FrancophonIA/ELRC3.0 huggingface dataset:
English: However, Tracleer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Danish: Efter seks måneders behandling medførte Tracleer imidlertid et fald i modstanden mod blodgennemstrømningen på 23 %, hvilket indikerer en udvidelse af blodkarrene, sammenholdt med placebo.
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups.
Danish: I et studie hos 185 patienter med PAH af klasse II kunne patienterne i Tracleer-gruppen og placebogruppen gå lige langt på 6 minutter.
English: How is Tracleer used?
Danish: Hvordan anvendes Tracleer?
English: Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.
Danish: Bosentan forbedrer blodomløbet og forebygger dermed udviklingen af nye sår på fingre og tæer.
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Danish: Hos patienter med systemisk sklerose og sår på fingre og tæer sker der en forsnævring af blodkarrene på fingrene og tæerne, hvilket medfører sår.
English: What benefits of Tracleer have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tracleer?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tracleer have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tracleer.
English: Tracleer is given to reduce the number of new digital ulcers.
Danish: Tracleer gives med det formål at reducere antallet af nye sår på fingre og tæer.
English: Treatment of systemic sclerosis with digital ulcers
Danish: Behandling af systemisk sklerose med sår på fingre og tæer
English: For the full list of side effects Tracleer, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Tracleer fremgår af indlægssedlen.
English: The CHMP concluded that training of the user is of paramount importance.
Danish: CHMP konkluderede, at oplæring af brugeren er af største vigtighed.
English: The review of adrenaline auto-injectors was initiated at the request of the United Kingdom in April 2014, under Article 31 of Directive 2001/83/EC.
Danish: EU-gennemgangen af adrenalin-autoinjektorer blev indledt i april 2014 på anmodning af Det Forenede Kongerige i medfør af artikel 31 i direktiv 2001/83/EF.
English: Adrenaline auto-injectors have been approved through national procedures in all the EU Member States.
Danish: Adrenalin-autoinjektorer er godkendt ved nationale procedurer i alle EU medlemsstater.
English: • A study in 2013 by Brown et al. showed that 15% of the mothers were unable to use the autoinjector successfully in their children.
Danish: • En undersøgelse fra 2013 udført af Brown et al. viste, at 15 % af mødrene ikke var i stand til at bruge autoinjektoren rigtigt på deres børn.
English: • Several factors may affect whether adrenaline reaches the muscle layer.
Danish: • Flere faktorer kan have indflydelse på, om adrenalinet når frem til muskellaget.
English: They are designed so that they can be easily used by the patient themselves or a carer.
Danish: De er konstrueret, så de er lette at bruge for patienten selv eller for en omsorgsgiver.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's final opinion.
Danish: EU-gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • Your family members, carers or teachers should also be instructed in the correct use of the autoinjector.
Danish: • Også dine pårørende, omsorgsgivere eller lærere bør instrueres i korrekt brug af autoinjektoren.
English: The CHMP recommendation was sent to the European Commission which endorsed it and issued a legally binding decision that is valid throughout the EU.
Danish: CHMP's anbefaling blev overgivet til Europa-Kommissionen, som har godkendt den og truffet en endelig bindende beslutning med gyldighed i hele EU.
English: • It is important that you use the auto-injector correctly so that the adrenaline is delivered into your muscle and works as quickly as possible.
Danish: • Det er vigtigt, at du bruger autoinjektoren korrekt, så adrenalinet afgives til muskelvævet og virker hurtigst muligt.
English: On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors successfully.
Danish: Den 25. juni 2015 anbefalede Det Europæiske Lægemiddelagentur (EMA) en række foranstaltninger, herunder bedre instruktionsmateriale, der skal sikre, at patienter og omsorgsgivere bruger adrenalinautoinjektorer rigtigt.
English: • It is likely that your doctor will recommend that you carry 2 injectors, in case a second dose is needed while you wait for emergency assistance.
Danish: • Lægen vil sandsynligvis anbefale, at du har to injektorer på dig for det tilfælde, at du behøver endnu en dosis, indtil du kan få akut hjælp.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 14/08/2015.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 14/08/2015 vedtog en endelig beslutning med gyldighed i hele EU.
English: This supports the introduction of proper training and comprehensive educational material for patients and healthcare professionals.
Danish: Dette viser nødvendigheden af korrekt oplæring og fyldestgørende oplysningsmateriale til patienter og sundhedspersoner.
English: Anaphylaxis is a life-threatening reaction that causes a drop in blood pressure and breathing difficulties.
