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 low attenuation live infectious bursal disease virus 102.2- 103.7EID50 per dose. Oral solution following reconstitution of the freeze-dried vaccine in water. Nystatin and Neomycin or gentamicin at trace levels.

Uses

For vaccination of healthy, susceptible, immune competent chickens against infectious bursal disease.

Dosage and administration

For administration to broiler chickens via the drinking water from two weeks of age when maternal antibody levels have declined to a low level.

Drinking Water

1. Make sure that all conduit pipes, tubing, troughs, drinkers etc are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc.

2. Allow water to be consumed so that levels in drinkers are minimal before vaccine is applied. If water is still present, drain lines before applying vaccine. Apply vaccine over up to 3 hours, ensuring that all birds drink during this time. Birds drinking behaviour varies. It may be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period. The aim is to give every bird one dose of vaccine.

3. Water used for drinking water administration of a live virus vaccine must be non-chlorinated and contain as few as possible metal ions. This can be achieved by allowing mains water to stand for 12 hours or by use of deionised water. The addition of milk powder is recommended where this is not possible.

4. Open the vaccine ampoule under water and dissolve thoroughly. As the concentrated vaccine is slightly viscous, care should be taken to empty the ampoule and its top completely by rinsing them in water. Then thoroughly dissolve in a 1 litre jug and stir well before mixing with more water in a two gallon bucket before application. Vaccine must be stirred thoroughly for several minutes at each stage. Do not split large vials to vaccinate more than 1 house or drinking system, as this leads to mixing errors. Apply diluted vaccine to cold and fresh water at the rate of 1,000 doses of the vaccine to 1 litre of water per day of age for 1,000 chickens, eg 10 litres would be needed for 1,000 10 day old chickens.

Low-fat skimmed milk powder (ie <1% fat) may be added to the water (2-4 grams per litre) or skimmed milk (1 pint per 5 gallons of water) to increase the stability of the virus.

All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. Ideally vaccine should be administered in the volume of water consumed by the birds in up to 3 hours. If in doubt, measure water intake the day before administering vaccine.

5. Administer the dissolved vaccine to birds immediately after dilution.

6. Avoid exposure of the vaccine suspension to sunlight.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Poulvac Bursa Plus is an invasive vaccine indicated for the control of very virulent gumboro disease. Poulvac Bursa Plus persistently damages the bursa of inoculated birds. Immunosuppression results from bursal damage. Use carefully as Poulvac Bursa Plus spreads from bird to bird and may also spread to nearby flocks.

Avoid stress before, during and after vaccination.

Only healthy birds should be vaccinated.

Do not vaccinate birds under 2 weeks of age.

Administer the dissolved vaccine to birds immediately after dilution.

Poulvac Bursa Plus vaccine should be administered with care. It is recommended that where possible, vaccine is applied directly to drinkers, so that vaccine virus is not subject to temperature variation, inhibition, or delay in reaching birds.

Do not allow vaccine to come into contact with disinfectant.

The vaccine should not be administered within 14 days before or after any other vaccine as Poulvac Bursa Plus has been shown to be immunosuppressive.

Wash and disinfect hands after use.

Duration of immunity has been studied up to 32 days post vaccination.

Response to vaccine is optimal in birds with no or low maternal antibody.

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

Keep the vaccine and the materials used for vaccination out of the reach of children.

Withdrawal period – Zero days.

For use on sites where infectious bursal disease cannot be controlled by the correct use of Bursine 2 as part of a general control programme.

Pharmaceutical precautions

Store and transport refrigerated (2°C to 8°C). Use before the expiry date printed on the pack.

Keep out of the reach of children.

Legal category

POM-V

Packaging Quantities

Single vials of 1,000, 2,000 and 5,000 doses respectively.

Further information

Poulvac Bursa Plus is a less attenuated vaccine for use on sites where challenge is severe. 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 timing of vaccination should be altered in such cases. Determination of gumboro Elisa antibody levels in day old chicks can be made. This allows prediction of the age when maternal antibody levels are sufficiently low to allow effective vaccination and can be made using the "Kouenhoven'' formula (maximum MDA titre 1:500 ELISA units at 14 days by iddex Flockcheck™ Anti-IBD assay kit). Additional information on application and disease control is available from Fort Dodge Animal Health.

Only use as part of a complete gumboro control programme involving hygiene, biosecurity, management, stocking density and disinfection, etc. Overwhelming levels of field virus may overcome vaccinal immunity.

Consult your veterinary surgeon for specific advice on how to vaccinate your birds.

Marketing authorisation number

Vm 01596/4230.