Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Live, modified, freeze dried vaccine. Each dose contains at least 104 CCID50 attenuated IBD virus, strain S706. Contains traces of kanamycin and pimafucin.

Uses

The active immunisation of chickens against Infectious Bursal (Gumboro) Disease.

Dosage and administration

The vaccine should be re-constituted in the drinking water immediately before use. All the water to come into contact with the vaccine should be treated with skimmed milk powder at a rate of 2g per litre or 10g per gallon at least 20 minutes prior to adding the vaccine.

The choice of vaccination schedule employed should be determined at the discretion of a veterinary surgeon taking into account the historical vaccination programme employed, level of IBD field challenge on the farm and level of maternally derived antibody in the birds to be vaccinated.

The recommended vaccination schedules are :

Three doses :

At one day of age in the hatchery, one dose administered to each bird by coarse spray.

At 9-12 days of age, one dose administered to each bird via the drinking water.

At 17-25 days of age, one dose administered to each bird via the drinking water.

Two doses:

At 0-14 days of age, one dose administered to each bird by coarse spray at day old, otherwise via the drinking water.

At 14-28 days of age, one dose administered to each bird via the drinking water.

ADMINISTRATION BY SPRAY

Day old chicks may be dosed by coarse spray, in their chick boxes in the hatchery. The vaccine should be reconstituted in fresh distilled or demineralised water. Application can be best carried out in an automatic cabinet, as for Infectious Bronchitis vaccine. The spray nozzle should be adjusted for a coarse spray with separate droplets which can be checked by spraying into an empty chick box. Droplets fall mainly on the head and shoulders, and bright light will facilitate rapid intake by birds preening each other. Where an automatic cabinet is not available, a garden type spray, producing large droplets, may be used.

ADMINISTRATION IN DRINKING WATER

The vaccine should be administered to the birds in the drinking water over a 1-2 hour period.

The volume of water required should be calculated and treated with skimmed milk powder at a rate of 2g per litre or 10g per gallon at least 20 minutes prior to re-constituting the vaccine.

The required number of doses should be re-constituted in a small volume of water which has been treated with the milk powder in a clean, disinfectant free plastic bucket.

Once re-constituted, add the vaccine to the drinking water volume previously calculated and mix thoroughly.

Drinker lines should be primed with vaccinated water prior to allowing the birds access to the drinkers.

Birds may be deprived of water for up to one and a half hours prior to vaccination, if necessary, in order to encourage drinking. Activating feeding systems during vaccination will also encourage drinking.

Contra-indications, warnings, etc

For animal treatment only.

Do not vaccinate unhealthy birds. The usual aseptic precautions should be applied to all administration procedures. Reconstitution should be in plastic, not metal containers. Only sterile antiseptic-free materials should be used for the preparation of vaccine solution. The freeze-dried vaccine must not be reconstituted with water containing antiseptic or disinfectant.

The vaccine can be administered concurrently with infectious bronchitis and Newcastle Disease vaccines, but should not be administered within 14 days of other live vaccines.

Laboratory studies have shown that when the vaccine virus was experimentally passed from bird to bird, damage to the bursa increased. This was detected by histological examination of the bursae. However, a test which measured results of the ability of the bird to produce antibodies suggested that their immunological ability was not impaired.

In the field, it is probable that some spread of the virus from bird to bird will take place, and this can assist flock immunisation.

During spray administration, to avoid hay fever like reactions, operators should not inhale the vaccine. This can be achieved by the use of a close fitting face mask, of the Siebe Gorman type, BS2091.

Care should be taken during reconstitution of the vaccine and drinking water application. Hands should be washed and disinfected after vaccinating.

Withdrawal period

Nil.

Pharmaceutical precautions

Keep out of reach of children.

Protect from light.

Store between +2°C and + 8°C. Use reconstituted vaccine immediately. Do not freeze.

Empty bottles and unused contents should be decontaminated by heating or immersion in approved disinfectant before disposal.

Legal category

POM-V

Packaging Quantities

Glass vials containing 1000 and 2500 doses.

Further information

Nil.

Marketing authorisation number

Vm 08327/4192.