FrancophonIA/ELRC3.0 huggingface dataset:
English: Women using Benepali should not breast-feed, since Benepali passes into human breast milk.
Danish: Kvinder i Benepali-behandling må ikke amme, da Benepali udskilles i human brystmælk.
English: The impact of long-term treatment with etanercept on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning en langvarig behandling med etanercept vil have på udviklingen af autoimmunsygdomme.
English: Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites.
Danish: Derudover udviklede nogle patienter fornyede injektionsstedsreaktioner, som var karakteriseret af en hudreaktion på det nyeste injektionssted og en samtidig fremkomst af injektionsstedsreaktioner på tidligere injektionssteder.
English: The known side effects of Benepali include the following in groups of decreasing frequency:
Danish: Nedenstående bivirkninger for Benepali er inddelt i grupper efter faldende frekvens.
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Danish: Disse omfattede hovedpine (19 % af patienterne, 1,7 forekomst pr. patientår), kvalme (9 %, 1,0 forekomst pr. patientår), abdominalsmerte (19 %, 0,74 forekomst pr. patientår) og opkastning (13 %, 0,74 forekomst pr. patientår).
English: In each case Benepali is used, usually when other widely used treatments have not worked well enough or are not suitable for you.
Danish: Benepali bruges sædvanligvis, når andre gængse behandlinger har været utilstrækkelige eller ikke er egnede til dig.
English: Inspect the pre-filled pen:
Danish: Kontrollér den fyldte pen:
English: In a double-blind, placebocontrolled, 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, placebo-kontrolleret klinisk studie med voksne patienter med psoriasisartrit, modtog 184 af patienterne også en multivalent pneumokok polysakkarid vaccine i uge 4.
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Danish: I de dobbeltblinde og åbne studier med psoriasisartrit indberettede én patient en alvorlig infektion (pneumoni).
English: If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Danish: Hvis du har glemt en dosis, skal du injicere, så snart du kommer i tanke om det, medmindre at den næste planlagte dosis er den følgende dag.
English: Reintroduction of treatment with etanercept after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received etanercept without interruption of therapy based on results of open-label studies.
Danish: Gentoptaget behandling med etanercept efter ophør i op til 24 måneder resulterede i samme størrelse af respons som hos patienter, som fik etanercept uden behandlingsafbrydelse, baseret på resultater fra åbne studier.
English: The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Danish: I studiet blev 215 voksne patienter (modificeret intent-to-treat-population) i alderen 18 til 49 år med aktiv nr-AxSpa, defineret som de patienter, der opfyldte ASAS-klassifikationskriterierne for aksial spondylartrit, men ikke opfyldte de modificerede New York-kriterier for AS, vurderet.
English: Patients who “failed to respond to” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Danish: Patienter, som "ikke responderer" er defineret ved utilstrækkeligt respons (PASI < 50 eller PGA mindre end god) eller forværring af sygdommen under behandling med mindst én af de tre systemiske behandlinger i tilstrækkelige doser og af tilstrækkelig varighed for at opnå respons.
English: Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Danish: I sammenligning med placebo gav behandlingen med etanercept en statistisk signifikant forbedring i ASAS 40, ASAS 20 og ASAS 5/6.
English: (<1/10,000); not known (cannot be estimated from the available data).
Danish: (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Danish: Stevens-Johnson syndrom, kutan vaskulitis (inklusive leucocytoklastisk vaskulitis), erythema multiforme, Lichenoide reaktioner
English: Patient Alert Card Benepali Etanercept
Danish: Patientkort Benepali Etanercept
English: The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
Danish: Studiet evaluerede 234 patienter med aktiv reumatoid artrit, hvor behandlingen var mislykkedes med mindst ét men ikke flere end fire sygdomsmodificerende antireumatiske lægemidler (DMARD'er).
English: The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Danish: Det primære slutmål for effekt var i alle fire studier antallet af patienter i hver gruppe, som opnåede PASI 75 (dvs. mindst 75 % forbedring i Psorisis- arealet og på Severity Indexscoren i forhold til baseline) efter 12 ugers behandling.
