FrancophonIA/ELRC3.0 huggingface dataset:
English: • Once the solvent is added to the Enbrel, the plunger may move up by itself.
Danish: • Når solvensen er tilsat til Enbrel, kan stemplet bevæge sig opad af sig selv.
English: The other ingredients in Enbrel are:
Danish: De andre indholdsstoffer i Enbrel er:
English: There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
Danish: Der har været postmarketingrapporter om forværring af CHF, med og uden identificerbare fremskyndende faktorer hos patienter der tager Enbrel.
English: Talk to your doctor before taking Enbrel.
Danish: Kontakt lægen, før du tager Enbrel.
English: Some vaccines, such as oral polio vaccine, should not be given while using Enbrel.
Danish: Nogle vacciner, som for eksempel oral poliovaccine, må ikke gives, mens man får Enbrel.
English: Enbrel N=103 to 105*
Danish: Enbrel N=103 til 105*
English: If this occurs, you should stop using Enbrel.
Danish: Hvis dette sker, skal du ophøre med at bruge Enbrel.
English: A total of 401 patients were enrolled, from which 203 were treated with Enbrel.
Danish: Ialt 401 patienter blev inkluderet, af hvilke 203 blev behandlet med Enbrel.
English: Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Danish: Patienter, som udvikler en ny infektion, mens de gennemgår behandling med Enbrel, bør overvåges nøje.
English: In this situation, the benefit/risk balance of Enbrel therapy should be very carefully considered.
Danish: I denne situation bør risk-benefit-forholdet ved behandlingen med Enbrel overvejes meget nøje.
English: Responses of Patients with Psoriasis in Studies 2, 3 And 4
Danish: RESPONS HOS PATIENTER MED PSORIASIS I STUDIE 2, 3 OG 4
English: The use of Enbrel is not expected to affect the ability to drive or use machines.
Danish: Anvendelse af Enbrel forventes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før behandling med Enbrel påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.
Danish: Hyppigheden af ikke-kutane maligniteter af forskellig type var signifikant højere hos patienter behandlet med Enbrel end i kontrolgruppen.
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of Enbrel following its long-term use in patients with JIA.
Danish: Desuden er der ikke gennemført studier til vurdering af virkningen af seponering af Enbrel eller reduktion af den anbefalede dosis ved langvarig behandling af patienter med JIA.
English: Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Danish: Patienterne bør undersøges for infektioner før, under og efter behandling med Enbrel, under hensyntagen til at middeleliminationshalveringstiden for etanercept er ca. 70 timer (spændende fra 7 til 300 timer).
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of Enbrel (10 mg, 25 mg or 50 mg).
Danish: Lægen vil beregne den rette dosis for barnet og ordinere en passende styrke af Enbrel (10 mg, 25 mg eller 50 mg).
English: • Make sure your syringe does not contain any air bubbles.
Danish: • Kontroller at sprøjten ikke indeholder nogen luftbobler.
English: It is recommended that you record the date that Enbrel is removed from the refrigerator and the date after which Enbrel should be discarded (no more than 4 weeks following the removal from the refrigerator).
Danish: Det anbefales, at du noterer den dato, hvor Enbrel tages ud af køleskabet, og den dato, hvor Enbrel skal kasseres (højst 4 uger efter, at det er taget ud af køleskabet).
English: Adding solvent
Danish: Tilsætning af solvens
English: Disposing of supplies a.
Danish: Bortskaffelse af udstyr a.
English: • Push the plunger in VERY SLOWLY until all the water for injections is in the vial.
Danish: • Skub stemplet MEGET LANGSOMT ind, indtil alt vand til injektionsvæsker er i glasset.
English: The long-term safety of Enbrel in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Danish: Sikkerheden på lang sigt ved Enbrel-behandling i kombination med andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) er ikke fastslået.
English: Lightly pinching the skin around the injection site between the thumb and index finger of your free hand may make the injection easier and more comfortable.
Danish: Hvis du klemmer let om huden omkring injektionsstedet mellem tommel- og pegefinger på den frie hånd, gør det injektionen lettere og mere behagelig.
English: If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Enbrel er for stærk eller for svag, skal du kontakte din læge eller apotek.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af at en vigtig milepæl
English: If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “pop”.
