FrancophonIA/ELRC3.0 huggingface dataset:
English: The different figures provided by the available data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Danish: De forskellige tal, der fremgår af datakilderne (spontane rapporter, retsmedicinske centre, giftinformationscentraler, nationale dødsstatistikker), viste generelt et betydeligt antal af dødsfald, hvor dextropropoxyfen fandtes på toksisk niveau.
English: After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Danish: Efter at have gennemgået de tilgængelige data vurderede CHMP, at de forskellige tal, der fremgår af datakilderne (spontane rapporter, retsmedicinske centre, giftinformationscentraler, nationale dødsstatistikker), generelt viste et betydeligt antal af dødsfald, hvor dextropropoxyfen fandtes på toksisk niveau.
English: The CHMP also considered that data collected from national poison centres have limitations in this situation as dextropropoxyphene can cause death extremely rapidly (in under an hour); if a patient dies before reaching medical attention, the poisons centre is unlikely to be contacted.
Danish: CHMP mente desuden, at de indsamlede data fra de nationale giftinformationscentraler har begrænsninger i denne situation, eftersom dextropropoxyfen kan være dødbringende efter ekstremt kort tid (under en time).
English: The CHMP, having considered the matter as set out in the appended referral assessment report recommended the suspension of the Marketing Authorisations for all parenteral medicinal products referred to in Annex I to be effected within 15 months of the Commission Decision in order to allow healthcare professionals to prepare for a potential switch to using alternatives.. For the suspension to be lifted the Marketing Authorisation Holders would need to provide evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
Danish: Anbefalede CHMP, efter at have overvejet sagen, som den fremstår i den vedlagte vurderingsrapport, suspendering af markedsføringstilladelserne for alle de parenterale lægemidler, der er nævnt i bilag I, hvilket skal ske inden for en periode på 15 måneder fra Kommissionens afgørelse, så sundhedspersonalet kan forberede sig på et eventuelt skift til alternative behandlinger.
English: - The Committee considered that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established;
Danish: - CHMP fandt ikke, at virkningen af parenterale lægemidler indeholdende dextropropoxyfen var fastslået.
English: Because of this, the most reliable data come from forensic analysis and national mortality statistics, and complete review of the fatal overdoses associated with dextropropoxyphene (alone and in combination with paracetamol/caffeine)
Danish: Derfor stammer de mest pålidelige data fra retsmedicinske analyser og nationale dødsstatistikker, og en komplet gennemgang af de dødelige overdoser, der kan sammenkædes med dextropropoxyfen (alene og i kombination med paracetamol/koffein), understøttede den vigtigste betænkelighed ved den dødelige toksicitet ved lægemidler indeholdende dextropropoxyfen under normale anvendelsesbetingelser på grund af deres snævre terapeutiske indeks.
English: However, there is no clear evidence from clinical trials of superiority of efficacy of the combination of dextropropoxyphene and paracetamol compared with normal therapeutic doses of paracetamol alone, the trials which have suggested superiority to paracetamol alone have used sub-therapeutic doses of paracetamol.
Danish: Der foreligger dog ikke tilstrækkelig dokumentation fra kliniske undersøgelser om, at virkningen af kombinationen af dextropropoxyfen og paracetamol skulle være bedre end ved normale terapeutiske doser af paracetamol.
English: Nevertheless, the CHMP also took the well-established narrow therapeutic index into account, as well as other known risks associated with the use of parenteral opioids and potentially associated with the use of parenteral dextropropoxyphene such as abuse and dependence and given that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established, the CHMP concluded that the benefit-risk balance for the parenteral dextropropoxyphene containing medicinal products was negative and recommended the suspension of the Marketing Authorisations to be effected within 15 months of the Commission Decision to allow healthcare professionals to prepare for a potential switch to using alternatives.
Danish: Da virkningen af parenterale lægemidler indeholdende dextropropoxyfen ikke er fastslået, konkluderede CHMP dog, at benefit/risk-forholdet for parenterale lægemidler indeholdende dextropropoxyfen var negativt, og anbefalede suspendering af markedsføringstilladelserne inden for en periode på 15 måneder fra Kommissionens afgørelse, så sundhedspersonalet kunne forberede sig på et eventuelt skift til alternative behandlinger.
English: Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Danish: CHMP konkluderede derfor ved flertalsafgørelse, at benefit/risk-forholdet for lægemidler indeholdende dextropropoxyfen er negativt, og at dets udtalelse af 25. juni 2009 ikke skulle revideres for orale/rektale lægemidler indeholdende dextropropoxyfen,
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MA (EU)-nummer (Sær)navn Styrke Lægemiddelform Administrationsvej Indre emballage
English: Immediate Packaging Pack size bottle (HDPE)
Danish: EU/1/15/1054/002 Cinacalcet Mylan 30 mg Filmovertrukket tablet Til oral anvendelse flaske (HDPE)
English: ATC vet code: QI07AI08.
