NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE,IF DIFFERENT
Bioveta, a. s., Komenského 212, 683 23 Ivanovice na Hané, Czech republic
2.NAME OF THE VETERINARY MEDICINAL PRODUCT
ORNIBURIntermediate
Lyophilizate for suspension for domestic fowl
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTSActive substances:
Virus bursitidis infectiosae aviumIBDV OP-23,min. 104,0TCID50, max. 105,3TCID50in one dose
TCID50–50% infectious dose for tissue culture
Excipients:Nutrimentum pro lyophilisatione
4.INDICATION
Active immunization of chickens fromthe seven daysof age against aviary infectious bursitidis.
Immunity starts in the chickens within 14 days after vaccination and persists in the fattening chickens tillthe end of the fattening period.
5.CONTRAINDICATIONS
It is not recommended to vaccinate sick poultry
6.ADVERSE REACTIONS
Not known
7.TARGET SPECIES
Domestic fowl.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Individual application:
The vaccine is diluted in sterile saline or in water for injection. One drop of the diluted vaccine isadministered to the conjunctival pouch–intraconjunctivally–to the individual birds.
Massapplication:
The vaccine is administrated in diluted form in such an amount of drinking water that the fowls consumewithin two hours from vaccine dilution.
It is convenient to vaccinate the chickens from hens with fair passive immunity, vaccinated withinactivated vaccines, at the age of 21 to 28 days. Chickens of endangered breeds are recommendedto be vaccinated as early as in the second week of age, and re-vaccinated one to two weeks later,preferably on the basis of serological examination of one-day-old chickens.
9.ADVICE ON CORRECT ADMINISTRATION
In case of oral vaccination, the vaccine mayonly be diluted in cold and uncontaminated drinking water,free of antiseptics and disinfection substances. Elevated temperature and content of antiseptic and disinfection substances in water significantly reduce the content of the vaccination virus in a dose.
10.WITHDRAWAL PERIOD

Without withdrawal period.

11.SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.Store in a refrigerator (2°C-8°C).
Shelf-life of the veterinary medicinalproduct as packaged for sale: 30months.Shelflife after reconstitution:within 2 hours

SPECIAL WARNING(S)
Use usual aseptic measures during all procedures related to the product administration.
The safety studies proved that the vaccination viruses of the strain IBDV OP-23 are safe to target animalsand passaging on the target animal does not increase theirvirulence or produce clinical symptomsof disease. Therefore, it is not necessary to take any special veterinary and animal husbandryactions in respect of the vaccination.
No information isavailable on the safety and efficacy of this vaccine when administered concurrentlywith other veterinary medicinal products. Decision about using this vaccine before or after anyother veterinary medicinal product must be based on consideration of individual cases.
Veterinary medicinal product must not be mixed with other veterinary medicinal products.Is not indicated vaccination of laying  hens in lay
Special precautions to be taken by the person administering the veterinary medicinal product toanimals
Avoid exposure to the virus during vaccination and wear protective goggles and a mask during the spray application. Wash and disinfect your hands after the vaccination is finished. Wash used equipment and inactivate vaccine residues with an effective disinfectant, or by heat treatment (boiling and burning).

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved foruse bythe competent authorities.
14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
October 2010
15.OTHER INFORMATION
For animal treatment only-to be supplied only on veterinary prescription.
The vaccine is supplied in glass vials, hydrolytic classI, comply with Ph.Eur.;closed with rubberlyophilisation stopper andluminium cap.
Package:
500 doses, 2000 doses,2500 doses,5000 doses
10x500 doses, 10x2000 doses,10x2500 doses,10x5000 doses

Not all pack sizes may be marketed.