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
2.5 1og10-3.8 log 10 TCID 50
Lyophilisate for suspension
POM
Fowl - Chicken
Avian rhinotracheitis virus vaccine
Immunological - Live Vaccine
Authorised
2016-11-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cevac Meta L lyophilisate for 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 TCID50* *TCID50 = 50 % Tissue culture infective dose: the virus titre required to produce infection in 50 % of the tissue culture inoculated. EXCIPIENTS: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension Yellowish white lyophilisate 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken 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. Duration of immunity: 9 weeks. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy birds only. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/11/2016_ _CRN 7021629_ _page number: 1_ 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 should be taken to avoid spread of the vaccine strain to susceptible species such as cleaning and disinfection procedures. Unva Llegiu el document complet