FrancophonIA/ELRC3.0 huggingface dataset:
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild.
Danish: Typen og frekvensen af bivirkninger hos patienter med juvenil idiopatisk artrit var de samme som dem, man så i studier af etanercept til voksne patienter med reumatoid artrit, og hovedparten var lette.
English: These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly.
Danish: Disse middelkoncentrationer var de samme som dem, der blev observeret hos voksne patienter med plaque psoriasis behandlet med 25 mg etanercept to gange om ugen.
English: In a group of 2,711 plaque psoriasis patients treated with etanercept in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Danish: I dobbeltblinde og åbne studier af op til 2,5 års varighed omfattende 2.711 patienter med plaque psoriasis behandlet med etanercept blev der rapporteret 30 maligniteter og 43 tilfælde af ikke-melanom hudkræft.
English: In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks.
Danish: I den dobbeltblindede periode fik patienterne etanercept 50 mg ugentligt eller placebo i 12 uger.
English: In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly.
Danish: I dette studie fik 53 patienter placebo, 214 patienter fik 50 mg etanercept en gang om ugen, og 153 patienter fik 25 mg etanercept to gange om ugen.
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks.
Danish: 112 patienter blev randomiseret til at få 25 mg etanercept (n = 57) eller placebo (n = 55) to gange om ugen i 24 uger.
English: Firmly press the pre-filled pen down into the site to start the injection.
Danish: Tryk den fyldte pen ind i huden på injektionsstedet for at starte injektionen.
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Danish: Den anbefalede dosis er 0,4 mg/kg (op til maksimalt 25 mg per dosis) indgivet to gange ugentligt som subkutan injektion med et interval på 3-4 dage mellem doserne, eller 0,8 mg/kg (op til maksimalt 50 mg per dosis) indgivet en gang om ugen.
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Danish: De hyppigst rapporterede bivirkninger er reaktioner på injektionsstedet (som smerte, hævelse, kløe, rødme og blødning på indstiksstedet), infektioner (som infektioner i de øvre luftveje, bronkitis, blærebetændelse og hudinfektioner), allergiske reaktioner, udvikling af autoantistoffer, kløe og feber.
English: If needed, cover the injection site with a plaster.
Danish: Sæt om nødvendigt et plaster på injektionsstedet.
English: Adult patients with non-radiographic axial spondyloarthritis The efficacy of etanercept 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 etanercept hos patienter med nonradiografisk aksial spondylartrit (nr-AxSpa) blev vurderet i et randomiseret, placebo-kontrolleret studie, der var dobbeltblindt i 12 uger.
English: Inspect the solution: Look at the medicine in the pre-filled syringe.
Danish: Kontrollér opløsningen: Se på lægemidlet i den fyldte pen.
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 mg × hr/l vs. 316 mg × hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept 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 etanercept 50 mg en gang om ugen (n = 21) vs. etanercept 25 mg to gange om ugen (n = 16).
English: After the 12-week double-blind treatment period, all patients received etanercept 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Danish: Efter den 12 uger lange dobbeltblinde behandlingsperiode fik alle patienter 0,8 mg/kg etanercept (op til 50 mg) en gang om ugen i yderligere 24 uger.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept.
Danish: Der er i meget sjældne tilfælde rapporteret om Merkelcellekarcinom postmarketing hos patienter behandlet med etanercept.
English: Benepali is supplied as a pre-filled syringe containing a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Danish: Benepali leveres som en fyldt injektionssprøjte, der indeholder en klar til svagt opaliserende, farveløs eller svagt gul injektionsvæske, opløsning (injektionsvæske).
English: Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving etanercept compared with control patients, particularly in patients with psoriasis.
Danish: Ved kombination af resultater fra kontrollerede kliniske studier blev der observeret flere tilfælde af NMSC hos patienter behandlet med etanercept, specielt psoriasispatienter, sammenlignet med kontrolpatienterne.
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 μg × hr/ml and 474 μg × hr/ml for 50 mg etanercept once weekly (n = 154) and 25 mg twice weekly (n = 148), respectively.
