FrancophonIA/ELRC3.0 huggingface dataset:
English: The double-blind period was followed by an open-label period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode, hvor patienterne fik adalimumab 40 mg subkutant hver anden uge i op til yderligere 144 uger.
English: • rheumatoid arthritis,
Danish: • reumatoid artrit,
English: One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Danish: Én pakning indeholder 2 æsker, der hver indeholder 1 hætteglas, 1 tom steril injektionssprøjte, 1 kanyle, 1 hætteglasadapter og 2 spritservietter.
English: Imraldi is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Danish: Imraldi bruges til at behandle hidrosadenitis suppurativa hos unge fra 12 år.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Danish: Efter at have gennemførst de første 52 uger blev 457 patienter optaget i et åbent forlængelsesstudie, hvor 40 mg adalimumab/MTX blev administreret hver anden uge i op til 10 år.
English: Of 207 patients who were randomised to adalimumab 40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for 5 years.
Danish: Ud af 207 patienter, som blev randomiseret til adalimumab 40 mg hver anden uge, fortsatte 114 patienter på adalimumab 40 mg hver anden uge i 5 år.
English: DO NOT put the clear needle cap back on the needle.
Danish: Sæt IKKE den klare kanylehætte tilbage på kanylen.
English: Very common Leukopenia (including neutropenia and agranulocytosis), anaemia
Danish: Blod og lymfesystem * Meget almindelig Leukopeni (inklusive neutropeni og agranulocytose), anæmi
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 71 patienter med moderat til svær kronisk plaque-psoriasis og psoriasis på hænder og/eller fødder.
English: No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 × ULN i fase 3-studiet med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit, som var fra 2 til < 4 år.
English: Week 26 Week 52
Danish: Uge 26 Uge 52
English: • vasculitis (inflammation of blood vessels);
Danish: • vaskulitis (betændelse i blodkar);
English: Imraldi Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Danish: Imraldi-dosis til pædiatriske patienter med plaque psoriasis Patient vægt
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Danish: I PsA-studie I blev 313 voksne patienter, som havde et utilstrækkeligt respons på nonsteroid anti-inflammatorisk behandling, behandlet i 24 uger.
English:  Do not remove the cap just yet!
Danish:  Hætten må ikke tages af endnu!
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Imraldi and during treatment with Imraldi.
Danish: - Din læge vil også udlevere et Patientkort til dig, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under dit barns behandling med Imraldi.
English: • multiple sclerosis;
Danish: • dissemineret sklerose;
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Imraldi and during treatment with Imraldi.
Danish: - Din læge vil også udlevere et Patientkort til dig, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Imraldi.
English: The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every two weeks as a single dose.
Danish: Den almindelige dosis til voksne med reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis og til patienter med psoriasisartrit er 40 mg adalimumab hver anden uge som enkeltdosis.
English: Other medicines and Imraldi
Danish: Brug af anden medicin sammen med Imraldi
English: Note: P = Placebo (Number at Risk); H = Adalimumab (Number at Risk).
Danish: Bemærk: P = Placebo (Antal med risiko); H = Adalimumab (Antal med risiko).
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Danish: Figur 1: Kaplan-Meier-kurver opsummerende tid til opblussen af sygdom i Studie nr-axSpA II
English: • symptoms of nerve root compression(including low back pain and leg pain);
Danish: • symptomer på nerverodskompression (inklusive smerter i den nederste del af ryggen og bensmerter);
English: This risk may increase if his/her lung function is impaired.
Danish: Risikoen kan stige, hvis dit barns lungefunktion er svækket.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis dit barn bruger anden medicin eller har gjort det fornylig.
English: • facial oedema associated with allergic reactions;
Danish: • ødem i ansigtet forbundet med allergiske reaktioner;
English: Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Danish: Imraldi bruges også til at behandle alvorlig plaque-psoriasis hos børn og unge, der vejer 30 kg eller derover, hos hvem lokal behandling og lysbehandlinger enten ikke har virket godt nok eller ikke er egnede.
English: Crohn's disease is an inflammatory disease of the digestive tract.
Danish: Crohns sygdom er en inflammatorisk sygdom i mave-tarm-kanalen.
English: Among patients whose adalimumab treatment was withdrawn at week 12 in studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Danish: Blandt patienter, som fik afbrudt behandlingen med adalimumab ved uge 12 i HS-studie I og II, var HiSCR-raten 12 uger efter genoptagelse af behandling med adalimumab 40 mg ugentligt tilbage på samme niveau, som før behandlingsafbrydelsen (56,0 %).
