FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8 % of subjects with juvenile idiopathic arthritis.
Danish: I kliniske studier af op til 12 måneders varighed med patienter i behandling med godkendte doser af etanercept var den kumulative incidens af anti-etanercept antistoffer ca. 6 % af patienterne med reumatoid artrit, 7,5 % af patienterne med psoriasisartrit, 2 % af patienterne med ankyloserende spondylitis, 7 % af patienterne med psoriasis, 9,7 % af patienterne med pædiatrisk psoriasis og 4,8 % af patienterne med juvenil, idiopatisk artrit.
English: Antibodies to Enbrel
Danish: Antistoffer mod Enbrel
English: Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Danish: Behandling med Enbrel bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af reumatoid artrit, juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylitis, nonradiografisk aksial spondylartrit, plaque psoriasis eller pædiatrisk plaque psoriasis.
English: The instructions below explain how to use the MYCLIC pen to inject Enbrel.
Danish: Nedenstående vejledning forklarer, hvordan MYCLIC pennen bruges til injektion af Enbrel.
English: The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Danish: Der er mulighed for, at TNF-antagonister, herunder Enbrel, kan påvirke patientens modstandsdygtighed over for infektioner og maligniteter, eftersom TNF formidler betændelse og modulerer celleimmunrespons.
English: Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Danish: For voksne patienter i behandling med Enbrel og anakinra blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med patienter behandlet med enten Enbrel eller anakinra alene (historiske data).
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Enbrel treatment.
Danish: Alle patienter skal informeres om at søge lægelig rådgivning, hvis der viser sig tegn/symptomer, som kunne tyde på tuberkulose (f.eks. vedvarende hoste, vægtøgning/vægttab, let feber) under eller efter behandling med Enbrel.
English: • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Enbrel.
Danish: • Kræft: Fortæl det til lægen, hvis du har eller har haft kræft i lymfesystemet (lymfom) eller andre former for kræft.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including Enbrel, in the postmarketing setting.
Danish: Efter markedsføring er der rapporteret om maligniteter, heraf nogle letale, hos børn, unge og unge voksne (op til 22 år), der er behandlet med TNF-antagonister (start på behandling ≤ 18 år), herunder Enbrel.
English: In an open-label, singledose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Danish: I et åbent, enkeltdosis, dobbeltbehandling, cross-over studie med raske frivillige blev etanercept givet som en enkelt 50 mg/ml injektion fundet at være bioækvivalent med to samtidige injektioner af 25 mg/ml.
English: • With the needle still inserted in the vial, check the syringe for air bubbles.
Danish: • Mens kanylen stadig sidder i glasset, skal du kontrollere, om der er luftbobler i sprøjten.
English: Placing the needle on the syringe g.
Danish: Placering af kanylen på sprøjten g.
English: T hrombocyt openia, anaemia, leukopenia, neutropenia
Danish: Thrombocytopeni, anæmi, leukopeni, neutropeni
English: There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
Danish: Generelt er anvendelse af Enbrel til børn under 2 år med juvenil idiopatisk artrit ikke relevant.
English: In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive Enbrel for up to 10 years.
Danish: I et åbent, udvidet sikkerhedsstudie fortsatte 58 pædiatriske patienter fra ovenstående studie (i alderen fra 4 år ved studiestart) med at få Enbrel i op til 10 år.
English: After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Danish: Efter at have trukket Enbrel tilbage fra hætteglasset kan der være noget luft i sprøjten.
English: Int erst it ial lung disease (including pneumonitis and pulmonary fibrosis)*
Danish: Interstitiel lungesygdom (herunder pneumonitis og lungefibrose)*
English: Setting up for an injection c.
Danish: Forberedelse til injektion c.
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on Enbrel, they should seek immediate medical advice.
Danish: Alle patienter og forældre/ plejere skal informeres om, at hvis patienten udvikler tegn eller symptomer, som kan pege på bloddyskrasi eller infektioner (f.eks. vedvarende feber, øm hals, blå mærker, blødning, bleghed), mens de er i behandling med Enbrel, skal de omgående søge læge.
English: The active substance in Enbrel is etanercept.
