FrancophonIA/ELRC3.0 huggingface dataset:
English: This disease causes fever, skin lesions, convulsions and often leads to death of the animals.
Danish: Sygdommen medfører høj feber, hudlæsioner og kramper, og er ofte dødelig.
English: Protection prevents mortality and reduces infection and disease.
Danish: Vaccinen forhindrer, at dyrene dør, og begrænser infektionen og sygdommen.
English: When the vaccine is given to a healthy pig, the animal's immune system recognises the vaccine virus as ‘foreign' and makes antibodies against it.
Danish: Når vaccinen gives til et raskt svin, opfatter dyrets immunsystem vaccinevirusset som “fremmed”, og danner antistoffer mod det.
English: The vaccine is available as a lyophilisate (freeze dried powder) and solvent for injection.
Danish: Vaccinen fås som et frysetørret pulver (lyofilisat) med opløsningsvæske (solvens) til injektion.
English: As CSF is a notifiable disease, it is not possible to conduct standard field studies.
Danish: Da klassisk svinefeber er en anmeldelsespligtig sygdom, kan der ikke udføres sædvanlige feltundersøgelser.
English: The withdrawal period for Suvaxyn CSF Marker for pigs is zero days.
Danish: Tilbageholdelsestiden for Suvaxyn CSF Marker for svin er 0 døgn.
English: The laboratory studies showed that the vaccine had its full effect against CSFV by two weeks.
Danish: Laboratorieundersøgelserne viste, at vaccinen gav fuld virkning mod klassisk svinefebervirus inden for to uger.
English: Suvaxyn CSF Marker should not be used to vaccinate sows.
Danish: Suvaxyn CSF Marker må ikke anvendes til vaccination af søer.
English: There are no known side effects with Suvaxyn CSF Marker when it is used according to the approved indication of the product information.
Danish: Der er ingen kendte bivirkninger ved Suvaxyn CSF Marker, når det anvendes til den godkendte anvendelse (indikation) som anført i produktinformationen.
English: The field study showed that vaccination with Suvaxyn CSF Marker resulted in 19 out of 20 piglets developing antibodies against E2 protein.
Danish: Feltundersøgelsen viste, at vaccination med Suvaxyn CSF Marker resulterede i, at 19 ud af 20 smågrise dannede antistoffer mod E2-proteinet.
English: Suvaxyn CSF Marker is a vaccine containing bovine viral diarrhoea virus, which can infect pigs but does not normally cause disease in them.
Danish: Suvaxyn CSF Marker er en vaccine, der indeholder bovint viral diarré virus, som kan smitte svin, men som normalt ikke forårsager sygdom.
English: Twenty piglets were given Suvaxyn CSF Marker and 10 piglets were given a placebo (dummy) injection.
Danish: 20 af smågrisene fik Suvaxyn CSF Marker, mens de 10 fik en virkningsløs injektion (placebo).
English: Suvaxyn CSF Marker is a recombinant veterinary vaccine that contains live bovine viral diarrhoea virus (BVDV) which has been modified to replace the envelope (E2) gene of BVDV with the corresponding gene of classical swine fever virus (CSFV).
Danish: Suvaxyn CSF Marker er en rekombinant veterinær vaccine, der indeholder levende bovin viral diarré virus (BVDV), der er modificeret, så genet (E2) for kapslen hos BVDV er erstattet med det tilsvarende gen fra klassisk svinefebervirus (CSFV).
English: In the future, if the animals are exposed to CSFV, their immune system will be triggered by the virus and be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for klassisk svinefebervirus, vil immunsystemet reagere hurtigere på virusset.
English: The vaccine virus in Suvaxyn CSF Marker has been modified so that it will produce the E2 protein, which is part of the outer coat of the closely related virus CSFV, which it provides protection against.
Danish: Vaccinevirusset i Suvaxyn CSF Marker er modificeret, så det producerer E2-proteinet, der indgår i den ydre kapsel hos det nært beslægtede virus klassisk svinefebervirus, som det giver beskyttelse mod.
English: Suvaxyn CSF Marker is used to protect pigs against outbreaks of classical swine fever, a very severe and highly contagious viral disease of both wild and domestic pigs.
