Land: Storbritannia
Språk: engelsk
Kilde: 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 2023 AN: 02470/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEMOVAC lyophilisate for oculonasal suspension/use in drinking water 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live avian pneumovirus, PL21 strain, at least 2.3 log10 CCID50* * CCID50 = 50% cell culture infective dose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension Pale Pellet 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For broiler chickens: For active immunisation of chickens between 7 and 14 days to reduce upper respiratory signs associated with avian pneumovirus infection (Swollen Head Syndrome). Onset of immunity: 17 days Duration of immunity: 3 weeks 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. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Revised November 2023 AN: 02470/2022 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE i). Special precautions for use in animals 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 4.5, 4.9, and 6.6. It is advised not to vaccinate in the presence of other sensitive species (guinea fowl, pheasant), taking into account the spread of the vaccine strain and the lack of safety data for these species. ii). Spec Les hele dokumentet