FrancophonIA/ELRC3.0 huggingface dataset:
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 placebo-armen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde en kontraindikation mod NSAID.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week
Danish: Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ±1,9 i adalimumab-gruppen (ved uge 48) (p<0,001).
English: • ankylosing spondylitis,
Danish: • ankyloserende spondylitis
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Danish: N/A N/A *** p<0,001 for alle sammenligninger mellem adalimumab og placebo * p<0,05 for alle sammenligninger mellem adalimumab og placebo N/A ikke relevant
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (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 baseline-PGA-score varierede fra “moderat” (53 % af de inkluderede patienter) til “svær” (41 %) og “meget svær” (6 %).
English: • Gently pinch the skin at the injection site (see Figure H).
Danish: • Klem forsigtigt om huden på injektionsstedet (se Figur H).
English: Respiratory, thoracic and mediastinal disorders*
Danish: Luftveje, thorax og mediastinum*
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age
Danish: Børn og unge fra 2 år med kronisk ikke-infektiøs uveitis
English: • if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
Danish: • hvis du taber sprøjten, så brug den ikke, hvis den ser ud til at være beskadiget, eller hvis du tabte den, uden at kanylehætten var på.
English: Reproductive system and breast disorders
Danish: Det reproduktive system og mammae
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 statistisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (tabel 14).
English: Induction dose
Danish: Induktionsdosering
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: 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: Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg / m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Danish: Patienter, der udviste pædiatrisk ACR 30-respons ved uge 16, var egnede til randomisering i den dobbeltblindede fase og fik enten adalimumab 24 mg/m2 op til maksimalt 40 mg eller placebo hver anden uge i yderligere 32 uger eller indtil opblussen af sygdommen.
English: Hefiya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Danish: Hefiya kan nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: If these medicines do not work well enough, you will be given Hefiya to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, kan du få Hefiya til behandling af din reumatoide artrit.
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: RA-studie I evaluerede 271 patienter, der var ≥18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Danish: I en analyse af non-respondenter, defineret som patienter, som udgik af studiet på grund af bivirkninger eller manglende effekt, eller hvor dosis blev trappet op var PASI 75- og PGA clear/minimal responsrater henholdsvis 69,6 % og 55,7 % efter yderligere 108 ugers åben-behandling (i alt 160 uger).
English: The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later.
Danish: Den sædvanlige startdosis er 40 mg adalimumab efterfulgt af 20 mg to uger senere.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Danish: • tegn og symptomer på infektion, såsom feber, følelse af sygdom, sår, tandproblemer eller smerter ved vandladning, følelse af svaghed eller træthed eller hoste;
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Danish: Adalimumabs virkning er undersøgt i et randomiseret, dobbeltblindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller > 20 % BSA (body surface area)-involvering eller > 10 % BSA-involvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestationer i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling.
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: RA Study Ia**
Danish: RA-studie Ia**
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 Hefiya.
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 Hefiya.
English: clinical response clinical remission mucosal healing steroid-free remission for ≥ 90 daysa
Danish: klinisk respons klinisk remission slimhindeheling steroid-fri remission i ≥ 90 dagea
English: • Keep the syringes in the original carton until ready to use to protect from light.
Danish: • Opbevar sprøjterne i den originale pakning, indtil du er klar til at bruge den, for at beskytte den mod lys.
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Danish: Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f.eks. trombocytopeni, leukopeni) er rapporteret efter behandling med adalimumab.
English: • bacterial infections;
Danish: • bakterieinfektioner
English: Hefiya 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1287/001
Danish: Hefiya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte med kanylebeskyttelse EU/1/18/1287/001
English: Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose
Danish: Startdosis på 40 mg, efterfulgt af 40 mg givet hver anden uge startende en uge efter den initiale dosis
English: The usual dose of adalimumab is 20 mg every other week with methotrexate.
Danish: Den normale dosis adalimumab er 20 mg hver anden uge med methotrexat.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Danish: Det anbefales at fordelen og risikoen ved fortsat langvarig behandling vurderes årligt (se pkt.
English: Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: Hefiya er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: If you forget to give yourself an injection, you should inject the next dose of Hefiya as soon as you remember.
Danish: Hvis du glemmer at give dig selv en injektion, skal du injicere den næste dosis af Hefiya, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindeligt fastlagte dag, som om du ikke havde glemt en dosis.
English: Table 27 paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission standard dose 40 / 20 mg eow low dose 20 / 10 mg eow p value1
Danish: Tabel 27 Pædiatrisk CD-studie seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler standard-dosis 40/20 mg hver anden uge lavdosis 20/10 mg hver anden uge p-værdi1
English: Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen (SensoReady) with transparent window and label.
Danish: Hefiya leveres i en fyldt engangssprøjte samlet til en trekantformet pen med transparent vindue og etiket (SensoReady pen).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge sygeplejerske eller apoteket.
English: • multiple sclerosis;
Danish: • dissemineret sklerose
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: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Danish: Psoriasis-studie IV sammenlignede adalimumabs virkning og sikkerhed overfor placebo i 217 voksne patienter med moderat til svær neglepsoriasis.
English: Infections
Danish: Infektioner
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.
Danish: Sjældne tilfælde af pancytopeni herunder aplastisk anæmi er rapporteret efter behandling med TNFantagonister.
English: If these medicines do not work well enough, patients will be given Hefiya to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis man ikke reagerer tilstrækkeligt godt på disse lægemidler, vil man få Hefiya til behandling af polyartikulær juvenil idiopatisk artrit eller entesopatirelateret artrit.
