NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDERAND OF THE MANUFACTURINGAUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Bioveta, a. s., Komenského 212,683 23 Ivanovice na Hané,Czech Republic
NAME OF THE VETERINARY MEDICINALPRODUCT
ORNIBUR INTERMEDIATE PLUS lyophilizate for the preparation of suspension for chickens
STATEMENT OF THEACTIVE SUBSTANCEAND OTHER INGREDIENT
One vaccination dose contains:Active substance:
Virus bursitidis infectiosae avium,strain IBDV OP-1,
min. 104.0TCID– max. 105.2TCID5050
Excipients:Nutrimentum pro lyophilisatione
4.INDICATION
Preventive vaccination of chickensfrom the seventh day of age in flocks endangered with very virulent strainsof infectious bursitis virus.
Immunity onset:
The onset of immunity is observed within two weeks after vaccination.
Duration of immunity:
In chickens intended to fattening, the immunity lasts till the end of fattening; in layers till the end of breeding.
5.CONTRAINDICATIONS
Vaccinate only healthy animals.
It is not recommended to vaccinate sick animals.

6.ADVERSE REACTIONS
Not known.
7.TARGET SPECIES
Domestic fowl – chickens fromthe seventh day of age.
DOSAGE FOR EACH SPECIES,ROUTEAND METHOD OF ADMINISTRATION
Individual intraconjunctival application:
The lyophilized vaccine is dissolved ina sterile solvent (e.g. water for injection).The vaccine is applied with an ordinary dropper on the conjunctival mucosa of individual birds.
Mass application into drinking water:
The vaccine is administered dissolvedin such a quantity of drinking waterwhich can be drunk by poultry withinone or two hours.The vaccine is administered in the morning, i.e. in the time when the poultry is most thirsty.
The preventive vaccination is performed once at the age of 21 days.In endangered flocks, it is recommended to vaccinate on the basis of serological examination of maternal antibodies and to revaccinate a week later.
The first vaccination of chickens from mothers vaccinated with a live vaccineis made from 7 to 14 days of age.
The first vaccination of chickens from mothers vaccinated with an inactivated vaccine is made from 14 to 21 daysof age.
ADVICE ON CORRECT ADMINISTRATION
The content of antiseptic anddisinfective agents, the presenceof chlorine and iron in water usedto dissolve the vaccine have negative effects on the vaccination virus and affect adversely the vaccine efficacy.

The technical equipment used for application of the vaccine, including feeders, must be maintained clean,free of detergents and disinfectants.
Special precautions for use in animals
Only healthy animals should be vaccinated.
Special precautions to be taken by the person administeringthe veterinary medicinal productto animals
Avoid exposure to virus during vaccination and use safety gogglesand a mask during spray application.Wash and disinfect your hands afterthe vaccination is finished. Wash used equipment and inactivate the vaccine residues with an efficient disinfectant,or by heat treatment (boiling or burning).
10.WITHDRAWALPERIOD
Without withdrawal period.
.SPECIALSTORAGE PRECAUTIONS
Keep out of the reach and sightof children.
Shelf-life of the veterinarymedicinal product in the intactcontainer: 30 months.
Shelf-life after first opening: consume immediately.
Shelf-life after dilution: within 3 hours.
12.SPECIALWARNINGS
During all procedures related tothe product administration use usual aseptic measures.
Safety studies proved that the vaccination viruses of the strain IBDV OP-1 are safe for target animals and passaging on a target animal doesnot increase their virulence and
does not produce clinical symptomsof disease.Therefore, no special veterinary or zootechnical measures related to vaccination are necessary.No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal

product.Adecision to use this vaccine before or after any other veterinary medicinal product therefore needs tobe made on a case by case basis.In the absence of compatibility studies,this veterinary medicinal product must not be mixed with other veterinary medicinal products.
SPECIALPRECAUTIONS FOR THE DISPOSALOF UNUSED PRODUCT OR WASTE MATERIALS,IFANY
Dispose of waste material by boiling,incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
18/1/2021
15.OTHER INFORMATION
The vaccine is delivered in glass vialsof type I, compliant with Ph.Eur., closed with a rubber lyophilization stopper and an aluminium cap.
Pack sizes:
200 doses, 500 doses, 1000 doses,
2 500 doses, 5000 doses,
10×200 doses, 10×500 doses,10×1000 doses, 10×2 500 doses,10×5000 doses
Not all pack sizes may be marketed.
Imported by:
Biovet Egypt Co.,Mansura City, Egypt Slaughterhouse district ofAl Wahda street, Neighborhood trees - Nasreddine St. No.5.