FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products
Danish: Desuden blev markedsføringstilladelsesindehaverne anmodet om at godtgøre fordelene ved at bruge kombinationsprodukter, der indeholder colistin, i forhold til monoterapi til behandling af de respektive sygdomme, navnlig under hensyntagen til CVMP's retningslinjer for kombinationspræparater
English: Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary.
Danish: Efter vurdering af de foreliggende data konkluderede CVMP, at der ikke kan påvises nogen fordele ved anvendelse af colistin kombineret med andre stoffer i forhold til monoterapi, og at der ikke kan fastsættes nogen egnede risikominimeringsforanstaltninger til imødegåelse af den identificerede potentielle risiko for menneskers sundhed, da selv begrænset anvendelse af colistin kombineret med andre stoffer anses for unødvendig.
English: Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally
Danish: Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration
English: Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
Danish: Kommissionenes beslutning om markedsføringstilladelse i henhold til artikel 35 i Europa Parlamentets og Rådets direktiv 2001/82/EF for alle veterinærlægemidler, som indeholder "Colistin" til oral administration ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
English: On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Danish: Den 21. april 2016 afsluttede Det Europæiske Lægemiddelagentur (EMA) en undersøgelse af virkning og antimikrobiel resistens, hvad angår alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration.
English: Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, undersøgt?
English: The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).
Danish: CVMP anbefalede, at alle markedsføringstilladelser for veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, inddrages i hele Den Europæiske Union (EU).
English: Therefore the CVMP recommended that all marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn.
Danish: CVMP anbefalede derfor, at alle markedsføringstilladelser for alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, inddrages.
English: On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Danish: I maj 2015 indledte Europa-Kommissionen en indbringelsesprocedure i medfør af artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration.
English: London, 13 April 2007 EMEA/CHMP/75285/2007
Danish: London, den 13. april 2007 EMEA/CHMP/75285/2007
English: The final opinion was converted into a Decision by the European Commission on 13 April 2007.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 13. april 2007.
English: The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 27. juli 2006 med vedtagelsen af liste med spørgsmål.
English: A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”.
Danish: Der er påvist et fald i forekomsten af vertebrale frakturer, men ikke i forekomsten af ikke-vertebrale frakturer”.
English: Sweden referred the reasons for disagreement to the EMEA on 10 July 2006.
Danish: Sverige fremsendte begrundelserne for uenigheden til EMEA den 10. juli 2006.
English: The Marketing Authorisation Holder provided written explanations on 19 October 2006.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 19. oktober 2006.
English: Significant difference has been identified with regard to the indication for treatment of osteoporosis in men and this was considered to be of serious public health concern.
Danish: Der blev konstateret betydelige forskelle med hensyn til indikationen til behandling af osteoporose hos mænd, og dette blev anset for at udgøre et alvorligt problem for folkesundheden.
English: The Rapporteur was Dr. Tomas Salmonson and Co-Rapporteur(s) was Dr. Frits Lekkerkerker.
Danish: Rapportøren var Dr. Tomas Salmonson, og medrapportøren var Dr. Frits Lekkerkerker.
English: In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS): Belgium, Greece and Denmark.
Danish: Ansøgningen blev ved gentagen anvendelse af den gensidige anerkendelsesprocedure, som blev indledt den 11. oktober 2005, indgivet til følgende berørte medlemsstater (CMS): Belgien, Grækenland og Danmark.
English: The CHMP considered that the benefit/risk ratio was considered to be favourable in the following indication: “Treatment of osteoporosis in men at increased risk of fracture.
Danish: CHMP var af den opfattelse, at benefit/risk-forholdet var gunstigt for følgende indikation: “Behandling af osteoporose hos mænd med forhøjet risiko for brud.
English: The Reference Member State was Sweden and in the first wave of the mutual recognition procedure, the concerned Member States which have already granted the marketing authorisation were Germany and Poland.
Danish: Referencemedlemsstaten var Sverige, og i den første fase af den gensidige anerkendelsesprocedure var de berørte medlemsstater, som allerede havde udstedt markedsføringstilladelse, Tyskland og Polen.
English: During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral, should not prevent the granting of a Marketing Authorisation for Alendronate HEXAL and associated names.
