FrancophonIA/ELRC3.0 huggingface dataset:
English: No side effects have been noted in the newborn baby.
Danish: Der blev ikke konstateret bivirkninger hos de nyfødte.
English: If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.
Danish: Hvis veerne vender tilbage, kan behandlingen med Tractocile gentages op til tre gange mere i løbet af graviditeten.
English: Tractocile atosiban EPAR summary for the public
Danish: Tractocile atosiban EPAR - sammendrag for offentligheden
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Danish: • regelmæssige veer, der varer mindst 30 sekunder og har en hyppighed på mindst 4 for hver 30
English: The full EPAR for Tractocile is available here.
Danish: Den fuldstændige EPAR for Tractocile findes her.
English: Other information about Tractocile:
Danish: Andre oplysninger om Tractocile:
English: The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Danish: Det aktive stof i Tractocile, atosiban, er en antagonist til det naturlige hormon oxytocin.
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Danish: Behandlingen skal påbegyndes snarest muligt efter, at diagnosen truende for tidlig fødsel er stillet.
English: Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Danish: Tractocile gives i en vene i tre omgange i løbet af højst 48 timer: først en indsprøjtning i en vene (6,75 mg) efterfulgt af en højdosisinfusion (18 mg i timen) over 3 timer og derefter en infusion med lavere dosis (6 mg i timen) i indtil 45 timer.
English: Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Danish: Tractocile bør ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for atosiban eller andre af indholdsstofferne.
English: Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Danish: Samlet viste resultaterne af de tre hovedundersøgelser, at 60 % af de kvinder, der var blevet behandlet med Tractocile, stadig var gravide en uge efter behandlingen (201 ud af 337), sammenholdt med 48 % af de kvinder, der var behandlet med sammenligningspræparaterne (163 ud af 342).
English: The Committee decided that Tractocile's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Tractocile opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This means that atosiban blocks the action of oxytocin.
Danish: Det betyder, at atosiban blokerer virkningen af oxytocin.
English: By blocking the action of oxytocin, Tractocile prevents contractions and causes the womb to relax, helping to delay birth.
Danish: Ved at blokere oxytocinets virkning forhindrer Tractocile veerne og får livmoderen til at slappe af, hvilket medvirker til at udsætte fødslen.
English: Tractocile is a solution for injection, and a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Tractocile er en injektionsvæske, opløsning, og et koncentrat, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: Treatment with Tractocile should be carried out by a doctor who has experience in the treatment of pre-term labour.
Danish: Behandlingen med Tractocile bør gives af en læge med erfaring i behandling af truende for tidlig fødsel.
English: The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Tractocile (som optræder hos flere end 1 ud af 10 patienter) er kvalme.
English: It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby.
Danish: Det må ikke anvendes til kvinder, som endnu ikke er i 24. svangerskabsuge, eller som har passeret 33. svangerskabsuge, eller hos kvinder med for tidlig hindesprængning (når vandet går for tidligt) efter 30 ugers graviditet, blødning fra livmoderen, fødselskramper (en alvorlig tilstand i slutningen af graviditeten forårsaget af toksiner i blodet), truende fødselskramper (en tilstand, som kan medføre fødselskramper) eller problemer med spædbarnet eller moderkagen, eller når en videreførelse af graviditeten kan udgøre en fare for moder eller barn.
English: Tractocile was compared with ritodine, terbutaline and salbutamol (all from a different class of medicines used in pre-term labour called beta-agonists).
Danish: Tractocile blev sammenlignet med ritodin, terbutalin og salbutamol (som alle er beta-agonister, en anden gruppe lægemidler, der anvendes ved truende for tidlig fødsel).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Tractocile har vist sig lige så effektivt som beta-agonister til at udsætte truende for tidlig fødsel, og at resultaterne med Tractocile er bedre, fordi dette lægemiddel tåles bedre.
English: The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.
Danish: De bedre behandlingsresultater med Tractocile end med beta-agonister kan muligvis forklares ved, at Tractocile medfører færre bivirkninger og derfor gør det muligt for patienten at gennemgå et fuldt behandlingsforløb.
English: For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tractocile fremgår af indlægssedlen.
English: There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group.
Danish: Der var for få kvinder, som endnu ikke var i 28. svangerskabsuge, til, at Tractociles virkning hos denne gruppe kunne sammenlignes med virkningen af beta-agonister.
