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Poulvac TRT/SHS, Lyophilisate for solution for oculonasal use and spray application for Turkeys

Description

Active substances:Per 1 ml dose
Turkey rhinotracheitis virus, strain clone K 103.2 - 104.5 CCID50

*CCID50 = Cell Culture Infectious Dose

INDICATIONS

For active immunisation of turkeys to reduce clinical signs associated with infection with TRT.
Immunity to challenge has been demonstrated 3 weeks after vaccination and has been shown to persist for 14 weeks.

CONTRAINDICATIONS

Do not vaccinate unhealthy birds.

ADVERSE REACTIONS

Turkeys may display mild TRT like symptoms (i.e. nasal exudate) from day 7 to 8 post vaccination. In field trials occasional reactions of a transient nature lasting 1-2 days were seen between day 10 and 21 days post vaccination.

TARGET SPECIES

Broiler turkeys from one day of age.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

One dose per bird to be administered by spray, eye drop or nose drop. Only disinfectant-free and/or antiseptic free materials should be used for the preparation of vaccine solution.
Spray
The vaccine should be reconstituted with water of good quality at room temperature, e.g. deionised water or good quality drinking water. Treat water with milk powder if necessary but ensure there are no particles which may block the spray nozzle.
Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should be removed whilst the vial is immersed in a clean plastic measuring jug containing 0.2-0.5 litre of water (as noted below for sprayer types). Half fill the vial with water, replace the stopper and shake to dissolve any remaining vaccine. Pour into the jug and stir carefully to ensure even dispersal of the vaccine. The vaccine should then be added to the sprayer.
The quantity of water depends on the method of administration:

Hand spray: 0.2 L/1,000 birds
Knapsack spray: 0.5 L/1,000 birds, if the birds are housed on the ground.
0.25 L/1,000 birds, if the birds are housed in a battery.
Automatic spray equipment: 0.15-0.50 L/1,000 birds (hatchery)
If administered by spray, spray equipment, providing a droplet size of 0.12 - 0.15 mm has to be used (hand spray, knapsack spray, automatic spray equipment). The distance from the spraying head to the birds must be approximately 50 cm. Hold birds in boxes for approximately 30-45 minutes. Ensure the temperature of the holding area is 70-80°F and draught free, to avoid chilling.
Spray application is only to be carried out in housings which can be closed properly. Turn off ventilation fans, if any, avoid air movement.
Eye drop/nose drop
30-50 ml/1000 birds, 0.03-0.05 ml/eye or nostril.
Reconstitute vaccine by dissolving in deionised water for eye drop at the rate of 30ml to 1,000 doses. The deionised water should be at room temperature. Remove the aluminium cap and rubber stopper from the vaccine vial and add deionised water from 30ml to half fill the vial. Replace the rubber stopper and shake so that all the vaccine material is completely dissolved. Pour the vaccine concentrate into the rest of the 30ml and mix well.
Administer by dropper at the rate of one drop (0.03ml) per bird onto one eye. The use of standardised droppers is recommended. Hold the bird so that one eye is pointing upwards and allow one drop of vaccine to fall into the eye. Birds should swallow during vaccination.

WITHDRAWAL PERIOD

Zero days

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 20 months.
Reconstituted vaccine should be used immediately.

SPECIAL STORAGE PRECAUTIONS

Store and transport refrigerated (2oC - 8oC).
Protect from light.
Do not freeze.

SPECIAL WARNINGS

In order to prevent risks of dissemination of the vaccine in the site, all the birds at the same site should be correctly vaccinated.
Do not vaccinate in mixed breeding farms where broiler turkeys and other avian species, except chickens, are raised. The virus contained in the vaccine was shown to spread for approximately 10 days. This spreading appeared to be without any consequence for broiler chickens.
There is a possibility that the virus may be disseminated to other avian species and care should be taken to avoid contact with other birds.
Do not vaccinate turkeys in lay
No information is available for the concurrent use of this vaccine with other products and it is therefore recommended that no other vaccine should be administered within 14 days post vaccination.
Special precautions for use in animals
The use of the vaccine in turkeys older than 10 days does not induce sufficient protection due to the resistance against TRT increasing with age.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
If the vaccine is administered by spray, the eyes must be protected by safety goggles and the nose and mouth by a dust mask. A helmet with filtered air circulation may be used instead of goggles and a mask.
Dispose of waste material by boiling, incineration or immersion in appropriate disinfectant in accordance with national requirements.

OTHER INFORMATION

ATCVet Code:QI01AD09
Nature and composition of immediate packaging
Vial:
Type I glass vial containing freeze dried pellet of 1,000, 2,000 or 5,000 doses
Closure:
Siliconised Type I rubber secured with an aluminium cap.
Pack sizes:
Cardboard boxes containing 10 vials of 1,000 doses
Cardboard boxes containing 10 vials of 2,000 doses
Cardboard boxes containing 10 vials of 5,000 doses
Not all pack sizes may me marketed.

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