FrancophonIA/ELRC3.0 huggingface dataset:
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Danish: Blandt disse viste 40 patienter ingen progression i strukturel ødelæggelse defineret som mTSS-ændring fra baseline på 0,5 eller mindre.
English: MTX n = 257 confidence interval)
Danish: MTX n=257 konfidensinterval)
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Danish: Blandt disse viste 48 patienter ingen progression af strukturel ødelæggelse defineret som ændring af mTSS fra baseline på 0,5 eller mindre.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard.
Danish: • Injicer ikke i et område, hvor huden er øm, har blå mærker, er rød, skæller eller er hård.
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Danish: • Der er set meget sjældne tilfælde af visse kræfttyper hos patienter, som tager adalimumab eller andre TNFα-hæmmere.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1), pruritus
Danish: Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis)1), urticaria, blå mærker (inklusive purpura), dermatitis (inklusive eksem), onychoclasis, hyperhidrosie alopeci1), pruritus
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis Study I, and continued adalimumab in the open-label extension trial.
Danish: I alt 233 PASI 75-respondenter ved uge 16 og 33 fik kontinuerlig adalimumab-behandling i 52 uger i Psoriasis-studie I og fortsatte med adalimumab i det åbne forlængelsesstudie.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Danish: PASI 75 og PGA clear eller minimal steg med stigende adalimumab-koncentration, begge med sammenlignelig tilsyneladende EC50 på omkring 4,5 μg/ml (henholdsvis 95 % CI 0,4-47,6 og 1,9-10,5).
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Danish: Studie nr-axSpA II var et behandlingsseponerings-studie hos patienter med aktiv nr-axSpA, som opnåede remission i den åbne periode af behandlingen med adalimumab.
English: Patients may first be given other disease-modifying medicines, such as methotrexate.
Danish: Patienter skal først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Danish: Sygdommen påvirker oftest bestemte områder af huden, såsom under brystet, i armhulerne, på inderlårene, i lyskeområdet og på balderne.
English: Patients treated with Hefiya should be given the Patient Reminder Card.
Danish: Patienter i Hefiya-behandling bør få udleveret et patientkort.
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), benigne neoplasmer
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte / macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med adalimumab, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B-, NK-celler, monocytter/makrofager og neutrofiler.
English: Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg / day).
Danish: Studie UV I undersøgte 217 patienter med aktiv uveitis på trods af behandling med kortikosteroid (oral prednison i doser fra 10 til 60 mg/dag).
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Danish: I kliniske studier er der set andre alvorlige infektioner inklusive pneumoni, pyelonefritis, septisk artrit og sepsis.
English: Figure C: needle guard is not activated - the syringe is ready for use
Danish: Figur C: kanylebeskyttelse er ikke aktiveretsprøjten er klar til brug
English: Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Danish: Opblussen af sygdom blev defineret som ASDAS ≥ 2,1 ved to på hinanden følgende besøg med fire ugers mellemrum.
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Danish: • tegn på hudkræft som en bule eller åbent sår, som ikke vil hele;
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Danish: Efter 16 ugers behandling gik de patienter, der mindst havde opnået et PASI 75-respons (forbedring i PASI-score på mindst 75% i forhold til baseline), over i periode B og fik åben 40 mg adalimumab hver anden uge.
English: Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Hefiya kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: • Store your pen within the carton in a refrigerator, between 2°C to 8°C.
Danish: • Opbevar din pen i pakningen i et køleskab mellem 2 °C og 8 °C.
English: • angioedema (localised swelling of the skin);
Danish: • angioødem (lokal hævelse af huden)
English: a time to treatment failure at or after week 6 in study UV I
Danish: for HRa tid til behandlingssvigt i eller efter uge 6 i studie UV I
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: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine / 6-mercaptopurine compared with adalimumab alone.
Danish: I studier hos voksne med Crohns sygdom blev der set en højere forekomst af maligne og alvorlige infektionsrelaterede bivirkninger ved kombination af adalimumab og azathioprin/6-mercaptopurin end med adalimumab alene.
English: If your doctor considers that methotrexate is inappropriate, Hefiya can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Hefiya anvendes alene.
English: What you need to know before you use Hefiya Do not use Hefiya
Danish: Det skal du vide, før du begynder at tage Hefiya Tag ikke Hefiya
English: Figure K: slowly release the plunger
Danish: Figur K: giv langsomt slip på stemplet
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: • ≥ 40 kg: 40 mg hver uge eller 80 mg hver anden uge Fortsat behandling skal overvejes nøje hos patienter, som ikke responderer inden uge 12.
