Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Attenuated turkey rhinotracheitis virus, strain clone K vaccine, 103.2 *TCID50 to 104.5 TCID50 per 1ml dose.

*TCID = Tissue Culture Infectious Dose

Uses

For active immunisation of broiler chickens to reduce clinical signs associated with infection with avian pneumovirus.

Immunity to challenge has been demonstrated 4 weeks after vaccination.

Dosage and 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 birds so that one eye is pointing upwards and allow one drop of vaccine to fall into the eye. Birds should swallow during vaccination.

Contra-indications, warnings, etc

Do not vaccinate unhealthy chickens.

Do not vaccinate chickens in lay.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Poulvac NDW (live Newcastle Disease vaccine), Poulvac IB Primer (live infectious bronchitis vaccine) and Marek vaccines in the Poulvac range at one day of age, with no adverse effects being noted. It is therefore recommended that no other vaccines than these should be administered within 14 days after vaccination with Poulvac SHS.

Do not mix with any other vaccines.

Adverse Reactions:

None

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 chickens are raised with other avian species.

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.

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.

Withdrawal Period: Zero days.

Pharmaceutical precautions

For Animal Treatment Only.

Keep out of the reach and sight of children.

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

Following reconstitution, the vaccine should be used within 2 hours.

Legal category

POM-V

Packaging Quantities

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.

Further information

Disposal:

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Marketing authorisation number

Vm 01596/4214.