NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Bioveta, a. s.,Komenského 212,
683 23 Ivanovice na Hané,Czech Republic
 NAME OF THE VETERINARY MEDICINALPRODUCT
ORNIBRON (IB H120), Live Lyophilized vaccine againstAvian Infectious Bronchitis of Poultry
 STATEMENT OF THEACTIVE SUBSTANCEAND OTHERINGREDIENTS
One vaccination dose contains:
Active substances:
Virus bronchitidis infectiosae avium H 120
min. 103,0EID, max. 105,3EID5050
 EID50– 50% infection dose for chicken embryos
Excipients:
Nutrimentum pro lyophilisatione , gelatine,saccharose, water for injections
4. INDICATION
Active immunization of chickens from the one day of age against infectiousbronchitis.
After spray vaccination of one-day-old susceptible chickens the onset of immunity was established 10-14 days later. Chickens are revaccinated by spray or administration in drinking water, most frequently at the age of 4 weeks and between 12 and 14 weeks of age. If the prescribed vaccination schedule is observed, the immunity lasts until the end of laying season.
5. CONTRAINDICATIONS
It is not recommended to vaccinate sick poultry and layers during the laying season.

6.ADVERSE REACTIONS
None known.
If you observe any serious adverse reactions or other reactions,that are not listed in this package insert, report them please to your veterinary surgeon.
7. TARGET SPECIES
Domestic fowl
 DOSAGE FOR EACH SPECIES,ROUTE(S)AND METHOD OF ADMINISTRATION
Individual ocular administration:
Reconstituted vaccine is administered ina single drop on the conjunctival mucosaof individual birds.
In one-day-old chickens the vaccine is administered to the nasal mucosa by dipping their beaks into the vaccinesolution.
Mass spray application:
The vaccine is administered diluted with water for injection, using a spray gun generating microdroplets.
Mass application to drinking water:
The vaccine is administered dissolved ina quantity of drinking water that can be drunk by the poultry within 1 to 2 hoursafter dilution of the vaccine.
To induce solid immunity, one-day-old chickens should by primary vaccinated by spraying.
Chickens are revaccinated by sprayingor administration in drinking water, most frequently at the age of 4 weeks and between 12 and 14 weeks of age.
ADVICE ON CORRECT ADMINISTRATION
Spray vaccination ensures better immunity than the vaccine in drinking water. One-day-old chickens should be vaccinated by application of a coarse spray, sprayed evenly over an appropriate number of poultry from a distance of 30-50 cm.Too fine microdroplets (aerosol fog) cause inhalation of the vaccine virus into the lower

airways and, consequently, development of the respiratory disease.The aerosol application is suitable only for revaccination of older poultry and spray mist is generated through a spray gun in the area of ​​poultry.For oral administration the vaccine can be diluted only in sound cold drinking water free of antiseptics and disinfectants.Increased temperature and the volumeof antiseptics and disinfectants in water reduce significantly the content of the vaccine virus in a dose.
10. WITHDRAWALPERIOD
Not applicable.
11. SPECIALSTORAGE PRECAUTIONS
Keep out of the reach of children.Keep in a dry and dark place at a temperature of 2 to 8 °C.
Do not expose the vaccine to the temperatures above 8 °C for a long time.Do not use after expiring of the expiration period stated on the etiquette.
Usage period after dilution according to the manual: use immediately.
12. SPECIALWARNING(S)
No information is available on the safety and efficacy of this vaccine when administered concurrently with other veterinary medicinal products. Decision about using this vaccine before or after any other veterinary medicinal product must be based on consideration of individual cases.It is not recommended to vaccinate sick poultry and layers during the laying season.
Special procuration determined to the persons, that dose the veterinary drug product to the animals
During the vaccination it is necessary to avoid the exposition to the virus and during spraying to use the protective googles and mask.After finish of vaccination it is necessary to wash and disinfect the hands.The used equipment must be washed and the residui of vaccine to inactivate by the active disinfection product. or by impactof heat (boiling and incineration).
 SPECIALPRECAUTIONS FOR THE DISPOSALOF UNUSED PRODUCT OR WASTE MATERIALS, IFANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.
 DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
2/11/2017
15. OTHER INFORMATION
After vaccination of the live virus against the infectious bronchitis the nesterile immunity forms, with which the persistence of the vaccination virus in organism is not excluded for a period of several days or weeks.The virus against infectious bronchitis of poultry is not transmisibleto humans.
Package:
200 doses, 500 doses, 1000 doses,
2500 doses
10 × 200 doses, 10 × 500 doses,
10 × 1000 doses, 10 × 2500 dosesNot all sizes of package may be on the
market
Only for animals - to be supplied only on veterinary prescription.
Imported by:
Biovet-Egypt,Egypt-Mansura City,
Slaughterhouse district ofAl Wahda street,Neighborhood trees - Nasreddine St. No.5