A freeze dried vaccine of attenuated live Turkey Rhinotracheitis (TRT) virus, strain Clone K, 103.2 to 104.5 *CCID50 per dose.

CCID = Cell Culture Infectious Dose 50%

For active immunisation of turkeys to reduce clinical signs associated with infection with TRT.

Onset of immunity: Immunity to challenge has been demonstrated 3 weeks after vaccination.

Duration of immunity: 14 weeks.

One dose per bird from 1 day of age 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.

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:

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.

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.

Vaccinate healthy animals only.

Do not use in turkeys in lay.

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.

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

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

The frequency of adverse reactions is defined using the following convention:

Administration of a 10 fold overdose does not result in significantly worse adverse reactions to those seen after administration of a single dose.

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.

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 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 consequences for 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.

Zero days

If the vaccine is administered by spray, personal protective equipment consisting of safety goggles and dust mask or a helmet with filtered air circulation should be worn.

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

Shelf life after dilution or reconstitution according to directions: 4 hours.

Keep out of the sight and reach of children.

For animal treatment only.

Cardboard boxes containing 1 vial of 1000 doses

Cardboard boxes containing 1 vial of 2000 doses

Cardboard boxes containing 1 vial of 5000 doses

Cardboard boxes containing 10 vials of 1000 doses

Cardboard boxes containing 10 vials of 2000 doses

Cardboard boxes containing 10 vials of 5000 doses

Not all pack sizes may be marketed.

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

Vm 42058/4113