NAMEANDADDRESS OF THE MARKETINGAUTHORISATION 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
NAME OF THE VETERINARY MEDICINALPRODUCT
ORNIMIX CLONE B1+H120, lyophilizatefor the preparation of suspension for chickens
STATEMENT OF THEACTIVE SUBSTANCEAND OTHER INGREDIENTS
One vaccination dose contains:
Active substances:
Paramyxovirus pseudopestis avium,strain Bio 52: NDV B1
min. 106,0EID– max. 107,5EID5050
Virus bronchitidis infectiosae avium,strain Bio 53: IBV H 120
min. 103,0EID– max. 104,8EID5050
Excipients:
Nutrimentum pro lyophilisatione
4.INDICATION
For active immunization of fowl against Newcastle avian disease and infectious bronchitis of Massachusetts type.For prevention of infection and mortality caused by Newcastle disease virus andby infectious bronchitis virus.
Onset of immunity:
The immunity against Newcastle diseaseand infectious bronchitis starts not laterthan 14 and 7 days after primovaccination,respectively, and maternal antibodies haveno negative influence on the efficacyof vaccination.
Time of immunity duration:
The immunity persists for 6 weeks after spray and oculonasal primovaccination and 4 weeks after peroral primovaccination.
After revaccination, the immunity persists for6 weeks as a minimum.
The level of immunity against Newcastle disease can be evaluated after revaccination on the basis of serological examination.

5.CONTRAINDICATIONS
Only healthy animals should be vaccinated.Do not use in animals that are showing signs of disease.
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.
7.TARGET SPECIES
Domestic fowl – chickens from the age ofone day.
DOSAGE FOR EACH SPECIES,
ROUTE(S)AND METHODOFADMINISTRATION
Individual oculonasal application:
The lyophilized vaccine is dissolved in a sterile solvent (e.g. water for injections).The vaccine is applied by a common eye-dropper ontothe conjunctiva mucosa or nostril of individual birds; it is necessary to provide breath suction of the droplet by the animal.
Mass spray application:
Distilled water or cool purified water free from chlorine and iron residues is used for vaccine dissolving.The device, specified exclusivelyfor this purpose and generating droplets(diameter of 30 to 100μm) is used for vaccination. For one day chickens 1000 doses will be dissolved in the 200 – 250 volume;the sprayer nozzle has to be set to generation of a “coarse spray” = small droplets fallingas a fine rain. For older poultry 1000 dosesare 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 distance of 30 to 50 cm above the adequate number of animals under soft lighting.
Mass application into potable water:
It is recommended to vaccinate the chickens from the 4thday 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 within 2 hours.
Re-vaccination is carried out every sixweeks after the first oculonasal or spray administration and in 4 weeks after the first peroral vaccination. Further vaccinationsare carried out every six weeks.
In the regions with endemic occurrence of the Newcastle disease re-vaccination should be realized in four-week intervals and the first vaccination shall be carried out oculonasally or by spraying; before egg-laying the inactivated vaccine against Newcastle disease and avian infectious bronchitis should be applied.
ADVICE ON CORRECT ADMINISTRATION
Content of antiseptics and disinfectants,presence of chlorine and iron in the waterused for vaccine dissolving affects the vaccination virus negatively and has adverse impact on vaccine efficiency. Virus activitycan be potentiated by adding the skimmed cow's milk – 50 ml and/or powdered milk –2g/lt of the vaccination solution.The technical device specified for vaccine application, incl.the watering place must be kept clean, free from any detergent and disinfectant residues.
Special precautions for use in animals
Only healthy animals should be vaccinated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid exposure to virus during vaccinationand use safety goggles and a mask during spray application. Wash and disinfect your hands after the 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.
11.SPECIALSTORAGE PRECAUTIONS
Keep out of the reach and sight of children.Store in a refrigerator (2 °C – 8 °C).
Shelf-life of the veterinary medicinal productin the intact container: 2 years
Shelf-life after first opening:consume immediately
Shelf-life after dilution: within 3 hours
12.SPECIALWARNING(S)
Use usual aseptic measures duringall procedures related to the product administration.

The vaccination virus of avian Newcastle disease, strain Bio 52: NDV B1, and the vaccination virus of avian infectious bronchitis,strain Bio 53: IBV H120, reproduce and proliferate in the organism of vaccinated chickens after application. Several daysafter vaccination, the vaccination viruses are excreted into the environment to a limited extent, where they can attack other sensitive animals.The safety studies proved that the vaccination viruses are safe to target animals and passaging on the target animal does not increase their virulence or produce clinical symptoms of disease.Therefore, it is not necessary to take any special veterinary and animal husbandry actions in respect of the vaccination.
No information is available on the compatibility of this vaccine with any other.Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated”.
Do not mix with any other vaccine /immunological product.
13.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 thecompetent authorities.
DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
17/1/2021
15.OTHER INFORMATION
The vaccine is supplied in glass vials type I complying with Ph.Eur., closed with a rubber bung for lyophilization and sealed witha aluminium cap.
Package:
200 doses, 500 doses, 1000 doses,
2500 doses, 5000 doses
10 × 200 doses, 10 × 500 doses,
10 × 1000 doses, 10 × 2500 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.