English: • ulcerative colitis and
Danish: • colitis ulcerosa og
English: The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Danish: De pivotale kontrollerede studier, som omfattede 6.089 patienter, der fik adalimumab, og 3.801 patienter, der fik enten placebo eller aktiv kontrol i den kontrollerede behandlingsperiode.
English: Infections and infestations*
Danish: Infektioner og parasitære sygdomme*
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Danish: Multipel sklerose, demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom)1)
English: Disposing of used syringes” at the end of these Instructions for Use.
Danish: Bortskaffelse af brugte sprøjter” i slutningen af denne brugsvejledning.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and / or gold salts.
Danish: Disse terapier omfatter methotrexat, leflunomid, hydroxychloroquin, sulfasalazin og/eller guldsalt.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Danish: I RA-studie IV var ACR 20-respons for patienter behandlet med adalimumab plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0,001).
English: • if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Danish: • hvis du har en alvorlig infektion, herunder tuberkulose, sepsis (blodforgiftning) eller andre atypiske infektioner (usædvanlige infektioner, som er forbundet med et svækket immunforsvar).
English: Usually, Hefiya is used with methotrexate.
Danish: Normalt gives Hefiya sammen med methotrexat.
English: Population pharmacokinetic and pharmacokinetic / pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Danish: Farmakokinetiske og farmakokinetiske/farmadynamiske populationsmodeller og simulering viste sammenlignelig adalimumab-eksponering og virkning hos patienter behandlet med 80 mg hver anden uge, når der sammenlignes med 40 mg hver uge (herunder voksne patienter med RA, HS, UC, CD eller psoriasis, unge patienter med HS og pædiatriske patienter ≥ 40 kg med CD).
English: Hefiya can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: Hefiya kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: Study nr-axSpA I
Danish: Studie nr-axSpA I
English: • inflammation of the skin (such as eczema);
Danish: • inflammation i huden (såsom eksem)
English: Do not remove the finger flange before the injection.
Danish: Fjern ikke fingerstøtten før injektionen.
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 21) ved uge 12.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Danish: Opportunistiske infektioner, inklusive invasive fungicide infektioner, er observeret hos patienter, som modtog adalimumab.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Hefiya.
Danish: • Hvis du har eller udvikler demyeliniserende sygdom (en sygdom, der påvirker det isolerende lag rundt om nerverne som dissemineret sklerose), vil din læge afgøre, om du skal have eller fortsætte med at få Hefiya.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies 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 disse studier og igangværende og afsluttede åbne opfølgningsstudier 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 ikkemelanom hudkræft, cirka 8,5 pr. 1.000 patientår.
English: These results suggest that some patients who have not responded by Week 4 benefit from continued maintenance therapy through Week 12.
Danish: Disse resultater tyder på, at nogle patienter, som ikke har responderet ved uge 4, har fordel af fortsat vedligeholdelsesbehandling til og med uge 12.
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Danish: I de pivotale kontrollerede studier med voksne og børn var infektionshyppigheden 1,51 pr. patientår hos adalimumab-behandlede patienter og 1,46 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Danish: RA-studie V vurderede 799 methotrexat-naive voksne patienter med moderat til alvorlig aktiv reumatoid artrit i tidligt stadium (gennemsnitlig sygdomsvarighed på mindre end 9 måneder).
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Danish: Sammenlignet med placebo blev der ved uge 12 påvist større forbedringer i forhold til baseline i hudspecifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Danish: I HS-I-studie (PIONEER I) blev 307 patienter med 2 behandlingsperioder evalueret.
English: Table 13 efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms response placebo N=107
Danish: Tabel 13 Effektrespons i placebokontrolleret AS-studie I Reduktion af tegn og symptomer respons placebo N=107
English: Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Adalimumab har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at forbedre den fysiske funktion, når det gives i kombination med methotrexat.
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Danish: Statistisk og klinisk signifikante forbedringer fra baseline i livskvalitetsparametre (inklusive IMPACT III) blev også set i begge behandlingsgrupper.
English: Among patients who were not in response at week 4, 43 % of adalimumab maintenance patients responded by week 12 compared to 30 % of placebo maintenance patients.
Danish: Blandt de patienter, som ikke havde respons i uge 4, responderede 43 % af patienterne i adalimumab vedligeholdelsesbehandling ved uge 12 sammenlignet med 30 % af patienterne i placebogruppen.
