FrancophonIA/ELRC3.0 huggingface dataset:
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 kontrol-behandlede patienter.
English: - Not applicable
Danish: Ikke kendt
English: Antibiotics may be continued during treatment with Imraldi if necessary.
Danish: Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under Imraldi-behandlingen.
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: 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: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis du udvikler nye eller får forværrede symptomer på hjertesvigt (f. eks. stakåndethed eller hævede fødder), skal du kontakte din læge øjeblikkeligt.
English: **p <0.01, adalimumab versus placebo - Not applicable
Danish: **p < 0,01, adalimumab over for placebo - Ikke relevant
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: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Imraldi.
Danish: Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkulose (f.eks. vedvarende hoste, tæring/vægttab, lav feber, apati) under eller efter behandling med Imraldi.
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: Induction Dose
Danish: Induktionsdosering
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).
Danish: Adalimumab forsinkede tiden til behandlingssvigt signifikant sammenlignet med placebo (se figur 1, P < 0,0001 fra log rank test).
English: • When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.
Danish: • Når du er sikker på at hætteglasadapteren sidder fast på hætteglasset, skal pakningen løftes af hætteglasadapteren.
English: • DO NOT inject in an area where the skin is sore, bruised, scarred, scaly, or has red patches.
Danish: • Injicer IKKE i et område, hvor huden er øm, har blå mærker, er arret, skællet eller har røde pletter.
English: Imraldi is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Imraldi kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: Imraldi 40 mg solution for injection in pre-filled syringe EU/1/17/1216/001
Danish: Imraldi 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/17/1216/001
English: • high blood measurements for lactate dehydrogenase;
Danish: • høje blodmålinger af lactatdehydrogenase;
English: Table 20 Paediatric CD Study PCDAI Clinical Remission and Response
Danish: Tabel 20 Pædiatrisk CD-studie PCDAI klinisk remission og respons
English: Tell your doctor as soon as possible if you notice any of the following:
Danish: Kontakt lægen så hurtigt som muligt, hvis du får et eller flere af følgende symptomer:
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede sig fra “let” (< 1 %) til “moderat” (48 %), “alvorlig” (46 %) og “meget alvorlig” (6 %).
English: If you accidentally inject Imraldi more frequently than you should, call your doctor or pharmacist and explain that you have taken more.
Danish: Hvis du ved en fejltagelse injicerer Imraldi hyppigere, end du skal, skal du kontakte lægen eller apoteket og forklare, at du har taget mere.
English: Imraldi is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Danish: Imraldi bruges til at behandle polyartikulær juvenil idiopatisk artrit og entesopati-relateret artrit.
English: Hold the syringe steady and press the plunger all the way down.
Danish: Hold sprøjten fast, og tryk stemplet helt i bund.
English: Table 26 Paediatric CD Study PCDAI Clinical Remission and Response
Danish: Tabel 26 Pædiatrisk CD-studie PCDAI klinisk remission og respons
English: DO NOT touch the tip of the syringe.
Danish: Rør IKKE ved sprøjtens spids.
English: • If you dropped your syringe with the cap ON, it is okay to use the syringe.
Danish: • Hvis du taber sprøjten med hætten PÅ, er det okay at anvende sprøjten.
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 svær aktiv colitis ulcerosa (Mayo-score 6 til 12 med endoskopi-subscore på 2 til 3) i randomiserede, dobbeltblinde placebo-kontrollerede studier.
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Danish: Ud af 342 patienter som startede i det åbne forlængelsesstudie og blev randomiseret til adalimumab-monoterapi eller adalimumab/methotrexat-kombinationsterapi, afsluttede 171 patienter 10 års behandling med adalimumab.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (Creactive 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: • sensation of heart beating rapidly;
Danish: • fornemmelse af hurtige hjerteslag;
English: Citric acid monohydrate Histidine
Danish: Citronsyremonohydrat Histidin
English: Should treatment be interrupted, Imraldi 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 Imraldi 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: Also this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder endvidere mindre end 1 mmol natrium (23 mg) pr. 0,8 ml-dosis, dvs. det i det væsentlige er ”natriumfrit”.