Danish: Aktivt stof: etanercept.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: Enbrel did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Danish: Enbrel fremkaldte ikke dosisbegrænsende eller målorgantoksicitet hos cynomolgus-aber efter subkutan indgivelse to gange ugentligt i 4 eller 26 uger i træk med en dosis (15 mg/kg), som resulterede i AUC-baserede serumkoncentrationer af stoffet, der var over 27 gange højere end dem, der blev opnået hos mennesker ved den anbefalede dosis på 25 mg.
English: Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Danish: Af de patienter med reumatoid artrit, som blev evalueret for antinukleare antistoffer (ANA), var den procentdel af patienter, som udviklede nye positive antinukleare antistoffer (1:40), højere hos patienter, som modtog behandling med Enbrel (11 %), end hos patienter med placebo-behandling (5 %).
English: Choosing an injection site
Danish: Valg af injektionssted
English: In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Danish: Samtidig behandling hvor interaktioner ikke er observeret Der er ikke observeret nogen interaktion i kliniske forsøg, hvor Enbrel blev indgivet sammen med glukocorticoider, salicylater (undtagen sulfasalazin), non-steroide antiinflammatoriske lægemidler (NSAID), smertestillende midler eller methotrexat.
English: Allergic reactions associated with Enbrel administration have been reported commonly.
Danish: Der er hyppigt rapporteret om allergiske reaktioner associeret med indgivelse af Enbrel.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of Enbrel (see section 4.8).
Danish: Der er blevet rapporteret om alvorlige infektioner, sepsis, tuberkulose og opportunistiske infektioner, herunder invasive svampeinfektioner, listeriose og legionærsygdom i forbindelse med brugen af Enbrel (se pkt.
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with Enbrel at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Danish: I et andet åbent, enkelt-arm studie med 60 patienter med udvidet oligoartrit (15 patienter i alderen 2-4 år, 23 patienter i alderen 5-11 år og 22 patienter i alderen 12-17 år), 38 patienter med enthesitisrelateret artrit (i alderen 12-17 år) og 29 patienter med psoriasisartrit (i alderen 12-17 år) blev behandlet med 0,8 mg/kg Enbrel (op til maksimalt 50 mg per dosis) indgivet en gang om ugen i 12 uger.
English: • Leave the syringe in place.
Danish: • Lad sprøjten sidde.
English: Using the MYCLIC pre-filled pen to inject Enbrel
Danish: Brug af MYCLIC fyldt pen til at injicere Enbrel
English: Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the green button on top of the pen with your thumb to start the injection (see Diagram 5).
Danish: Mens pennen presses fast mod huden for at sikre, at sikkerhedshætten er presset helt ind i pennen, skal du trykke med tommelfingeren midt på den grønne aktiveringsknap øverst på pennen for at begynde injektionen (se billede 5).
English: ---------------Study 4-----------
Danish: ---------------Enbrel-----------
English: Enbrel is administered by an injection under the skin (by subcutaneous injection).
Danish: Enbrel indgives som en injektion under huden (subkutan injektion).
English: The MYCLIC pen contains a clear, colourless to pale yellow or pale brown solution for injection.
Danish: MYCLIC pennen indeholder en klar, farveløs til svagt gul eller lysebrun opløsning til injektion.
English: Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
Danish: Slå let på sprøjten for at få boblerne til at stige op til toppen af sprøjten i nærheden af kanylen (se billede 8).
English: In this study, most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
Danish: I dette studie var de fleste psoriasisartrit patienter behandlet med Enbrel i stand til at rejse en effektivt B-celle immunrespons mod pneumokok polysakkarid vaccine, men aggregrattitrene var moderat lavere, og få patienter havde dobbelt stigning i titrene i sammenligning med patienter, som ikke fik Enbrel.
English: T uberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Danish: Tuberkulose, opportunistisk infektion (herunder invasive fungale, protozoale, bakterielle, atypiske mykobakterielle og virale infektioner samt Legionellainfektion)*
English: Choosing an injection site g.
Danish: Valg af injektionssted g.
English: The efficacy of Enbrel in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Danish: Voksne patienter med nonradiografisk aksial spondylartrit Effekten af Enbrel hos patienter med nonradiografisk aksial spondylartrit (nr-AxSpa) blev vurderet i et randomiseret, placebokontrolleret studie, der var dobbeltblindet i 12 uger.