English: It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede.
English: Antibiotics may be continued during treatment with Hefiya if necessary.
Danish: Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under Hefiya-behandlingen.
English: • Hefiya pre-filled syringe/s (see Figure A).
Danish: • Hefiya fyldt(e) injektionssprøjte(r) (se Figur A).
English: Patients were randomised to 40 mg of adalimumab or placebo every other week for 24 weeks.
Danish: Patienterne blev randomiseret til 40 mg adalimumab eller placebo hver anden uge i 24 uger.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160 / 80 mg or 80 / 40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40 / 20 mg eow) or Low Dose (20 / 10 mg eow) maintenance treatment groups based on their body weight.
Danish: Hos pædiatriske patienter med moderat til svær CD var åben-label adalimumab-induktionsdosis henholdsvis 160/80 mg eller 80/40 mg i uge 0 og 2, afhængigt af legemsvægt med en skillelinje ved 40 kg. Ved uge 4 blev patienterne randomiseret 1:1 til vedligeholdelsesbehandlingsgrupper: enten standarddosis (40/20 mg hver anden uge) eller lavdosis (20/10 mg hver anden uge) baseret på deres legemsvægt.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Hefiya 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: Hefiya 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: Figure A: Hefiya pre-filled syringe with needle guard and add-on finger flange
Danish: Figur A: Hefiya fyldt injektionssprøjte med kanylebeskyttelse og fingerstøtte som tilføjelse
English: Paediatric ulcerative colitis
Danish: Pædiatrisk colitis ulcerosa
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: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Danish: Adalimumab er blevet undersøgt hos patienter med reumatoid artrit, polyartikulær juvenil idiopatisk artrit og psoriasisartrit, der udelukkende blev behandlet med adalimumab, og hos patienter, der også samtidigt tog methotrexat.
English: • Dispose of the used syringe in a sharps container (closable, puncture-resistant container).
Danish: • De brugte sprøjter bortskaffes i en kanylebeholder (lukkelig, brudfast beholder).
English: Do not shake
Danish: Må ikke rystes
English: Adults with hidradenitis suppurativa
Danish: Voksne med hidrosadenitis suppurativa
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Danish: b p-værdi for den parvise sammenligning af adalimumab-monoterapi og adalimumab /methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test c p-værdi for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
English: Allergic reaction
Danish: Allergisk reaktion
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Danish: Blandt disse havde 86 patienter (75,4 %) ACR 20-respons, 72 patienter (63,2 %) ACR 50-respons og 41 patienter (36 %) ACR 70-respons.
English: Fever, bruising, bleeding or looking pale
Danish: Feber, blå mærker, blødning eller bleghed
English: • vasculitis (inflammation of blood vessels);
Danish: • vaskulitis (betændelse i blodkar)
English: Autoantibodies
Danish: Autoantistoffer
English: Cleaning your injection site:
Danish: Rensning af injektionsstedet:
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 µg / ml during adalimumab 40 mg every other week monotherapy treatment.
Danish: Hos voksne patienter med psoriasis var den gennemsnitlige steady state dal-koncentration af adalimumab 5 µg/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge.
English: Sarcoidosis1), vasculitis
Danish: Ikke almindelig Sarkoidose1) vaskulitis
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory 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: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Danish: Børn, unge og voksne med polyartikulær juvenil idiopatisk artrit Børn, unge og voksne fra 2 år, der vejer 30 kg eller mere Den anbefalede dosis Hefiya er 40 mg hver anden uge.
English: Table 22 proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Danish: Tabel 22 Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af behandling ved uge 12 (fra ugentlig adalimumab) placebo (behandlingen afbrydes) N = 73
English: Hefiya is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Danish: Hefiya bruges også til at behandle alvorlig plaque-psoriasis hos børn og unge i alderen 4 til 17 år, hos hvem lokal behandling og behandlinger med ultraviolet lys enten ikke har virket godt nok eller ikke er egnede.
English: The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Danish: Den tredje gruppe fik 40 mg adalimumab hver anden uge og placeboinjektioner i de øvrige uger.
English: b among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0-10;
Danish: 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
English: Adalimumab-treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Danish: I DLQI viste patienter behandlet med adalimumab statistisk signifikant forbedring ved uge 26 sammenlignet med placebo.
English: 2D barcode carrying the unique identifier included
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Danish: 4.4 og 5.1 vedrørende kombination med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat.
English: Contact your pharmacist if the syringe fails any of the above mentioned checks.
Danish: Kontakt apotekspersonalet, hvis sprøjten ikke kan klare alle de ovenstående tjek.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Danish: Gastrointestinal blødning, dyspepsi, gastroøsofageal reflukssygdom, Sjøgrens syndrom
English: Table 14 efficacy response in placebo-controlled study nr-axSpA I
Danish: Tabel 14 Respons på effektmål i placebokontrolleret studie nr-axSpA I
English: • mouth infections (including tooth infections and cold sores);
Danish: • infektioner i munden (inklusive tandinfektioner og forkølelsessår)
English: Upon completion of the first 52 weeks, 457 patients enrolled in an openlabel extension phase in which 40 mg of adalimumab / MTX was administered every other week up to 10 years.
Danish: Efter at have gennemført 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: 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: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in table 26.
Danish: Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10. Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 26.
English: Thereafter, the usual dose is 20 mg every other week.
Danish: Derefter er den sædvanlige dosis 20 mg hver anden uge.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Danish: Reumatoid artrit er en betændelsessygdom i leddene.