danish: • Hold eller træk ikke i stemplet, imens beskyttelseshætten tages af
English: Contents of the pack and other information Injecting Humira
Danish: Pakningsstørrelser og yderligere oplysninger Injektion af Humira
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
Danish: • sygdomme i immunsystemet som kan påvirke lungerne, huden og lymfeknuderne (viser sig oftest som sarkoidose)
English: • heart problems that can cause shortness of breath or ankle swelling
Danish: • hjerteproblemer, som kan forårsage kortåndethed og hævede ankler
English: Do not remove the caps until just before injection.
Danish: Fjern først hætterne umiddelbart før injektion.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Danish: • tegn og symptomer, som kan tyde på blodsygdomme så som vedvarende feber, blå mærker, blødning, bleghed
English: Amongst those who responded at Week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received Humira throughout the study.
Danish: Blandt de patienter, som responderede ved uge 16 (n=144), blev Pædiatrisk ACR 30/50/70/90responser opretholdt i op til seks år i den åbne forlængelsesfase hos dem, der fik Humira gennem hele studiet.
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Danish: Tabel 14 Respons på effektmål i placebokontrolleret Studie nr-axSpA I
English: Cap 2
Danish: Hætte 2
English: • Ulcerative colitis
Danish: • Colitis ulcerosa
English: Humira 40 mg weekly N = 70
Danish: Humira 40 mg ugentlig N = 70
English: • Humira can be used during breast-feeding.
Danish: • Humira kan anvendes under amning.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Humira-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis dit barn bruger anden medicin eller har gjort det for nylig.
English: leflunomide and injectable gold preparations)
Danish: hydroxychloroquin, leflunomid og guldpræparater til injektion)
English: • Your child might get infections more easily while receiving Humira treatment.
Danish: • Infektioner hos dit barn kan opstå lettere under behandling med Humira.
English: Humira is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Danish: Humira er beregnet til behandling af Crohns sygdom hos børn i alderen 6-17 år.
English: Patients in steroid-free remission for >=90 days
Danish: Steroid-fri remission i > 90 dagea
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Danish: Kvinder i den fertile alder bør overveje at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste Humira-behandling.
English: • Check with your doctor before your child receives any vaccines.
Danish: • Tal med lægen, før dit barn får nogen form for vaccine.
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Danish: Børn og unge fra 6 til 17 år, som vejer 40 kg eller mere Den sædvanlige startdosis er 80 mg (som to40 mg injektioner på en dag) efterfulgt af 40 mg to uger senere.
English: In patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years old or aged 4 and above weighing <15 kg, anti-adalimumab antibodies were identified in 7% (1/15) of patients, and the one patient was receiving concomitant methotrexate.
Danish: Hos patienter med polyartikulær juvenil idiopatisk arthritis, som var fra 2 til 4 år eller over 4 år og som vejede <15 kg, blev der påvist antistoffer mod adalimumab hos 7 % (1/15) af patienterne, og denne ene patient fik samtidig methotrexat.
English: It is important to tell your doctor if your child has had or has a serious heart condition.
Danish: Det er vigtigt, at fortælle din læge, hvis dit barn har haft eller har alvorlige problemer med hjertet.
English: Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Danish: Fortæl straks din læge, hvis du oplever ændringer i dit syn, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: Table 8 Ped ACR 30 Responses in the JIA study
Danish: Tabel 8 Pædiatrisk ACR 30-respons i JIA-studiet
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Humirabehandling, kan lægen vælge at ordinere Humira 40 mg hver uge eller 80 mg hver anden uge.
English: • Look at the expiry date on the box to be used.
Danish: • Kontrollér udløbsdatoen på hætteglasset.
English: Humira is administered every other week via subcutaneous injection.
Danish: Humira administreres hver anden uge som subkutan injektion.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis);
Danish: • sygdomme i immunsystemet som kan påvirke lungerne, huden og lymfeknuderne (viser sig oftest som sarkoidose);
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Danish: Før behandling med Humira påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overenstemmelse med gældende immuniseringsvejledninger.
