FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no differences in rates of infection among patients treated with etanercept and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Danish: Der var ingen forskel i infektionsraten blandt patienter behandlet med etanercept og patienter, som fik placebo mod plaque psoriasis, i placebokontrollerede studier af op til 24 ugers varighed.
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Danish: Undersøgelsen kan omfatte en grundig gennemgang af din eller barnets helbredstilstand, røntgenbillede af brystkassen og en tuberkulinundersøgelse.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n = 153) and 1.40 the spine (n = 154).
Danish: I uge 104 var den gennemsnitlige ændring fra baseline i SPARCC-scoren målt ved hjælp af MR hos alle patienter, der fik etanercept 4,64 for SI-leddet (n = 153) og 1,40 for rygsøjlen (n = 154).
English: • Signs of cancers: cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Danish: kræft kan påvirke hele kroppen, herunder hud og blod, og mulige tegn på kræft afhænger af typen og lokalisering i kroppen.
English: Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller barnet bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin (herunder anakinra, abatacept eller sulfasalazin).
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 etanercept, in the post-marketing 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 etanercept.
English: There have been post-marketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Danish: Der er efter markedsføring rapporteret om interstitiel lungesygdom (herunder pneumonitis og lungefibrose), nogle med dødelig udgang.
English: • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
Danish: • Tegn på autoimmune reaktioner (hvor der dannes antistoffer, der kan skade normalt væv), som f.eks. smerter, kløe, svaghed og unormal vejrtræking, tankegang, følesans eller syn.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA)
Danish: Inflammatorisk tarmsygdom (IBD) og uveitis hos patienter med juvenil idiopatisk artrit (JIA)
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
Danish: Den procentdel af patienter, som udviklede nye positive anti-dobbeltstrengede DNA-antistoffer, var også højere ved radioimmun-bestemmelse (15 % af patienter, der blev behandlet med etanercept, sammenlignet med 4 % af de patienter, der fik placebo) og ved Crithidia liciliae-bestemmelse (3 % af patienter, der blev behandlet med etanercept sammenlignet med ingen af de patienter, der fik placebo).
English: Take the syringe out of the blister.
Danish: Tag injektionssprøjten ud af blisterpakningen.
English: In a 2-year active-controlled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Danish: I et to-årigt aktivt kontrolleret forsøg, hvor patienterne blev behandlet med enten etanercept alene, methotrexat alene eller etanercept i behandling med methotrexat, var antallet af alvorlige infektioner det samme i behandlingsgrupperne.
English: In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), non-steroidal 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 etanercept blev indgivet sammen med glukocorticoider, salicylater (undtaget sulfasalazin), non-steroide antiinflammatoriske lægemidler (NSAID), smertestillende midler eller methotrexat.
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: Typerne og andelen 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 milde.
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their etanercept dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Danish: I studie 3 opretholdt hovedparten af de patienter (77 %), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres etanercept dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75-respons til uge 36.
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Erelzi in case the infection worsens.
Danish: • Hepatitis C: Fortæl det til lægen, hvis du eller barnet har hepatitis C. Lægen kan ønske at overvåge behandlingen med Erelzi, i tilfælde af at infektionen forværres.
English: In the post-marketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
Danish: Efter markedsføring af lægemidlet er der rapporteret leukæmitilfælde hos patienter, der har fået behandling med TNF-antagonister.
English: Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Danish: Etanercept, alene eller i kombination med methotrexat, er vist at reducere udviklingen af ledskader, målt ved hjælp af røntgen, og at forbedre den fysiske funktion.
English: Your doctor will determine if Erelzi is an appropriate treatment.
Danish: Lægen vil afgøre, om behandling med Erelzi er hensigtsmæssig.
English: To help you remember, it may be helpful to write in a diary which day(s) of the week Erelzi should be used.
Danish: For at hjælpe dig med at huske hvilke ugedage Erelzi skal tages, kan det være en hjælp at skrive det i en kalender.
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 etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in a 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 etanercept i op til ca. 6 år, inklusiv 231 patienter behandlet med etanercept i kombination med methotrexat i et to-årigt aktivt kontrolleret forsøg.
English: Store in the refrigerator between 2 °C to 8 °C.
Danish: Opbevares i køleskab ved mellem 2 °C - 8 °C.
English: The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg.
Danish: Forskellene i TSS og JSN mellem methotrexat og Etanercept 25 mg var ikke statistisk signifikant.
English: Choose your injection site:
Danish: Vælg dit indsprøjtningssted:
English: • Reminder to record brand name and batch number of the medication
Danish: • Påmindelse om at registrere medicinens handelsnavn og batchnummer
English: Thus, the combined use of Erelzi and anakinra is not recommended (see sections 4.5 and 4.8).