Danish: ATCvet-kode: QI07AI08.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/172/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/172/001
English: Date of last renewal: 11/04/2019.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 11/04/2019.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til canidae, levende virusvacciner og inaktiverede bakterievacciner.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Danish: Varighed af immunitet: Mindst et år efter basisvaccination for alle komponenter i Versican Plus Pi/L4.
English: Primary vaccination scheme: Two doses of Versican Plus Pi/L4 3-4 weeks apart from 6 weeks of age.
Danish: Basisvaccination: To doser af Versican Plus Pi/L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen.
English: Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Danish: Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundesygevirus, hundeparvovirus, hundeadenovirus type 1 og 2, hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae.
English: Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.
Danish: Rekonstitueret vaccine: Lyserød eller gullig farve, let opalisering.
English: The visual appearance is as follows:
Danish: Hyppigheden af bivirkninger er defineret som:
English: Re-vaccination scheme: A single dose of Versican Plus Pi/L4 to be given annually.
Danish: Revaccinationsprogram: Der anbefales en årlig vaccination med Versican Plus Pi/L4.
English: PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection
Danish: LÆGEMIDDELFORM Lyofilisat og suspension til injektionsvæske, suspension.
English: L. interrogans serovar Icterohaemorrhagiae
Danish: Suspension (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
English: EXP {month/year} Once reconstituted, use immediately.
Danish: UDLØBSDATO EXP {måneder/år} Anvendes straks efter anbrud.
English: − 4 weeks after the completion of primary course for Leptospira components.
Danish: Indtræden af immunitet: - 3 uger efter basisvaccination for CPiV - 4 uger efter basisvaccination for Leptospira komponenter.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 lyofilisat til hund
English: PACKAGE LEAFLET: Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus Pi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 suspension til hund
English: CLINICAL PARTICULARS 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Hund
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
Danish: − for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
English: Article 34 of Directive 2001/82/EC, as amended
Danish: Artikel 34 i direktiv 2001/82/EF, med senere ændringer
English: The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Danish: Udvalget udpegede G. Johan Schefferlie som rapportør og dr. Michael Holzhauser-Alberti som medrapportør.
English: International non-proprietary name (INN): tilmicosin
Danish: Internationalt fællesnavn (INN): tilmicosin
English: The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 18. oktober 2013.
English: Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 18. september 2012, den 11. februar 2013 og den 26. maj 2013.
English: The referral procedure started on 15 May 2012.
Danish: Indbringelsesproceduren påbegyndtes den 15. maj 2012.
English: Oral explanations were given on 11 June 2013.
Danish: Der blev afgivet mundtlige redegørelser den 11. juni 2013.
English: Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne med hensyn til tilladelserne for Micotil 300 Injectie og tilknyttede navne, indbragte Nederlandene den 24. april 2012 sagen for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF, for at få løst uoverensstemmelserne i produktoplysningerne i hele EU.
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, labelling and package leaflet in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og det ændrede produktresumé, etikettering og indlægsseddel findes i bilag III.
English: 18 October 2013
Danish: juli 2013.
English: Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Danish: Micotil 300 Injectie og tilknyttede navne er veterinærlægemidler, der er godkendt til anvendelse hos måldyrearterne kvæg, får og kaniner til behandling af forskellige infektioner forårsaget af tilmicosinfølsomme mikroorganismer.
English: Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Danish: På grundlag af de tilgængelige data var CVMP af den opfattelse, at benefit/risk-forholdet for Micotil 300 Injectie og tilknyttede navne fortsat er positiv, forudsat at markedsføringstilladelserne ændres i overensstemmelse med de anbefalede produktoplysninger.
English: Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Danish: Micotil 300 Injectie er en injektionsvæske, der indeholder tilmicosin i styrken 300 mg/ml.
English: Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Danish: Det har et antibakterielt spektrum svarende til tylosin med øget aktivitet over for Pasteurella multocida og Mannheimia haemolytica.
English: Opinion following an Article 340F referral for Micotil 300 Injectie and its associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 340F om Micotil 300 Injectie og tilknyttede navne
English: Opinion following an Article 341 referral for Micotil 300 Injectie and its associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel om Micotil 300 Injectie og tilknyttede navne
English: The Committee adopted a positive opinion by consensus on 18 July 2013.
Danish: CPMP vedtog derfor en positiv udtalelse ved konsensus den18.
English: Posaconazole SP 40 mg/ml Oral suspension Oral use
Danish: Posaconazole SP 40 mg/ml Oral suspension Oral anvendelse Flaske (glas)
English: Content (concentration) Package size
Danish: Indhold (koncentration) Pakningsstørrelse
English: Invented name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: 270 capsules blister (PVC/Aclar (PCTFE)) Initiation pack: 63 (1 x 21 and 2 x 21) tablets
Danish: Startpakning: 63 (1 x 21 og 2 x 21) tabletter
English: Immediate Packaging Pack size blister (PVC/PE/PCTFE/alu) Initiation pack: 63 (7 x 3 and 7 x 6) capsules blister (PVC/PE/PCTFE/alu) 252 x 1 capsules (unit dose)
Danish: Startpakning: 63 (7 x 3 og 7 x 6) kapsler
English: This overview was last updated in 03-2019
Danish: Denne oversigt blev sidst ajourført i 03-2019.
