FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of AMGEVITA should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af AMGEVITA bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: Firmly push the pre-filled pen down onto the skin until it stops moving.
Danish: Tryk den fyldte pen godt ned i huden, indtil den ikke bevæger sig længere.
English: Uncommon (may affect up to 1 in 100 people) • elevated bilirubin measurement (liver blood test).
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 personer) • forhøjet indhold af bilirubin i blodet (leverblodprøve).
English: Systemic infections (including sepsis, candidiasis and influenza),
Danish: Systemiske infektioner (inklusive sepsis, candidiasis og influenza),
English: A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
Danish: A. Tag det antal AMGEVITA fyldte injektionssprøjter, du skal bruge, ud af pakningen.
English: There were three groups in this study.
Danish: Der var tre grupper i dettestudie.
English: - On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome.
Danish: - I sjældne tilfælde kan behandling med AMGEVITA resultere i lupus-lignende syndrom.
English: ≥30% Reduction in Skin Painb
Danish: ≥30 % reduktion af hudsmerterb
English: Treatment with AMGEVITA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med AMGEVITA skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: • If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du har fået AMGEVITA, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion.
English: Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: - Rådfør dig med lægen, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N = 53 n (%)
Danish: Ps-studie II (CHAMPION) - effektresultater ved uge 16 Placebo N = 53 n (%)
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Danish: Plaque-psoriasis kan også ramme neglene, så de smuldrer, fortykkes og løfter sig fra neglelejet, hvilket kan være smertefuldt.
English: Efficacy results at 12 weeks, HS studies I and II
Danish: Effektresultater ved uge 12, HS-Studie I og II
English: Yellow window (injection complete)
Danish: Gul rude (injektion færdig)
English: 73% of patients enrolled in psoriasis studies I and II had received prior systemic therapy or phototherapy.
Danish: 73 % af patienterne i Psoriasis-studie I og II havde tidligere fået systemisk behandling eller lysbehandling.
English: Carriers of HBV who require treatment with AMGEVITA should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med AMGEVITA, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: If your doctor determines that methotrexate is inappropriate, AMGEVITA can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan AMGEVITA anvendes alene.
English: • high blood pressure;
Danish: • højt blodtryk,
English: PGA: Clear/minimalc a MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX c P = 0.083, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc a MTX = methotrexat b P = 0,027, adalimumab 0,8 mg/kg versus MTX c P = 0,083, adalimumab 0,8 mg/kg versus MTX
English: Treatment with AMGEVITA can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med AMGEVITA kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for standard dose versus low dose comparison
Danish: Uge 26 Klinisk remission Klinisk respons Uge 52 Klinisk remission Klinisk respons * p-værdi for sammenligning af standard-dosis versus lav-dosis
English: Statistically significant increases (improvement) from baseline to week 26 and 52 in body mass index and height velocity were observed for both treatment groups.
Danish: Statistisk signifikant øgning (forbedring) fra baseline til uge 26 og 52 i Body Mass Index og højdevækst blev set i begge behandlingsgrupper.
English: In patients who develop HBV reactivation, AMGEVITA should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør AMGEVITA seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med AMGEVITA, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrolleredestudie, som var et allerede specificeret primært endepunkt ved uge 52 i RA-studie III.
English: Rare (may affect up to 1 in 1,000 people) • low blood measurements for white blood cells, red blood cells and platelet count.
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer) • nedsat antal hvide blodlegemer, røde blodlegemer og blodplader.
English: Your doctor may recommend temporary discontinuation of AMGEVITA.
Danish: Din læge kan anbefale midlertidig afbrydelse af behandling med AMGEVITA.
English: • Merkel cell carcinoma (a type of skin cancer);
Danish: • Merkelcelle karcinom (en type hudkræft),
English: • a bump or open sore that doesn't heal;
Danish: • en bule eller åbent sår, som ikke vil hele,
English: Time to treatment failure in studies UV I and UV II
Danish: Tid til behandlingssvigt i studie UV I og UV II Analyse
English: In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 17 and 18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se Tabel 17 og 18).
English: Keep AMGEVITA in the outer carton in order to protect from light.
Danish: Opbevar AMGEVITA i den ydre karton for at beskytte mod lys.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
Danish: Vurderinger af neglepsoriasis omfattede Modified Nail Psoriasis Severity Index (mNAPSI), Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og Nail Psoriasis Severity Index (NAPSI) (se tabel 19).
English: • blood in urine;
Danish: • blod i urinen,
English: Congestive heart failure
Danish: Kongestiv hjertesvigt
English: AMGEVITA is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: AMGEVITA bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: Very common Abdominal pain, Nausea and vomiting
Danish: Meget almindelig Abdominalsmerter, Kvalme og opkastning
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week
Danish: Klinisk remission (defineret som Mayo-score < 2 med ingen subscore > 1) blev vurderet i uge 8.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Danish: Det primære endepunkt i RA-studie V var procentdelen af patienter, som opnåede et ACR50-respons i uge 52.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Danish: I RA-studie III opretholdt de fleste af de patienter, der opnåede forbedringer i fysisk funktion og fortsatte behandlingen forbedring gennem 520 uger (120 måneder) med åben behandling.
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by x-ray results).
Danish: RA-studierne III og V havde yderligere primære endepunkter i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Danish: Blandt de patienter, der afbrød studiet inden uge 78, blev 11 % afbrudt på grund af bivirkninger og 5 % på grund af utilstrækkelig respons på adalimumab behandling.