Danish: Derfor anbefales denne kombinerede brug af Erelzi og anakinra ikke (se pkt.
English: A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Danish: Styrken med et hætteglas på 10 mg kan være mere velegnet til indgivelse til børn med juvenil idiopatisk artrit (JIA), der vejer under 25 kg.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Danish: CNSdemyeliniseringstil fælde som antyder multipel sklerose eller lokaliserede demyeliniseringsfo rhold som for eksempel opticus neuritis og transversel myelitis (se pkt 4.4), perifere demyeliniserende hændelser herunder GuillainBarrés syndrom, kronisk inflammatorisk demyeliniserende polyneuropati, demyeliniserende polyneuropati og multifokal motorisk neuropati (se pkt 4.4), anfald
English: • Cotton ball or gauze
Danish: • Vatkugle eller gaze
English: Never leave the syringe lying around where others might tamper with it.
Danish: Lad aldrig injektionssprøjten ligge tilgængeligt, så andre kan komme til at pille ved den.
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 etanercept (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 etanercept (11 %), end hos patienter med placebo-behandling (5 %).
English: 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: Generelt var bivirkningerne hos de pædiatriske patienter med juvenil idiopatisk artrit af samme hyppighed og type som dem, man så hos voksne patienter.
English: The double-blind period was followed by an open-label period during which all patients received etanercept 50 mg weekly for up to an additional 92 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben studieperiode, hvor alle patienter fik etanercept 50 mg ugentligt i op til yderligere 92 uger.
English: Hold the syringe finger flange as shown.
Danish: Hold injektionssprøjten i fingerkanten som vist.
English: The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Danish: Den andel af patienter, der fik behandling med etanercept, og som udviklede anticardiolipin-antistoffer, steg i samme omfang som for patienter, der fik placebo.
English: If any of the following happen, do not inject more Erelzi.
Danish: Hvis en eller flere af følgende reaktioner optræder, må du ikke injicere mere Erelzi.
English: If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
Danish: Hvis disse tegn opstår, skal du omgående fortælle det til lægen eller tage på skadestuen på det nærmeste hospital.
English: 70b a: 25 mg etanercept SC twice weekly b: p < 0.001, etanercept vs. placebo c: p < 0.01, etanercept vs. placebo
Danish: 70b a: 25 mg etanercept subkutant to gange om ugen b: p < 0,001, etanercept vs. placebo c: p < 0,01, etanercept vs. placebo
English: The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
Danish: Effekten af etanercept blev sammenlignet med methotrexat i et randomiseret, aktivt kontrolleret forsøg med blindet radiografisk evaluering som primært mål hos 632 voksne patienter med aktiv reumatoid artrit (< 3 års varighed), som ikke tidligere var blevet behandlet med methotrexat.
English: Clinical improvement, including onset of action within 2 weeks with etanercept 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 etanercept 25 mg var det samme, som man havde set i de tidligere forsøg, og blev vedligeholdt i op til 24 måneder.
English: For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly.
Danish: Til psoriasis hos patienter fra 6 års-alderen, der vejer 62,5 kg eller mere, er den sædvanlige dosis 50 mg, og den skal gives en gang om ugen.
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Danish: Typen af infektioner, som blev observeret i kliniske studier med patienter med juvenil idiopatisk artrit i alderen 2 til 18 år, var generelt milde til moderate og svarende til dem, som almindeligvis ses hos ambulante, pædiatriske populationer.
English: ASAS 20 2 weeks
Danish: ASAS 20 2 uger
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 Erelzi 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 Erelzi.
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
Danish: I fase 3-forsøgene med reumatoid artrit, psoriasisartrit og ankyloserende spondylitis blev der ikke observeret nogen overordnede forskelle i bivirkninger, alvorlige bivirknnger og alvorlige infektioner hos patienter over 65 år, som fik etanercept, sammenlignet med yngre patienter.
English: Slowly press the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
Danish: Pres langsomt stemplet helt i bund, så stempelhovedet når helt ind mellem aktiveringsklipsene.
English: 25 mg etanercept administered twice weekly is the recommended dose.
Danish: 25 mg etanercept, indgivet to gange om ugen, er den anbefalede dosis.
English: Remember to take the blister out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
Danish: Husk at tage blisterpakningen ud af køleskabet, og lad den opnå stuetemperatur, før den klargøres til indsprøjtning (15-30 minutter).
English: Approximately 15% of subjects who received etanercept achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Danish: Ca. 15 % af de forsøgspersoner, der fik etanercept, opnåede ACR 70 respons ved måned 3 og måned 6 sammenlignet med færre end 5 % af forsøgspersonerne i placebo gruppen.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstiller(de fremstillere) , der er ansvarlig(e) for batchfrigivelse
English: • The 1st click indicates the injection has started.