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis, malignancies, other than lymphoma and nonmelanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Danish: I de kontrollerede dele af de pivotale adalimumab-studier med voksne af mindst 12 ugers varighed hos patienter med moderat til svær aktiv reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, Crohns sygdom, colitis ulcerosa og uveitis blev der observeret maligniteter, fraset lymfomer og ikke-melanom hudkræft, med en hyppighed (95 % konfidensinterval) på 6,8 (4,4-10,5) pr. 1.000 patientår blandt 5.291 adalimumab behandlede patienter mod en hyppighed på 6,3 (3,4-11,8) pr. 1.000 patientår blandt3.444 kontrolpatienter (gennemsnitlig varighed af behandlingen var 4,0 måneder for adalimumab og 3,8 måneder for de kontrol-behandlede patienter).
English: The syringe inside the pen is made from type I glass with a stainless steel needle, a rigid needle shield, a rubber plunger (bromobutyl).
Danish: Injektionssprøjten inde i pennen er lavet af type 1-glas med en kanyle af rustfrit stål, en stiv kanylebeskytter og et gummistempel (brombutyl).
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p <0.001) for adalimumab/methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Danish: I RA-studie V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p< 0,001) for adalimumab/methotrexat-kombinationsterapi end for methotrexat-monoterapi og adalimumab-monoterapi efter 52 uger.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Imraldi.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte din læge, før du begynder at bruge Imraldi.
English: Table 8 Paed ACR 30 Responses in the JIA study
Danish: Tabel 8 Pædiatrisk ACR 30-respons i JIA-studiet
English: Imraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Danish: Imraldi er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og pan-uveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English:  1 pre-filled pen, with 2 alcohol pads
Danish:  1 fyldt pen med 2 spritservietter
English: • Use each syringe only once.
Danish: • Hver sprøjte må kun bruges én gang.
English: For single use only
Danish: Udelukkende til engangsbrug
English: Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Danish: Der blev vist signifikante forbedringer i DLQI (Dermatology Life Quality Index) i forhold til baseline ved uge 16 sammenlignet med placebo (studie I og II) og MTX (studie II).
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 18,9, og baselinePGA-score varierede fra “moderat” (53 % af de inkluderede patienter) til “alvorlig” (41 %) og “meget alvorlig” (6 %).
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Danish: Patienterne fik en startdosis på 80 mg efterfulgt af 40 mg hver anden uge (med start en uge efter den første dosis) eller placebo i 26 uger efterfulgt af åben adalimumab-behandling i yderligere 26 uger.
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Danish: Der blev observeret en significant mindre radiografisk progression hos adalimumab-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 9).
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (<40 kg or ≥40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score >30.
Danish: Adalimumabs sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt (< 40 kg eller ≥ 40 kg) er undersøgt i et multicenter, randomiseret, dobbeltblindet klinisk studie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
English: Table 8 ACR Responses in RA Study V (Percent of Patients)
Danish: Tabel 8 ACR-respons i RA-studie V (Procentdel af patienter)
English: If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
Danish: Hvis væsken i sprøjten har et volumen der er mindre, må du IKKE bruge spøjten, men skal kontakte lægen.
English: Imraldi is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: Imraldi bruges til at behandle børn fra 2 år med kronisk ikke-infektiøs uveitis med inflammation (betændelseslignende tilstand), som påvirker forreste del af øjet.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, and hidradenitis suppurativa after treatment with adalimumab.
Danish: Efter behandling med adalimumab blev også observeret et hurtigt fald i CRP-niveau hos patienter med polyartikulær juvenil idiopatisk artrit, Crohns sygdom, colitis ulcerosa og hidrosadenitis suppurativa.
English: Table 12 Paed ACR 30 Responses in the JIA study
Danish: Tabel 12 Pædiatrisk ACR 30-respons i JIA-studiet
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 adalimumabgruppen oplevede forværring af abscesser (henholdvis 23,0 % vs 11,4 %) og suppurerende fistler (henholdvis 30,0 % vs 13,9 %) i de første 12 uger af HS-studie I og II.
English: Consequently, adalimumab can be used during breastfeeding.
Danish: Adalimumab kan som konsekvens heraf anvendes ved amning.
English: • If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Imraldi.
Danish: • Hvis dit barn har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte din læge, før du begynder at bruge Imraldi.
English: Dosing Regimen
Danish: Dosisregime
English: Your single-dose pre-filled pen
Danish: Din fyldte pen med enkeltdosis
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).
Danish: Benefit/risk-forholdet ved fortsat langtidsbehandling skal løbende evalueres (se data for voksne i pkt.
English: Imraldi is used to treat moderate to severe plaque psoriasis in adults.
Danish: Imraldi bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: Table 10 ACR Responses in RA Study V (Percent of Patients)
Danish: Tabel 10 ACR-respons i RA-studie V (Procentdel af patienter)
English: Mean steady-state trough levels of approximately 7 μg/ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Danish: Gennemsnitlige dal-niveauer på omtrent 7 µg/ml ved steady state blev set hos patienter med Crohns sygdom, som fik vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
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 entesopati-relateret artrit.
