Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: VMD (Veterinary Medicines Directorate)
Avian pneumovirus
Boehringer Ingelheim Animal Health UK Ltd
QI01AD01
Avian pneumovirus
Powder for oral solution
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
1999-04-16
Revised: November 2018 AN: 01034/2018 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEMOVAC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live pneumovirus, PL21 strain, at least 2.3 log 10 CCID 50 CCID 50 = 50% cell culture infective dose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Broiler chickens between 7 and 14 days. Breeder and layer pullets from 14 weeks of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For broiler chickens: For active immunisation of chickens to reduce upper respiratory signs associated with avian pneumovirus infection (Swollen Head Syndrome). Immunity has been demonstrated 17 days after vaccination and has been shown to persist for a further three weeks. For breeder and layer pullets: Priming for active immunisation of pullets before booster vaccination with an inactivated vaccine containing avian pneumovirus to reduce respiratory signs associated with avian pneumovirus infection. For onset of immunity and duration of immunity of full schedule, see SPC of the inactivated booster vaccine. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds. Do not use in chickens in lay. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product is a live vaccine and is excreted from vaccinated birds and so spreads to unvaccinated chickens and turkeys. Reversion to virulence trials carried out in the Revised: November 2018 AN: 01034/2018 Page 2 of 5 laboratory have shown that the strain does not revert to virulence neither in chickens nor in turkeys. However, precautionary measures have to be followed in order to diminish the spread, see 4.3, 4.5, 4.9, and 6.6. The safety studies were carried out by oculo-nasal and oral administration and no side effects were observed. It is advised not to vaccinate in the presence of other sensitive species (guinea fowl, pheasant), taking into account the s Prečítajte si celý dokument