natgillin/translations-raw huggingface dataset:
ACR 20 og 50 respons var højere hos patienter, der blev behandlet med Enbrel, ved 3 og 6 måneder, end hos patienter behandlet med placebo (ACR 20: Enbrel 62 % og 59 %, placebo 23 % og 11 % ved henholdsvis 3 og 6 måneder; ACR 50: Enbrel 41 % og 40 %, placebo 8 % og 5 % ved henholdsvis 3 og 6 måneder; p<0,01 Enbrel versus placebo ved alle tidspunkter for både ACR 20 og ACR 50 respons. 
ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20: Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 Enbrel vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Nogle børne- og teenage-patienter, som har fået Enbrel eller anden medicin, der virker på samme måde som Enbrel, har udviklet kræft, inkl. 
Some children and teenage patients who have received Enbrel or other medicines that work the same way as Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Bevæg hætteglasset med cirkelformede bevægelser et par gange, således at pulveret opløses (se billede 6). 
Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6).
I et studie med 49 voksne patienter med reumatoid artrit, som blev behandlet med Enbrel, var der ingen tegn på nedsættelse af tardiv overfølsomhed, nedsættelse af immunoglobulinniveauer eller ændring i optællingen af effektorcellepopulationer. 
In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
112 patienter blev randomiseret til at få 25 mg Enbrel (n = 57) eller placebo (n = 55) to gange om ugen i 24 uger. 
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
Patienter, der udvikler HBV-infektion, bør stoppe behandlingen med Enbrel og starte effektiv antiviral behandling med passende supportiv behandling. 
In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Generelt er anvendelse af Enbrel til børn under 6 år med plaque psoriasis ikke relevant. 
There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
Det er en alkoholserviet fra Enbrel-æsken eller et stykke gaze. 
These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
Patienterne fik 0,8 mg/kg Enbrel (op til 50 mg) eller placebo en gang om ugen i 12 uger. 
Patients received Enbrel 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Fortsat, varigt respons er set i op til 10 år i åbne, forlængede studier hos patienter, som fik Enbrel unden afbrydelse. 
Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received Enbrel without interruption.
Forberedelse af Enbrel dosis til injektion 
Preparing the Enbrel dose for injection
Sikkerhed og effekt ved brug af Enbrel til patienter med kroniske infektioner er ikke blevet vurderet. 
The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.
Hvis du herved kommer til at presse væske tilbage i glasset, skal du langsomt trække stemplet ud for at trække væsken tilbage i sprøjten igen. 
When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Se venligst afsnit 5 vedrørende opbevaring af Enbrel. 
Please see section 5 for instructions on how to store Enbrel.
• Lægen har ordineret Enbrel til et barn, som du har ansvar for. 
• This medicine has been prescribed for a child in your care.
Tilsvarende blev også observeret signifikante fordele ved Enbrel monoterapi sammenlignet med methotrexat monoterapi efter 24 måneder. 
Similarly, the significant advantages for Enbrel monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Bemærk: Hvis du ikke kan injicere som beskrevet, skal du presse pennen fastere mod huden og trykke på den grå knap igen. 
Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the grey button again.
Inflammatorisk tarmsygdom (IBD) og uveitis hos patienter med juvenil idiopatisk artrit (JIA) Der har været rapporter om IBD og uveitis hos JIA-patienter, som behandles med Enbrel (se pkt. 
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Lægen kan beslutte at fortsætte med at kontrollere, om du eller barnet har infektioner, efter at du eller barnet er holdt op med at bruge Enbrel. 
Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
I studier, hvor voksne patienter blev behandlet samtidig med Enbrel og anakinra, blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med Enbrel alene, og 2 % af patienterne (3/139) udviklede neutropeni (absolut neutrofiltælling < 1000/mm 
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
• Træk kanylen helt ud af hætteglasset. 
• Pull the needle completely out of the vial.
Hos patienter med psoriasisartrit har Enbrel vist sig at forbedre den fysiske funktion og at reducere udviklingen af perifere ledskader, målt ved hjælp af røntgen, hos patienter med polyartikulære, symmetriske undertyper af sygdommen. 
Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Hvis en eller flere af følgende reaktioner optræder, må du ikke injicere mere Enbrel. 
If any of the following happen, do not inject more Enbrel.
I kontrollerede studier med patienter med plaque psoriasis-fik ca. 13.6 % af patienterne behandlet med Enbrel reaktioner på injektionsstedet i løbet af de første 12 ugers behandling sammenlignet med 3,4 % af patienterne behandlet med placebo. 
In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
• Placer Enbrel hætteglasset på en plan flade, f.eks. et bord, og stik kanylen lige ned igennem midten af hætteglassets grå prop (se billede 2). 
• With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
Det vil hjælpe med til at reducere dannelse af luftbobler (se billede 5). 
This will help reduce foaming (lots of bubbles) (see Diagram 5).
I løbet af en randomiseret aftrapningsperiode fik signifikant flere patienter, som var gen-randomiseret til placebo, sygdomstilbagefald (tab af PASI 75-respons) sammenlignet med patienter, som var genrandomiseret til Enbrel. 
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel.
Enbrel må normalt ikke bruges til behandling af polyartrit eller udvidet oligoartrit hos børn under 2 år, til behandling af børn med enthesitis-relateret artrit eller psoriatisartrit under 12 år, eller til behandling af psoriasis hos børn under 6 år. 