Danish: Suvaxyn CSF Marker anvendes til at beskytte svin mod udbrud af klassisk svinefeber (svinepest), der er en meget alvorlig og stærkt smitsom virussygdom hos vildsvin og tamsvin.
English: Other information about Suvaxyn CSF Marker:
Danish: Andre oplysninger om Suvaxyn CSF Marker:
English: The vaccine has potential marker properties which may allow detection of pigs infected with field CSFV as distinct from Suvaxyn CSF Marker vaccinated pigs, in accordance with the DIVA principle (differentiation of infection from vaccination).
Danish: Det vil sige, at svin smittet med klassisk svinefebervirus af vildtypen kan skelnes fra vaccinerede svin i overensstemmelse med princippet om DIVA (differentiering af infektion fra vaccination).
English: What is the risk associated with Suvaxyn CSF Marker?
Danish: Hvilken risiko er der forbundet med Suvaxyn CSF Marker?
English: Why has Suvaxyn CSF Marker been approved?
Danish: Hvorfor blev Suvaxyn CSF Marker godkendt?
English: What is Suvaxyn CSF Marker?
Danish: Hvad er Suvaxyn CSF Marker?
English: This is because if given to pregnant sows it does not prevent them from passing CSFV infection to their offspring but can hide signs of infection in the piglets, allowing them to spread the disease.
Danish: Grunden er, at hvis det gives til drægtige søer, forhindrer dette ikke, at de smitter deres afkom med klassisk svinefebervirus.
English: What is Suvaxyn CSF Marker used for?
Danish: Hvad anvendes Suvaxyn CSF Marker til?
English: How has Suvaxyn CSF Marker been studied?
Danish: Hvordan blev Suvaxyn CSF Marker undersøgt?
English: What benefit has Suvaxyn CSF Marker shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Suvaxyn CSF Marker?
English: How does Suvaxyn CSF Marker work?
Danish: Hvordan virker Suvaxyn CSF Marker?
English: 3 August 2009 Doc.
Danish: 3. august 2009 Dok.
English: The final opinion was converted into a Decision by the European Commission on 3 August 2009.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 3. august
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal and Spain.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Det Forenede Kongerige og de berørte medlemsstater Østrig, Belgien, Danmark, Frankrig, Tyskland, Grækenland, Irland, Italien, Nederlandene, Portugal og Spanien.
English: The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Danish: Den udpegede rapportør og medrapportør var dr. Bruno Urbain og dr. Michael Holzhauser-Alberti.
English: Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
Danish: Florfenicol er et syntetisk bredspektret antibiotikum med en række virkeområder, herunder mange gramnegative og grampositive organismer.
English: The Mutual Recognition Procedure started on 28 February
Danish: Den gensidige anerkendelsesprocedure blev indledt den 28. februar 2008.
English: Oral explanations were given on 16 April 2009.
Danish: Der blev afgivet mundtlige redegørelser den 16. april 2009.
English: However, the CVMP also considered that the wording of the therapeutic indication as authorised in the Reference Member State should be amended to clearly state the limitations of the approved use and avoid incorrect interpretation.
Danish: CVMP fandt imidlertid også, at ordlyden af den terapeutiske indikation, som var godkendt i referencemedlemsstaten, burde ændres med henblik på tydeligt at angive begrænsningerne for den godkendte anvendelse og undgå ukorrekt fortolkning.
English: Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the use of the product as recommended for therapeutic use only does not constitute a risk for the environment.
Danish: På grundlag af evalueringen af rapportørernes vurdering af de aktuelt foreliggende oplysninger vurderede CVMP, at den anbefalede anvendelse af lægemidlet udelukkende til terapeutisk behandling ikke udgjorde en miljørisiko.
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Shotaflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Danish: På grund af betænkeligheder rejst af Tyskland og Nederlandene under den gensidige anerkendelsesprocedure om, at Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg, kan udgøre en potentielt alvorlig miljørisiko, indbragte Det Forenede Kongerige sagen for EMEA den 31. juli 2008 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: Therefore the Committee adopted an opinion on 14 May 2009 recommending the variation of the Marketing Authorisation in line with the proposed amendments to the Summary of Product Characteristics and package leaflet.