Danish: På sit møde i januar 2007 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at de indsigelser, der havde givet anledning til artikel 29-indbringelsen, ikke bør være til hinder for udstedelse af en markedsføringstilladelse for Alendronat HEXAL og tilknyttede navne.
English: Hexal A/S submitted applications for mutual recognition of Alendronate HEXAL and associated names, 10 mg tablets on the basis of the marketing authorisation granted by Sweden on 3 December 2004.
Danish: Hexal A/S indgav ansøgninger om gensidig anerkendelse af Alendronat HEXAL og tilhørende navne, 10 mg tabletter, på baggrund af den markedsføringstilladelse, Sverige havde udstedt den 3. december 2004.
English: Therefore the CHMP issued a positive opinion on 24 January 2007 recommending the granting of the Marketing Authorisation and the amendments of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
Danish: Den 24. januar 2007 vedtog CHMP en positiv udtalelse, som anbefalede udstedelse af markedsføringstilladelsen og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate)
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Alendronat HEXAL og tilknyttede navne Internationalt fællesnavn (INN): alendronsyre (i form af alendronatnatriumtrihydrat)
English: Alendronate HEXAL and associated names, 10 mg tablets, contains alendronic acid as sodium alendronate trihydrate, which is a bisphosphonate indicated in the treatment of post-menopausal osteoporosis.
Danish: Alendronat HEXAL og tilhørende navne, 10 mg tabletter, indeholder alendronsyre i form af alendronatnatriumtrihydrat, som er et biphosphonat, der er indiceret til behandling af postmenopausale patienter med osteoporose.
English: This clinical sign has been reported very rarely from the field.
Danish: De kliniske symptomer er blevet rapporteret meget sjældent fra marken.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Danish: Administrer en dosis på 2 ml i henhold til følgende vaccinationsprogram: Første injektion: fra 3 måneders-alderen.
English: On day 2 after vaccination, rectal temperatures had returned to normal values.
Danish: På dag 2 efter vaccinationen var rektaltemperaturen igen normal.
English: In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.
Danish: I et laboratorium studie, der blev ikke observeret nogen bivirkninger efter den første injektion af en enkeltdosis vaccine til kalve.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for Bluetongue virus (BTV).
English: No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle.
Danish: Der foreligger ingen oplysninger om brugen af vaccinen til seropositive dyr, herunder dyr med maternelle antistoffer, men det er vist, at vaccinen er sikker og effektiv hos seropositivt kvæg.
English: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
Danish: − Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling)
English: Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.
Danish: Lokale reaktioner på mere end 2 cm er almindelige efter en dobbelt overdosis, mens reaktioner på op til 5 cm lejlighedsvis forekommer efter administration af en overdosi; disse forsvinder efter højst 57 dage.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Danish: Et revaccinationsprogram skal aftales med den ansvarlige myndighed eller den ansvarlige dyrlæge, der bør tage den lokale epidemiologiske situation med i betragtning.
English: To stimulate active immunity against bluetongue virus, serotype 8 in cattle.
Danish: Til stimulation af aktiv immunitet mod bluetonguevirus, serotype 8 hos kvæg.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær anvendelse.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 20ml / Carton box 1 x 100 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med 1 x 20 ml / Kartonæske med 1 x 100 ml
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Danish: 10. UDLØBSDATO EXP {måneder/år} Efter anbrud: anvendes straks.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG Må kun udleveres efter veterinærrecept.
English: Special precautions for use in animals: Only use in healthy animals
Danish: Særlige forsigtighedsregler vedrørende brug til dyr: Må kun anvendes til raske dyr.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Bovis suspension for injection for cattle
Danish: VETERINÆRLÆGEMIDLETS NAVN ZULVAC 8 Bovis injektionsvæske, suspension, til kvæg
English: Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomer closure
Danish: 6.5 Den indre emballages art og indhold Type I glasflaske (10 doser) eller type II glasflaske (50 doser) med butylelastomer prop. Pakningsstørrelser
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 2 ml of vaccine contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER En dosis på 2 ml vaccine indeholder:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanser) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at
English: 4.2 Indications for use, specifying the target species Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af kvæg fra 3 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af bluetonguevirus, serotype 8.