English: Do not use this medicine after the expiry date which is stated on the label of the carton after EXP.
Danish: Brug ikke Imraldi efter den udløbsdato, der står på etiketten på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Carefully pull off the needle cap.
Danish: Træk forsigtigt kanylehætten af.
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 27.
Danish: Rater for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 27.
English: Low dose
Danish: Lav-dosis
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Danish: I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt 40 mg adalimumab hver anden uge i 16 uger.
English: 40 mg Adalimumab every week
Danish: 40 mg adalimumab hver uge
English: Place your pre-filled syringe and alcohol pads on a clean, dry surface.
Danish: Anbring din fyldte injektionssprøjte og spritservietter på en ren tør overflade.
English: • Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid.
Danish: • Skub den hvide stempelstang forsigtigt ind i sprøjten, indtil sprøjten indeholder den foreskrevne væskemængde.
English: • oedema (a build up of fluid in the body which causes the affected tissue to swell);
Danish: • ødem (ophobning af væske i kroppen, der medfører, at det berørte væv hæver);
English: Fever, bruising, bleeding or looking pale
Danish: Feber, blå mærker, blødning eller blegt udseende
English: Imraldi is given by injection under the skin (by subcutaneous injection).
Danish: Imraldi gives ved injektion under huden (subkutan injektion).
English: Imraldi is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: Imraldi bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
English: • Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the syringe as indicated by the arrow in the picture until firm.
Danish: • Hold sprøjten opad, sæt sprøjtens spids ind i den gule sprøjtevedhæftning og drej sprøjten, som vist med pilen på billedet nedenfor, indtil den er stram.
English: Week 12 Week 24 *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Danish: Uge 24 *** p < 0,001 for alle sammenligninger mellem adalimumab og placebo * p < 0,05 for alle sammenligninger mellem adalimumab og placebo - Ikke relevant
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 and18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75respons i forhold til baseline ved uge 16 (se tabel 17 og 18).
English: How to inject with your pre-filled pen Gather supplies
Danish: Sådan injiceres med den fyldte pen Saml materialerne sammen
English: RA study Ia**
Danish: RA-studie Ia**
English: Uncommon Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Danish: Ikke almindelig Neurologiske infektioner (inklusive viral meningitis), opportunistiske infektioner og tuberkulose (inklusive kokcidioidomykose, histoplasmose og mycobacterium avium complex-infektion), bakterielle infektioner, øjeninfektioner, diverticulitis1)
English: Patients participating in studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Danish: Patienter, som deltog i HS-studie I og II, var kvalificerede til inklusion i et åbent forlængelsesstudie, hvor adalimumab 40 mg blev givet hver uge.
English: • increased uric acid in the blood;
Danish: • forhøjet urinsyre i blodet;
English: If your child develops a fever that does not go away, or he/she bruises or bleeds very easily or looks very pale, call your doctor right away.
Danish: Hvis dit barn får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal du omgående henvende dig til din læge.
English: The needle is now attached to the syringe.
Danish: Kanylen sidder nu fast på sprøjten.
English:  2 pre-filled pens, each with 1 alcohol pad  4 pre-filled pens, each with 1 alcohol pad  6 pre-filled pens, each with 1 alcohol pad
Danish:  2 fyldte penne hver med 1 spritserviet  4 fyldte penne hver med 1 spritserviet  6 fyldte penne hver med 1 spritserviet
English: • skin cancer;
Danish: • hudkræft;
English: • Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe out of the package.
Danish: • Træk den klare beklædning så langt tilbage at den hvide stempelstang kommer fri, men tag ikke sprøjten ud af pakningen.
English: Imraldi can slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Danish: Imraldi kan nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og forbedre de fysiske funktioner.
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: P value*
Danish: P-værdi*
English: Time to Treatment Failure At or After Week 6 in Study UV I
Danish: Tid til behandlingssvigt i eller efter uge 6 i studie UV I
English: Imraldi may have a minor influence on the ability to drive and use machines.
