FrancophonIA/ELRC3.0 huggingface dataset:
English: When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Danish: Når blodet koagulerer, skyldes det, at bestemte celler i blodet, blodpladerne, klæber sammen (aggregerer).
English: There are no consequences on the use of Iscover/Plavix with acetylsalicylic acid in the authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Iscover/Plavix med acetylsalicylsyre til den godkendte indikation, for hvilken benefit/risk-forholdet forbliver uændret.
English: See here for information on the outcome of the resubmission.
Danish: Information om resultatet af denne genansøgning findes her.
English: What is happening for Iscover/Plavix with acetylsalicylic acid for treatment of atherothrombotic events?
Danish: Hvad vil der ske med Iscover/Plavix med acetylsalicylsyre til behandling af aterotrombotiske hændelser?
English: DuoPlavin is a medicine containing the active substances clopidogrel and acetylsalicylic acid in one tablet.
Danish: DuoPlavin er et lægemiddel, der indeholder de aktive stoffer clopidogrel og acetylsalicylsyre i én tablet.
English: This included patients who were having an acute myocardial infarction (heart attack) with an ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thought that they would have benefited from the treatment.
Danish: Dette omfatter patienter, som har haft akut myokardieinfarkt (hjertetilfælde) med ”forhøjelse af ST-segmentet” (dvs. en unormal visning på elektrokardiogrammet (EKG)), når lægen vurderede, at patienterne ville have haft gavn af denne behandling.
English: Furthermore, the studies of Iscover and Plavix used with acetylsalicylic acid as separate tablets were used to support the use of DuoPlavin in the same indication.
Danish: Undersøgelserne af Iscover og Plavix, anvendt sammen med acetylsalicylsyre som særskilte tabletter, blev desuden anvendt til at underbygge brugen af DuoPlavin til samme indikation.
English: The CHMP was concerned that the bioequivalence studies that were carried out did not use the recommended methods and did not provide sufficient evidence that the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Danish: CHMP var betænkelig ved, at bioækvivalensundersøgelserne ikke blev gennemført ved hjælp af de anbefalede metoder, og ikke gav tilstrækkelig dokumentation for, at den kombinerede tablet blev optaget i kroppen på samme måde som de to lægemidler givet hver for sig.
English: It was expected to be used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as ‘acute coronary syndrome'.
Danish: Det forventedes anvendt til forebyggelse af aterotrombotiske hændelser (problemer forårsaget af blodpropper og åreforkalkning) hos patienter, der lider af ”akut koronarsyndrom”.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the company had not fully addressed their concerns and the benefit of DuoPlavin combined tablet compared with the separate medicines had not been sufficiently demonstrated.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at virksomheden ikke havde behandlet udvalgets betænkeligheder fuldt ud, og at fordelene ved den kombinerede DuoPlavin-tablet ikke var tilstrækkeligt påvist.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoPlavin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse med DuoPlavin?
English: It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Danish: DuoPlavin forventedes også anvendt til patienter, som ikke har haft en sådan unormal visning på EKG'et, patienter, der har ustabil angina (en svær form for brystsmerter) eller har haft et myokardieinfarkt uden forekomst af Q-takker (en form for slagtilfælde), og har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from binding to a special receptor on their surface.
Danish: Clopidogrel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på blodpladernes overflade.
English: The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoPlavin or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Danish: Virksomheden meddelte CHMP, at tilbagetrækningen ikke får konsekvenser for patienter, som det er planen skal deltage i kliniske undersøgelser med DuoPlavin, eller patienter, som allerede deltager i kliniske undersøgelser med clopidogrel og acetylsalicylsyre som særskilte lægemidler.
English: Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
Danish: Clopidogrel er i forvejen blevet godkendt særskilt i EU under navnene Iscover og Plavix til forebyggelse af aterotrombotiske hændelser hos patienter med akut koronarsyndrom, i kombination med acetylsalicylsyre.
English: The active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoPlavin to reduce the number of tablets the patients need to take every day.