English: Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Danish: Aktiv immunisering af kvæg fra 3 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af bluetonguevirus, serotype 8.
English: a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: TARGET SPECIES Cattle
Danish: DYREARTER Kvæg.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 2 ml: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) En dosis med 2 ml: Inaktiveret bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til hætteglas 20 ml
English: PACKAGE LEAFLET FOR: ZULVAC 8 Bovis suspension for injection for cattle
Danish: INDLÆGSSEDDEL TIL: ZULVAC 8 Bovis injektionsvæske, suspension, til kvæg
English: Rue Laid Burniat 1 1348 Louvain-la-Neuve
Danish: 1348 Louvain-la-Neuve BELGIEN
English: After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7ºC was recorded in the vaccinated calves during the first 24 hours.
Danish: Efter injektion af en dobbeltdosis blev der rapporteret om en svag og forbigående men signifikant stigning i den gennemsnitlige rektaltemperatur på 0,7°C hos vaccinerede kalve i løbet af de første 24 timer.
English: Marketing authorisation holder: Zoetis Belgium SA
Danish: Indehaver af markedsføringstilladelsen: Zoetis Belgium SA
English: The vaccine can be used during pregnancy.
Danish: Veterinærlægemidlet kan anvendes under drægtighed.
English: After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
Danish: Efter injektion af den anden enkeltdosis blev meget almindelige rapporterede svag og forbigående men signifikant stigning i den gennemsnitlige rektaltemperatur på 0,4°C hos vaccinerede kalve i løbet af de første 24 timer.
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Danish: − Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)
English: Name and address of the manufacturer of the biological active substance(s): Zoetis Manufacturing & Research Spain, S.L.
Danish: Navn og adresse på fremstillerne af de(t) biologisk aktive stof(fer) Zoetis Manufacturing & Research Spain, S.L.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ingen.
English: Pack of 1 bottle of 50 doses (100 ml).
Danish: Pakke med 1 flaske á 10 doser (20 ml) Pakke med 1 flaske á 50 doser (100 ml)
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 BOVIS must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende ZULVAC 8 BOVIS, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: ADVICE ON CORRECT ADMINISTRATION In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Det anbefales at anvende et multiinjektions-vaccinationssystem, når der anvendes store doser.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket på 100 ml hætteglas
English: MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zoetis Belgium SA
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af ZULVAC 8 Bovis er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 Bovis may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af ZULVAC 8 BOVIS er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: Name and address of the manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Danish: Navn og adresse på fremstillernen ansvarlig for batchfrigivelse Zoetis Manufacturing & Research Spain, S.L.
English: Shelf-life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes straks 6.4 Særlige opbevaringsforhold
English: Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
Danish: Farmakoterapeutisk gruppe: Inaktiverede virale vacciner - Vaccine mod bluetonguevirus, ATCvet-kode: QI02AA08
English: Each dose of 2 ml of the vaccine contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis på 2 ml vaccine indeholder:
English: WITHDRAWAL PERIOD Withdrawal period: zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 dage.
English: ROUTE(S) OF ADMINISTRATION IM
Danish: INDGIVELSESVEJ(E)
English: Strength Pharmaceutical Form
Danish: Intramuskulær injektion Heste: intravenøs injektion
English: EU Number
Danish: EU/2/11/133/001 Recocam 20mg/ ml
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Danish: [nedenstående aktuelt godkendte indikationer skal slettes (den specifikke ordlyd af indikationen kan variere fra produkt til produkt)]
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Danish: Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk svækkelse hos ældre (ekskl.
English: • Ancillary treatment of Raynaud's syndrome
Danish: Supplerende behandling af Raynauds syndrom
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Danish: Ændringer til relevante afsnit i produktresumeer og indlægssedler
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Danish: Alle henvisninger til ovennævnte indikationer skal slettes i de relevante afsnit i indlægssedlerne
English: B. Package Leaflet
Danish: B. indlægssedlen
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kadcyla den 15. november 2013.
English: This is a summary of the European public assessment report (EPAR) for Kadcyla.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kadcyla.
English: The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Kadcyla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • DM1, a toxic substance that kills cells when they attempt to divide and grow.
Danish: • DM1 er et giftigt stof, som dræber celler, når de forsøger at dele sig og vokse.