Enbrel should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
I det to-årige aktivt kontrollerede forsøg, hvor patienterne blev behandlet med enten Enbrel alene, methotrexat alene eller Enbrel i kombination med methotrexat, var antallet af alvorlige infektioner det samme i behandlingsgrupperne. 
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
For patienter som fik 25 mg to gange om ugen igennem hele studiet, fortsatte PASI 75responset med at forbedres mellem uge 12 og 36. 
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Desuden viste et studie, at barnet hyppigere havde medfødte misdannelser, når kvinden havde taget Enbrel under graviditeten, sammenlignet med kvinder, der ikke havde taget Enbrel eller andre tilsvarende lægemidler (TNF-antagonister) under graviditet. 
In addition, one study found more birth defects when the mother had received Enbrel in pregnancy, compared with mothers who had not received Enbrel or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Ved kombination af resultater fra kontrollerede kliniske forsøg blev der observeret flere tilfælde af NMSC hos patienter behandlet med Enbrel, specielt psoriasispatienter, sammenlignet med kontrolpatienterne. 
Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis.
Patientinformationskortet til patienter, der behandles med Enbrel, skal indeholde følgende hovedelementer: 
The Patient's Alert Card should contain the following key elements for patients treated with Enbrel:
Efter den 12 uger lange dobbeltblinde behandlingsperiode fik alle patienter 0,8 mg/kg Enbrel (op til 50 mg) en gang om ugen i yderligere 24 uger. 
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
I et studie af 48 ugers varighed med 211 børn i alderen 4 til 17 år med pædiatrisk plaque psoriasis var de indberettede bivirkninger de samme som dem, man havde set i tidligere studier hos voksne med plaque psoriasis. 
In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Injektionen er færdig, når det andet klik lyder (eller efter at der er gået 10 sekunder) (se billede 6). 
On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Patienter i behandling med Enbrel bør få udleveret et eksemplar af 'Patientkort'. 
Patients treated with Enbrel should be given the Patient Alert Card.
Se efter nålespidsen inde i propvinduet (se billede 3). 
Look for the needle tip inside the stopper window (see Diagram 3).
Der har været sjældne rapporter om CNS-demyeliniseringslidelser hos patienter behandlet med Enbrel (se pkt. 
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8).
Lægen kan beslutte at fortsætte med at kontrollere, om barnet har infektioner, efter at barnet er holdt op med at bruge Enbrel. 
Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using Enbrel.
Effekten af Enbrel blev bedømt i et randomiseret, dobbeltblindt placebokontrolleret studie med 205 patienter med psoriasisartrit. 
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
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. 
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.
Antistoffer mod Enbrel 
Antibodies to Enbrel
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. 
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.
Nedenstående vejledning forklarer, hvordan MYCLIC pennen bruges til injektion af Enbrel. 
The instructions below explain how to use the MYCLIC pen to inject Enbrel.
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. 
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.
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). 
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).
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. 
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.
• Kræft: Fortæl det til lægen, hvis du har eller har haft kræft i lymfesystemet (lymfom) eller andre former for kræft. 
• 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.
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. 
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.
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. 
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.
• Mens kanylen stadig sidder i glasset, skal du kontrollere, om der er luftbobler i sprøjten. 
• With the needle still inserted in the vial, check the syringe for air bubbles.
Placering af kanylen på sprøjten g. 
Placing the needle on the syringe g.
Thrombocytopeni, anæmi, leukopeni, neutropeni 
T hrombocyt openia, anaemia, leukopenia, neutropenia
Generelt er anvendelse af Enbrel til børn under 2 år med juvenil idiopatisk artrit ikke relevant. 
There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
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. 
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.
Efter at have trukket Enbrel tilbage fra hætteglasset kan der være noget luft i sprøjten. 
After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Interstitiel lungesygdom (herunder pneumonitis og lungefibrose)* 
Int erst it ial lung disease (including pneumonitis and pulmonary fibrosis)*
Forberedelse til injektion c. 
Setting up for an injection c.
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. 
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.
Aktivt stof: etanercept. 
The active substance in Enbrel is etanercept.
VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE 
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
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. 
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.
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 %). 
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%).
Valg af injektionssted 
Choosing an injection site
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. 
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.
Der er hyppigt rapporteret om allergiske reaktioner associeret med indgivelse af Enbrel. 
Allergic reactions associated with Enbrel administration have been reported commonly.
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. 
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).
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. 
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.
• Lad sprøjten sidde. 
• Leave the syringe in place.
Brug af MYCLIC fyldt pen til at injicere Enbrel 
Using the MYCLIC pre-filled pen to inject Enbrel
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). 
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).
---------------Enbrel----------- 
---------------Study 4-----------
Enbrel indgives som en injektion under huden (subkutan injektion). 
Enbrel is administered by an injection under the skin (by subcutaneous injection).
MYCLIC pennen indeholder en klar, farveløs til svagt gul eller lysebrun opløsning til injektion. 
The MYCLIC pen contains a clear, colourless to pale yellow or pale brown solution for injection.
Slå let på sprøjten for at få boblerne til at stige op til toppen af sprøjten i nærheden af kanylen (se billede 8). 
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
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. 
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.
Tuberkulose, opportunistisk infektion (herunder invasive fungale, protozoale, bakterielle, atypiske mykobakterielle og virale infektioner samt Legionellainfektion)* 
T uberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Valg af injektionssted g. 
Choosing an injection site g.
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. 
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.