Danish: Clopidogrel og acetylsalicylsyre, de aktive stoffer i DuoPlavin, kombineres i én tablet for at mindske det daglige antal tabletter, patienten skal tage, hvilket skulle gøre det lettere at følge behandlingen.
English: DuoPlavin was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Danish: DuoPlavin forventedes anvendt til voksne patienter, som allerede tager clopidogrel- og acetylsalicylsyretabletter hver for sig.
English: ‘bioequivalence' studies to establish whether the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Danish: Til støtte for ansøgningen om markedsføringstilladelse for DuoPlavin gennemførte virksomheden ”bioækvivalensundersøgelser” for at fastslå, om den kombinerede tablet blev optaget i kroppen på samme måde som de to lægemidler givet hver for sig.
English: This means that it helps to prevent blood clots from forming.
Danish: Clopidogrel er et trombocytfunktionshæmmende middel, hvilket betyder, at det hjælper med til at forhindre dannelse af blodpropper.
English: These measures should help protect the environment.
Danish: Disse foranstaltninger skal bidrage til at beskytte miljøet.
English: 4.3 Contraindications None.
Danish: 4.3 Kontraindikationer Ingen.
English: * (for details see section 12)
Danish: * (For detaljer se afsnit 12)
English: 3 weeks after vaccination.
Danish: 3 måneder efter vaccination.
English: Shake the bottle before use and periodically during use.
Danish: Ryst flasken før brug og regelmæssigt under brug.
English: * (for details see section 4.4)
Danish: * (For detaljer se afsnit 4.4)
English: A post inactivation antigen quantification test should be developed after the production of 10 commercial batches
Danish: En post inaktiveringsantigen kvantificeringstest skal udvikles efter produktion af 10 kommercielle batch.
English: In very rare cases hypersensitivity reactions may occur.
Danish: I meget sjældne tilfælde kan overfølsomhedsreaktioner forekomme.
English: EU/2/10/106/003 EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
Danish: EU/2/10/106/004 EU/2/10/106/005 EU/2/10/106/006 EU/2/10/106/007 EU/2/10/106/008 EU/2/10/106/009 EU/2/10/106/010 EU/2/10/106/011 EU/2/10/106/012 EU/2/10/106/013 EU/2/10/106/014
English: Use clean and sterile vaccination equipment and avoid the introduction of contamination.
Danish: Brug rent og sterilt vaccinationsudstyr og undgå kontaminering.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/09/2010.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 06/09/2010
English: The CVMP also agreed that the periodic safety update report (PSUR) cycle for would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Danish: CVMP aftalte ligeledes at den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
English: Fertility:
Danish: Fertilitet:
English: Opalescent pink with resuspendable sediment.
Danish: Opaliserende pink med genoprysteligt sediment.
English: Zero days.
Danish: 0 døgn.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 dosis (1 ml) 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 adjuvanter) 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 MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - 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: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Danish: FREMSTILLERENS BATCHNUMMER Lot, {nummer}
English: However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period.
Danish: Dog kan stigningen i kropstemperaturen blive 0,5 °C højere og hævelserne mere udtalte og palpable i en længere periode.
English: It is recommended to use a multiject vaccination system.
Danish: Det anbefales at bruge automatsprøjter (multiject vaccination system).
English: Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Danish: Drægtighed og laktation: Vaccinen kan anvendes under drægtighed og laktation.
English: *(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating absence of infectious virus)
Danish: * (En cyklusværdi (Ct) >30 ved en valideret rRT-PCR-metode indikerer fravær af infektiøs virus)
English: Water for injection
Danish: Vand til injektionsvæsker
English: Intervet International GmbH Osterather Strasse 1a 50739 Köln
Danish: Intervet International GmbH Osterather Strasse 1a DE-50739 Köln Tyskland
English: No information is available on the use of the vaccine in seropositive animals, including those with maternally derived antibodies.
