FrancophonIA/ELRC3.0 huggingface dataset:
English: This study evaluated the efficacy of adalimumab 40 mg every other week / methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Danish: Dette studie vurderede virkningen af adalimumab 40 mg hver anden uge/methotrexat-kombinationsterapi, adalimumab monoterapi 40 mg hver anden uge og methotrexat-monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hefiya.
Danish: I overensstemmelse med klinisk praksis kan samtidig kortikosteroidbehandling nedtrappes med start to uger efter initiering af Hefiya-behandling.
English: In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
Danish: I det åbne forlængelsesstudie RA III bibeholdt de fleste af de patienter, som var ACR-respondere, respons, når de blev fulgt i op til 10 år.
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg / day) at baseline to control their disease.
Danish: Studie UV II undersøgte 226 patienter med inaktiv uveitis, hvor kronisk kortikosteroidbehandling (oral prednison 10 til 35 mg/dag) ved baseline var nødvendig for at kontrollere sygdommen.
English: Immune system disorders*
Danish: Immunsystemet*
English: In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Danish: I CD-studie III fik 854 patienter open-label 80 mg i uge 0 og 40 mg i uge 2.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hefiya, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Hefiya startes.
English: Disposing of used syringes:
Danish: Bortskaffelse af brugte sprøjter:
English: Thirty-three (18 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79 %) patients with NSAIDs at baseline.
Danish: Treogtredive (18 %) patienter fik samtidig behandling med sygdomsmodificerende anti-reumatiske lægemidler, og 146 (79 %) patienter fik NSAID ved baseline.
English: • mood swings (including depression);
Danish: • humørsvingninger (inklusive depression)
English: • heart problems that can cause shortness of breath or ankle swelling;
Danish: • hjerteproblemer, som kan forårsage kortåndethed og hævede ankler
English: The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the known safety profile of adalimumab.
Danish: Sikkerhedsprofilen hos patienter med uveitis, som behandles med adalimumab hver anden uge, var den samme som den kendte sikkerhedsprofil for adalimumab.
English: Adults with psoriasis
Danish: Voksne med psoriasis
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia hyperglycaemia, hypophosphataemia, dehydration
Danish: Hypokaliæmi, forhøjet urinsyre, unormal blod-natrium, hypokalcæmi hyperglykæmi, hypofosfatæmi, dehydrering
English: • Hefiya should only be used during a pregnancy if needed.
Danish: • Hefiya bør kun anvendes under graviditeten, hvis det er tydeligvis nødvendigt.
English: • Alcohol wipe
Danish: • Alkoholserviet
English: At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Danish: I uge 52 opnåede 42,9 % af patienterne, som fik adalimumab /methotrexat-kombinationsterapi, klinisk remission (DAS28 < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4 % af patienterne, som fik adalimumab-monoterapi.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
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: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92 / 349) and 37.8 % (132 / 349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Danish: I et åbent forlængelsesstudie med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentlig på grund af PASI-respons under 50 %, opnåede 26,4% (92/349) og 37,8 % (132/349) af patienterne PASI 75-respons ved henholdsvis uge 12 og 24.
English: Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Danish: Patienterne fik enten placebo eller 20 mg adalimumab (hvis < 30 kg) eller 40 mg adalimumab (hvis ≥ 30 kg) hver anden uge i kombination med deres baseline dosis af methotrexat.
English: • Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.
Danish: • Brug ikke 40 mg fyldt pen, hvis det anbefales at bruge andre doser end 40 mg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Danish: I HS-II-studie (PIONEER II) blev 326 patienter med 2 behandlingsperioder evalueret.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Danish: Der er endvidere rapporteret melanom og Merkelcellekarcinom hos patienter i behandling med TNF-antagonister inklusive adalimumab (se pkt.
English: Abdominal pain, nausea and vomiting
Danish: Abdominalsmerter, kvalme og opkastning
English: Hefiya can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Hefiya kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), kortikosteroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Danish: Post marketing er der rapporteret om tilfælde af leukæmi hos patienter, som blev behandlet med en TNF-antagonist.
English: discontinuation of Immunomodulators2
Danish: Seponering af immunomodulerende midler2
English: During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
Danish: I løbet af 52 uger i studierne UC-I og UC-II blev der observeret lavere forekomst af indlæggelser forårsaget af enhver årsag samt UC-relaterede indlæggelser i adalimumab-behandlingsarmen sammenlignet med placebo-armen.