Danish: I en farmakokinetisk populationsanalyse af patienter med ankyloserende spondylitis var etanercept steady-state-AUC henholdsvis 466 μg × t/ml tog 474 μg × t/ml for 50 mg etanercept en gang om ugen (n = 154) og 25 mg to gange om ugen (n = 148).
English: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Danish: Behandling af voksne med moderat til svær plaque psoriasis, som har vist utilstrækkeligt respons på, eller viste sig at være intolerante over for anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen og ultraviolet-A lys (PUVA) eller hvor den systemiske behandling inklusive ciclosporin, methotrexat eller PUVA er kontraindiceret (se pkt.
English: Study 2
Danish: Studie 2
English: Within the System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10);
Danish: Inden for systemorganklassen er bivirkningerne opført under overskrifter om hyppighed (antal patienter, der forventes at komme ud for reaktionen).
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Danish: Disse infektioner omfattede f.eks. absces (forskellige steder), bakteriæmi, bronkitis, bursitis, cellulitis, cholecystitis, diaré, divertikulitis, endocarditis (mistænkt), gastroenteritis, hepatitis B, herpes zoster, sår på benene, infektioner i munden, osteomyelitis, ototis, peritonitis, pneumoni, pyelonephritis, sepsis, septisk artrit, sinuitis, hudinfektion, sår på huden, urinvejsinfektion, vaskulitis og sårinfektion.
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Danish: Effekten af etanercept blev bedømt i et randomiseret, dobbeltblindt placebo-kontrolleret studie med 205 patienter med psoriasisartrit.
English: Serious infections experienced by etanercept-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Danish: Blandt de alvorlige infektioner, som patienter i behandling med etanercept kunne blive ramt af, var cellulitis, gastroenteritis, pneumoni, kolecystit, osteomyelitis, gastritis, appendicitis, streptokok-fasciitis, myositis, septisk shock, divertikulitis og absces.
English: At week 12, more patients randomised to etanercept had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
Danish: Efter 12 uger havde flere patienter, der var randomiseret til etanercept, positiv effekt-respons (f.eks. PASI 75) end patienter, der var randomiseret til placebo.
English: Patients received etanercept 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Danish: Patienterne fik 0,8 mg/kg etanercept (op til 50 mg) eller placebo en gang om ugen i 12 uger.
English: • Signs of serious infections (including pneumonia, deep skin infections, joint infections and blood infection), such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
Danish: • Tegn på alvorlig infektion (herunder lungebetændelse, dybe hudinfektioner, ledinfektioner og blodinfektion), som f.eks. høj feber evt. ledsaget af hoste, stakåndethed, kuldegysninger, slaphed eller et varmt, rødt, ømt, smertende område på hud eller led.
English: In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) etanercept subcutaneously twice weekly.
Danish: I første del af studiet fik alle patienter 0,4 mg/kg (maksimalt 25 mg per dosis) etanercept subkutant to gange om ugen.
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Danish: Kutan lupus erythematosus, subakut kutan lupus erythematosus, lupuslignende syndrom
English: Disposal:
Danish: Bortskaffelse:
English: The pen contains a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Danish: Pennen indeholder en klar til svagt opaliserende, farveløs eller svagt gul injektionsvæske, opløsning (injektionsvæske).
English: Rotate the site for each injection.
Danish: Vælg et ny sted til injektion hver gang.
English: • Trouble swallowing or breathing
Danish: • Besvær med at synke eller trække vejret.
English: A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Danish: Ét observationsstudie viste, at der var en øget hyppighed af alvorlige medførte misdannelser hos kvinder eksponeret for etanercept (n=370) i første trimester sammenlignet med kvinder, der ikke var blevet eksponeret for etanercept eller andre TNF-antagonister (n=164) under graviditeten (justeret oddsratio 2,4; 95 % CI: 1,0-5,5).
English: Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Danish: Tilsvarende blev også observeret signifikante fordele ved etanercept-monoterapi sammenlignet med methotrexat-monoterapi efter 24 måneder.
English: Samsung Bioepis NL B.V. Olof Palmestraat 10
Danish: Samsung Bioepis NL B.V.
