Package Insert

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

PESTIPHARM B1 Live lyophilised vaccine against Newcastle disease of poultry

2. Qualitative and quantitative composition of veterinary medicinal product

One dose of vaccine contains:

Paramyxovirus pseudopestis avium (phyl. Hitchner B1)

(Newcastle disease virus of poultry, strain Hitchner B1) min. 106 EID50, max. 107,0 EID50 *

* infection dose for chicken’s embryos 50%

3. Indications

Active immunisation of chicks against Newcastle disease. Vaccine can be used in chicks from the 1st day of life.

Onset of immunity: 14 days after vaccination

Lasting of immunity: min. 14 days after vaccination

4.TARGET SPECIES

Chicks (from the 1st day of life).

5.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Vaccine is dissoluted in necessary volume of drinking water,which depends on method of application, and is applied at the furthest to two hours by dissolution of lyophilisate.

Water for dissolution of vaccine must be fresh drinking water free of any essences of

disinfects agents,cleaners, chlorides and ions of metals.

a) Individual (intraconjuctival / intranasal) application

The volume of vaccine for vaccination of one animal is 0,1 ml therefore for vaccination of 100 chicks is one vial with volume of 100 vaccinated doses dissolved in 10 ml of drinking water. In the course of intranasal vaccination is to vaccinated chick closed one nasal hole by finger and vaccine is administered to the second nasal hole . Providing intracojuctival way of vaccination is the vaccine administered into intraconjuctival sac.During vaccination acceptance of full vaccination dose by every subject is monitoring.

b) Mass application in feed water

During mass peroral applicationis lyophilised vaccine dissoluted immediately beforeusing in cold fresh drinking water free of any essences of disinfects agents,cleaners,and without chlorides and ions of metals.With purpose to save vaccinated virus defeat milk-powder in volume 0,4%(4grams per one litter of drinking water) is added.. Vaccine is dissoluted in such volume of drinking water, which is consumed by vaccinated poultry throughout 2 till 3 hours and fill the bill approximately 1/7 of daily volume of drinking water.Approximate volume can be dedicated from reference: for vaccination to 1000 subjects of chicks at the age of one day is needful one litter of drinking water, for vaccination to 1000 subjects of chicks at the age of seven days is needful seven litters of drinking water,for vaccination to 1000 subjects of chicks at the age of ten days is needful 10 litters of drinking water, for vaccination to 1000 subjects of chicks at the age of 28 days is needful 28 litters of drinking water and so on..For vaccination to 1000 subjects of animals at the age of 40 and more days ,volume for dissolution of vaccine is minimum 40 litters of drinking water .Feed water is taking off animals approximately at atime of two hours before vaccination .

Drinking water with vaccine is in adequate amount of feeding pump served and is necessary to save it in the face of radiant heat..

c) Mass application by aerosol

Vaccine is dissoluted in drinking water free of any essences of disinfects agents,cleaners, chlorides and ions of metals.

For vaccination to animals at the age of 1 till 28 days is vaccine assigned for 1000 subjects of animals dissolved in 200 ml of water.

For vaccination to older animals is vaccine assigned for 1000 subjects of animals dissolved in 400 ml of water.

During primovaccination is vaccine administered by sprayer created small sprinkles(robust spray) sized amount 30 till 60 μm.

During revaccination vaccine is applied by sprayer created soft spray with sprinkles sized amount 20 till 30 μm.

6. EXPIRY DATE

12 months