FrancophonIA/ELRC3.0 huggingface dataset:
English: Improved physical function continued during the open-label extension up to week 136.
Danish: Den forbedrede fysiske funktion fortsatte i den åbne forlængelse frem til uge 136.
English: Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.
Danish: Stræk huden godt ud ved at bevæge tommeltotten og fingrene i modsat retning, så der bliver et område på cirka 5 cm bredde.
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: Thus additional caution should be exercised in considering AMGEVITA treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med AMGEVITA overvejes til sådanne patienter (se pkt.
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to AMGEVITA in utero is not recommended for 5 months following the mother's last AMGEVITA injection during pregnancy.
Danish: Administration af levende vacciner (f.eks. BCG vaccine) til spædbørn, som har været eksponeret for AMGEVITA in utero, anbefales ikke i 5 måneder efter moderens sidste AMGEVITAinjektion under graviditeten.
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Danish: Adalimumabs virkning og bivirkningsprofil blev vurderet i fem randomiserede, dobbeltblindede og velkontrolleredestudier.
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med AMGEVITA.
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Danish: Det er normalt, at man kan se en dråbe væske medicin i enden af kanylen eller den gule afskærmning.
English: If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more AMGEVITA and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Danish: - Hvis du oplever allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere AMGEVITA, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Vaccinations: if possible children should be up to date with all vaccinations before using AMGEVITA.
Danish: - Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før behandling med AMGEVITA startes.
English: • asthma;
Danish: • astma,
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: Statistically and clinically significant improvements from baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Danish: Statistitisk og klinisk signifikante forbedringer fra baseline i livskvalitetsparametre (inklusive IMPACT III) blev også set i begge behandlingsgrupper.
English: All patients received a 2 week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Danish: Ved studiestart fik alle patienter standarddosis af prednison 60 mg/dag i 2 uger efterfulgt af en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid ved uge 15.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with AMGEVITA should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med AMGEVITA overvejes, inden behandlingen iværksættes (se Opportunistiske infektioner).
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev opretholdt i den åbne forlængelsesfase op til uge 156.
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Danish: • systemisk lupus erythematosus (indbefatter betændelse i huden, hjertet, lungerne, leddene og andre organsystemer),
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), Benign neoplasm
Danish: Hudkræft eksklusive melanom (inklusive basal celle-karcinom og spinocellulært karcinom), Benign neoplasmer
English: The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment every other week for 52 weeks.
Danish: De gennemsnitlige dal-koncentrationer blev opretholdt hos patienter, som fortsatte med at få adalimumab-behandling hver anden uge i 52 uger.
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Danish: Ved behov for hurtigere behandlingsrespons kan nedenstående dosis anvendes med opmærksomheden rettet mod, at risikoen for bivirkninger kan være øget med den højere induktionsdosering:
English: ACR responses in RA study V (percent of patients)
Danish: ACR-respons i RA-studie V (procentdel af patienter)
English: Week 4 Clinical remission Clinical response (CR-100) All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Danish: Uge 4 Klinisk remission Klinisk respons (CR-100) Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo * p < 0,001 ** p < 0,01
English: AMGEVITA 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: AMGEVITA 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: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager AMGEVITA.
English: There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.
Danish: - Der er set meget sjældne tilfælde af visse kræfttyper hos patienter, som tager adalimumab eller andre TNF-hæmmere.
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 significant mindre radiografisk progression hos adalimumab-/ methotrexat-patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 9).
English: AMGEVITA contains the active substance adalimumab.
Danish: AMGEVITA indeholder det aktive stof adalimumab.
English: Oral infections (including herpes simplex, oral herpes and tooth infections),
Danish: Orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner),
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: AMGEVITA 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: AMGEVITA 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: Deafness, Tinnitus
Danish: Ikke almindelig Døvhed, Tinnitus
English: • sicca syndrome (including dry eyes and dry mouth);
Danish: • Sjøgrens syndrom (inklusive tørre øjne og tør mund),
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Danish: Blandt patienter, som var minimum delvise respondere ved uge 12, og som fik løbende ugentlig adalimumab-behandling, var HiSCR-raten 68,3% ved uge 48 og 65,1% ved uge 96.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en kræftsygdom, som påvirker lymfesystemt) og leukæmi (en kræftsygdom) som påvirker blod og knoglemarv).
English: What you need to know before you use AMGEVITA
Danish: Det skal du vide, før du begynder at tage AMGEVITA
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 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 (CRP) < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexatmonoterapi og 23,4% af patienterne, som fik adalimumab-monoterapi.
English: Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Danish: Ikke almindelig Lungeemboli1), Interstitiel lungesygdom, Kronisk obstruktiv lungesygdom, Pneumonitis,
English: Induction of clinical remission and response (percent of patients)
Danish: Induktion af klinisk remission og respons (procent af patienterne)
English: If you forget to give yourself an injection, you should inject the next dose of AMGEVITA as soon as you remember.
Danish: Hvis du glemmer at give dig selv en injektion, bør du injicere den næste dosis af AMGEVITA, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindelig fastlagte dag, som om du ikke havde glemt en dosis.
English: • inflammation of the skin (such as eczema);
Danish: • inflammation i huden (såsom eksem),
English: AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Danish: AMGEVITA hæmmer udviklingen af leddestruktion bedømt ved måling med røntgen og forbedrer den fysiske funktion, når det gives i kombination med methotrexat.
