País: Reino Unido
Idioma: inglés
Fuente: VMD (Veterinary Medicines Directorate)
Marek's disease virus
Zoetis UK Limited
QI01AD03
Marek's disease virus
Powder and solvent for suspension for injection
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Chickens
Live Viral Vaccine
Authorized
2005-10-28
Revised: July 2022 AN: 02480/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac Marek CVI. (To be suspended in Poulvac Marek Diluent) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.2 ml contains: ACTIVE SUBSTANCE: Live Marek’s disease virus (MDV), strain CVI 988, cell associated: 250 CCID 50 * *CCID 50 = 50 % cell culture infective dose EXCIPIENT(S): For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Frozen virus-infected cell suspension and diluent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES One day old chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of chickens to reduce mortality and lesions caused by Marek’s Disease. The onset of immunity is from 9 days of vaccination and the duration of immunity is not known but has been shown by challenge to be at least 4 weeks. Vaccine virus and antibodies to Marek’s disease virus have been shown to persist in vaccinated chickens for up to 2 years. 4.3 CONTRAINDICATIONS Do not use in sick chickens. Revised: July 2022 AN: 02480/2021 Page 2 of 6 4.4 SPECIAL WARNINGS Vaccine virus spreads from bird to bird. In a study in highly susceptible Rhode Island Red birds, vaccine virus was shown to increase in virulence after ten passages. Maternally derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly. 4.5 SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS i. Special precautions for use in animals Avoid stress in chickens before and after vaccination. Avoid injection into or near joints and tendons. ii. Special precautions to be taken by the person administering the veterinary medicinal pro Leer el documento completo