English: Placebo n = 106 to 109*
Danish: Placebo n = 106 til 109*
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Benepali, and in accordance with local recommendations.
Danish: Hvis diagnosen inaktiv (latent) tuberkulose stilles, skal behandling af latent tuberkulose påbegyndes med antituberkulosebehandling i overensstemmelse med nationale anbefalinger, før behandling med Benepali påbegyndes.
English: A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Danish: En enkelt 50 mg/ml injektion med etanercept viste sig at være bioækvivalent til to samtidige injektioner med 25 mg/ml.
English: There is no known antidote to etanercept.
Danish: Der er ingen kendt modgift mod etanercept.
English: The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma.
Danish: De mest almindeligt indberettede invasive svampeinfektioner var forårsaget af Candida, Pneumocystis, Aspergillus og Histoplasma.
English: Physicians should exercise caution when considering the use of Benepali in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Danish: Læger skal være forsigtige, når de overvejer brug af Benepali til patienter, der har en anamnese med tilbagevendende eller kroniske infektioner eller med tilgrundliggende sygdomstilstande, som kan prædisponere patienterne for infektioner, for eksempel fremskreden eller dårligt kontrolleret diabetes.
English: Response
Danish: Respons
English: • Wegener's granulomatosis: Benepali is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Danish: • Wegeners granulomatose: Benepali frarådes til behandling af Wegeners granulomatose, som er en sjælden betændelsessygdom.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept.
Danish: Der er indberettet tilfælde af aktiv tuberkulose, herunder miliær tuberkulose og tuberkulose med ekstrapulmonal position, hos patienter i behandling med etanercept.
English: Benepali contains the active substance, etanercept.
Danish: Benepali indeholder det aktive stof etanercept.
English: Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali.
Danish: Pædiatriske patienter, der har behov for en anden dosis end en fuld 25 mg- eller 50 mg-dosis, kan ikke få Benepali.
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Danish: Der bør udføres hensigtsmæssige screeningsstudier, dvs. Mantoux' intrakutane tuberkulinreaktion og røntgen af thorax, på alle patienter (nationale anbefalinger kan være gældende).
English: If Benepali has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Danish: Hvis Benepali ikke har nogen virkning på barnets tilstand efter 12 uger, kan lægen fortælle dig, at behandlingen stoppes.
English: (Scoreb) Baseline (Scoreb) Week 52
Danish: (Scoreb) Baseline 5,5 (Scoreb) Uge 52 3,0
English: ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
Danish: ACR 20 og 50 respons var højere hos patienter, der blev behandlet med etanercept, ved 3 og 6 måneder, end hos patienter behandlet med placebo (ACR 20: etanercept 62 % og 59 %, placebo 23 % og 11 % ved henholdsvis 3 og 6 måneder: ACR 50: etanercept 41 % og 40 %, placebo 8 % og 5 % ved henholdsvis 3 og 6 måneder; p < 0,01 etanercept versus placebo ved alle tidspunkter for både ACR 20 og ACR 50 respons).
English: Evidence of efficacy for the once-weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis.
Danish: Evidens for effekt af behandlingen med én ugentlig dosis hos denne patientgruppe er baseret på data fra studiet af patienter med ankyloserende spondylitis.
English: Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Danish: Behandling med etanercept resulterede i forbedret fysisk funktion i den dobbeltblinde studieperiode, og denne bedring blev fastholdt i det forlængede studie på op til 2 år.
English: Results:
Danish: Resultater:
English: The solution is clear to slightly opalescent, colourless or pale yellow, and is formulated at pH 6.2 ± 0.3.
Danish: Opløsningen er klar til svagt opaliserende, farveløs eller svagt gul og er sammensat ved pH 6,2 ± 0,3.
English: From the start of part 2, the median time to flare was 116 days for patients who received etanercept and 28 days for patients who received placebo.
