Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A freeze dried vaccine of attenuated live Turkey Rhinotracheitis virus, strain Clone K. Not less than 103.2 CCID50, not more than 104.5 CCID50 per dose. There is a trace of gentamicin.

Uses

For active immunisation of healthy susceptible, immune competent turkeys to reduce clinical signs associated with infection with Turkey Rhinotracheitis. Immunity to challenge has been demonstrated 3 weeks after vaccination and has been shown to persist for 14 weeks.

Dosage and administration

For administration to turkeys by eye drop or by coarse spray at one day of age. Only disinfectant-free and/or antiseptic free materials should be used for the preparation of vaccine solution.

Eye drop /nose drop

30 ml/1000 birds, 0.03ml/eye or nostril

Reconstitute vaccine by dissolving in deionised water for eye drop at the rate of 30 mls 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 30mls to half fill the vial. Replace the rubber stopper and shake so that all the vaccine material is completely dissolved. Pour the vaccine concentrated into the rest of the 30mls 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.

Coarse 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/1000 birds
Knapsack spray:	0.5 L/1000 birds, if the birds are housed on the ground
	0.25 L/1000 birds, if the birds are housed in a battery
Automatic spray equipment:	0.15-0.50 L/1000 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.

Contra-indications, warnings, etc

Do not vaccinate turkeys in lay. Do not use in unhealthy turkeys.

No information is available on 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.

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 10days. This spreading appeared to be without any consequences 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.

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.

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.

Use the reconstituted vaccine immediately.

Wash and disinfect hands after use.

If the vaccine is administered by spray, the eyes must be protected by safety goggles and the nose and mouth by dust mask. A helmet with filtered air circulation may be used instead of goggles and a mask.

Destroy the empty vials and all unused vaccine by burning or chemical disinfectant.

Withdrawal period – Zero days

Pharmaceutical precautions

Store at between +2°C to +8°C in the dark and use before expiry date printed on the pack.

Keep out of the reach of children. For animal treatment only.

Legal category

POM-V

Packaging Quantities

10 vials of 1000 or 2000 doses.

Further information

In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal's ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc.

Recent field infection or vaccination of the parent flock can stimulate a high antibody titre and consequently a high level of maternally derived antibody (MDA). Such MDA can interfere with the development of active immunity.

The severity of clinical disease depends upon management, age at infection, ventilation, hygiene, stocking density and the nature of secondary infection present in the flock. Overwhelming or variant challenge may overcome vaccinal immunity for example on multi-age sites.

Immunosuppressive agents such as haemorrhagic enteritis virus in turkeys may also lead to an increased severity of disease.

The content of a maximum 75 nanograms of gentamicin per dose is considered to be a negligible quantity, detectable in the vaccine directly, but not in the bird. It must be remembered that under normal conditions antibiotic may be found as a result of fungal growth on dust in the atmosphere of the average room.

For further information on application, please consult Fort Dodge Animal Health Ltd., Southampton.

Marketing authorisation number

Vm 01596/4213.