País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Avian metapneumovirus, subtype B, CRR126 strain
CEVA-Phylaxia Veterinary Biologicals Co. Ltd
QI01AD01
Avian metapneumovirus, subtype B, CRR126 strain
.
Lyophilisate for oculonasal suspension/use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
avian rhinotracheitis virus
Immunological - Live Vaccine
Authorised
2016-11-11
Health Products Regulatory Authority 01 October 2021 CRN00C48L Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cevac Meta L lyophilisate for oculonasal suspension for chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains: ACTIVE SUBSTANCE: Live, attenuated avian metapneumovirus_, _subtype B, strain CRR126 2.5-3.8 log10 TCID 50 * *TCID 50 = 50% Tissue culture infective dose: the virus titre required to produce infection in 50% of the tissue culture inoculated. EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for oculonasal suspension Yellowish white lyophilisate 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of future layer chickens in order to reduce respiratory signs and virus shedding associated with infection by avian metapneumovirus which is known to be the primary etiological agent of Swollen Head Syndrome. Onset of immunity: 3 weeks after vaccination. Duration of immunity: 9 weeks after vaccination. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination. The vaccine strain can spread to unvaccinated birds. In order to reduce the chance of circulation of the vaccine strain, it is recommended to vaccinate all susceptible animals on a site, preferably at the same time Appropriate veterinary and husbandry measures, such as cleaning and disinfection, should be taken to avoid spread of the vaccine strain to susceptible species. Unvaccinated birds should be separated from vaccinated chickens. Health Products Regulatory Authority 01 October 2021 CRN00C48L Page 2 of 4 Turkeys in contact with vaccinated chickens may react to the vaccine strain and show clinical signs such as slight sneezing or conjunctivitis, which may Llegiu el document complet