Danish: Imraldi kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Imraldi.
Danish: Du kan få en fornemmelse af, at rummet drejer rundt (vertigo), og synsforstyrrelser, efter at have taget Imraldi.
English: For single use only.
Danish: Udelukkende til engangsbrug.
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: ***,** Statistisk signifikant ved p < 0,001, < 0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Efficacy results
Danish: Effekt-resultater
English: Imraldi is administered every other week via subcutaneous injection.
Danish: Imraldi administreres hver anden uge som subkutan injektion.
English: interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Danish: Ikke almindelig Lungeemboli1), interstitiel lungesygdom kronisk obstruktiv lungesygdom, pneumonitis, pleuraeffusion1)
English: 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
Danish: 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 sammeligning af andelene ** p< 0,001 for adalimumab versus placebo ved parvis sammeligning af andelene a
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6% (median percent change -50.0 %) in patients in the placebo group.
Danish: Det primære endepunkt var den procentvise ændring i antallet af led med aktiv artrit (hævelse, som ikke skyldes deformitet, eller led med tab af bevægelse plus smerte og/eller ømhed) fra baseline til uge 12, som blev opnået med et mediant fald på -62,6 % (median procentvise ændring -88,9 %) hos patienter i adalimumab-gruppen sammenlignet med et fald på -11,6 % (median procentvise ændring -50,0 %) hos patienter i placebogruppen.
English: CD Study I: Infliximab Naive Patients
Danish: CD-StudieI I: Infliximab-naive patienter CD-Studie II: Infliximaberfarne patienter
English: Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: Imraldi er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Danish: Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (Tabel 14).
English: * p<0.05, ***p<0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0
Danish: * p < 0,05, ***p < 0,001; adalimumab versus placebo a Blandt alle randomiserede patienter b Blandt patienter med HS-relateret evaluering af hudsmerte ≥ 3 ved baseline, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig
English: Hold the syringe on the graduated area and pull the syringe from its package.
Danish: Hold sprøjten på området med inddelinger og træk den ud af pakningen.
English: Hepatitis reactivation of hepatitis B1)
Danish: Sjælden hepatit reaktivering af hepatitis B1) autoimmun hepatit1)
English: Imraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Danish: Imraldi er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Danish: Der blev ikke observeret nogen maligniteter hos 249 pædiatriske patienter med en samlet eksposition på 655,6 patientår i adalimumab-studier hos patienter med juvenil idiopatisk artrit (polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit).
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré
Danish: Multipel sklerose, demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom)
English: Imraldi 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: Imraldi 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: In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥1 NSAIDs, or a contraindication for NSAIDs.
Danish: I Studie nr-axSpA I blev adalimumab 40 mg hver anden uge vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placeboarmen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde en kontraindikation mod NSAID.
English: • bacterial infections;
Danish: • bakterieinfektioner;
English: HS Study II
Danish: HS-studie II
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 17).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 17) ved uge 12.
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 21.
Danish: Rater for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 21.
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
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7 % and 59.0 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Danish: PASI 75- og PGA clear/minimal responsrater hos disse patienter var henholdvis 74,7 % og 59,0 % efter yderligere 108 ugers åben behandling (i alt 160 uger).
English: Clinical remission 12% Clinical response (CR-100)
Danish: Klinisk remission Klinisk respons (CR-100)
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2<4 years old or aged 4 and above weighing <15 kg) with moderately to severely active polyarticular JIA.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2 < 4 år gamle eller 4 år og derover med en vægt < 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
English: Tell your doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Danish: Fortæl det straks til lægen, hvis dit barn får symptomer som ændringer i synet, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Imraldi.
Danish: • Hvis dit barn har eller udvikler demyeliniserende sygdom (en sygdom, der angriber det isolerende lag omkring nerverne, såsom dissemineret sklerose), vil dit barns læge afgøre, om dit barn skal have eller fortsætte med at få Imraldi.
English: • mouth infections (including tooth infections and cold sores);
Danish: • infektioner i munden (inklusive tandinfektioner og forkølelsessår);