English: Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the grey button on top of the pen with your thumb to start the injection (see Diagram 5).
Danish: Mens pennen presses fast mod huden for at sikre, at sikkerhedshætten er presset helt ind i pennen, skal du trykke med tommelfingeren midt på den grå aktiveringsknap øverst på pennen for at begynde injektionen (se billede 5).
English: Each injection should be given at least 3 cm from where you last injected.
Danish: Hver injektion skal gives mindst 3 cm fra et tidligere anvendt sted.
English: In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly.
Danish: I dette studie fik 53 patienter placebo, 214 patienter fik 50 mg Enbrel en gang om ugen, og 153 patienter fik 25 mg Enbrel to gange om ugen.
English: T oxic epidermal necrolysis
Danish: Toksisk epidermal nekrolyse
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
Danish: Der blev rapporteret om ialt 2 maligniteter i kliniske studier af ca. 2 års varighed omfattende 240 patienter med psoriasisartrit behandlet med Enbrel.
English: Enbrel is administered by subcutaneous injection.
Danish: Enbrel indgives ved subkutan injektion.
English: Mannitol (E421) Sucrose Trometamol
Danish: Mannitol (E421) Saccharose Trometamol
English: Enbrel is reconstituted with 1 ml water for injections before use and administered by subcutaneous injection.
Danish: Enbrel rekonstitueres med 1 ml vand til injektionsvæsker før brug og indgives som en subkutan injektion.
English: Adding water for injections
Danish: Tilsætning af vand til injektionsvæsker
English: Powder for solution for injection (powder for injection).
Danish: Pulver til opløsning til injektion (pulver til injektion).
English: Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Danish: Tag Enbrelæsken med de fyldte injektionssprøjter ud af køleskabet, og placer den på en plan arbejdsflade.
English: Enbrel 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Danish: Enbrel 25 mg leveres som et hvidt pulver og solvens til opløsning til injektion (pulver til injektion).
English: • Infections/surgery: If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with Enbrel.
Danish: • Infektioner/operation: Hvis barnet udvikler en ny infektion eller skal gennemgå en større operation i den nærmeste fremtid, vil lægen muligvis ønske at overvåge barnets behandling med Enbrel.
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Enbrel.
Danish: • Infektioner/operation: Hvis du eller barnet udvikler en ny infektion eller skal gennemgå en større operation i den nærmeste fremtid, vil lægen muligvis ønske at overvåge behandlingen med Enbrel.
English: Baseline scoreb
Danish: DAS Baseline score
English: What you need to know before you use Enbrel
Danish: Det skal du vide, før du begynder at tage Enbrel
English: After preparing the Enbrel solution, immediate use is recommended.
Danish: Efter tilberedning af Enbrel-injektionsvæsken anbefales umiddelbar brug.
English: Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Danish: Der er også rapporteret om forskellige maligniteter i forbindelse med brugen af Enbrel, herunder cancer i bryst, lunger, hud og lymfekirtler (lymfom).
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p <0.001, b:<0.01 and c:<0.05, respectively between Enbrel and placebo
Danish: ASAS** 40 ASAS 20 ASAS 5/6 ASAS delvis remission BASDAI***50 *Nogle patienter leverede ikke fuldstændige data for alle endepunkter **ASAS=Assessment in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p<0,001; b: p<0,01 og c: p<0,05 mellem henholdsvis Enbrel og placebo
English: Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 7).
Danish: Træk langsomt stemplet tilbage for at trække væsken ind i sprøjten (se billede 7).
English: In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Danish: I et dobbeltblindt, placebokontrolleret, randomiseret klinisk studie med voksne patienter med psoriasisartrit, modtog 184 af patienterne også en multivalent pneumokok polysakkarid vaccine i uge 4.
English: Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Danish: Før injektion bør Enbrel engangs fyldte injektionssprøjter få stuetemperatur (ca. 15-30 minutter).
English: Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
Danish: Der bør udvises forsigtighed hos patienter i behandling med Enbrel, som tidligere har haft bloddyskrasi.
English: • While still in the plastic package, place the vial adaptor on top of the Enbrel vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper (see Diagram 2).