Danish: Udvalget vedtog derfor en udtalelse den 14. maj 2009, hvori det anbefalede godkendelse af ændringen af markedsføringstilladelsen i overensstemmelse med de foreslåede ændringer i produktresumé og indlægsseddel.
English: Written explanations were provided by the Marketing Authorisation Holder on 15 January 2009.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. januar 2009.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics and package leaflet in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede indlægsseddel findes i bilag III.
English: The referral procedure started on 16 September 2008.
Danish: Indbringelsesproceduren blev indledt den 16. september 2008.
English: The Marketing Authorisation Holder, Virbac S.A., submitted an application via mutual recognition for Shotaflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen Virbac S.A. indgav en ansøgning om gensidig anerkendelse af Shotaflor 300 mg/ml injektionsvæske, opløsning, til kvæg, på grundlag af en markedsføringstilladelse udstedt af Det Forenede Kongerige.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR SHOTAFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Danish: SHOTAFLOR 300 MG/ML INJEKTIONSVÆSKE, OPLØSNING, TIL KVÆG Internationalt fællesnavn (INN): florfenicol
English: DuoPlavin must not be used during the last three months of pregnancy.
Danish: DuoPlavin må ikke anvendes under de sidste tre måneder af graviditeten.
English: The European Commission granted a marketing authorisation valid throughout the EU for DuoPlavin on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for DuoPlavin den 15. marts 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for DuoPlavin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for DuoPlavin.
English: The full EPAR for DuoPlavin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for DuoPlavin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about DuoPlavin:
Danish: Andre oplysninger om DuoPlavin:
English: It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Danish: Det fås som tabletter, der indeholder 75 mg clopidogrel og enten 75 mg eller 100 mg acetylsalicylsyre.
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 use for DuoPlavin.
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, hvordan DuoPlavin skal anvendes.
English: For more information about treatment with DuoPlavin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med DuoPlavin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
Danish: Den fremlagde også resultaterne af tre tidligere undersøgelser, der omfattede mere end 61 000 patienter med svære, ustabile brystsmerter (angina), eller som havde haft et hjerteanfald.
English: The Committee therefore decided that DuoPlavin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede derfor, at fordelene ved DuoPlavin opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: DuoPlavin clopidogrel / acetylsalicylic acid
Danish: DuoPlavin clopidogrel/acetylsalicylsyre
English: • patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
Danish: • patienter, der behandles for hjerteanfald med elevation af ST-segmentet, når lægen mener, at de ville have gavn af trombolytisk behandling (behandling til opløsning af blodpropper).
English: What is the risk associated with DuoPlavin?
Danish: Hvilken risiko er der forbundet med DuoPlavin?
English: DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Danish: DuoPlavin er et lægemiddel, som indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre (også kendt som aspirin).
English: The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Danish: De hyppigste bivirkninger ved DuoPlavin (der optræder hos mellem 1 og 10 patienter af 100) er hæmatom (blodsamling under huden), epistaksis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), diarré, mavesmerter, dyspepsi (halsbrand), blå mærker og blødning på punkturstedet.
English: Why has DuoPlavin been approved?
Danish: Hvorfor er DuoPlavin blevet godkendt?
English: The combination of the two active substances has an additive effect, reducing the risk of blood clots forming, more than either medicine alone.
Danish: Virkningen af de to aktive stoffer supplerer hinanden, dvs. risikoen for blodpropper nedsættes mere end med hvert lægemiddel for sig.
English: For the full list of all side effects reported with DuoPlavin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved DuoPlavin fremgår af indlægssedlen.
English: Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Danish: Begge aktive stoffer i DuoPlavin, nemlig clopidogrel og acetylsalicylsyre, er antitrombocytlægemidler.
English: It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
Danish: Det må ikke anvendes hos patienter, som har en blødningssygdom som f.eks. mavesår eller blødning i hjernen, eller hos patienter med mastocytose (højt indhold i blodet af særlige hvide blodlegemer kaldet mastceller).
English: Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Danish: Resultaterne af de tre undersøgelser omfattende patienter, der havde ustabile brystsmerter eller havde haft et hjerteanfald, viste, at kombinationen clopidogrel og acetylsalicylsyre, taget som separate tabletter, var bedre til at forebygge hændelser som hjerteanfald end acetylsalicylsyre alene.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
Danish: Det reducerer produktionen af et stof, der kaldes tromboxan, som normalt medvirker til blodets koagulering ved at få blodpladerne til at klæbe sammen.