English: The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies.
Danish: Tractociles evne til at udsætte truende for tidlig fødsel blev undersøgt i tre hovedundersøgelser med 742 kvinder i 23.- 33. svangerskabsuge.
English: What is the risk associated with Tractocile?
Danish: Hvilken risiko er der forbundet med Tractocile?
English: • dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
Danish: • en udvidelse af livmoderhalsen på 1 til 3 cm og en udslettelse af livmoderhalsen på mindst 50 %.
English: Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely).
Danish: Tractocile anvendes til at udsætte fødslen hos voksne kvinder, som er gravide i 24-33 uge, når de udviser symptomer på truende for tidlig fødsel.
English: Oxytocin is the hormone involved in starting contractions of the womb.
Danish: Oxytocin er det hormon, der får livmoderen til at begynde at trække sig sammen.
English: Why has Tractocile been approved?
Danish: Hvorfor blev Tractocile godkendt?
English: What benefit has Tractocile shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tractocile?
English: How has Tractocile been studied?
Danish: Hvordan blev Tractocile undersøgt?
English: What is Tractocile?
Danish: Hvad er Tractocile?
English: What is Tractocile used for?
Danish: Hvad anvendes Tractocile til?
English: How is Tractocile used?
Danish: Hvordan anvendes Tractocile?
English: How does Tractocile work?
Danish: Hvordan virker Tractocile?
English: Further information on Prasugrel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Prasugrel Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The materials will include information on how to prescribe the medicine safely and remind doctors that the medicine is not recommended for patients over the age of 75 years.
Danish: Materialet vil indeholde information om, hvordan lægemidlet ordineres sikkert, og minde lægerne om, at det ikke anbefales til patienter over 75 år.
English: It is recommended that treatment with Prasugrel Mylan and aspirin continue for up to a year.
Danish: Det anbefales, at behandlingen med Prasugrel Mylan og aspirin fortsætter i op til et år.
English: It includes unstable angina (a severe type of chest pain) and heart attack.
Danish: Det omfatter bl.a. ustabil angina (en type alvorlige brystsmerter) og hjerteanfald.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Firmaet har også udført studier, der har vist, at det er "bioækvivalent" med referencelægemidlet.
English: This means that it helps to prevent blood clots from forming.
Danish: Det betyder, at det medvirker til at forhindre dannelse af blodpropper.
English: In this case, the patient should take 5 mg daily following a 60-mg starting dose.
Danish: I så fald bør patienten tage 5 mg dagligt efter en startdosis på 60 mg.
English: The use of Prasugrel Mylan is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Prasugrel Mylan as necessary.
Danish: Prasugrel Mylan anbefales ikke til patienter over 75 år, medmindre lægen har vurderet fordele og risici omhyggeligt og mener, at behandling med Prasugrel Mylan er nødvendig.
English: Prasugrel Mylan is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Danish: Prasugrel Mylan fås som tabletter (5 og 10 mg) og udleveres kun efter recept.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Efient, and do not need to be repeated for Prasugrel Mylan.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Efient, og de behøver ikke at blive gentaget for Prasugrel Mylan.
English: Because Prasugrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Prasugrel Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: For more information about using Prasugrel Mylan, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Prasugrel Mylan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Prasugrel Mylan are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Prasugrel Mylan vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Prasugrel Mylan has been shown to have comparable quality and to be bioequivalent to Efient.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Prasugrel Mylan er af sammenlignelig kvalitet og er bioækvivalent med Efient.
English: This means that Prasugrel Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Efient.
Danish: Det betyder, at Prasugrel Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Efient.
English: Prasugrel Mylan is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Danish: Prasugrel Mylan anvendes sammen med aspirin til forebyggelse af aterotrombotiske hændelser (problemer, der skyldes blodpropper og åreforkalkning) hos patienter med akut koronarsyndrom, som gennemgår perkutan koronarintervention.
English: What measures are being taken to ensure the safe and effective use of Prasugrel Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Prasugrel Mylan?
English: The company that markets Prasugrel Mylan will make sure that educational materials are available for doctors who will treat patients with the medicine.
Danish: Virksomheden, der markedsfører Prasugrel Mylan, vil sørge for, at der udleveres informationsmateriale til læger, som behandler patienter med lægemidlet.