Danish: Fra anden dels begyndelse var mediantiden til sygdomsopblussen 116 dage for patienter, som fik etanercept, og 28 dage for patienter, som fik placebo.
English: In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Danish: Ved plaque psoriasis fører infiltration med inflammatoriske celler, inklusive T-celler, til forhøjede TNF niveauer i psoriasis læsionerne sammenlignet med niveauerne i ikke-angrebet hud.
English: There is insufficient evidence of the efficacy of etanercept in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Danish: Der er ikke tilstrækkeligt bevis for effekten af etanercept hos patienter med ankyloserende spondylitislignende og artritis mutilans psoriasis artropatier på grund af det lille antal patienter, der er undersøgt.
English: If you have used more Benepali than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Danish: Hvis du har bruget for meget Benepali (enten ved at injicere for meget en enkelt gang eller ved at anvende det for ofte), bør du straks tale med lægen eller apotekspersonalet.
English: This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Danish: Dette afsnit indeholder data fra fire randomiserede, kontrollerede studier hos voksne med reumatoid artrit, et studie hos voksne med psoriasisartrit, et studie hos voksne med ankyloserende spondylitis, et studie hos voksne med nonradiografisk aksial spondylartrit, fire studier hos voksne med plaque psoriasis, tre studier hos patienter med juvenil idiopatisk artrit og et studie hos pædiatriske patienter med plaque psoriasis.
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Danish: TNF og lymfotoksin er pro-inflammatoriske cytokiner, som binder sig til to adskilte celleoverfladereceptorer: 55-kilodalton (p55) og 75-kilodalton (p75) tumornekrosefaktorreceptorer (TNFR).
English: If this occurs, you should stop using Benepali.
Danish: Hvis dette sker, skal du ophøre med at bruge Benepali.
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months.
Danish: I et fase II randomiseret, placebo-kontrolleret studie med 48 indlagte patienter behandlet med etanercept eller placebo for moderat til svær alkoholisk hepatitis var etanercept ikke effektivt, og mortaliteten for patienter behandlet med etanercept var signifikant højere efter 6 måneder.
English: Etanercept was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Danish: Etanercept blev anset for at være non-genotoksisk på grundlag af en serie in vitroog in vivo-studier.
English: The efficacy of etanercept versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing etanercept with other systemic therapies.
Danish: Effekten af etanercept versus andre systemiske behandlinger til patienter med moderat til svær psoriasis (responderende på andre systemiske behandlinger) er endnu ikke evalueret i direkte sammenlignende studier med etanercept over for andre systemiske behandlinger.
English: Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept.
Danish: Sjældne tilfælde af pancytopeni og meget sjældne tilfælde af aplastisk anæmi, nogle med dødeligt udfald, er rapporteret hos patienter i behandling med etanercept.
English: Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal failure.
Danish: Selvom der udskilles radioaktivitet i urinen efter indgivelse af radioaktivt mærket etanercept til patienter og frivillige, blev der ikke observeret øgede etanercept-koncentrationer hos patienter med akut nyresvigt.
English: Some have occurred within a few weeks after initiating treatment with etanercept in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Danish: Nogle forekom i løbet af et par uger efter start af behandling med etanercept hos patienter, som har tilgrundliggende sygdomsforhold (for eksempel diabetes, hjertestop, patientanamnese med aktive eller kroniske infektioner) ud over reumatoid artrit (se pkt.
English: Treatment with Benepali may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Danish: Behandling med Benepali kan medføre genopblussen af hepatitis B hos patienter, som tidligere har haft hepatitis B-infektion.
English: Benepali should be used with caution in patients with a history of hepatitis C.
Danish: Benepali skal anvendes med forsigtighed til patienter med en anamnese med hepatitis C.
English: Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued etanercept therapy in patients who do not respond within 3 months of initiating etanercept therapy.
Danish: Der er ikke udført studier med patienter med juvenil idiopatisk artrit til evaluering af fortsat etanercept-behandling til patienter, som ikke responderede inden for 3 måneder efter påbegyndelse af etanercept-behandling.