English: Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Danish: Humira har vist sig at reducere den udviklingshastighed, hvormed de perifere led destrueres, bedømt ved måling med røntgen hos patienter med polyartikulære, symmetriske undertyper af sygdommen (se pkt.
English: With automatic needle guard
Danish: Med automatisk beskyttelseshætte
English: • elevated bilirubin measurement (liver blood test)
Danish: • forhøjede bilirubinmålinger (lever blodtest)
English: The usual dose of Humira is 40 mg every other week with methotrexate.
Danish: Den normale dosis er 40 mg hver anden uge med methotrexat.
English: Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Danish: Humira-dosis til patienter med polyartikulær juvenil idiopatisk artrit Patient vægt
English: Do not try to touch the needle housed in the barrel.
Danish: Rør ikke ved kanylen inden i beholderen.
English: • With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
Danish: • Mens hætteglasadapteren stadig er i den klare pakning placeres den ovenpå hætteglas proppen og skubbes ned til den klikker på plads.
English: Cerebrovascular accident tremor, neuropathy
Danish: Ikke almindelig Cerebrovaskulært attak1),tremor, neuropati Sjælden
English: • Do not use the pre-filled syringe if it has been dropped or crushed
Danish: • Brug ikke den fyldte injektionssprøjte, hvis den har været tabt eller knust
English: It is important to tell your doctor if you have had or have a serious heart condition.
Danish: Det er vigtigt, at fortælle din læge, hvis du har haft eller har alvorlige problemer med hjertet.
English: Serious allergic reactions associated with Humira were rare during clinical trials.
Danish: Alvorlige allergiske reaktioner relateret tilHumira var meget sjældne i de kliniske studier.
English: The usual dose of Humira is 20 mg every other week with methotrexate.
Danish: Den normale dosis er 20 mg hver anden uge med methotrexat.
English: Ulcerative colitis is an inflammatory disease of the bowel.
Danish: Colitis ulcerosa er en inflammatorisk sygdom i tyktarmen.
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.
Danish: Alle patienter fik åben induktionsbehandling med doser baseret på deres baseline-legemsvægt: henholdsvis 160 mg i uge 0 og 80 mg i uge 2 til patienter ≥ 40 kg og 80 mg henholdsvis 40 mg til patienter < 40 kg.
English: Humira 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.
Danish: Humira er indiceret til behandling af pædiatrisk kronisk non-infektiøs anterior uveitis hos børn fra 2 år, som har haft utilstrækkeligt respons på konventionel behandling eller, som er intolerante eller, som ikke er egnet til konventionel behandling.
English: Humira can slow down the damage to the joints caused by the disease and can help them move more freely.
Danish: Humira kan nedsætte hastigheden for ødelæggelse i leddene forårsaget af sygdommen og kan hjælpe dem til at bevæge sig mere frit.
English: In patients with ankylosing spondylitis anti-adalimumab antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab.
Danish: Hos patienter med ankyloserende spondylitis blev der påvist anti-adalimumab antistoffer hos 17/204 patienter (8,3 %) behandlet med adalimumab.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Humira therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Danish: Før initiering af Humira og regelmæssigt under behandlingen bør der foretages en neurologisk udredning for at vurdere allerede eksisterende eller udvikling af demyeliniserende sygdomme hos patienter med non-infektiøs intermediær uveitis.
English: • cancer
Danish: • kræft
English: • sensation of heart beating rapidly
Danish: • fornemmelse af hurtige hjerteslag
English: Patients received either placebo or
Danish: 246 patienter fik placebo.
English: Clear Liquid in Syringe
Danish: Vindue Klar væske i sprøjten
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Danish: 38% (25/66) og 55% (36/66) af de patienter, som mistede tilstrækkeligt respons efter genrandomisering til placebo, og som derefter fortsatte i det åbne forlængelsesstudie, genvandt PASI 75-respons efter henholdsvis 12 og 24 ugers behandling.
English: • serious infections (including blood poisoning and influenza)
Danish: • Alvorlige infektioner (inklusive blodforgiftning og influenza)
English: 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.
Danish: Den almindelige dosis til voksne med reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis,og til patienter med psoriasisartrit er 40 mg adalimumab hver anden uge som enkeltdosis.