English: The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets.
Danish: CHMP bemærkede, at DuoPlavin svarer til clopidogrel- og acetylsalicylsyretabletter, der tages separat, og udvalget konkluderede, at en kombination af begge aktive stoffer i én DuoPlavin-tablet gør behandlingen enklere for patienterne, eftersom de skal tage færre tabletter.
English: • patients who have ‘unstable angina' (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Danish: • patienter, der har svære, ustabile brystsmerter (angina) eller har haft et hjerteanfald uden den unormale forandring i elektrokardiogrammet ("ST-segmentøgning"), herunder patienter, der har fået indsat en kort slange (en stent) i en arterie for at undgå, at den blokeres
English: DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Danish: DuoPlavin anvendes til forebyggelse af problemer, der skyldes blodpropper og åreforkalkning, såsom hjerteanfald hos voksne, der allerede tager både clopidogrel og acetylsalicylsyre som separate tabletter.
English: It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Danish: Det må ikke anvendes hos patienter, som har alvorligt nedsat levereller nyrefunktion, eller som har en sygdom, der omfatter en kombination af astma, rhinitis (tilstoppet og løbende næse) og næsepolypper (gevækster i næsens slimhinde).
English: DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin.
Danish: DuoPlavin må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for clopidogrel, nonsteroide antiinflammatoriske stoffer (såsom acetylsalicylsyre) eller andre af indholdsstofferne i DuoPlavin.
English: This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Danish: Det betyder, at de ved at forhindre blodpladerne i at klæbe til hinanden og danne blodpropper er med til forebygge nye hjerteanfald.
English: DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Danish: Der skal tages én DuoPlavin-tablet om dagen i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienten tidligere har taget separat.
English: DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Danish: Det blev påvist, at DuoPlavin svarer til clopidogrel og acetylsalicylsyre taget separat, og det kan derfor anvendes i stedet for de clopidogrel- og acetylsalicylsyretabletter, som patienterne tidligere har taget.
English: Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Danish: Virksomheden fremlagde derfor undersøgelser, der viser, at de aktive stoffer i DuoPlavin optages på samme måde i kroppen, når de tages som en enkelt tablet, som når de to lægemidler tages hvert for sig.
English: What benefit has DuoPlavin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved DuoPlavin?
English: How has DuoPlavin been studied?
Danish: Hvordan er DuoPlavin blevet undersøgt?
English: What is DuoPlavin used for?
Danish: Hvad anvendes DuoPlavin til?
English: How is DuoPlavin used?
Danish: Hvordan anvendes DuoPlavin?
English: How does DuoPlavin work?
Danish: Hvordan virker DuoPlavin?
English: Further information on Pelmeg can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pelmeg.
Danish: Yderligere information om Pelmeg findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/pelmeg.
English: Other information about Pelmeg
Danish: Andre oplysninger om Pelmeg
English: What measures are being taken to ensure the safe and effective use of Pelmeg?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pelmeg?
English: This means that Pelmeg is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Pelmeg i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: An overview of Pelmeg and why it is authorised in the EU
Danish: En oversigt over Pelmeg, og hvorfor det er godkendt i EU
English: What is Pelmeg and what is it used for?
Danish: Hvad er Pelmeg, og hvad anvendes det til?
English: The reference medicine for Pelmeg is Neulasta.
Danish: Referencelægemidlet for Pelmeg er Neulasta.
English: The most common side effect with Pelmeg (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Pelmeg (som optræder hos mere end 1 ud af 10 patienter) er knoglesmerter.
English: As for all medicines, data on the use of Pelmeg are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Pelmeg løbende overvåget.
English: Why is Pelmeg authorised in the EU?
Danish: Hvorfor blev Pelmeg godkendt i EU?
English: Side effects reported with Pelmeg are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Pelmeg vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Pelmeg is a ‘biosimilar medicine'.
Danish: Pelmeg er et "biosimilært lægemiddel".
English: What are the risks associated with Pelmeg?
Danish: Hvilke risici er der forbundet med Pelmeg?
English: Pelmeg can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Pelmeg udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.