NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE,IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release:Bioveta, a. s., Komenského 212/12,
683 23 Ivanovice na Hané, Czech Republic
NAME OF THE VETERINARY MEDICINALPRODUCT
ORNIBRON H120 + D274 lyophilizate for the preparation of suspension for chickens
3. STATEMENT OF THEACTIVE SUBSTANCE(S)AND OTHER INGREDIENT(S)
One vaccination dose contains:
Active substances:
Virus bronchitidis infectiosae avium, strain
H120 min. 103.0EID- max. 104.8EID*5050
Virus bronchitidis infectiosae avium, strain
D274 min. 103.0EID- max. 104.8EID*5050
EID50 – 50% infective dose for chicken embryos
Excipient:
Lyophilization medium
4. INDICATION(S)
Active immunization of chickems from one day of age for the prevention of infection produced bx Massachusetts serotype strains of infectious bronchitis virus and variant strains corresponding to D274 protectotype.
Onset of immunity:
Asufficient protection is created within a week.Duration of immunity:
Immunity persists for at least 6 weeks after primovaccination. Immunity is extended by revaccination.
5. CONTRAINDICATIONS
Vaccinate healthy animals only.
6.ADVERSE REACTIONS
Post-vaccination reactions may occur in particular after unsuitable vaccine application by spraying, because fine micro-droplets(aerosol mist) cause inhalation of the vaccination virus into the lower air passages and respiratory disease as its consequence.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
7. TARGET SPECIES
Domestic fowl.
DOSAGE FOR EACH SPECIES,ROUTE(S)AND METHOD OF ADMINISTRATION
Individual oculonasal application:
200 vaccination doses are dissolved in 10 mlof a sterile solvent (e.g. water for injection).The volume of 0.05 ml is administered oculonasally, i.e. into the conjunctival sac and nostril of individual birds.
Mass spray application:
Distilled water or cool purified water free from chlorine and iron residues is used for vaccine dissolving.The device, specified exclusively for this purpose and generating droplets (diameter of 30 to 100 μm) is used for vaccination.For one day chickens1000 doses will be dissolved in the 200-250 volume; the sprayer nozzle has to be set to generation of a “coarse spray” = small droplets falling as a fine rain.For older poultry 1000 doses are dissolved in one litre of water and the sprayer nozzle is set to generation of fine droplets.The vaccination solution is sprayed uniformly at the distanceof 30 to 50 cm above the adequate numberof animals under soft lighting.
Mass application into potable water:
It is recommended to vaccinate the chickens from the 4th day after hatching, when reliable intake of the vaccination dose in potable water can be assumed.The vaccine is administered in the morning, when the poultry is thirsty enough.The vaccine is administered(depending on age) dissolved in such potable water quantity which will be consumed within2 hours.
Revaccination against avian infectious bronchitis is performed between 28 and 35 days after primovaccination and at the agefrom 10 to 12 weeks.
The collective vaccination with a coarse spray and the individual intranasal/ocular vaccination will ensure a better immune response than the vaccination in drinking water.
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