English: Patients taking Prasugrel Mylan should also take aspirin as prescribed by their doctors.
Danish: Patienter, der tager Prasugrel Mylan, bør også tage den dosis aspirin, lægen har ordineret.
English: As for every medicine, the company provided studies on the quality of Prasugrel Mylan.
Danish: Som for alle lægemidler har firmaet leveret studier vedrørende kvaliteten af Prasugrel Mylan.
English: An overview of Prasugrel Mylan and why it is authorised in the EU
Danish: En oversigt over Prasugrel Mylan, og hvorfor det er godkendt i EU
English: Blood clots are caused by special cells in the blood, the platelets, sticking together (aggregating).
Danish: Blodpropper skyldes, at bestemte celler i blodet (blodpladerne) klæber sammen (aggregerer).
English: What is Prasugrel Mylan and what is it used for?
Danish: Hvad er Prasugrel Mylan, og hvad anvendes det til?
English: Prasugrel Mylan treatment starts with one 60-mg dose.
Danish: Behandlingen med Prasugrel Mylan indledes med én dosis på 60 mg.
English: As for all medicines, data on the use of Prasugrel Mylan are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Prasugrel Mylan løbende overvåget.
English: Percutaneous coronary intervention is a procedure used to unblock the blood vessels supplying the heart.
Danish: Perkutan koronarintervention er en procedure, der anvendes til at fjerne blokeringer i de blodkar, der forsyner hjertet.
English: What are the benefits and risks of Prasugrel Mylan?
Danish: Hvilke fordele og risici er der forbundet med Prasugrel Mylan?
English: Other information about Prasugrel Mylan
Danish: Andre oplysninger om Prasugrel Mylan
English: Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor (target) on their surface.
Danish: Prasugrel forhindrer blodpladerne i at aggregere ved at forhindre stoffet ADP i at binde sig til en såkaldt receptor (målet) på blodpladernes overflader.
English: Acute coronary syndrome is a group of conditions in which blood supply in the vessels supplying the heart is interrupted so heart tissue cannot work properly or dies.
Danish: Akut koronarsyndrom er en gruppe af tilstande, hvor blodforsyningen til de blodkar, der forsyner hjertet, stopper, så hjertevævet ikke virker, som det skal, eller dør.
English: Therefore, the Agency's view was that, as for Efient, the benefit of Prasugrel Mylan outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene af Prasugrel Mylan opvejer de identificerede risici, som for Efient, og det kan godkendes til anvendelse i EU.
English: This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Danish: Patienter, der vejer mindre end 60 kg, bør dog kun tage 5 mg én gang dagligt.
English: Why is Prasugrel Mylan authorised in the EU?
Danish: Hvorfor blev Prasugrel Mylan godkendt i EU?
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.
Danish: Dette nedsætter risikoen for, at der dannes en blodprop, og er med til at forebygge hjerteanfald og slagtilfælde.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prasugrel Mylan 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 Prasugrel Mylan.
English: Prasugrel Mylan contains the active substance prasugrel and is a ‘generic medicine'.
Danish: Prasugrel Mylan indeholder det aktive stof prasugrel.
English: How has Prasugrel Mylan been studied?
Danish: Hvordan blev Prasugrel Mylan undersøgt?
English: How is Prasugrel Mylan used?
Danish: Hvordan anvendes Prasugrel Mylan?
English: How does Prasugrel Mylan work?
Danish: Hvordan virker Prasugrel Mylan?
English: The active substance in Prasugrel Mylan, prasugrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Prasugrel Mylan, prasugrel, hæmmer blodpladernes funktion.
English: Prasugrel Mylan received a marketing authorisation valid throughout the EU on 16 May 2018.
Danish: Prasugrel Mylan (prasugrel) EMA/203583/2018
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: London, 14 November 2008 EMEA/CHMP/633842/2008
Danish: London, den 14. november 2008 EMEA/CHMP/633322/2008
English: The Reference Member State was Hungary and the Concerned Member States were Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Romania and Slovak Republic.
Danish: Referencemedlemsstaten var Ungarn, og de berørte medlemsstater var Den Tjekkiske Republik, Estland, Ungarn, Litauen, Letland, Polen, Rumænien og Slovakiet.