English: Your doctor may decide to continue to monitor you or the child for the presence of infections after you stop using Benepali.
Danish: Lægen kan beslutte at fortsætte med at kontrollere, om du eller barnet har infektioner, efter at du er holdt op med at bruge Benepali.
English: You can let go of the skin that you are pinching after the needle is completely inserted.
Danish: Du kan slippe hudfolden, som du klemmer sammen, når kanylen er indført helt.
English: Patients with a significant exposure to varicella virus should temporarily discontinue Benepali therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Danish: Patienter, som er signifikant udsat for varicellavirus, bør midlertidigt stoppe behandlingen med Benepali, og profylaktisk behandling med varicella zoster immunglobulin bør overvejes.
English: Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept during pregnancy.
Danish: Etanercept passerer placenta og er påvist i serum hos spædbørn født af kvinder, der er blevet behandlet med etanercept under graviditeten.
English: Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Danish: Det er rapporteret, at etanercept udskilles i human mælk efter subkutan administration.
English: In this study, most psoriatic arthritis patients receiving etanercept 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 etanercept.
Danish: I dette studie var de fleste psoriasisartrit patienter behandlet med etanercept i stand til at rejse et 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 etanercept.
English: Live vaccines should not be given concurrently with Benepali.
Danish: Levende vacciner bør ikke gives samtidigt med Benepali.
English: In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone.
Danish: I et kontrolleret klinisk studie af to års varighed med patienter med reumatoid artrit resulterede kombinationen etanercept og methotrexat ikke i uventede sikkerhedsfund, og sikkerhedsprofilen for etanercept givet i kombination med methotrexat var den samme som de profiler, der er rapporteret fra studier af etanercept og methotrexat alene.
English: Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Danish: Samtidig administration af etanercept og anakinra er blevet forbundet med en øget risiko for alvorlige infektioner og neutropeni sammenlignet med etanercept alene.
English: Although no clinical trials have been performed evaluating etanercept therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Danish: Selvom der ikke har været foretaget nogle kliniske studier for at evaluere etanercept-behandling af patienter med multipel sklerose, har kliniske studier af andre TNF antagonister hos patienter med multipel sklerose vist forøgelse i sygdomsaktiviteten.
English: Patients should be tested for HBV infection before initiating treatment with Benepali.
Danish: Patienter bør testes for HBV-infektion inden opstart af behandling med Benepali.
English: In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
Danish: I kliniske studier resulterede samtidig administration af abatacept og etanercept i et øget antal tilfælde af alvorlige bivirkninger.
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving etanercept during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of openlabel extension therapy.
Danish: I et studie med børn i alderen 4 til 17 år med juvenil, idiopatisk artrit fik 43 af 69 (62 %) af børnene en infektion, mens de fik etanercept i løbet af studiets 3 måneder (del 1, open-label), og hyppigheden og sværhedsgraden af infektioner var ens hos 58 patienter, som gennemførte 12 måneders ikke-blindet forlænget behandling.
English: Benepali is not recommended for the treatment of Wegener's granulomatosis.
Danish: Benepali frarådes til behandling af Wegeners granulomatose.
English: The largest of these trials (n = 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Danish: Det største af disse studier (n = 277) inkluderede patienter mellem 18 og 70 år, som havde aktiv ankyloserende spondylitis defineret som en visuel analogskala (VAS) score på ≥ 30 for gennemsnitsvarighed og intensiteten af morgenstivhed, plus VAS score på ≥ 30 for mindst 2 af følgende 3 parametre: Patientens almene bedømmelse, gennemsnit af VAS-værdier for natlig rygsmerte og total rygsmerte, gennemsnit af 10 spørgsmål om Bath Ankylosing Spondylitis Functional Index (BASFI).
English: Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Danish: Derudover har der i sjældne tilfælde været rapporteret om perifere demyeliniserende polyneuropatier (herunder Guillain-Barré-syndrom, kronisk inflammatorisk demyeliniserende polyneuropati, demyeliniserende polyneuropati og multifokal motorisk neuropati).