Danish: Hvis nålen ikke er korrekt placeret, føles konstant modstand, når den går igennem proppen og intet “pop”.
English: The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Danish: Sikkerheds- og effektprofilerne af de to Enbrel behandlingsformer var sammenlignelige ved uge 8 med hensyn til effekten på tegn og symptomer ved reumatoid artrit; data fra uge 16 viste ikke sammenlignelighed (non-inferiority) mellem de to behandlingsformer.
English: The effect of Enbrel on radiographic progression was maintained in patients who continued on treatment during the second year.
Danish: Enbrels effekt på den røntgenologiske progression blev fastholdt hos de patienter, som fortsatte med behandling i løbet af det andet år.
English: Another study found no increased risk of birth defects when the mother had received Enbrel in pregnancy.
Danish: Et andet studie fandt ingen øget risiko for fødselsdefekter, hvis moderen havde taget Enbrel under graviditeten.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.
Danish: • Din læge vil give dig et 'Patientkort', som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandlingen med Enbrel.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (except for biosimilars), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for etanercept (undtagen biosimilært lægemiddel) er CHMP nået frem til følgende videnskabelige konklusioner:
English: Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response.
Danish: Lægen vil afgøre, hvor længe du skal tage Enbrel, og om gentagende behandling er nødvendig, afhængig af hvordan du reagerer på behandlingen.
English: Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer.
Danish: Børn og voksne, som får Enbrel, kan have øget risiko for at udvikle kræft i lymfesystemet eller andre former for kræft.
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Danish: Dette omfatter rapporter om reaktivering af hepatitis B hos patienter, som var anti-HBc-positive, men HBsAgnegative.
English: Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Enbrel kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with Enbrel due to the development of neutralising antibodies in rodents.
Danish: Carcinogenitetsstudier samt standardvurderinger af fertilitet og postnatal toksicitet blev ikke udført med Enbrel på grund af udvikling af neutraliserende antistoffer hos gnavere.
English: There have been reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Danish: Der har været indberetninger om, at hypoglykæmi er opstået, efter behandling med Enbrel er påbegyndt hos patienter, der får medicin mod diabetes, hvilket har nødvendiggjort en nedsættelse af dosis af den antidiabetiske medicin hos nogle af disse patienter.
English: There have been reports of worsening of hepatitis C in patients receiving Enbrel.
Danish: Der er indberetninger om forværring af hepatitis C hos patienter i behandling med Enbrel.
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three Enbrel doses.
Danish: I de første 12 uger af den dobbeltblinde behandlingsperiode fik patienterne placebo eller en af ovennævnte tre Enbrel doser.
English: Enbrel 0.8 mg/kg Once Weekly (N = 106)
Danish: 0,8 mg/kg 1 gang om ugen (N = 106)
English: If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper.
Danish: Hvis nålen er korrekt placeret, føles en let modstand og derefter et “pop”, når nålen går igennem midten af proppen.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use.
Danish: Centrale og perifere demyeliniserende hændelser er blevet set henholdsvis sjældent og meget sjældent i forbindelse med brug af Enbrel.
English: Mean (SE) Annualized Change from Baseline in Total Sharp Score
Danish: MIDDEL (SE) ÆNDRING FRA BASELINE I TOTAL SHARP SCORE PÅ ÅRSBASIS Placebo
English: In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident.
Danish: I de toksikologiske studier med Enbrel var der ingen tydelig dosisbegrænsning eller målorgantoksicitet.
English: If the window is not completely purple, contact your nurse or pharmacist for assistance, since the pen may not have injected the Enbrel solution completely.
Danish: Hvis vinduet ikke er helt lilla, skal du spørge lægen, sygeplejersken eller apoteket om hjælp, da pennen muligvis ikke har injiceret al Enbrel-injektionsvæsken.
English: After cleaning, do not touch the stopper with your hands.
Danish: Efter rengøring må du ikke berøre proppen med fingrene.
English: There is no known antidote to Enbrel.
Danish: Der er ingen kendt modgift mod Enbrel.
English: After discontinuation of Enbrel, symptoms of arthritis generally returned within a month.
Danish: Efter ophør med Enbrel vendte symptomerne på arthritis almindeligvis tilbage inden for en måned.