Danish: • Placer adapteren på toppen af Enbrel hætteglasset, mens den stadig er i plastikbeholderen, så spidsen på adapteren er placeret midt i den markerede cirkel på toppen af hætteglassets prop (se billede 2).
English: What Enbrel is and what it is used for What you need to know before you use Enbrel How to use Enbrel
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Enbrel Sådan skal du tage Enbrel Bivirkninger
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
Danish: I kliniske studier af mere end 2 års varighed med 351 patienter med ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med Enbrel.
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Danish: Typerne og andelen af andre bivirkninger hos patienter med juvenil idiopatisk artrit var de samme som dem, man så i studier af Enbrel til voksne patienter med reumatoid artrit, og hovedparten var milde.
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
Danish: Der er observeret 129 nye maligniteter af forskellig type hos 4.114 patienter med reumatoid artrit, som i kliniske forsøg blev behandlet med Enbrel i op til ca. 6 år, inklusiv 231 patienter behandlet med Enbrel i kombination med methotrexat i det to-årige aktivt kontrollerede forsøg.
English: Your doctor will determine if Enbrel is an appropriate treatment.
Danish: Lægen vil afgøre, om behandling med Enbrel er hensigtsmæssig.
English: Clinical improvement including onset of action within 2 weeks with Enbrel 25 mg was similar to that seen in the previous trials, and was maintained for up to 24 months.
Danish: virkningsstart inden for 2 uger for Enbrel 25 mg var det samme, som man havde set i de tidligere forsøg, og blev vedligeholdt i op til 24 måneder.
English: At week 12, more patients randomised to Enbrel had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
Danish: Efter 12 uger havde flere patienter, der var randomiseret til Enbrel, positiv effekt-respons (f.eks. PASI 75) end patienter, der var randomiseret til placebo.
English: If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Danish: Ovenstående anbefalinger vedrørende behandlingsvarighed bør følges, hvis gentagen behandling med Enbrel er indiceret.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg Enbrel once weekly (n=21) vs. 25 mg Enbrel twice weekly (n=16), respectively.
Danish: Middelserumkoncentrationsprofilerne ved steady-state hos behandlede patienter med reumatoid artrit var henholdsvis Cmax på 2,4 mg/l vs. 2,6 mg/l, Cmin på 1,2 mg/l vs. 1,4 mg/l og partiel AUC på 297 mg•t/l vs. 316 mg•t/l for Enbrel 50 mg en gang om ugen (n=21) vs. Enbrel 25 mg to gange om ugen (n=16).
English: • The syringe and needle should NEVER be re-used.
Danish: • Sprøjten og kanylen må ALDRIG genbruges.
English: Undesirable effects in paediatric patients with plaque psoriasis
Danish: Uønskede virkninger hos pædiatriske patienter med plaque psoriasis
English: Enbrel was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Danish: Enbrel blev givet i doser på 25 mg en gang om ugen, 25 mg to gange om ugen eller 50 mg to gange om ugen i 6 på hinanden følgende måneder.
English: The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticularcourse juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Danish: Enbrels sikkerhed og virkning blev vurderet i et to-delt studie med 69 børn med et polyartikulært forløb af juvenil idiopatisk artrit, som havde forskellige begyndelsestyper af juvenil idiopatisk artrit (polyartrit, pauciartrit, systemisk frembrud).
English: Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Danish: Herudover er Enbrels farmakokinetik den samme for patienter med reumatoid artrit, ankyloserende spondylitis og plaque psoriasis.
English: In a polyarticular-course juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/kg twice weekly for three months.
Danish: I et forsøg med etanercept til patienter med et polyartikulært forløb af juvenil idiopatisk artrit, fik 69 patienter (i alderen 4 til 17 år) 0,4 mg/kg to gange om ugen i tre måneder.
English: There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with Enbrel from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Danish: Der har været rapporter om inflammatorisk tarmsygdom og uveitis hos JIA-patienter, som behandles med Enbrel, fra post-marketingkilder, herunder et meget lille antal tilfælde, som kunne tyde på genopblussen af symptomer ved genoptagelse af behandling (se pkt.
English: In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
Danish: I studie 4 havde gruppen, som blev behandlet med Enbrel, en højere andel af patienter med PASI 75 i uge 12 (38 %) sammenlignet med gruppen, som fik placebo (2 %) (p<0,0001).