SUMMARY OF PRODUCT CHARACTERISTICS

Poulvac TRT Vaccine

Qualitative composition

Attenuated turkey rhinotracheitis virus, strain clone K vaccine for veterinary use.

Quantitative composition

Active Ingredients Per 1ml dose

Turkey rhinotracheitis virus, strain clone K 10^3.2*CCID₅₀to 10^4.5CCID₅₀

*CCID₅₀= Cell Culture Infectious Dose

Excipients

For a full list of excipients, see section 6.1

Lyophilisate for solution for oculonasal use and spray application.

4.1 Target Species

Broiler turkeys, one day of age.

4.2 Indications for use specifying the target species

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.

4.3 Contraindications

Do not vaccinate unhealthy turkeys.

4.4 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.

4.5 Special precautions for use

i.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.

ii.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.

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation or lay

Do not vaccinate turkeys in lay

.

4.8 Interactions with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

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 30 ml 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 30 ml 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 30 ml and mix well.

Administer by dropper at the rate of one drop (0.03 ml) 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Administration of an overdose does not result in significantly worse adverse reactions to those seen after administration of a single dose.

4.11 Withdrawal period

Zero days.

To stimulate active immunity against TRT virus.

ATC Vet Code: QI01CD01

6.1 List of excipients

Mannitol

NZ Case Plus

Gelatin

Inositol

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except diluents or other component recommended for use with the veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as package for sale:
20 months

Shelf-life after reconstitution according to directions: use immediately.

6.4 Special precautions for storage

Store and transport refrigerated (2°C - 8°C).

Keep the container in the outer carton.
Protect from light.
Do not freeze.

6.5 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 be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm42058/4113

Date:05 November 1997

Date:October 2013

Approved:25/10/2013