FrancophonIA/ELRC3.0 huggingface dataset:
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test.
Danish: a p-værdi for den parvise sammenligning af methotrexat-monoterapi og adalimumab /methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test.
English: • do not open the outer box until you are ready to use the pen.
Danish: • ikke åbner den ydre emballage, før du er klar til at bruge pennen
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21 / 41 (51 %) were in remission at week 52.
Danish: I studie UC-II var 21/41 (51 %) af de adalimumab-behandlede patienter, der var i remission i uge 8, også i remission i uge 52.
English: Hefiya dose for paediatric patients with Crohn's disease
Danish: Hefiya-dosis til pædiatriske patienter med Crohns sygdom
English: Prescribers should exercise caution in considering the use of Hefiya in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Hefiya should be considered if any of these disorders develop.
Danish: Lægen bør udvise forsigtighed, når behandling med Hefiya overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet eller det perifere nervesystem, og seponering skal overvejes, hvis nogle af disse sygdomme opstår.
English: week 8 and 52 sustained response sustained remission sustained mucosal healing clinical remission is Mayo score ≤ 2 with no subscore > 1; clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a of those receiving corticosteroids at baseline
Danish: uge 8 og 52 vedligeholdt respons vedligeholdt remission vedligeholdt slimhindeheling klinisk remission er Mayo-score ≤ uden subscore >1; klinisk respons er fald fra baseline i Mayo-score på ≥ 3 point og ≥ 30 % samt et fald i rektal blødning-subscore [RBS] på ≥ 1 eller en absolut RBS på 0 eller 1; * p<0,05 for adalimumab versus placebo ved parvis sammenligning af andelene ** p<0,001 for adalimumab versus placebo ved parvis sammenligning af andelene a af de patienter, der fik steroid ved baseline
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Danish: Efter 10 år, blev 79 af 207 patienter, som oprindeligt blev behandlet med 40 mg adalimumab hver anden uge, evalueret radiografisk.
English: • You might get infections more easily while you are receiving Hefiya treatment.
Danish: • Infektioner kan opstå lettere under behandling med Hefiya.
English: Should treatment be interrupted, Hefiya 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Hefiya 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: Figure I: complete your injection
Danish: Figur I: afslut din injektion
English: Patients who had been randomised to placebo in period A were assigned to receive adalimumab 40 mg every week in period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt adalimumab 40 mg hver uge i periode B.
English: Doses of 20, 40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks.
Danish: Doser på 20, 40 eller 80 mg adalimumab eller placebo blev givet hver anden uge i 24 uger.
English: The Hefiya 40 mg pre-filled pen should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg.
Danish: Hefiya 40 mg fyldt pen skal ikke bruges til børn og unge, der vejer mindre end 40 kg med Crohns sygdom, da det ikke er muligt at håndtere mindre doser end 40 mg.
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Danish: Sikkerhed og effekt af gentagne doser af adalimumab blev undersøgt hos voksne patienter med moderat til svært aktiv colitis ulcerosa (Mayo-score 6 til 12 med endoskopi-subscore på 2 til 3) i randomiserede, dobbeltblindede placebokontrollerede studier.
English: Paraesthesias (including hypoaesthesia), migraine, nerve root compression
Danish: Paræstesi (inklusive hypæstesi), migræne, nerverodskompression
English: PsA study II
Danish: PsA-studie II
English: • Cotton ball or gauze
Danish: • Bomuldsvatkugle eller gazebind
English: The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥ 40 kg (160 / 80 mg) and 10.6 ± 6.1 µg / ml for patients < 40 kg (80 / 40 mg).
Danish: De gennemsnitlige dal-serumkoncentrationer (±SD) af adalimumab, som blev opnået ved uge 4, var 15,7±6,6 µg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6±6,1 µg/ml for patienter < 40 kg (80/40 mg).
English: Of 542 patients who were randomised to adalimumab 40 mg every other week, 170 patients continued on adalimumab 40 mg every other week for 10 years.
