FrancophonIA/ELRC3.0 huggingface dataset:
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 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Danish: I en analyse, hvor alle patienter, som uanset grund udgik af studiet, blev anset for at have progression, var procentdelen af patienter uden progession (TSS ændring ≤ 0,5) efter 24 måneder højere i gruppen, som fik Enbrel i kombination med methotrexat sammenlignet med grupperne som fik Enbrel alene og methotrexat alene (henholdsvis 62 %, 50 %, og 36 %; p<0,05).
English: Your doctor may decide if you or the child need less anti-diabetic medicine while taking Enbrel.
Danish: Lægen kan beslutte, at du eller barnet skal have en mindre dosis medicin mod sukkersyge, mens du eller barnet får Enbrel.
English: Do not mix the Enbrel solution with any other medicine.
Danish: Bland ikke Enbrel opløsningen med andre lægemidler.
English: Step 1: Setting up for an injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of supplies
Danish: Trin 1: Forberedelse til injektion Trin 2: Valg af injektionssted Trin 3: Injektion af Enbrel injektionsvæsken Trin 4: Bortskaffelse af udstyr
English: Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Danish: Sikkerheden og effekten af Enbrel er i stedet for blevet evalueret i fire randomiserede, dobbeltblinde, placebo-kontrollerede studier.
English: Pancytopenia*
Danish: Pancytopeni* Aplastisk
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of Enbrel per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
Danish: Til polyartrit eller udvidet oligoartrit hos patienter fra 2-års-alderen, og til enthesitis-relateret artrit eller psoriasisgigt hos patienter fra 12 års alderen er den sædvanlige dosis 0,4 mg Enbrel per kg kropsvægt (op til højst 25 mg per dosis) to gange om ugen, eller 0,8 mg Enbrel per kg kropsvægt (op til højst 50 mg per dosis) en gang om ugen.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using Enbrel.
Danish: Inden lancering i hvert medlemsland skal indehaveren af markedsføringstilladelsen blive enig med de nationale myndigheder om uddannelsesmaterialet til alle de læger, der forventes at ordinere produktet.
English: Each pack contains 4 single-dose vials and 8 alcohol swabs.
Danish: Hver pakke indeholder 4 enkeltdosis hætteglas og 8 alkoholservietter.
English: Doses of 25 mg of Enbrel (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 Enbrel (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 Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg Enbrel with placebo.
Danish: Effekten af Enbrel over for ankyloserende spondylitis blev bedømt i 3 randomiserede, dobbeltblinde studier, hvor indgivelse af 25 mg Enbrel to gange om ugen blev sammenlignet med placebo.
English: In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly.
Danish: I første del af studiet fik alle patienter 0,4 mg/kg (maksimum 25 mg per dosis) Enbrel subkutant to gange om ugen.
English: There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment.
Danish: Der var tegn på at patienter, som initialt responderede på Enbrel-behandlingen, havde gavn af en genoptagelse af Enbrel-behandling.
English: Enbrel powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Danish: Enbrel pulver til injektionsvæske skal rekonstitueres i 1 ml solvens inden brug (se pkt.
English: Clinical responses among nr-AxSpa patients who received Enbrel were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Danish: Det kliniske respons hos nr-AxSpa-patienter, der blev behandlet med Enbrel, var tydeligt ved det første besøg (2 uger) og blev opretholdt gennem 2 års behandling.
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 Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Danish: I en farmakokinetisk populationsanalyse af patienter med ankyloserende spondylitis var etanercept steadystate-AUC henholdsvis 466 g•t/ml og 474 g•t/ml for 50 mg Enbrel en gang om ugen (N = 154) og 25 mg to gange om ugen (N = 148).
English: Your doctor may decide if the child needs less anti-diabetic medicine while taking Enbrel.
Danish: Lægen kan beslutte, at barnet skal have en mindre dosis medicin mod sukkersyge, mens barnet får Enbrel
English: Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open-label 50 mg Enbrel once weekly for an additional 12 weeks.
Danish: I dette studie fik patienterne en dosis Enbrel på 50 mg eller placebo én gang om ugen i 12 uger, og derefter fik alle patienterne open-label Enbrel 50 mg én gang om ugen i yderligere 12 uger.
