Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus
Intervet International B.V.
QI01AD16
Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)
Chicken; Embryonated chicken eggs
avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus
For active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by Newcastle disease (ND) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus,to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus.
Revision: 5
Authorised
2017-08-22
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: INNOVAX-ND-IBD CONCENTRATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ND-IBD concentrate and solvent for suspension for injection for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for _in ovo_ use) contains: Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 10 3.3 – 10 4.6 PFU 1 . 1 PFU – plaque forming units. Concentrate and solvent for suspension for injection. Cell concentrate: off-red to red cell concentrate. Solvent: clear, red solution. 4. INDICATION(S) For active immunisation of one-day-old chicks or 18–19 day-old embryonated chicken eggs: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus, - to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus. Onset of immunity: ND: 4 weeks of age, IBD: 3 weeks of age, MD: 9 days. Duration of immunity: ND: 60 weeks, IBD: 60 weeks, MD: entire risk period. 5. CONTRAINDICATIONS None. 16 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Chickens and embryonated chicken eggs. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION After dilution, administer 1 dose of 0.2 ml va Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ND-IBD concentrate and solvent for suspension for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for _in ovo_ use) contains: ACTIVE SUBSTANCE: Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 10 3.3 – 10 4.6 PFU 1 . 1 PFU – plaque forming units. EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection. Cell concentrate: off-red to red cell concentrate. Solvent: clear, red solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens and embryonated chicken eggs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of one-day-old chicks or 18–19 day-old embryonated chicken eggs: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus, - to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus. Onset of immunity: ND: 4 weeks of age, IBD: 3 weeks of age, MD: 9 days. Duration of immunity: ND: 60 weeks, IBD: 60 weeks, MD: entire risk period. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety trials have shown that the strain is safe for turkeys. However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys. Special precautions to be taken by the person administering the veterinary medicinal product to animals Lesen Sie das vollständige Dokument