English: Other medicines and Benepali
Danish: Brug af anden medicin sammen med Benepali
English: Radiographic changes were assessed in the psoriatic arthritis study.
Danish: I psoriasisartrit-studiet blev de røntgenologiske forandringer bedømt.
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
Danish: Der blev rapporteret om i alt 2 maligniteter i kliniske studier af ca. 2 års varighed omfattende 240 patienter med psoriasisartrit behandlet med etanercept.
English: If Benepali has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.
Danish: Hvis der ikke er nogen effekt af Benepalibehandlingen efter 12 uger, fortæller lægen dig måske, at behandlingen skal stoppes.
English: Etanercept 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.
Danish: Hos patienter med psoriasisartrit har etanercept 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.
English: Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Danish: Resultater for pædiatrisk plaque psoriasis efter 12 uger
English: 196 n = 46 n =
Danish: n = 196 n = 46 n = 96 n = 90
English: Allow the medicine to reach room temperature: Remove one pre-filled syringe from the refrigerator and leave at room temperature for at least 30 minutes before injecting.
Danish: Lad lægemidlet opnå stuetemperatur: Tag én fyldt injektionssprøjte ud af køleskabet, og lad den ligge ved stuetemperatur i mindst
English: There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
Danish: Der har været sjældne rapporter om CNS-demyeliniseringslidelser hos patienter behandlet med etanercept (se pkt.
English: The possibility exists for TNF-antagonists, including etanercept, 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 etanercept, kan påvirke patientens modstandsdygtighed over for infektioner og maligniteter, eftersom TNF formidler betændelse og modulerer celleimmunrespons.
English: In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Danish: Desuden viste et studie, at barnet hyppigere havde medfødte misdannelser, når kvinden havde taget etanercept under graviditeten, sammenlignet med kvinder, der ikke havde taget etanercept eller andre tilsvarende lægemidler (TNF-antagonister) under graviditet.
English: • Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
Danish: • Tegn på nervesygdom, som f.eks. følelsesløshed eller snurren, synsforstyrrelser, øjensmerte eller pludselig svaghed i en arm eller et ben.
English: The dose should be 50 mg once weekly.
Danish: Dosis bør være 50 mg én gang om ugen.
English: Uncommon ≥ 1/1,000 to
Danish: Ikke almindelig ≥ 1/1.000 to
English: disodium hydrogen phosphate heptahydrate, and water for injections.
Danish: dinatriumhydrogenphosphatheptahydrat og vand til injektionsvæsker.
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Benepali to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Danish: neurologisk vurdering, anbefales, når Benepali ordineres til patienter med eksisterende eller begyndende demyeliniseringssygdomme, eller til patienter som vurderes at have en øget risiko for at udvikle demyeliniseringssygdom.
English: Pancytopenia* Aplastic anaemia*
Danish: Pancytopeni* Aplastisk
English: Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of
Danish: Patienter, som var i gang med methotrexat-behandling (stabile ≥ 2 måneder) kunne fortsætte på en fast dosis på ≤ 25 mg/uge methotrexat.
English: • Do not use the pre-filled pen if it has been dropped onto a hard surface.
Danish: • Du må ikke bruge den fyldte pen, hvis den har været tabt på en hård flade.
English: Clear glass (type I) pre-filled syringe with stainless steel needle, rubber needle cover and rubber plunger containing 0.51 ml of solution.
Danish: Gennemsigtig (type I) fyldt sprøjte med kanyle af rustfrit stål, kanylehætte af gummi og gummistempel indeholdende 0,51 ml opløsning.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (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 etanercept (se pkt.
English: Gently stretch the skin at the cleaned injection site.
Danish: Stræk forsigtigt huden ud på det rengjorte injektionssted.
English: In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Danish: I et fjerde studie blev sikkerhed og effekt af 50 mg etanercept (to gange 25 mg subkutane injektioner) indgivet en gang om ugen versus 25 mg etanercept indgivet to gange om ugen vurderet i et dobbeltblindt, placebo-kontrolleret studie med 356 patienter med aktiv ankyloserende spondylitis.
