FrancophonIA/ELRC3.0 huggingface dataset:
English: Lonquex 6 mg solution for injection in pre-filled syringe
Danish: Lonquex 6 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: When to use Lonquex
Danish: Hvornår skal du bruge Lonquex?
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Danish: Spørg lægen eller sygeplejersken til råds, hvis du ikke er sikker på, at du kan injicere dig selv, eller du har spørgsmål.
English: Information for injecting yourself
Danish: Oplysninger til selvinjektion
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8).
Danish: Der er indberettet kapillærlækage-syndrom efter indgift af G-CSF eller derivater, hovedsageligt hos cancerpatienter i kemoterapi (se pkt.
English: It could be a consequence of a spleen disorder (see section4 “Possible side effects”).
Danish: Det kan skyldes en lidelse i milten (se pkt.
English: If you use more Lonquex than you should
Danish: Hvis du har brugt for meget Lonquex
English: ● Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Committee for medicinal products for veterinary use (CVMP)
Danish: Udvalget for Lægemidler til Dyr (CVMP)
English: Pigs should be vaccinated twice with a 3 week interval.
Danish: Svinene bør vaccineres to gange med tre ugers interval.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was France2 and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland, Hungary, Ireland, Italy, Malta, Luxembourg, Lithuania, Latvia, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia and the United Kingdom.
Danish: Ansøgningen blev indgivet i henhold til artikel 6 i Kommissionens forordning (EF) nr. 1084/2003, hvor referencemedlemsstaten var Frankrig2, og de berørte medlemsstater var Østrig, Belgien, Cypern, Den Tjekkiske Republik, Tyskland, Danmark, Estland, Grækenland, Spanien, Finland, Ungarn, Irland, Italien, Malta, Luxembourg, Litauen, Letland, Nederlandene, Norge, Polen, Portugal, Sverige, Slovenien, Slovakiet og Det Forenede Kongerige.
English: The Mutual Recognition Procedure (FR/V/0158/001/II/002) started on 30 January 2009.
Danish: Den gensidige anerkendelsesprocedure (FR/V/0158/001/II/002) blev indledt den 30. januar 2009.
English: The final opinion was converted into a Decision by the European Commission on 16 August 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 16. august
English: 1 Article 6(12) of Commission Regulation (EC) No 1084/2003.
Danish: 1 Artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003.
English: The referral procedure started on 14 October 2009.
Danish: Indbringelsesproceduren blev indledt den 14. oktober 2009.
English: The United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement
Danish: 2 Det Forenede Kongerige repræsenterede Frankrig som referencemedlemsstat i en arbejdsdelingsordning.
English: Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. januar 2010, og der blev fremsendt supplerende oplysninger den 20. april 2010.
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae.
Danish: Porcilis M Hyo er et immunologisk lægemiddel til dyr, der indeholder Mycoplasma hyopneumoniae.