NAMEANDADDRESSOF THE MARKETING
AUTHORISATION HOLDERAND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCHRELEASE, IF DIFFERENT
Bioveta, a. s.,Komenského 212,
683 23 Ivanovice na Hané
2.NAME OF THE VETERINARY MEDICINALPRODUCTORNIPRIM lyof. ad us. vet.
Life lyophilized vaccine against Newcastle disease of poultry
3.STATEMENT OF THEACTIVE SUBSTANCE(S)AND OTHER INGREDIENT(S)
One vaccination dose contains:
a)Active substance:Paramyxovirus pseudopestis avium(Hitchner B1)
min. 106,0EID50– max. 107,5EID50
 EID50 – 50% infection dose for chicken embryos
Adjuvant
Nutrimentum pro lyophilisatione
4.INDICATION(S)
Vaccination of chickens one to fourteen days old against Newcastle poultry disease.
Immunity is developed in one week after vaccination and lasts at least five weeks.
5.CONTRAINDICATIONS
It is not recommended to vaccinate poultry that is already ill.
6.ADVERSE REACTIONS
Not known.
If you notice any serious effects or other effects not mentioned in this leaflet,please inform your veterinary surgeon.

7.TARGET SPECIES
Domestic fowl.
DOSAGE FOR EACH SPECIES,
ROUTE(S)AND METHODOFADMINISTRATION
Individual application:
200 vaccine doses are diluted in 10 ml water for injection.Administer onedrop of the diluted vaccine into the conjunctiva sac of individual birds.In the case of one-day-old chickens,apply the vaccine onto the nasal mucosa by dipping the beak into the vaccination solution.
Mass application by spray:
Administer the vaccine dilutedin drinking water by means ofa micro-droplet-making sprayer.1000 vaccine doses are dilutedin 200 to 250 ml water for injection.
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.
ADVICE ON CORRECT ADMINISTRATION
Vaccinate chickens by application ofa “coarse spray” evenly sprayed over equivalent number of poultry from the distance of 30 to 50 cm.Too fine droplets (aerosol fog) cause inhalation of the vaccination virus into the lower airways and, as a consequence,development of a respiratory disease.

10.WITHDRAWALPERIOD
Without withdrawal period.
.SPECIALSTORAGE PRECAUTIONS
Store in a refrigerator (2°C – 8°C).Do not expose the vaccine to the temperatures above 8°C for a long time.
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 B reproduce and proliferate inthe organism of vaccinated chickens after application. Several days after vaccination, the vaccination virusesare excreted into the environment toa limited extent, where they can attack other sensitive animals.The safety studies proved that the vaccination viruses are safe to target animalsand 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 withany other.Therefore the safety and efficacy of this product when usedwith any other (either when used onthe 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 approvedfor use by the competent authorities.

DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
15.3.2018
15.OTHER INFORMATION
3 ml and 9 ml vials of type I hydrolytic glass containing 200, 500, 1000, 2500,5000 doses of freezedried vaccine.The vial is closed with a rubber bungfor lyophilizuation and sealed witha aluminium cap.
Vaccine is packaged in plasticor cardboard box:
Individual packaging:
1 × 200 doses, 1 × 500 doses,
1 × 1000 doses, 1 × 2500 doses,
1 × 5000 dosesGroup packaging:
10 × 200 doses, 10 × 500 doses,
10 × 1000 doses, 10 × 2500 doses,
10 × 5000 doses
Approved “Package insert” is enclosed to each packet.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Imported by:
Biovet Egypt, Mansura city,Slaughterhouse district ofAl Wahda street, Neighborhood trees - Nasreddine St. No.5, Egypt 20