English: Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.
Danish: Instanyl fik en markedsføringstilladelse med gyldighed i hele EU den 20. juli 2009.
English: Further information on Instanyl can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Danish: Yderligere information om Instanyl findes på agenturets websted under: ema.europa.eu/medicines/Human/EPAR/Instanyl.
English: Other information about Instanyl
Danish: Andre oplysninger om Instanyl
English: The medicine can only be obtained by ‘special' prescription.
Danish: Lægemidlet udleveres kun efter "særlig" recept.
English: As for all medicines, data on the use of Instanyl are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Instanyl løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Instanyl?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Instanyl?
English: An overview of Instanyl and why it is authorised in the EU
Danish: En oversigt over Instanyl, og hvorfor det er godkendt i EU
English: Why is Instanyl authorised in the EU?
Danish: Hvorfor blev Instanyl godkendt i EU?
English: The doctor should keep in mind the potential for Instanyl to be abused.
Danish: Lægen bør være opmærksom på, at Instanyl kan misbruges.
English: For more information about using Instanyl, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Instanyl, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Instanyl's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Instanyl opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What are the risks associated with Instanyl?
Danish: Hvilke risici er der forbundet med Instanyl?
English: Side effects are similar to those of other medicines containing fentanyl, and measures have been put in place to minimise the risk of misuse and overdose.
Danish: Bivirkningerne svarer til bivirkningerne ved andre lægemidler, der indeholder fentanyl, og der er truffet foranstaltninger til at minimere risikoen for misbrug og overdosis.
English: A patient's breakthrough pain was considered to have responded to treatment if there was a reduction of at least 2 points.
Danish: Patientens gennembrudssmerte blev anset for at have responderet på behandlingen, hvis der var en reduktion på mindst 2 point.
English: What is Instanyl what is it used for?
Danish: Hvad er Instanyl, og hvad anvendes det til?
English: The active substance in Instanyl, fentanyl, is an opioid.
Danish: Det aktive stof i Instanyl, fentanyl, er et opioid.
English: Side effects reported with Instanyl are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Instanyl vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: It is available in singledose containers and in multidose containers.
Danish: Det leveres i enkeltdosisbeholdere og flerdosisbeholdere.
English: It must not be used to treat short-term pain other than breakthrough pain.
Danish: Det må ikke anvendes til behandling af andre kortvarige smerter end gennembrudssmerter.
English: Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out, which showed that Instanyl was more effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.
Danish: Eftersom fentanyl har været anvendt i mange år, fremlagde virksomheden data fra faglitteraturen og fra studier, den havde foretaget, som viste, at Instanyl var mere effektivt end placebo (en uvirksom behandling) til at behandle gennembrudssmerter hos kræftpatienter.
English: Instanyl contains the active substance fentanyl.
Danish: Instanyl indeholder det aktive stof fentanyl.
English: Each patient then used the identified dose of Instanyl or placebo to treat breakthrough pain.
Danish: Hver patient brugte så den identificerede dosis Instanyl eller placebo til at behandle gennembrudssmerter.
English: In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal' fentanyl (absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than patients who received transmucosal fentanyl .
Danish: I et tredje studie, som omfattede 139 patienter og sammenlignede Instanyl med "transmukosal" fentanyl (som absorberes gennem mundslimhinden), oplevede de patienter, som fik Instanyl, hurtigere smertelindring end de patienter, der fik transmukosal fentanyl.
English: When the patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the blood vessels in the nose.
Danish: Når patienten sprøjter Instanyl ind i næsen, absorberes en dosis fentanyl i blodbanen via blodkarrene i næsen.
English: The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating).
Danish: De hyppigste bivirkninger ved Instanyl (som kan forekomme hos op til 1 ud af 10 personer) er søvnighed, svimmelhed, hovedpine, vertigo (en følelse af, at alt kører rundt), rødmen, hedeture, irritation i halsen, kvalme, opkastning og hyperhidrose (overdreven svedtendens).
English: In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo when they experienced breakthrough pain.
Danish: I et hovedstudie tog 178 voksne kræftpatienter med gennembrudssmerter et pust af enten Instanyl (50, 100 eller 200 mikrogram) eller placebo, når de oplevede gennembrudssmerter.
English: Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose).
Danish: Instanyl fås som næsespray (50, 100 og 200 mikrogram pr. dosis).
English: The company that markets Instanyl will also provide educational materials to be supplied to patients, doctors and pharmacists, explaining the correct and safe use of the medicine.
Danish: Virksomheden, der markedsfører Instanyl, skal desuden udlevere oplysningsmateriale til patienter, læger og apotekspersonale med beskrivelse af, hvordan lægemidlet anvendes korrekt og sikkert.
English: In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached.
Danish: I et andet hovedstudie fik 128 patienter stigende doser af Instanyl, indtil en tilstrækkelig smertestillende dosis var opnået.
English: The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.
Danish: Antallet af patienter, der responderede på behandlingen, var også højere i Instanylgruppen end i placebogruppen.