English: • You will also need the following items: A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs
Danish: • Du skal også bruge følgende: En steril sprøjte og nål(e) på 25 x 16 mm eller lignende Et hætteglas eller ampul med vand til injektionsvæsker 2 alkoholservietter
English: Treatment with Enbrel 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Danish: Behandling med Enbrel 25 mg resulterede i i betydelig bedring efter 12 måneder, hvor omkring 44 % af patienterne havde opnået en normal SHT score (mindre end 0,5).
English: In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Danish: I åbne langtidsstudier (op til 34 måneder), hvor Enbrel blev givet uden afbrydelser, blev det kliniske respons opretholdt, og sikkerheden var den samme som i korttidsstudier.
English: The known side effects of Enbrel include the following in groups of decreasing frequency:
Danish: Nedenstående bivirkninger for Enbrel er inddelt i grupper efter faldende frekvens.
English: The pen's inspection window should now be completely purple, confirming that the dose has been injected correctly (see Diagram 8).
Danish: Inspektionsvinduet i pennen skal nu være helt lilla som tegn på at injektionen er udført korrekt (se billede 8).
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, 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 Enbrel påbegyndes.
English: On the basis of the scientific conclusions for etanercept (except for biosimilars) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing etanercept (except for biosimilars) is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for etanercept (undtagen biosimilært lægemiddel) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder etanercept (undtagen biosimilært lægemiddel), forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Enbrel showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Danish: Enbrel viste en statistisk signifikant større forbedring fra baseline til uge 12 sammenlignet med placebo i de fleste helbredsrelaterede vurderinger af livskvalitet og fysisk funktion, herunder BASFIfunktionsindekset (Bath Ankylosing Spondylitis Functional Index) og EuroQol 5D-spørgeskemaerne Overall Health State Score og SF-36 Physical Component Score.
English: ---------------Study 3-----------
Danish: -------------------------Studie 2------------- ------------Studie 3--------- ------------Studie 4--------
English: • A needle-free demonstration device
Danish: • Et demonstrationsdevice/apparat uden kanyle
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
Danish: Sådanne symptomer kan pege på tilstedeværelsen af en potentiel livstruende blodsygdom, som kan kræve, at behandling med Enbrel ophører.
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Danish: Patienter med alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have større risiko end gennemsnittet for at udvikle lymfom.
English: After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 µg/ml, and the area under the curve was 235 ± 96.6 µg•hr/ml.
Danish: Efter en enkelt subkutan dosis med 25 mg etanercept, var den gennemsnitlige maksimale serumkoncentration, som blev observeret hos sunde frivillige, 1,65 ± 0,66 g/ml, og arealet under kurven var 235 ± 96,6 g•t/ml.
English: Do not insert the needle at an angle, this may cause the needle to bend and/or prevent proper addition of the solvent into the vial (see Diagram 4).
Danish: Skub ikke nålen skævt ind, da dette kan få nålen til at bøje sig og/eller forhindre korrekt tilsætning af solvens i hætteglasset (se billede 4).
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Enbrel treatment.
Danish: Selvom de ikke er endelige, antyder data fra ét af disse forsøg en mulig tendens til forværret CHF hos de patienter, der var anvist til Enbrel-behandling.
English: Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy.
Danish: Der er ikke udført studier med patienter med juvenil idiopatisk artrit til evaluering af fortsat Enbrelbehandling til patienter, som ikke responderede inden for 3 måneder efter påbegyndelse af Enbrelbehandling.
English: After preparing the Enbrel solution, immediate use is recommended (up to a maximum of 6 hours).
Danish: Efter at have gjort Enbrel injektionsvæsken klar anbefales umiddelbar anvendelse (op til højst 6 timer).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE BATCHFRIGIVELSE
English: Based on the review of the literature and spontaneous reporting presented in this PSUSA, covering the period from 03 February 2018 to 02 February 2019, as well as cumulative data since the European birth date, the PRAC considered that a causal relationship between inflammatory bowel disease and etanercept cannot be excluded and therefore recommends that the product information of medicinal products containing the active substance etanercept should be updated as follows: update of section 4.8 of the SmPC to add inflammatory bowel disease with a frequency uncommon.
