Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Recombinant turkey herpesvirus, strain vhvt013-69, live
Boehringer Ingelheim Vetmedica GmbH
QI01AD15
Infectious bursal disease and Marek's disease vaccine (live recombinant)
Embryonated eggs; Chicken
Immunologicals for aves, Domestic fowl, Immunologicals
For active immunisation of chickens:To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.To reduce mortality, clinical signs and lesions of Marek's disease.
Revision: 17
Authorised
2002-08-09
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET VAXXITEK HVT+IBD SUSPENSION AND SOLVENT FOR SUSPENSION FOR INJECTION 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein Germany Manufacturer responsible for batch release Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes Rue de l’Aviation 69800 Saint-Priest France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Vaxxitek HVT+IBD Suspension and solvent for suspension for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of vaccine contains: Active ingredient: Live vHVT013-69 recombinant virus, at least ....................................................... 3.6 to 4.4 log10 PFU* Excipient ...................................................................................................................................... qs 1 dose Diluent: Diluent ......................................................................................................................................... qs 1 dose *Plaque forming unit 4. INDICATION(S) For active immunisation of chickens: • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease. The onset of protection is from 2 weeks and the protection extends to 9 weeks. • To reduce mortality, clinical signs and lesions of Marek’s disease. The onset of protection is from 4 days. A single vaccination is sufficient to provide protection during the risk period. 5. CONTRAINDICATIONS Do not use in birds in lay and breeding birds. 1 1 1 1 1 15 6. ADVERSE REACTIONS None known. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Day-old chickens and 18 days embryonated eggs. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous or _in ovo _ route. For _in o Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vaxxitek HVT+IBD Suspension and solvent for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of vaccine contains: Active substance: Live vHVT013-69 recombinant virus, at least ....................................................... 3.6 to 4.4 log10 PFU* Excipient ...................................................................................................................................... qs 1 dose Diluent: Diluent ......................................................................................................................................... qs 1 dose *Plaque forming unit For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Day-old chickens and 18 days embryonated eggs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens: • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease. The onset of protection is from 2 weeks and the protection extends to 9 weeks. • To reduce mortality, clinical signs and lesions of Marek’s disease. The onset of protection is from 4 days. A single vaccination is sufficient to provide protection during the risk period. 4.3 CONTRAINDICATIONS Do not use in birds in lay and breeding birds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy birds. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Apply the usual aseptic precautions to all administration procedures. As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety and reversion to virulence trials have shown that the strain is safe for turkeys. However, 3 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 pe Læs hele dokumentet