English: The final opinion was converted into a Decision by the European Commission on 12 November 2008.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 12. november 2008.
English: The Mutual Recognition Procedure started on 3 August 2007.
Danish: Proceduren for gensidig anerkendelse blev indledt den 3. august 2007.
English: The Czech Republic and Latvia referred the reasons for disagreement to the EMEA on 1 February 2008.
Danish: Den Tjekkiske Republik og Letland fremsendte begrundelserne for uenigheden til EMEA den 1. februar 2008.
English: A positive opinion was adopted by consensus on 24 July 2008.
Danish: En positiv udtalelse blev vedtaget med konsensus den 24. juli
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater kunne ikke nå til enighed om en gensidig anerkendelse af den markedsføringstilladelse, som referencemedlemsstaten havde udstedt.
English: Concerns related to the formal proof of bioequivalence and the lack of a wide therapeutic experience which were considered a potential serious risk to public health.
Danish: Bestænkelighederne angik det formelle bevis for bioækvivalens og manglen på terapeutisk erfaring, hvilket man betragtede som en potentiel alvorlig risiko for folkesundheden.
English: During their July 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lisonorm, that the objections raised by Czech Republic and Latvia should not prevent the granting of a Marketing Authorisation.
Danish: På sit møde i juli 2008 var CHMP på grundlag af de samlede forelagte oplysninger og de faglige drøftelser i udvalget af den opfattelse, at risk/benefit-forholdet var gunstigt for Lisonorm, og at Den Tjekkiske Republik og Letlands betænkeligheder ikke skulle forhindre udstedelse af en markedsføringstilladelse.
English: The Marketing Authorisation Holder provided written explanations on 2 June 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 2. juni 2008.
English: The arbitration procedure started on 21 February 2008 with the adoption of a list of questions.
Danish: Voldgiftsproceduren blev indledt den 21. februar 2008, hvor en række spørgsmål blev vedtaget.
English: Lisonorm tablet contains 5mg amlodipine/ 10mg lisinopril and is an anti-hypertensive indicated in patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Danish: Lisonorm tabletter indeholder 5 mg amlodipin/10 mg lisinopril og er et antihypertensivum, der er indiceret til patienter, hvis blodtryk kan holdes tilstrækkeligt under kontrol med lisinopril og amlodipin som kombinationsbehandling ved samme dosisniveau.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og produktresuméet i bilag III.
English: The Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Danish: Produktresumeét, etiketteringen og indlægssedlen for referencemedlemsstaten skulle ændres.
English: Gedeon Richter Plc obtained a national marketing authorisation for Lisonorm which was authorised in Bulgaria on 29 December 2006, before Bulgaria joined the European Union.
Danish: Gedeon Richter Plc fik udstedt en national markedsføringstilladelse for Lisonorm i Bulgarien den 29. december 2006, inden Bulgarien blev medlem af EU.
English: The Rapporteur was Dr Ondřej Slanař (CZ) and Co-Rapporteur(s) was Prof János Borvendég (HU).
Danish: Dr. Ondřej Slanař (CZ) var rapportør, og Prof. János Borvendég (HU) var medrapportør.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Lisonorm and associated names International Non-Proprietary Name (INN): lisinopril + amlodipine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK 41 Lisonorm og tilknyttede navne Internationalt fællesnavn (INN): lisinopril + amlodipin
English: Gedeon Richter Plc submitted a Marketing Authorisation Application (MAA) via mutual recognition procedure for Lisonorm on the basis of the marketing authorisation granted by Hungary on 30 April 2004.
Danish: Gedeon Richter Plc indsendte en ansøgning om markedsføringstilladelse for Lisonorm via proceduren for gensidig anerkendelse på baggrund af markedsføringstilladelsen udstedt af Ungarn den 30. april 2004.
English: 27 July 2010
Danish: 27. juli 2010
English: 1 Article 34 of Directive 2001/82/EC
Danish: 1 Artikel 34 i direktiv 2001/82/EF
English: Committee for medicinal products for veterinary use (CVMP)
Danish: Udvalget for veterinærlægemidler (CVMP)
English: The final opinion was converted into a Decision by the European Commission on 27 July 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 27. juli
English: Oral explanations were given on 10 February 2010.
Danish: Der blev afgivet mundtlige redegørelser den 10. februar 2010.