Danish: Der er ingen tilgængelig information om brug af vaccinen til seropositive dyr, inklusive dem med antistoffer overført fra moderdyret.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Special precautions for use in animals: Vaccinate healthy animals only.
Danish: Special forholdsregler til brug hos dyr: Kun raske dyr bør vaccineres.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Danish: Virkningen ved brug til andre dyrearter kan være forskellig fra virkningen hos kvæg og får.
English: Disposal: read package leaflet.
Danish: Destruktion: læs indlægssedlen.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Anvendelse af dette veterinære lægemiddel er kun tilladt under særlige omstændigheder, der er fastsat af EU-lovgivning vedr.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan brug.
English: In these categories of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against bluetongue virus.
Danish: Til disse dyregrupper bør vaccinen kun bruges efter en vurdering af fordele og ulemper foretaget af den ansvarlige dyrlæge eller den nationale ansvarlige myndighed, afhængig af den gældende vaccinationspolitik mod bluetonguevirus.
English: EXP {month/year} Once broached, use within 8 hours.
Danish: {måneder/år} Efter anbrud/åbning anvendes inden 8 timer.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1 ml) contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 1 dosis (1 ml) indeholder:
English: Pack size: cardboard box with 1 or 10 vials.
Danish: Pakningsstørrelser: Kartonæsker med enten 1 eller 10 hætteglas.
English: Before using the vaccine allow it to reach ambient temperature (15-25 °C).
Danish: Lad vaccinen opnå stuetemperatur (15-25 °C) inden anvendelse.
English: Cattle and sheep.
Danish: Kvæg og får.
English: Shelf life after first opening the immediate packaging: 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Danish: Opbevaringstid efter første åbning af den indre emballage: 8 timer, forudsat at veterinærlægemidlet ikke udsættes for temperatur over 37 °C eller kontaminering.
English: Any person intending to manufacture, import, possess, sell, supply and use Bovilis BTV8 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 anvende Bovilis BTV8, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: This vaccine has been shown to reduce but not prevent viraemia in cattle.
Danish: Det er dokumenteret, at vaccinen reducerer, men forhindrer ikke, viræmi hos kvæg.
English: In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site.
Danish: I meget sjældne tilfælde kan vaccination give en let stigning i kropstemperaturen (sædvanligvis ikke på mere end 0,5 °C, men i enkelte tilfælde på op til 2°C) i op til tre dage, samt en forbigående hævelse på injektionsstedet.
English: The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population.
Danish: Ved epidemiologiske modelstudier er det dokumenteret, at graden af reduktionen sandsynligvis kan nedsætte virustransmissionen til et niveau, som er i stand til at begrænse spredningen af et udbrud i en vaccineret population.
English: This vaccine has been tested for safety in sheep and cattle.
Danish: Vaccinens sikkerhed er undersøgt hos kvæg og får.
English: In sheep these swellings typically last for up to three weeks.
Danish: Disse hævelser vil hos får typisk vare i op til tre uger.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8
Danish: VETERINÆRLÆGEMIDLETS NAVN Bovilis BTV8
English: Sodium chloride Maleic acid Simeticone emulsion Aluminium hydroxide Saponin
Danish: Simeticonemulsion Aluminiumhydroxid Saponin
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials (10, 20 or 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas (10, 20 eller 50 ml)
English: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Danish: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer Holland
English: Onset of immunity:
Danish: Immuniteten varer:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/106/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/106/001
English: In sheep, swellings may still be palpable after six weeks.
Danish: Hos får kan hævelserne stadig være palperbare efter 6 uger.
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Danish: Da immunitetens varighed endnu ikke er endeligt fastsat, skal ethvert revaccinationsprogram godkendes af den ansvarlige myndighed eller ansvarlige dyrlæge, således at den lokale epidemiologiske situation kan tages i betragtning.
English: (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants
Danish: (* inducerer et virusneutraliserende antistofrespons i kyllinger på > 5,0 log2) Adjuvanser:
English: Vaccinate healthy animals only.