Danish: Ud af 542 patienter, som blev randomiseret til adalimumab 40 mg hver anden uge, fortsatte 170 patienter på adalimumab 40 mg hver anden uge i 10 år.
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Danish: Der foreligger ikke tilstrækkelige data fra anti-viral behandling i kombination med TNF-antagonister for at forebygge HBV-reaktivering hos patienter, som er bærere af HBV.
English: • children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: • børn fra 2 år med kronisk ikke-infektiøs uveitis, som påvirker forreste del af øjet.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Danish: Hvis der viser sig symptomer på tuberkulose (vedvarende hoste, vægttab, sløvhed, let feber) eller anden form for infektion under eller efter behandlingen, bør lægen straks informeres.
English: Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Hefiya er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: solution for injection 1 pre-filled pen (SensoReady) 2 pre-filled pens (SensoReady)
Danish: Injektionsvæske, opløsning 1 fyldt pen ( SensoReady) 2 fyldte penne (SensoReady)
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Danish: I det åbne forlængelsesstudie RA V blev ACR-respons bibeholdt når patienterne blev fulgt i op til 10 år.
English: Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Danish: Din læge kan også ordinere en induktionsdosis på 40 mg, som kan administreres en uge før start af den sædvanlige dosis.
English: Starting your injection:
Danish: Påbegynd din injektion:
English: The recommended Hefiya induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Danish: Det anbefalede Hefiya induktions-dosis-regime til voksne patienter med moderat til svær aktiv Crohns sygdom er 80 mg i uge 0 efterfulgt af 40 mg i uge 2.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Danish: Der er ingen tilgængelige data, som sammenligner behandling med adalimumab versus methotrexat i mere end 16 uger.
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Danish: Ud af 207 patienter fortsatte 81 patienter på adalimumab 40 mg hver anden uge i 10 år.
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studier af adalimumab hos pædiatriske patienter med plaque-psoriasis.
English: Clinical Response
Danish: Klinisk respons
English: The usual dose of Hefiya is 40 mg every other week with methotrexate.
Danish: Den normale dosis Hefiya er 40 mg hver anden uge med methotrexat.
English: In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
Danish: PASI 75- og PGA clear eller minimal respons blev opretholdt i op til yderligere 52 uger uden nye sikkerhedsfund i den åbne del af studiet.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Danish: Efter behandling med adalimumab blev der hos patienter med reumatoid artrit observeret et hurtigt fald i niveauet af inflammatoriske akutfasereaktanter (C-reaktivt protein (CRP) og erytrocytsænkningshastighed (ESR)) og serumcytokiner (IL-6) sammenholdt med baseline.
English: • 80 mg at week 0 and 40 mg at week 2 ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Danish: • 80 mg i uge 0 og 40 mg i uge 2 ≥ 40 kg • 80 mg i uge 0 og 40 mg i uge 2
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Danish: Ca. dobbelt så mange patienter i placebo-gruppen som i adalimumab-gruppen oplevede forværring af abscesser (henholdsvis 23,0 % vs 11,4 %) og suppurerende fistler (henholdsvis 30,0% vs 13,9%) i de første 12 uger af HS-studie I og II.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Danish: Adalimumab 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbeltblindede placebokontrollerede studier med 393 patienter med aktiv ankyloserende spondylitis (gennemsnitlig score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
English: • Dispose of the used pens in a sharps container (closable, puncture-resistant container).
Danish: • De brugte penne bortskaffes i en kanylebeholder (lukkelig, brudfast beholder).
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Danish: • ødem (væskeophobning i kroppen, som får det påvirkede væv til at hæve)
English: Infection
Danish: Infektion
English: Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Danish: Tabel 16 ACR-respons i placebokontrollerede psoriasisartrit-studier (procentdel af patienter)
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Danish: • luftvejsinfektioner (inklusive forkølelse, løbende næse, bihulebetændelse, lungebetændelse)
English: (injection) Clear to slightly opalescent, colourless to slightly yellowish solution.