English: Leucopaenia (including neutropaenia and agranulocytosis), anaemia
Danish: Meget almindelig Leukopeni (inklusive neutropeni og agranulocytose), anæmi
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Danish: Ikke almindelig Lymfom**, solide organ-neoplasmer (inklusive brystkræft, lungekræft og thyroideakræft), melanom**
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Danish: Alvorlige allergiske reaktioner relateret til adalimumab var meget sjældne i de kliniske studier.
English: • neuropathy (nerve damage);
Danish: • neuropati (nerveskade)
English: • increased lipids in the blood;
Danish: • forhøjede lipider i blodet
English: Hidradenitis suppurativa (sometimes called acne inversa) is a long-term and often painful inflammatory skin disease.
Danish: Hidrosadenitis suppurativa (kaldes somme tider svedkirtelbetændelse) er en langvarig, ofte smertefuld betændelseslignende (inflammatorisk) hudsygdom.
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab 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 adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit, som var fra 2 til <4 år.
English: Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.
Danish: Ikkealvorlige allergiske reaktioner relateret til adalimumab var ikke almindelige i de kliniske studier.
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: Adalimumab / methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 9).
Danish: Der blev observeret en signifikant mindre radiografisk progression hos adalimumab-/methotrexat-patienter end hos patienter, som alene fik methotrexat efter 6 måneder og 12 måneder (se tabel 9).
English: Disposing of used pens:
Danish: Bortskaffelse af brugte penne:
English: Nervous system disorders*
Danish: Nervesystemet*
English: Table 6 Undesirable effects
Danish: Tabel 6 Bivirkninger
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Danish: Alle patienter med colitis ulcerosa, som har en øget risiko for dysplasi eller colonkarcinom (for eksempel patienter med langvarig colitis ulcerosa eller primær skleroserende kolangit), eller patienter, som tidligere har haft dysplasi eller colonkarcinom, bør screenes for dysplasi med regelmæssige intervaller før behandlingen og gennem hele sygdomsforløbet.
English: • low blood measurements for calcium;
Danish: • lave blodmålinger af calcium
English: When Hefiya therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Danish: Når Hefiya behandlingen påbegyndes kan en induktionsdosis på 40 mg til patienter < 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesbehandling.
English: Hefiya 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: Hefiya 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: Tell your doctor immediately if you get 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 får symptomer såsom ændringer i dit syn, svaghed i arme eller ben eller følelsesløshed eller en snurrende fornemmelse et sted i kroppen.
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 svær aktiv reumatoid artrit hos voksne patienter, hvor responsen på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig.
English: • sicca syndrome (including dry eyes and dry mouth);
Danish: • Sjøgrens syndrom (inklusive tørre øjne og tør mund)
English: In RA study III, where adalimumab-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 adalimumab-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: Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Danish: Alvorlige infektioner, inklusive sepsis, forårsaget af bakterier, mykobakterier, invasive svampe, parasitter eller virus eller andre opportunistiske infektioner såsom listeriose, legionellose og pneumocystis er blevet rapporteret hos patienter, som fik adalimumab.
English: Study nr-axSpA II
Danish: Studie nr-axSpA II
English: Table 8 ACR responses in RA study V (percent of patients)
Danish: Tabel 8 ACR-respons i RA-studie V (procentdel af patienter)
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Danish: Hvis en anden dosis er nødvendig, skal der bruges et andet adalimumab-lægemiddel, som kan give den mulighed.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Danish: Resultaterne i begge studier viste en statistisk signifikant reduktion i risikoen for behandlingssvigt hos patienter behandlet med adalimumab versus patienter, som fik placebo (se tabel 29).
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Danish: Hvis der opnås tilstrækkeligt respons med 40 mg hver uge eller 80 mg hver anden uge, kan dosis efterfølgende reduceres til 40 mg hver anden uge.
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Danish: Patienterne skulle have haft svigt af konventionel CD-behandling (inklusive et kortikosteroid og/eller et immunmodulerende lægemiddel).
English: In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
Danish: I studie I var der også signifikante forbedringer i den fysiske og mentale komponent i den sammensatte SF-36-score sammenlignet med placebo.