English: • feeling weak or tired;
Danish: • følelse af svaghed eller træthed,
English: CD study I: infliximab naïve patients
Danish: CD-StudieI I: Infliximab naive patienter
English: • severe rash, hives or other signs of allergic reaction;
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion,
English: Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Danish: Uge 36 a Patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling b Patienter, som opfylder protokol-specifikke kriterier for tab af respons eller ingen forbedring, var forpligtet til at udgå af studierne og blev optalt som non-respondere
English: If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager AMGEVITA, kan din risiko for at få et lymfom, leukæmi eller andre former for kræft øges.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post-marketing setting.
Danish: Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før ≤ 18-års alderen), inklusive adalimumab post marketing.
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA.
Danish: Fortæl din læge, hvis du får azathioprin eller 6-mercaptopurin sammen med AMGEVITA.
English: • cancer;
Danish: • kræft,
English: Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.
Danish: - Rådfør dig med din læge, hvis du har fast bopæl eller rejser i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomyse eller blastomykose er endemisk.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), paediatric ACR 50 response, and paediatric ACR 70 response.
Danish: Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR70-respons.
English: • lupus-like syndrome;
Danish: • lupus-lignende syndrom,
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in table 27.
Danish: Raten for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 27.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Danish: Adalimumab udviste en behandlingsfordel hos patienter med neglepsoriasis med forskellige grader af involvering af hud (BSA ≥ 10% [60% af patienterne] og BSA < 10% og ≥ 5% [40% af patienterne]).
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see figure 3, P < 0.0001 from log rank test).
Danish: Adalimumab forsinkede tiden til behandlingssvigt signifikant sammenlignet med placebo (se figur 3, P < 0,0001 fra log rank test).
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Danish: Efter doser på 0,5 mg/kg (~40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Danish: Den tilsyneladende plasmakoncentation af adalimumab som giver 50 % sandsynlighed for PedACR 50-respons (EC50) var 3 μg/ml (95 % CI: 1-6 μg/ml).
English: Do not use AMGEVITA:
Danish: Tag ikke AMGEVITA:
English: The 40 mg pre-filled pen cannot be used for the 20 mg dose.
Danish: Den fyldte pen med 40 mg kan ikke bruges til dosen på 20 mg.
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i ≥ 90 dage ved uge 52.
English: Important: Keep the skin stretched or pinched while injecting.
Danish: Vigtigt: Hold huden udstrakt eller klemt sammen, mens du injicerer.
English: You may first be given other disease-modifying medicines, such as methotrexate.
Danish: Du skal først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Danish: Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95 % KI 0,45-2,73) for RA og CD kombineret.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of AMGEVITA in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med AMGEVITA skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negative test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: Response, remission and mucosal healing in study UC-II (percent of patients)
Danish: Respons, remission og slimhindeheling i studie UC-II (Procent patienter)
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis du ikke reagerer tilstrækkeligt godt på disse lægemidler, vil du få AMGEVITA til behandling af din polyartikulære juvenile idiopatiske artrit eller entesopati-relaterede artrit.
English: ● Belly, except for a 2 inch (5 centimetres) area around your belly button
Danish: ● Maven - bortset fra et område på 5 cm omkring navlen
English: The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Danish: Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %).
English: The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Danish: Mediantiden til behandlingssvigt var 24,1 uge for patienter behandlet med placebo mens mediantiden til behandlingssvigt hos patienter behandlet med adalimumab ikke var målbar, da mindre end halvdelen af disse patienter oplevede behandlingssvigt.
English: In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Danish: Derudover er der set tilfælde af ikke-melanom hudkræft hos patienter, der tager adalimumab.
English: The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Danish: Det aktive stof i AMGEVITA, adalimumab, er et humant monoklonalt antistof.
English: During treatment with AMGEVITA, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med AMGEVITA, bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres.
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (n=100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
English: Patient Weight
Danish: Patientens vægt
English: • reactivation of hepatitis B;
Danish: • genopblussen af hepatitis B,
English: A. Remove one AMGEVITA pre-filled pen from the package.
Danish: A. Tag én AMGEVITA fyldt pen ud af pakningen.
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [P=0,014]).
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Danish: Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis)1), Urticaria,
English: -56.2a a p < 0.001, adalimumab versus placebo
Danish: -56,2a a p < 0,001, adalimumab vs. placebo
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Danish: Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringrespons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis.
English: ● Do not try to warm the syringe by using a heat source such as hot water or microwave.
Danish: ● Forsøg ikke at opvarme sprøjten ved hjælp af en varmekilde, for eksempel varmt vand eller mikrobølgeovn.
English: • reduction in blood platelets which increases risk of bleeding or bruising;
Danish: • nedsat antal blodplader med forøget risiko for blødning eller blå mærker,
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
Danish: Der er en forøget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilketkomplicerer risikoestimeringen.
English: Week 2 Week 12 Week 24 ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Danish: Uge 2 Uge 12 Uge 24 ***,** Statistisk signifikant p<0,001, <0,01 for alle sammenligning mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Concomitant administration of AMGEVITA with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Danish: Samtidig administration af AMGEVITA og andre biologiske DMARDs (f.eks, anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt.
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Danish: Hepatosplenisk T-celle-lymfom1), Merkelcelle karcinom (neuroendokrint karcinom)1)
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Danish: Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artrit-patienter målt i serum var 31-96%.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in Cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Danish: Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsstudier foretaget på cynomolgusaber med 0, 30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
English: AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: AMGEVITA kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.