English: A 40 mg pre-filled syringe and pre-filled pen are available for patients to administer a full 40 mg dose.
Danish: En 40 mg fyldt injektionssprøjte og fyldt pen er tilgængelig til patienter til administration af en fuld dosis på 40 mg.
English: Week 24 Week 36
Danish: Uge 24 Uge 36
English: If you accidentally inject a smaller amount of Imraldi liquid, or if you inject Imraldi less frequently than you should, call your child's doctor or pharmacist and explain that your child has taken less.
Danish: Hvis du ved en fejltagelse injicerer en mindre mængde Imraldi-væske eller injicerer Imraldi mindre hyppigt, end du skulle, skal du kontakte dit barns læge eller apoteket og forklare, at dit barn har fået mindre Imraldi, end det skulle.
English: • abnormal blood measurements for sodium;
Danish: • unormale blodmålinger af natrium;
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Danish: 1 hætteglas (0,8 ml steril opløsning), 1 tom steril injektionssprøjte, 1 kanyle, 1 hætteglasadapter og 2 spritservietter
English: • polyarticular juvenile idiopathic arthritis,
Danish: • polyartikulær juvenil idiopatisk artrit,
English: • If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Imraldi.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, skal du fortælle lægen, at dit barn tager Imraldi.
English: • Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector.
Danish: • Klargør kanylen ved at åbne emballagen delvist fra enden tættest på den gule vedhæftning til sprøjten, så den gule vedhæftning til sprøjten netop er tilgængelig.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode (OL), hvor patienterne fik adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg hver anden uge subkutant i op til yderligere 192 uger.
English: • lung diseases causing shortness of breath (including inflammation);
Danish: • lungesygdom som forårsager kortåndethed (inklusive inflammation/vævsirritation);
English: • For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Danish: • Hvis den ordinerede dosis fx er 0,5 ml, må du IKKE skubbe den hvide stempelstang længere end til 0,5 mærket
English: Patients in steroid-free remission for >=90 daysa
Danish: Steroid-fri remission i > 90 dagea
English: Amongst those who responded at week 16 (n=144), the Paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Danish: Blandt de patienter, som responderede ved uge 16 (n = 144), blev pædiatriske ACR 30/50/70/90responser opretholdt i op til seks år i den åbne forlængelsesfase hos dem, der fik adalimumab gennem hele studiet.
English: Amongst those who responded (Paediatric ACR 30) at week 24 (n=27 out of 30 patients), the Paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Danish: Blandt de børn, som responderede (pædiatrisk ACR-30) ved uge 24 (n = 27 ud af 30 patienter), blev pædiatrisk ACR 30respons opretholdt i op til 60 uger i åben-label-fasen hos de patienter, som fik adalimumab gennem hele denne periode.
English: Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Danish: Hepatosplenisk T-celle-lymfom1), Merkelcelle karcinom (neuroendokrint karcinom i huden)1)
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med rheumatoid artrit (RA) var de gennemsnitlige dal steady state-koncentrationer på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat).
English: Imraldi may have a minor influence on your ability to drive, cycle or use machines.
Danish: Imraldi kan i mindre grad påvirke din evne til at føre motorkøretøj, cykle eller betjene maskiner.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 μg/ml.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge til voksne non-radiografisk aksial spondylartritis patienter var den gennemsnitlige (±SD) dal-steady state-koncentration ved uge 68 8,0 ± 4,6 µg/ml.
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Danish: Der blev observeret en significant mindre radiografisk progression hos adalimumab-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 11).
English: Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.
Danish: Imraldi bruges til at behandle svær plaque-psoriasis hos børn og unge i alderen 4 til 17 år, hos hvem lokal behandling og lysbehandlinger enten ikke har virket godt nok eller ikke er egnede.
English: and improvement of >30% in no more than 1 of the 6 criteria.
Danish: 6 pædiatriske ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Danish: Imraldi 40 mg injektionsvæske, opløsning i engangshætteglas (type 1-glas) med gummiprop, aluminiumklemme og letaftagelig forsegling.
English: Be sure to remove the vial adapter with the vial from the syringe.
Danish: Vær sikker på at du har fjernet hættegalsset med hætteglasadapteren fra sprøjten.
English: Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered.
Danish: Alternativt, kan Imraldi gen-administreres, hvis patienten er stoppet behandling med Imraldi, og tegn og symptomer på sygdommen kommer igen.
English: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af ikkemelanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt adalimumab-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne.
English: 36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare >32 weeks
Danish: 36,8 % (14/38) 64,9 % (24/37)b