País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Live pneumovirus, PL21 strain
Boehringer Ingelheim Vetmedica GmbH
QI01AD01
Live pneumovirus, PL21 strain
.
Lyophilisate for oculonasal suspension/use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
avian rhinotracheitis virus
Authorised
2000-06-08
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEMOVAC lyophilisate for oculonasal suspension/use in drinking water (FR, AT, DE, EL, IE, NL, ES, PT, UK (NI)) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live avian pneumovirus, PL21 strain, at least 2.3 log 10 CCID 50 * * CCID 50 = 50% cell culture infective dose. QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS _Casein hydrolysate_ _Bovine albumin_ _Povidone_ _Sucrose_ _Mannitol_ _Monopotassium phosphate_ _Dipotassium phosphate_ _Potassium glutamate_ Pale Pellet 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Chickens 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For broiler chickens: For active immunisation of chickens from 7 to 14 days of age to reduce upper respiratory signs associated with avian pneumovirus infection (Swollen Head Syndrome). Onset of immunity: 17 days after vaccination. Duration of immunity: 5 weeks after vaccination. For breeder and layer pullets: Priming for active immunisation of pullets from 14 weeks of age 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. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS Vaccinate healthy animals only. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the 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 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 sections 3.9 and 5.5. It is advised not to vaccinate in the presence of other sensitive species (guinea fowl, pheasant), taking into account th Leer el documento completo