Danish: Kun raske dyr bør vaccineres.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/106/001-014
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/106/001-014
English: Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Danish: Bovilis BTV8 er en dræbt virusvaccine til stimulation af aktiv beskyttelse mod bluetonguevirus serotype 8.
English: If used in other domestic or wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Danish: Hvis vaccinen bruges til andre domesticerede eller vilde drøvtyggere, som antages at være i smittefare, bør den bruges med omhyggelighed, og det anbefales at prøve vaccinen på et mindre antal dyr før massevaccination.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The safety and efficacy of the vaccine has not been established in breeding males.
Danish: Vaccinens sikkerhed og virkning er ikke fastlagt for handyr til avl.
English: Shelf life of the veterinary medicinal product as packaged for sale for 10, 20, 50 ml vials: 2 years Shelf life of the veterinary medicinal product as packaged for sale for 100, 200, 250, 500 ml vials: 1 year.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 10, 20, 50 ml hætteglas: 2 år Opbevaringstid for veterinærlægemidlet i salgspakning: 100, 200, 250, 500 ml hætteglas: 1 år.
English: Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic units*.
Danish: Bluetonguevirus, serotype 8, (inden inaktivering): 500 antigen enheder *.
English: Aluminium hydroxide (as 100%) 16.7 mg Saponin
Danish: Aluminiumhydroxid (som 100%)
English: PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Danish: PET-hætteglas a 10, 20, 50, 100, 200, 250 eller 500 ml, med gummiprop og aluminiumshætte.
English: The manufacture, import, possession, sale, supply and/or use of Bovilis BTV8 is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af Bovilis BTV8 er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: No adverse reactions other than those described in section 4.6 were observed following administration of a double dose in cattle and sheep.
Danish: Der er ikke observeret bivirkninger efter brug af dobbelt dosis til kvæg og får ud over dem, der er beskrevet i afsnit 4.6.
English: In sheep, these swellings typically last for up to three weeks, while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of vaccinates.
Danish: Disse hævelser vil hos får typisk vare i op til tre uger, mens der hos ca.. 1/3 af de vaccinerede kvæg kan mærkes små hævelser i op til 6 uger.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8 suspension for injection for cattle and sheep
Danish: VETERINÆRLÆGEMIDLETS NAVN Bovilis BTV8, injektionsvæske, suspension til kvæg og får
English: The vaccine is presented in cardboard boxes with 1 or 10 PET vials containing 10, 20, 50, 100, 200, 250 or 500 ml, closed with a rubber stopper and aluminium cap.
Danish: Vaccinen findes i kartonæsker med 1 eller 10 PET-hætteglas a 10, 20, 50, 100, 200, 250 eller 500 ml, med gummiprop og aluminiumshætte.
English: TARGET SPECIES Cattle and sheep.
Danish: DYREARTER Kvæg og får.
English: Duration of immunity: 6 months.
Danish: Immuniteten indtræder: 3 måneder efter vaccination.
English: PACKAGE LEAFLET FOR: Bovilis BTV8 suspension for injection for cattle and sheep
Danish: INDLÆGSSEDDEL Bovilis BTV8 Injektionsvæske, suspension til kvæg og får
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Bluetongue virus serotype 8: 500 antigenic units/ml.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Bluetonguevirus serotype 8: 500 antigen enheder/ml
English: Vials: 100 ml 200 ml 250 ml 500 ml
Danish: Hætteglas: 100 ml 200 ml 250 ml 500 ml
English: Cattle from 6 weeks of age: injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Danish: Kvæg fra 6-ugers-alderen gives to vaccinationer a 1 ml med et interval på ca. 3 uger.
English: PHARMACEUTICAL FORM Suspension for injection.
Danish: Injektionsvæske, suspension.
English: Primary vaccination:
Danish: Basisvaccination:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Bluetongue virus serotype 8: 500 antigenic units/ml.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Bluetonguevirus serotype 8: 500 antigen enheder/ml