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
Danish: • Tegn på lupus eller lupuslignende syndrom, herunder vægtændringer, vedvarende udslæt, feber, led- eller muskelsmerter eller træthed.
English: • Do not remove the needle cap until you are ready to inject.
Danish: • Du må ikke fjerne kanylehætten, inden du er klar til at injicere.
English: To help you remember, it may be helpful to write in a diary which day(s) of the week Benepali should be used.
Danish: For at hjælpe dig med at huske hvilke ugedage Benepali skal tages, kan det være en hjælp at skrive det ned i en kalender.
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Danish: Bivirkninger hos pædiatriske patienter med juvenil idiopatisk artrit Generelt var bivirkningerne hos de pædiatriske patienter med juvenil idiopatisk artrit af samme hyppighed og type som hos voksne patienter.
English: The efficacy of etanercept in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg etanercept with placebo.
Danish: Effekten af etanercept over for ankyloserende spondylitis blev bedømt i 3 randomiserede, dobbeltblinde studier, hvor indgivelse af 25 mg etanercept to gange om ugen blev sammenlignet med placebo.
English: The device will click a second time.
Danish: Pennen klikker igen.
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections and Legionella)*
Danish: Tuberkulose, opportunistisk infektion (inklusive invasive fungale, protozoale, bakterielle, atypiske mykobakterielle og virale infektioner samt Legionellainfektion)*
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Benepali needs to be used with caution under these circumstances.
Danish: • Hjertesvigt (kongestiv hjerteinsufficiens): Fortæl det til lægen, hvis du eller barnet lider af hjertesvigt, da Benepali i så fald skal bruges med forsigtighed.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and Φ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Danish: Parvis sammenligning af p-værdier: † = p < 0,05 for sammenligning af etanercept + methotrexat vs. methotrexat og Φ = p < 0,05 for sammenligning af etanercept + methotrexat vs. etanercept.
English: Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.
Danish: Saccharose, natriumchlorid, natriumdihydrogenphosphatmonohydrat, dinatriumhydrogenphosphatheptahydrat, vand til injektionsvæsker.
English: Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Danish: Doser på 25 mg etanercept (baseret på dosisstudier hos patienter med reumatoid artrit) eller placebo blev indgivet subkutant to gange om ugen i 6 måneder hos 138 patienter.
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study.
Danish: Etanercepts effekt blev vurderet i et randomiseret, dobbeltblindt, placebo-kontrolleret studie.
English: Dispose of the entire syringe in an approved sharps container.
Danish: Bortskaf hele injektionssprøjten i en godkendt kanyleboks.
English: Components inside the pre-filled syringe may be broken.
Danish: Indvendige dele i den fyldte injektionssprøjte kan være gået i stykker.
English: Paediatric patients with juvenile idiopathic arthritis The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Danish: Etanercepts 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: Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF.
Danish: Etanercept er en kompetitiv inhibitor af TNF-binding til celleoverfladereceptorer og hæmmer dermed TNF's biologiske aktivitet.
English: Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Danish: Herudover er etanercepts farmakokinetik den samme for patienter med reumatoid artrit, ankyloserende spondylitis og plaque psoriasis.
English: Multipack: 8 (2 packs of 4) pre-filled syringes Multipack: 24 (6 packs of 4) pre-filled syringes
Danish: Multipakning: 8 (2 pakninger á 4) fyldte injektionssprøjter Multipakning: 24 (6 pakninger á 4) fyldte injektionssprøjter
English: • Do not use the pre-filled pen past the expiration date.
Danish: • Du må ikke bruge den fyldte pen, hvis udløbsdatoen er overskredet.
English: Choose an injection site:
Danish: Vælg det sted, hvor du vil injicere:
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Danish: I en analyse, hvor alle patienter, som uanset grund udgik af studiet, blev anset for at have progression, var procentdelen af patienter uden progression (TSS-ændring ≤ 0,5) efter 12 måneder højere i gruppen, som fik etanercept, sammenlignet med placebo-gruppen (henholdsvis 73 % og 47 %, p ≤ 0,001).