Danish: På baggrund af gennemgangen af litteraturen og den spontane indberetning fremsat i denne PSUSA, der dækker perioden fra den 3. februar 2018 til den 2. februar 2019, samt samlede data siden datoen for den første europæiske markedsføringstilladelse, mener PRAC, at en kausal sammenhæng mellem inflammatorisk tarmsygdom og etanercept ikke kan udelukkes og anbefaler derfor, at produktinformationen for lægemidler, der indeholder det aktive stof etanercept, skal opdateres som følger: opdatering af produktresuméets punkt 4.8 med tilføjelse af inflammatorisk tarmsygdom med hyppigheden 'ikke almindelig'.
English: However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Danish: Hvilken som helst af ovennævnte symptomer kan dog tyde på en allergisk reaktion over for Enbrel, og du skal derfor søge øjeblikkelig lægehjælp.
English: In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: For at øge sporbarheden af biologiske lægemidler skal præparatnavnet og batchnummeret på det administrerede lægemiddel tydeligt noteres i patientjournalen.
English: Some patients receiving Enbrel have developed skin cancers.
Danish: Nogle patienter i behandling med Enbrel har udviklet hudkræft.
English: The impact of long-term treatment with Enbrel on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning en langvarig behandling med Enbrel vil have på udviklingen af autoimmunsygdomme.
English: • The risk of Congestive Heart Failure (CHF).
Danish: • Information om risikoen for hjerteinsufficiens (CHF)
English: Enbrel is also prescribed for the treatment of the following diseases in children and adolescents
Danish: Enbrel ordineres også til behandling af følgende sygdomme hos børn og unge:
English: Enbrel did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg.
Danish: Enbrel forårsagede ikke letalitet eller genkendelige tegn på toksicitet hos mus eller rotter efter en enkelt subkutan dosis på 2000 mg/kg eller en enkelt intravenøs dosis på 1000 mg/kg.
English: If you forget to inject Enbrel
Danish: Hvis du har glemt at injicere Enbrel
English: Enbrel is not recommended for the treatment of Wegener's granulomatosis.
Danish: Enbrel anbefales ikke til behandling af Wegeners granulomatose.
English: • if the child has an infection of any kind.
Danish: • hvis barnet lider af nogen form for infektion.
English: Radiographic progression at 12 months was significantly less in the Enbrel group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Danish: Radiografisk progession var signifikant mindre i Enbrel gruppen end i methotrexat gruppen ved 12 måneder, hvorimod kombinationen var signifikant bedre end begge monoterapier til at forsinke radiografisk progression (se nedenstående figur).
English: The combination Enbrel and anakinra has not demonstrated increased clinical benefit and is therefore not recommended.
Danish: Kombinationen af Enbrel og anakinra har ikke vist øgede kliniske fordele og anbefales derfor ikke.
English: Compared to placebo, treatment with Enbrel resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Danish: I sammenligning med placebo gav behandlingen med Enbrel en statistisk signifikant forbedring i ASAS 40, ASAS 20 og ASAS 5/6.
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Danish: Hvis du har spørgsmål, bedes du henvende dig til en læge, sygeplejerske eller apotekspersonale, som kender til Enbrel.
English: Women using Enbrel should not breast-feed, since Enbrel passes into human breast milk.
Danish: Kvinder i Enbrel-behandling må ikke amme, da Enbrel passerer over i mælken.
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Enbrel can slow down the structural damage to those joints caused by the disease.
Danish: Hos patienter med flere symmetriske, smertefulde eller opsvulmede led (f.eks. hænder, håndled og fødder) kan Enbrel nedsætte hastigheden, hvormed leddenes struktur ødelægges på grund af sygdommen.
English: Enbrel was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Danish: Enbrel blev anset for at være non-genotoksisk på grundlag af en serie in vitro- og in vivo-studier.
English: Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Danish: Gentoptaget behandling med Enbrel efter ophør i op til 24 måneder resulterede i samme størrelse af respons som hos patienter, som fik Enbrel uden behandlingsafbrydelse, baseret på resultater fra åbne studier.
English: After waiting approximately 15-30 minutes for the solution in the pen to warm to room temperature, wash your hands with soap and water.
Danish: Efter at have ventet ca. 15-30 minutter på at injektionsvæsken i pennen har opnået stuetemperatur, skal du vaske hænder med vand og sæbe.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.
Danish: Der er indberetninger om melanom og ikke-melanom hudkræft (NMSC) hos patienter behandlet med TNF-antagonister, herunder Enbrel.