Danish: Anafylaksi er en livstruende reaktion, der medfører blodtryksfald og vejrtrækningsbesvær.
English: • If you have been prescribed an adrenaline auto-injector because you are at risk of severe allergic reactions, you should ensure you are familiar with it and carry it with you at all times.
Danish: • Hvis du har fået ordineret en adrenalin-autoinjektor på grund af risiko for svære allergiske reaktioner, skal du sørge for at blive fortrolig med den og altid have den på dig.
English: EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.
Danish: EMA foretog en gennemgang af adrenalin-autoinjektorer som følge af betænkeligheder ved, at de foreliggende anordninger kan afgive adrenalinet under huden i stedet for i en muskel, og at dette kan forsinke virkningen af behandlingen.
English: Better training tools to support patients using adrenaline auto-injectors
Danish: Bedre oplæringsværktøjer til patienter, der bruger adrenalin-autoinjektorer
English: The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.
Danish: CHMP konkluderede desuden, at der skal skaffes yderligere data for at give bedre indsigt i vævspenetrationen af adrenalin ved indgift med hver af de forskellige autoinjektorer.
English: Training device and audio-visual material expected to promote appropriate use of auto-injectors
Danish: Øvelsesanordning og audiovisuelt materiale skal fremme korrekt brug af autoinjektorer
English: A training device will also be developed so that you can practise with it before you need the autoinjector in an emergency.
Danish: Desuden vil der blive udviklet en øvelsesanordning, som giver dig mulighed for at øve dig i at anvende injektoren, før du får brug for den i en nødsituation.
English: This includes a training device with which patients can practise; audio-visual material to show in detail how the device is to be used; and a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector.
Danish: Materialet består af en øvelsesanordning, som patienterne kan indøve brug af injektoren med, audiovisuelt materiale, der detaljeret viser, hvordan anordningen bruges, og en tjekliste til de ordinerende læger for at sikre, at patienterne får tilstrækkelige oplysninger, før de bruger autoinjektoren.
English: An injection of adrenaline helps to relieve the symptoms of anaphylaxis quickly by narrowing the blood vessels (thereby increasing the blood pressure) and opening up the airways to help with the breathing.
Danish: Injektion af adrenalin afhjælper hurtigt symptomerne på anafylaksi ved at få blodkarrene til at trække sig sammen (så blodtrykket stiger) og udvider luftvejene, så vejrtrækningen lettes.
English: However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.
Danish: CHMP bemærkede imidlertid, at flere faktorer kan have indflydelse på, om adrenalinen faktisk afgives til mennesker; dette gælder således nålens længde, tykkelsen af fedtlaget i underhuden, autoinjektorens virkemåde (f.eks. om den er fjederbelastet), den vinkel, den sættes an mod huden i, den kraft, injektoren aktiveres med, og brugerens overholdelse af anvisningerne for injektion.
English: Having assessed all the available data, EMA's Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.
Danish: Efter gennemgang af alle de foreliggende data bemærkede EMA's Udvalg for Lægemidler til Mennesker (CHMP), at det må foretrækkes at give lægemidlet ved injektion i en muskel af hensyn til hurtigt indsættende virkning ved anafylaksi.
English: • The companies that market adrenaline auto-injectors have been asked to carry out a pharmacokinetic/pharmacodynamic study to better understand how adrenaline penetrates body tissues when given through an auto-injector.
Danish: • De virksomheder, der markedsfører adrenalin-autoinjektorer, er blevet anmodet om at udføre en farmakokinetisk/farmakodynamisk undersøgelse, der skal give bedre indsigt i, hvordan adrenalin penetrerer vævet, når det gives med en autoinjektor.
English: A training video will be produced to show you in detail how to use the injector properly.
Danish: Der bliver udarbejdet en instruktionsvideo, der nøje viser, hvordan du bruger injektoren rigtigt.
English: • Educational material will be developed to ensure that patients or carers use adrenaline autoinjectors successfully.
Danish: • Der vil blive udarbejdet oplysningsmateriale for at sikre, at patienter eller omsorgsgivere bruger adrenalin-autoinjektorer korrekt.
English: The companies that market adrenaline auto-injectors have therefore been asked to develop more effective educational material for patients, as well as for healthcare professionals, to ensure their optimal use.
Danish: De virksomheder, der markedsfører adrenalin-autoinjektorer, er derfor blevet bedt om at udarbejde bedre oplysningsmateriale til patienter og til sundhedspersoner for at sikre optimal brug af injektorerne.
English: This will include a training device that patients can practise with, audiovisual material and a prescriber checklist.