Danish: • Det første klik markerer, at indsprøjtningen er begyndt.
English: Some children and teenage patients who have received Erelzi or other medicines that work the same way as Erelzi have developed cancers, including unusual types, which sometimes resulted in death.
Danish: Nogle børne- og teenage-patienter, som har fået Erelzi eller anden medicin, der virker på samme måde som Erelzi, har udviklet kræft, inkl.
English: INFORMATION IN BRAILLE Erelzi 25 mg
Danish: INFORMATION I BRAILLE-SKRIFT Erelzi 25 mg
English: Cartons contain 1, 2 or 4 pre-filled syringes or pre-filled pens of Erelzi.
Danish: Æskerne indeholder 1, 2 eller 4 fyldte injektionssprøjter eller fyldte penne med Erelzi.
English: • Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
Danish: • Tegn på hjerteinsufficiens eller forværring af hjerteinsufficiens, som f.eks. træthed eller stakåndethed ved aktivitet, opsvulmen af anklerne, en følelse af oppustethed i nakken eller maven, stakåndethed eller hosten om natten, blåligfarvning af neglene eller rundt om læberne.
English: Do not use if the syringe is broken or the needle guard is activated.
Danish: Brug ikke sprøjten, hvis injektionssprøjten er beskadiget, eller hvis kanylebeskytteren er aktiveret.
English: At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
Danish: Efter 24 uger havde 56 % af patienterne i den etanercept behandlede gruppe opnået PASI 75 sammenlignet med 5 % i den placebo behandlede gruppe.
English: Baseline scoreb Week 52 scoreb
Danish: Uge 52 scoreb
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received etanercept without interruption.
Danish: Fortsat, varigt respons er set i op til 10 år i åbne, forlængede studier hos patienter, som fik etanercept unden afbrydelse.
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Danish: Skub kanylen hele vejen ind for at sikre dig, at alt lægemidlet sprøjtes ind.
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Danish: I et andet aktivt kontrolleret, dobbeltblindt, randomiseret studie blev klinisk effekt, sikkerhed og radiografisk progession hos patienter med reumatoid artrit behandlet med etanercept alene (25 mg to gange om ugen), methotrexat alene (7,5 til 20 mg om ugen, median dosis 20 mg) og en kombination af etanercept og methotrexat påbegyndt samtidig, sammenlignet hos 682 voksne patienter med aktiv reumatoid artrit af 6 måneder til 20 års varighed (median 5 år), som havde en mindre end tilfredsstillende respons på mindst et sygdomsmodificerende antireumatisk lægemiddel (DMARD) bortset fra methotrexat.
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: Erelzi 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 Erelzi 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: TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defences against infection and cancer.
Danish: Der er også rapporteret om alvorlige bivirkninger for etanercept: TNF-antagonister som etanercept påvirker immunsystemet, og brugen af dem kan påvirke kroppens forsvar mod infektioner og cancer.
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 non-melanoma skin cancers were reported.
Danish: I dobbeltblinde og åbne studier af op til 1,5 års varighed omfattende 2.711 patienter med plaque psoriasis behandlet med etanercept blev der rapporteret om 30 maligniteter og 43 tilfælde af ikke-melanom hudkræft.
English: After the medicine has been injected, the needle guard will be activated to cover the needle.
Danish: Når lægemidlet er indsprøjtet, aktiveres kanylebeskytteren, så kanylen dækkes.
English: Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Danish: Studie 1, som er et fase 2 studie med patienter med aktiv, men klinisk stabil plaque psoriasis omfattende ≥ 10 % af kroppens overflade areal.
English: INFORMATION IN BRAILLE Erelzi 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Erelzi 50 mg
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 etanercept 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 24 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 etanercept (op til maksimalt 50 mg per dosis) indgivet en gang om ugen i 12 uger.
English: Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles.
Danish: Brug ikke pennen, hvis væsken er uklar, misfarvet eller har store klumper, flager eller farvede partikler.
English: Patients treated with Erelzi should be given the Patient Alert Card.
Danish: Patienter i behandling med Erelzi bør få udleveret et eksemplar af 'Patientkort'.
English: Injection site reactions usually occurred in the first month.
Danish: Reaktioner på injektionsstedet forekom som regel i den første måned og fortog sig efterfølgende i hyppighed.
English: Do not rub the injection site.
Danish: Du må ikke ryste injektionssprøjten.
English: A new and unused Erelzi SensoReady pen.
Danish: En ny og ubrugt Erelzi SensoReady-pen
English: There have been post-marketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Danish: Der har været postmarketingsrapporter om pancytopeni og aplastisk anæmi, hvoraf visse havde dødelig udgang (se pkt.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(FER) ANSVARLIG(E) FOR BATCHFRIGIVELSE