English: Serious infections experienced by Enbrel-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 Enbrel kunne blive ramt af, var cellulitis, gastroenteritis, pneumoni, kolecystit, osteomyelitis, gastritis, appendicitis, streptokok-fasciitis, myositis, septisk chok, diverticulitis og absces.
English: Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Danish: Der foreligger ikke tilstrækkelige data fra HBV-inficerede patienter, der har fået antiviral behandling samtidig med TNF-antagonist behandling.
English: • When the needle is completely inserted into the skin, release the skin that you are holding.
Danish: • Når nålen er helt inde i huden, giv da slip på det sammenklemte hudområde.
English: Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs. 9%).
Danish: Sammenlignet med placebo, forekom der en betydeligt højere procentdel af reaktioner på injektionsstedet blandt patienter med reumatiske sygdomme, som blev behandlet med Enbrel (36 % versus 9 %).
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Du må ikke give en injektion på et område, hvor huden er øm, stødt, rød eller hård.
English: The efficacy of Enbrel 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 Enbrel blev sammenlignet med methotrexat i et randomiseret, aktivt-kontrolleret forsøg med blindet radiografisk evaluering som primært mål hos 632 vosne patienter med aktiv reumatoid artrit (<3 års varighed), som ikke tidligere var blevet behandlet med methotrexat.
English: Thus, the combined use of Enbrel and anakinra is not recommended (see sections 4.5 and 4.8).
Danish: Derfor anbefales denne kombinerede brug af Enbrel og anakinra ikke (se pkt.
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Enbrel.
Danish: • Betændelse i tarmsystemet (inflammatorisk tarmsygdom): Der har været rapporter om betændelse i tarmsystemet hos patienter med juvenil idiopatisk artrit (JIA) (børnegigt), som behandles med Enbrel.
English: • This medicine has been prescribed for you or a child in your care.
Danish: • Lægen har ordineret Enbrel til dig eller dit barn.
English: • Hepatitis C: Tell your doctor if the child has hepatitis C. Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.
Danish: • Hepatitis C: Fortæl det til lægen, hvis barnet har hepatitis C. Lægen kan ønske at overvåge behandlingen med Enbrel, i tilfælde af at infektionen forværres.
English: Patients in this study received a dose of 25 mg or 50 mg Enbrel, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg Enbrel twice weekly for an additional 24 weeks.
Danish: Patienterne i dette studie fik en dosis Enbrel på 25 mg eller 50 mg, eller placebo 2 gange om ugen i 12 uger, og derefter fik alle patienter i åbent studie 25 mg Enbrel to gange om ugen i yderligere 24 uger.
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Enbrel in patients who have congestive heart failure (CHF).
Danish: Læger bør udvise forsigtighed ved brug af Enbrel i patienter med kongestiv hjerteinsufficiens (CHF).
English: Contact your doctor before using Enbrel if the needle cover will be handled by, or Enbrel will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Danish: Kontakt din læge før brug af Enbrel, hvis nålehætten skal håndteres af, eller Enbrel indgives til, en person med kendt eller mulig overfølsomhed (allergi) over for latex.
English: When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Danish: • Når sprøjten er tom, skal du trække kanylen ud af huden og sørge for at holde den i den samme vinkel, som da du førte den ind.
English: • Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Danish: • Hjerteinsufficiens (hjertesvigt): Fortæl det til lægen, hvis barnet lider af hjerteinsufficiens, da Enbrel i så fald skal bruges med forsigtighed.
English: See section 5 for instructions on how to store Enbrel.
Danish: 5 vedrørende vejledning i opbevaring af Enbrel.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Danish: Indehaveren af markedsføringstilladelsen : Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Doses of 10 mg or 25 mg Enbrel or placebo were administered subcutaneously twice a week for 6 consecutive months.
Danish: Der blev givet doser på 10 mg eller 25 mg Enbrel eller placebo subkutant to gange om ugen i 6 måneder i træk.