Danish: Materialet vil bestå i en øvelsesanordning, som giver patienterne mulighed for at øve sig i praksis, audiovisuelt materiale og en tjekliste til den ordinerende læge.
English: • The review of adrenaline auto-injectors showed that patients could benefit from further training to use the auto-injector successfully.
Danish: • Gennemgangen af adrenalin-autoinjektorer viste, at patienter kan få fordel af bedre indøvning af korrekt brug af autoinjektoren.
English: These include: needle length, the skin-to-muscle depth, the way the auto-injector works (e.g. if it is spring loaded or not), the angle of placement on the skin and the force used to activate the device.
Danish: Dette gælder således nålens længde, afstanden fra hud til muskel, autoinjektorens virkemåde (f.eks. om den er fjederbelastet), dens indføringsvinkel i forhold til nålen, og den kraft, injektoren aktiveres med.
English: • The review of adrenaline auto-injectors confirmed that intramuscular injection is the preferred route of administration in the treatment of anaphylaxis in order to obtain a rapid response.
Danish: • Ved gennemgangen af adrenalin-autoinjektorer blev det fastslået, at intramuskulær injektion må foretrækkes til behandling af anafylaksi for at opnå hurtig respons.
English: • Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance.
Danish: • Adrenalin-autoinjektorer anvendes til at behandle svære overfølsomhedsreaktioner i tiden indtil patienten kan få akut lægehjælp.
English: • You will receive training from your doctor or nurse on how to use your adrenaline auto-injector.
Danish: • Lægen eller sygeplejersken vil instruere dig i brug af adrenalin-autoinjektoren.
English: • If you have any question or concern, speak with your doctor or pharmacist.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere du vil vide, eller du har betænkeligheder.
English: Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.
Danish: Adrenalin-autoinjektorer kan være livsreddende ved svære allergiske reaktioner (anafylaksi) i tidsrummet indtil patienten kan få akut lægehjælp.
English: This followed a national review of all adrenaline autoinjector products approved in the UK, which concluded that there was no robust evidence that the devices deliver adrenaline into a muscle for all patients.
Danish: Konklusionen af denne gennemgang var, at der ikke var holdbare beviser for, at anordningerne afgiver adrenalin i muskelvævet hos alle patienter.
English: Adrenaline (epinephrine) auto-injectors are given to people who are at risk of anaphylaxis (severe allergic reaction) or have had a previous episode of anaphylaxis, to use as a first-aid measure in case of emergencies while waiting for emergency medical assistance.
Danish: Adrenalin-autoinjektorer gives til personer, der har risiko for en svær allergisk reaktion (anafylaksi) eller tidligere har haft en episode med anafylaksi.
English: The product information of adrenaline auto-injectors has also been updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector.
Danish: Det anbefales således at ordinere to autoinjektorer, som patienterne altid skal have på sig, og at instruere familiemedlemmer, omsorgsgivere eller lærere i brug af autoinjektoren.
English: • Because of the uncertainties over drug delivery from adrenaline auto-injectors and the consequent uncertainties around the onset of pharmacodynamic response, it is recommended that healthcare professionals prescribe 2 auto-injectors, which patients should carry at all times.
Danish: Dette begrundes med usikkerheden om lægemidlets afgivelse fra adrenalin-autoinjektorer og den deraf følgende usikkerhed om indsætten af farmakodynamisk respons.
English: Onsenal has been authorised under ‘exceptional circumstances'.
Danish: Onsenal er blevet godkendt under ‘særlige omstændigheder'.
English: After five years, the marketing authorisation was renewed for a further five years.
Danish: Markedsføringstilladelsen blev efter fem år fornyet i yderligere fem år.
English: This document is a summary of the European Public Assessment Report (EPAR) for Onsenal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Onsenal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onsenal on 17 October 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Onsenal den 17. oktober 2003.
English: The maximum recommended daily dose of Onsenal is 800 mg.
Danish: Den maksimale anbefalede daglige dosis Onsenal er 800 mg.
English: The company will submit a progress report on the study, including all safety information and details of how it is ensuring that patients are being recruited quickly enough.
Danish: Virksomheden skal også fremlægge en situationsrapport om undersøgelsen, herunder alle sikkerhedsoplysninger og nøjagtige oplysninger om, hvordan den sikrer, at der rekrutteres patienter tilstrækkeligt hurtigt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Onsenal.
English: Onsenal is a medicine that contains the active substance celecoxib.
Danish: Onsenal er et lægemiddel, der indeholder det aktive stof celecoxib.