Danish: (injektion) Klar til lettere opaliserende, farveløs til let gullig opløsning
English: In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.
Danish: Der er ingen erfaring ved behandling med adalimumab uden samtidig behandling med methotrexat i pædiatrisk uveitis.
English: Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment.
Danish: Tilgængelige data tyder på, at klinisk respons normalt opnås inden for 2-8 ugers behandling.
English: placebo / MTX
Danish: Placebo/MTXadalimumab /MTX
English: Do not use the syringe if the expiration date has passed.
Danish: Brug den ikke efter den angivne udløbsdato.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Danish: Disse studier omfattede patienter med reumatoid artrit af kortere og længere sygdomsvarighed, juvenil idiopatisk artrit (polyartikulær juvenil idiopatiske artrit og entesopatirelateret artrit) og patienter med aksial spondyloartritis (ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis (AS)), psoriasisartrit, Crohns sygdom, colitis ulcerosa, psoriasis, hidrosadenitis suppurativa og uveitis.
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at Weeks 0 and 2.
Danish: I CD-studie II blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at få enten 160 mg adalimumab i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
English: • high blood measurements for lactate dehydrogenase;
Danish: • høje blodmålinger af lactatdehydrogenase
English: Psoriasis Study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Danish: Psoriasis-studie III (REACH) sammenlignede adalimumabs virkning og sikkerhed versus placebo hos 72 patienter med moderat til svær kronisk plaque-psoriasis og psoriasis på hænder og/eller fødder.
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Danish: Hvis du har ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis, vil du først få anden medicin.
English: Adults with Crohn's disease
Danish: Voksne med Crohns sygdom
English: There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
Danish: Der er begrænset erfaring med sikkerhed for patienter, som får artroplastik under behandling med adalimumab.
English: • hepatitis (liver inflammation);
Danish: • hepatit (leverbetændelse)
English: Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: Hefiya er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: Hefiya is injected under the skin (subcutaneous use).
Danish: Hefiya injiceres under huden (subkutan anvendelse).
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Adults with ulcerative colitis
Danish: Voksne med colitis ulcerosa
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline
Danish: klinisk remission klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea * p<0,001 for adalimumab vs. placebo parvise sammenligninger af andelene ** p<0,02 for adalimumab vs. placebo parvise sammenligninger af andelene a
English: RA Study IIIa**
Danish: RA-studie IIIa**
English: After 12 weeks of therapy, patients who had received adalimumab in period A were rerandomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Danish: Efter 12 ugers behandling blev patienterne, som havde fået adalimumab i periode A, randomiseret på ny i periode B til 1 af 3 behandlingsgrupper (adalimumab 40 mg hver uge, adalimumab 40 mg hver anden uge eller placebo fra uge 12 til uge 35).
English: Paediatric Crohn's disease
Danish: Pædiatrisk Crohns sygdom
English: The Hefiya 40 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg.
Danish: Hefiya 40 mg fyldt injektionssprøjte skal ikke bruges til børn og unge, der vejer mindre end 40 kg med Crohns sygdom, da det ikke er muligt at håndtere mindre doser end 40 mg.
English: Patients received adalimumab 0.8 mg / kg eow (up to 40 mg), 0.4 mg / kg eow (up to 20 mg), or methotrexate 0.1-0.4 mg / kg weekly (up to 25 mg).
Danish: Patienterne fik adalimumab 0,8 mg/kg hver anden uge (op til 40 mg), 0,4 mg/kg hver anden uge (op til 20 mg) eller methotrexat 0,1- 0,4 mg/kg ugentlig (op til 25 mg).
English: • Hefiya can be used during breast-feeding.
Danish: • Hefiya kan anvendes under amning.
English: Adalimumab should only be used during pregnancy if clearly needed.