English: In a group of 2,711 plaque psoriasis patients treated with Enbrel in doubleblind 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 Enbrel blev der rapporteret om 30 maligniteter og 43 tilfælde af ikke-melanom hudkræft.
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel 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 Enbrel, i tilfælde af at infektionen forværres.
English: Other medicines and Enbrel
Danish: Brug af anden medicin sammen med Enbrel
English: Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Danish: Enbrel i kombination med methotrexat er indikeret til behandling af moderat til svær, aktiv reumatoid artrit hos voksne, hvor responset på sygdomsmodificerende antireumatiske lægemidler incl.
English: However, the solution may be used for up to 6 hours when stored at a temperature up to 25°C.
Danish: Injektionsvæsken kan dog anvendes i op til 6 timer, når den opbevares ved højst 25°C.
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Danish: Reaktioner på injektionsste det (herunder blødning, blå mærker, erytem, kløe, smerte, hævelse)*
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Danish: • Hjerteinsufficiens (hjertesvigt): Fortæl det til lægen, hvis du eller barnet lider af hjerteinsufficiens, da Enbrel i så fald skal bruges med forsigtighed.
English: • Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 1).
Danish: • Fjern kanylehætten ved at trække den lige af med et fast tag, og sørg for ikke at berøre kanylen, og for at kanylen ikke berører nogen anden overflade (se billede 1).
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Enbrel 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 Enbrel udskrives til patienter med eksisterende eller begyndende demyeliniseringssygdomme, eller til patienter som vurderes at have en øget risiko for at udvikle demyeliniseringssygdom.
English: Enbrel is available in strengths of 10, 25 and 50 mg.
Danish: Enbrel findes i styrkerne 10 mg, 25 mg og 50 mg.
English: • Wipe the site where Enbrel is to be injected with a new alcohol swab, using a circular motion.
Danish: • Tør området, hvor Enbrel skal injiceres, af med en ny alkoholserviet med cirkulære bevægelser.
English: In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
Danish: I studie 1 var der efter 12 uger et signifikant større antal patienter med PASI 75-respons i den Enbrel behandlede gruppe (30 %) sammenlignet med den placebo behandlede gruppe (2 %) (p<0,0001).
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of Enbrel 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 diseasemodifying 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 Enbrel alene (25 mg to gange om ugen), methotrexat alene (7,5 til 20 mg om ugen, median dosis 20 mg) og en kombination af Enbrel 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: Purple needle safety shield extends to cover needle
Danish: Lilla sikkerhedshætte dækker nålen
English: In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Danish: Hos voksne (18 år eller derover) kan Enbrel anvendes til moderat til svær reumatoid artrit (leddegigt), psoriasisartrit (psoriasisgigt), svær aksial spondylartrit, herunder ankyloserende spondylitis (rygsøjlegigt), og moderat eller svær psoriasis.
English: Enbrel 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Danish: Dosen på 10 mg Enbrel havde gennemgående mindre effekt på den strukturelle skade end dosen på 25 mg. Enbrel 25 mg var signifikant bedre end methotrexat med hensyn til erosion score efter både 12 og 24 måneder.
English: Treatment with Enbrel should not be initiated in patients with active infections including chronic or localised infections.
Danish: Behandling med Enbrel bør ikke påbegyndes hos patienter med aktive infektioner, inkl.
English: Leave the white needle cap in place and wait approximately 15-30 minutes to allow the Enbrel solution in the pen to reach room temperature.
Danish: Lad den hvide nålehætte blive siddende på pennen og vent ca. 15-30 minutter til Enbrelinjektionsvæsken i pennen har opnået stuetemperaturtur.
English: Each vial of Enbrel 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Danish: Hvert hætteglas Enbrel 10 mg pulver og solvens til injektionsvæske, opløsning, til pædiatrisk brug indeholder 10 mg etanercept.
English: Enbrel is supplied as a solution for injection in a pre-filled pen (MYCLIC) (solution for injection).
Danish: Enbrel leveres som en injektionsvæske til injektion i en fyldt pen (MYCLIC).