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Danish: Nogle af disse hepatospleniske T-cellelymfomer med adalimumab er forekommet hos unge voksne patienter i samtidig behandling med azathioprin eller 6-mercaptopurin for inflammatorisk tarmsygdom.
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Danish: Adalimumab -dosis hos disse patienter er fastlagt ud fra farmakokinetiske modeller og simulering (se pkt.
English: Similar remission rates were observed for the 160 / 80 mg and 80 / 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160 / 80 mg group.
Danish: Der sås sammenlignelige remissions-rater ved uge 8 for 160/80 mg og 80/40 mg induktionsregimerne, men bivirkninger var hyppigere i gruppen med 160/80 mg.
English: Table 9 radiographic mean changes over 12 months in RA study III
Danish: Tabel 9 Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: Following 3 years of adalimumab therapy, 75 % (301 / 402) continued to be in clinical remission per partial Mayo score.
Danish: Efter 3 års behandling med adalimumab fortsatte 75 (301/402) med at være i klinisk remission i forhold til partiel Mayo-score.
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Danish: Tuberkulose, herunder reaktivering og nye tilfælde af tuberkulose er rapporteret hos patienter, der fik adalimumab.
English: • skin cancer;
Danish: • hudkræft
English: The incidence of serious infections was 0.04 per patient year in adalimumab-treated patients and 0.03 per patient year in placebo and active control-treated patients.
Danish: Incidensen af alvorlige infektioner var 0,04 pr. patientår hos adalimumab-behandlede patienter og 0,03 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and / or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Danish: I de pivotale kontrollerede studier med voksne og børn havde 12,9 % af de patienter, som blev behandlet med adalimumab, reaktioner ved injektionsstedet (erythem og/eller kløe, blødning, smerter eller hævelse) sammenlignet med 7,2 % af de patienter, som fik placebo eller aktiv kontrol.
English: It is recommended that you use an antiseptic wash daily on the affected areas.
Danish: Det anbefales, at du dagligt vasker de berørte områder med et antiseptisk middel.
English: Multipack containing 6 (3 packs of 2) pre-filled pens Not all pack sizes may be marketed.
Danish: Multipakning indeholdende 6 (3 pakninger a 2) fyldte penne Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Danish: Polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit er sygdomme med betændelseslignende (inflammatoriske) reaktioner i leddene, som oftest viser sig første gang i barndommen.
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: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Danish: I begge kliniske studier blev patient-rapporterede oplysninger om synsrelateret funktion målt ved anvendelse af NEI VFQ-25.
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Danish: 79 (73,1) a, b a p<0,001 adalimumab versus placebo b p<0,001 adalimumab versus methotrexat c p<0,01 adalimumab versus placebo d p<0,05 adalimumab versus methotrexat
English: A patient who requires surgery while on Hefiya should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Hefiya, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Table 28 response, remission and mucosal healing in study UC-II (percent of patients)
Danish: Tabel 28 Respons, remission og slimhindeheling i studie UC-II (procent patienter)
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg / dl) values) improved at 24 or 26 weeks compared to placebo.
Danish: I RA-studie I-IV forbedredes alle individuelle komponenter af ACR-responskriterierne (antal af ømme og hævede led, læge- og patientvurderinger af sygdomsaktivitet og smerter, fysisk funktionsevneindeksværdier (HAQ) og CRP (mg/dl)-værdier) efter 24 eller 26 uger sammenlignet med placebo.
English: ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
Danish: Delvis opblussen af sygdomd a Assessment of SpondyloArthritis international Society b Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
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: 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 Hefiya 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 Hefiya- behandling.
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Danish: Behandlingssvigt blev defineret som et multipelt sammensat endepunkt bestående af inflammatoriske korioretinale og/eller inflammatoriske retinale vaskulære læsioner, antal celler i det anteriore kammer (AC), grad af glaslegemesløring (VH) og bedste korrigerede synsstyrke (BCVA).
English: • Do not touch the cleaned area before injecting.
Danish: • Rør ikke ved det rensede område, før du injicerer.
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Danish: Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo * p<0,001 ** p<0,01
English: • Using a circular motion, clean the injection site with an alcohol wipe.
Danish: • Rens injektionsstedet med en alkoholserviet ved hjælp af cirklende bevægelser.
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Danish: Adalimumab viste en statistisk signifikant større forbedring i HAQ-S total score og i SF-36 Physical Component Score (PCS) fra baseline til uge 12 sammenlignet med placebo.
English: If you stop using Hefiya
Danish: Hvis du holder op med at tage Hefiya