English: Figure J: lift the needle straight out
Danish: Figur J: løft kanylen lige ud
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON AF MULTIPAKNING (INKLUSIVE BLÅ BOKS)
English: MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Danish: MTX = methotrexat ** p < 0,01, adalimumab over for placebo
English: • For a more comfortable injection, take the blister containing the syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
Danish: • For at få en mere behagelig injektion, skal du tage blisterkortet med sprøjten ud af køleskabet og lade det ligge uåbnet på bordet i 15-30 minutter, indtil det får stuetemperatur.
English: Plaque psoriasis in adults and children
Danish: Plaque-psoriasis hos voksne og børn
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 adalimumab-remission i uge 52.
English: Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab.
Danish: Tilfælde af forværret hjerteinsufficiens er også rapporteret for patienter i behandling med adalimumab.
English: Figure H: start your injection
Danish: Figur H: påbegynd din injektion
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hefiya.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Hefiya.
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Danish: I PsA-studie II blev 100 patienter, som havde utilstrækkeligt respons på DMARD-terapi, behandlet i 12 uger.
English: Hefiya is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: Hefiya bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I RA-studie I-IV opnåede adalimumab-behandlede patienter statistisk signifikant ACR 20og 50-respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
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: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Danish: Fordele og risici ved fortsat behandling med 40 mg ugentlig eller 80 mg hver anden uge, skal overvejes nøje hos patienter med utilstrækkeligt respons efter øgning af dosis (se pkt.
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Danish: I de kontrollerede dele af de kliniske studier med TNF-antagonister, blev der observeret flere tilfælde af maligniteter inklusive lymfomer hos de patienter, som fik TNF-antagonister, sammenlignet med kontrolpatienterne.
English: week 26 week 52
Danish: uge 26 uge 52
English: Before your injection
Danish: Før injektion
English: Based on the observed data approach, 222 (80.4 %) 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 184 (66.7 %) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 222 (80,4 %) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis ≤ 7,5 mg pr. dag og 184 (66,7 %) var både steroidfri og inaktive.
English: There is a known association between intermediate uveitis and central demyelinating disorders.
Danish: Der er en kendt sammenhæng mellem intermediær uveitis og demyeliniserende sygdomme i centralnervesystemet.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Danish: • tegn og symptomer, som kan tyde på blodsygdomme såsom vedvarende feber, blå mærker, blødning, bleghed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON AF MULTIPAKNING (UDEN BLÅ BOKS)
English: Other medicines and Hefiya
Danish: Brug af anden medicin sammen med Hefiya
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Danish: I det største AS-studie I med 315 patienter, viste resultaterne statistisk signifikant forbedring af tegn og symptomer på ankyloserende spondylitis hos patienter behandlet med adalimumab sammenlignet med placebo.
English: Children and adolescents with plaque psoriasis
Danish: Børn og unge med plaque-psoriasis
English: Ear and labyrinth disorders
Danish: Øre og labyrint
English: After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Danish: Efter induktionsbehandling er den anbefalede dosis 40 mg hver anden uge via subkutan injektion.
English: Do not remove the cap until you are ready to inject.
Danish: Fjern ikke hætten, før du er klar til at injicere.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hefiya cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-cellelymfom hos patienter, der bliver behandlet med Hefiya kan ikke udelukkes (se pkt.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Danish: Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS < 1,3 ved uge 16, 20, 24 og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med adalimumab 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studievarighed 68 uger).
English: • autoantibodies present in the blood;
Danish: • tilstedeværelse af autoantistoffer i blodet
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hefiya.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Hefiya.
English: • inflammation of the pancreas which causes severe pain in the abdomen and back;
Danish: • inflammation i bugspytkirtlen, som kan give alvorlige smerter i maven og ryggen
English: Your healthcare provider should show you how to prepare and inject Hefiya properly using the pre-filled pen before you use it for the first time.
Danish: Din læge viser dig, hvordan du skal forberede og injicere Hefiya korrekt med den fyldte pen, inden du bruger det for første gang.
English: Malignancies and lymphoproliferative disorders
Danish: Maligniteter og lymfoproliferative sygdomme
English: Immunogenicity
Danish: Immunogenicitet