English: Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Danish: RESPONS HOS PATIENTER MED PSORIASISARTRIT I PLACEBOKONTROLLEREDE FORSØG % af patienter Placebo
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: Patienter, der testes positive for HBV-infektion, bør konsultere en læge med ekspertise i behandling af hepatitis B. Der bør udvises forsigtighed, hvis Enbrel gives til patienter, der tidligere har været inficeret med HBV.
English: 8 MYCLIC pre-filled pens 8 alcohol swabs
Danish: 8 MYCLIC fyldte penne 8 alkoholservietter
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Danish: I et dobbeltblindt placebo-kontrolleret studie blandt voksne patienter, der basalt blev behandlet med methotrexat, blev patienterne behandlet med Enbrel og anakinra desuden observeret at have en større hyppighed af alvorlige infektioner (7 %) og neutropeni end patienterne behandlet med Enbrel (se pkt.
English: The needle cover of the pre-filled syringe contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by, or when Enbrel is administered to, persons with known or possible latex sensitivity.
Danish: Nålehætten på den fyldte injektionssprøjte indeholder latex (tørt naturgummi), som kan forårsage overfølsomhedsreaktioner, hvis det håndteres af, eller hvis Enbrel indgives til, personer med kendt eller mulig overfølsomhed over for latex.
English: Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Danish: Blandt patienter med psoriasisartrit, som fik Enbrel, var det kliniske respons tydeligt på tidspunktet for første besøg (4 uger) og blev opretholdt gennem 6 måneders behandling.
English: CARTON TEXT - EU/1/99/126/003-005
Danish: YDERKARTON - EU/1/99/126/003-005
English: In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
Danish: I første del af studiet viste 51 af 69 (74 %) af patienterne klinisk respons og deltog i anden del. I anden del fik 6 af 25 (24 %) patienter, som fortsatte med Enbrel, sygdomsopblussen sammenlignet med 20 af 26 (77 %) patienter, som fik placebo (p=0,007).
English: 24 MYCLIC pre-filled pens 24 alcohol swabs
Danish: 24 MYCLIC fyldte penne 24 alkoholservietter
English: Serious and fatal infections have been reported during use of Enbrel; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Danish: Rapporterede patogener omfatter bakterier, mykobakterier (herunder tuberkulose), vira og svamp.
English: • The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
Danish: • De tre anbefalede injektionssteder for Enbrel omfatter: (1) foran midt på lårene; (2) maven, undtagen i et område på 5 cm omkring navlen; og (3) bagsiden af overarmen (se billede 17).
English: Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
Danish: Doser på 25 mg Enbrel (baseret på dosisstudier hos patienter med reumatoid artrit) eller placebo blev indgivet subkutant to gange om ugen i 6 måneder.
English: For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly.
Danish: Til psoriasis hos patienter fra 6 års-alderen er den sædvanlige dosis 0,8 mg Enbrel per kg kropsvægt (op til højst 50 mg per dosis) en gang om ugen.
English: Step 1: Preparing for an Enbrel injection 1.
Danish: Trin 1: Forberedelse til injektion af Enbrel
English: The needle cap of the pre-filled pen contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by or when Enbrel is administered to persons with known or possible latex sensitivity.
Danish: Nålehætten på den fyldte pen indeholder latex (tørt naturgummi), som kan forårsage overfølsomhedsreaktioner, hvis det håndteres af, eller hvis Enbrel indgives til, personer med kendt eller mulig overfølsomhed over for latex.
English: After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Danish: Efter 12 ugers behandling begyndte patienterne i placebogruppen behandling med blindet Enbrel (25 mg to gange om ugen).
English: A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener's granulomatosis.
Danish: cyclofosfamid eller methotrexate, og glucokortikoider) i gennemsnitligt 25 måneder, viste ikke at Enbrel var effektivt til behandling af Wegeners granulomatose.
English: Cartons contain 4 vials of Enbrel, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Danish: Æskerne indeholder 4 hætteglas Enbrel, 4 fyldte injektionssprøjter med vand til injektionsvæsker, 4 kanyler, 4 hætteglasadaptorer og 8 alkoholservietter.
English: Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Danish: Æskerne indeholder 4 flasker Enbrel med 8 alkoholservietter.