Danish: Adalimumab bør kun anvendes under graviditet på tvingende indikation.
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Danish: • symptomer på nerveproblemer som snurren og prikken, følelsesløshed, dobbeltsyn eller svaghed i arme og ben;
English: • shortness of breath with exertion or upon lying down or swelling of the feet.
Danish: • stakåndethed ved fysisk anstrengelse eller når du ligger ned, eller hævede fødder.
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Danish: < 40 kg • 40 mg i uge 0 og 20 mg i uge 2
English: • Only remove the cap when you are ready to use the pen.
Danish: • Fjern først hætten, når du er klat til at bruge pennen.
English: RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
Danish: RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg adalimumab givet hver anden uge c
English: Table 5.
Danish: Tabel 5.
English: It is only available as 40 mg pre-filled syringe and / or as 40 mg pre-filled pen.
Danish: Det er kun tilgængeligt som en 40 mg fyldt injektionssprøjte og/eller som en 40 mg fyldt pen.
English: If you do not respond well enough to these medicines, you will be given Hefiya to reduce the signs and symptoms of your Crohn's disease.
Danish: Hvis du ikke har tilstrækkelig effekt af den medicin, vil du blive tilbudt Hefiya til reduktion af sygdomstegn og symptomer på din Crohns sygdom.
English: The combination of adalimumab as well as other TNFantagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Danish: Det anbefales ikke at kombinere adalimumab såvel som andre TNF-antagonister og anakira eller abatacept, fordi der er øget risiko for infektion som for eksempel alvorlige infektioner og andre mulige farmakologiske interaktioner.
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Danish: Adalimumab er ikke undersøgt hos patienter med nedsat lever- eller nyrefunktion.
English: Hidradenitis suppurativa in adults and adolescents
Danish: Hidrosadenitis suppurativa hos voksne og unge
English: When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan Hefiya opbevares ved stuetemperatur (op til 25°C) i en periode på højst 14 dage - sørg for at beskytte den mod lys.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et randomiseret, dobbeltblindet multicenterstudie hos 46 pædiatriske patienter (6-17 år) med moderat entesopatirelateret artrit.
English: Among those, 154 patients (90.6 %) had ACR 20 responses; 127 patients (74.7 %) had ACR 50 responses; and 102 patients (60.0 %) had ACR 70 responses.
Danish: Blandt disse havde 154 patienter (90,6 %) ACR 20-respons, 127 patienter (74,7 %) ACR 50-respons og 102 patienter (60 %) ACR 70-respons.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Danish: Tabel 7 ACR-respons i placebokontrollerede studie (procent af patienter)
English: 20, 25 and 40 mg
Danish: 20, 25 og 40 mg
English: Thus additional caution should be exercised in considering Hefiya treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med Hefiya overvejes til sådanne patienter (se pkt.
English: General disorders and administration site conditions*
Danish: Almene symptomer og reaktioner på administrationsstedet*
English: Hefiya 40 mg solution for injection in pre-filled pen EU/1/18/1287/004
Danish: Hefiya 40 mg injektionsvæske, opløsning i fyldt pen EU/1/18/1287/004
English: Do not re-use a syringe.
Danish: Brug ikke sprøjten igen.
English: Choosing your injection site:
Danish: Valg af injektionsstedet:
English: Hefiya dose for patients with polyarticular juvenile idiopathic arthritis
Danish: Hefiya-dosis til patienter med polyartikulær juvenil idiopatisk artrit
English: • Do not give Hefiya to children with paediatric plaque psoriasis or paediatric ulcerative colitis below the age of 4 years.
Danish: • Giv ikke Hefiya til børn under 4 år med pædiatrisk plaque-psoriasis eller pædiatrisk colitis ulcerosa.
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Danish: For synsrelaterede effekter havde adalimumab ikke numerisk en fordel ved farvesyn i studie UV I og ved farvesyn, langsyn og nærsyn i studie UV II.