English: The company that makes Onsenal has committed to carrying out a study in patients with FAP, in order to collect more information on the medicine's safety and effectiveness.
Danish: Virksomheden, som fremstiller Onsenal, har forpligtet sig til at gennemføre en undersøgelse af patienter med FAP med henblik på at indsamle flere oplysninger om lægemidlets sikkerhed og virkning.
English: The CHMP decided that Onsenal's benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
Danish: CHMP fandt, at fordelene ved Onsenal opvejer risiciene, men bemærkede dog, at der ikke var blevet påvist nogen effekt af Onsenal på risikoen for at udvikle kræft i tarmene.
English: The full EPAR for Onsenal can be found here.
Danish: Den fuldstændige EPAR for Onsenal findes her.
English: Onsenal at a dose of 400 mg twice a day was more effective than placebo.
Danish: Onsenal i en dosis på 400 mg to gange dagligt var mere effektivt end placebo.
English: The Committee recommended that Onsenal be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Onsenal.
English: The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
Danish: De hyppigste bivirkninger ved Onsenal (som optræder hos flere end 1 ud af 10 patienter) er hypertension (forhøjet blodtryk) og diarré.
English: For more information about treatment with Onsenal, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Onsenal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number had fallen by 5% in the patients taking placebo.
Danish: Hos voksne havde Onsenal efter seks måneder reduceret det gennemsnitlige antal polypper med 28 %, mens antallet faldt med 5 % hos patienter, der fik placebo.
English: The company will also submit a full report on the study
Danish: Virksomheden skal også fremlægge en fyldestgørende rapport om undersøgelsen, når den er afsluttet.
English: The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Danish: Det primære effektmål var en reduktion i antallet af polypper i et afgrænset område af tyktarms- eller endetarmsvæggen efter seks måneders behandling.
English: Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
Danish: Onsenal anvendes til at reducere antallet af polypper hos patienter med familiær adenomatøs polypose (FAP).
English: The active substance in Onsenal, celecoxib, is a ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Danish: Det aktive stof i Onsenal, celecoxib, er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), der tilhører gruppen af ‘cyclo-oxygenase 2 (COX-2)-hæmmere'.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Onsenal.
Danish: Dette betyder, at det ikke har været muligt at opnå fuldstændige oplysninger om Onsenal, fordi sygdommen er sjælden.
English: Onsenal has been studied in one main study involving 83 adults (aged 18 years or over) with FAP, in which two doses of Onsenal were compared with placebo (a dummy treatment).
Danish: Onsenal blev undersøgt i en hovedundersøgelse, som omfattede 83 voksne (på 18 år og derover) med FAP, hvor to doser Onsenal blev sammenlignet med placebo (en uvirksom behandling).
English: What is the risk associated with Onsenal?
Danish: Hvilken risiko er der forbundet med Onsenal?
English: In the study, 25 patients had an intact colon, but the remainder had had some or all of their colon removed through surgery.
Danish: I undersøgelsen var tyktarmen intakt hos 25 patienter, men den øvrige del af patienterne havde fået fjernet tyktarmen helt eller delvist ved kirurgisk indgreb.
English: Because the number of patients with FAP is low, the disease is considered ‘rare', and Onsenal was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 November 2001.
Danish: Da der kun findes et lille antal patienter med FAP, anses sygdommen for at være sjælden, og Onsenal blev udpeget som lægemiddel til sjældne sygdomme den 20. november 2001.
English: The recommended dose of Onsenal is 400 mg twice a day with food.
Danish: Den anbefalede dosis Onsenal er 400 mg to gange dagligt i forbindelse med et måltid.
English: What information is still awaited for Onsenal?
Danish: Hvilke oplysninger afventes der stadig for Onsenal?
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Danish: Det blokerer COX-2-enzymet og hæmmer derved produktionen af prostaglandiner, der medvirker i processer såsom betændelsesreaktioner og aktiviteten i glat muskulatur (muskler, der udfører automatisk arbejde som f.eks. åbning og lukning af blodkar).
English: Onsenal must not be given to pregnant women or women who could become pregnant unless they are using an effective method of contraception, or to women who are breast-feeding.
Danish: Onsenal må ikke gives til gravide kvinder, kvinder, som kan blive gravide (medmindre de bruger en effektiv præventionsmetode), eller kvinder, som ammer.
English: An additional study looked at the effects of Onsenal in 18 patients aged 10 to 14 years with FAP.
Danish: I yderligere en undersøgelse så man på virkningerne af Onsenal hos 18 patienter i alderen 10 til 14 år med FAP.