Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain
CEVA-Phylaxia Co. Ltd.
QI01AD
Newcastle disease and Marek’s disease vaccine (live recombinant)
Chicken; Embryonated eggs
Immunologicals for aves, Live viral vaccines
For active immunisation of 18 day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by Marek’s disease virus with a phenotype "virulent".
Revision: 7
Authorised
2015-09-08
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: VECTORMUNE ND SUSPENSION 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: CEVA-Phylaxia Co. Ltd. 1107 Budapest Szállás u. 5. HUNGARY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectormune ND suspension and solvent for suspension for injection for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Cell-associated live recombinant viral turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle disease virus D-26 lentogenic strain: 2,500–8,000 PFU*/dose * PFU: plaque forming units Orange-yellowish semi-transparent frozen suspension. The solvent is a clear red solution. 4. INDICATION(S) For active immunisation of 18-day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by virulent Marek’s disease virus. Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age. Duration of immunity against Newcastle disease for broilers: 9 weeks of age. Duration of immunity against Newcastle disease for layers: 18 weeks of age. Onset of immunity against Marek’s disease for broilers and layers: 1 week of age. Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek’s disease virus. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None known. 17 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 In-ovo administration: One single inject Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectormune ND suspension and solvent for suspension for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine (0.05 ml in-ovo administration or 0.2 ml subcutaneous use) contains: ACTIVE SUBSTANCE: Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle disease virus D-26 lentogenic strain: 2,500 – 8,000 PFU* * PFU: plaque forming units. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension and solvent for suspension for injection. Orange-yellowish semi-transparent frozen suspension. The solvent is a 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 18-day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by virulent Marek’s disease virus. Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age. Duration of immunity against Newcastle disease for broilers: 9 weeks of age. Duration of immunity against Newcastle disease for layers: 18 weeks of age Onset of immunity against Marek’s disease for broilers and layers: 1 week of age. Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek’s disease virus. 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 The vaccine strain was shown to be excreted by chickens and there was a slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study. Safety trials show the excreted vaccine strain is not harmfu Przeczytaj cały dokument