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 AMGEVITA 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 AMGEVITA-behandling.
English: Yellow cap off
Danish: Gul hætte af
English: If you are about to undergo surgery or dental procedures please inform your doctor that you are taking AMGEVITA.
Danish: - Hvis du skal opereres eller have tandbehandling, bør du informere din læge om, at du tager AMGEVITA.
English: ● Put the used pre-filled pen in a sharps disposal container immediately after use.
Danish: ● Læg den brugte pen i en kanylebøtte straks efter brug.
English: Multipack: 6 (3 packs of 2) SureClick pre-filled pens.
Danish: Multipakning: 6 (3 pakninger à 2) SureClick fyldte penne.
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 henholdvis uge 12 og 24.
English: Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data vedrørende adalimumab tyder på, at klinisk respons sædvanligvis opnås inden for 12 uger.
English: Guide to parts
Danish: Guide til pennens dele
English: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Danish: Andel af patientera, som opnår HiSCRb ved uge 24 og 36 efter nytildeling af behandling ved uge 12 (fra ugentlig adalimumab)
English: Note: P# = Placebo (number of events/number at risk); A# = Adalimumab (number of events/number at risk).
Danish: Note: P# = Placebo (antal af hændelser/antal med risiko); A# = adalimumab (antal af hændelser/antal med risiko).
English: Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Danish: Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler
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 juvenile idiopatisk artrit, som var fra 2 til <4 år.
English: Figure 3: Kaplan-Meier curves summarising time to treatment failure in the paediatric uveitis study
Danish: Figur 3: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis studie
English: In all cases, use a new pre-filled pen.
Danish: Brug i alle disse tilfælde en ny fyldt pen.
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: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with AMGEVITA.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af AMGEVITA-behandling.
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: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Danish: *** p < 0,001 for alle sammenligninger mellem adalimumab og placebo * p < 0,05 for alle sammenligninger mellem adalimumab og placebo N/A ikke relevant
English: Paraesthesias (including hypoaesthesia), Migraine,
Danish: Paræstesi (inklusive hypæstesi), Migræne,
English: L. Examine the injection site.
Danish: L. Undersøg injektionsstedet.
English: Other medicines and AMGEVITA
Danish: Brug af anden medicin sammen med AMGEVITA
English: K. Examine the injection site.
Danish: K. Undersøg injektionsstedet.
English: In controlled and open-label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Danish: I kontrollerede og åbne studier med voksne og pædiatriske patienter med adalimumab blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis, candidiasis, aspergillose og listeriose).
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: Maintenance of clinical remission and response (percent of patients)
Danish: Vedligeholdelse af klinisk remission og respons (procent af patienterne)
English: - Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: - Injicer ikke i områder, hvor huden er øm, rød eller hård eller har blå mærker.
English: ● Do not touch this area again before injecting.
Danish: ● Rør ikke dette sted igen, før du giver injektionen.
English: ● Alcohol wipes
Danish: ● Alkoholvædede servietter
English: ● The needle cover of the AMGEVITA pre-filled pen is made from dry natural rubber, which contains latex.
Danish: ● Den fyldte pens kanylehætte er fremstillet af tørt naturgummi, der indeholder latex.
English: Do not throw away (dispose of) the pre-filled pen in your household waste.
Danish: Symptomerne kan være ømme knuder i huden (noduli) og abscesser (bylder), som kan udtømme pus.
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: • neuropathy;
Danish: • neuropati,
English: AMGEVITA slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Danish: AMGEVITA nedsætter hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with AMGEVITA cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter, der bliver behandlet med AMGEVITA, kan ikke udelukkes (se pkt.
English: Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Danish: Administration af adalimumab uden methotrexat øgede antistofdannelsen, clearance og reducerede effekten af adalimumab (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 randomised 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 studie varighed 68 uger).
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 CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Danish: I CD-studie I og CD-studie II blev der i uge 4 opnået statistisk signifikante forbedringer i total score i det sygdoms-specifikke tarmsygdoms-spørgeskema (IBDQ) hos patienter randomiseret til adalimumab 80/40 mg og 160/80 mg sammenlignet med placebo, og i CD-studie III blev det også set ved uge 26 og 56 hos de adalimumab-behandlede-grupper sammenlignet med placebo-gruppen.
English: Important: Keep the skin pinched while injecting.
Danish: Vigtigt: Hold huden klemt sammen, mens du injicerer.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Der kan dannes adalimumab-antistoffer under behandling med adalimumab.
English: Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Danish: Effekt respons i placebo-kontrolleret AS-studie I Reduktion af tegn og symptomer Respons
English: When combining controlled portions of these trials and ongoing and completed open-label extension studies of adalimumab, with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Danish: Når kontrollerede dele af dissestudier og igangværende og afsluttede åbne opfølgningsstudier af adalimumab med en gennemsnitlig varighed på omkring 3,3 år inkluderende 6.427 patienter og med over 26.439 patientårs behandling kombineres, er den observerede hyppighed af maligniteter, fraset lymfomer og ikke- melanom hudkræft, cirka 8,5 pr. 1.000 patient-år.
English: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Danish: Dal-serumkoncentration af adalimumab ved steady state blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg ved subkutan dosering hver anden uge og hver uge.