Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Infectious bursal disease virus strain Lukert ≥104.3TCID50 per dose.

Uses

For the vaccination of broilers, rearing birds, future layers and breeding birds to reduce clinical signs caused by Gumboro disease.

Dosage and administration

Future layers: Administer via drinking water.

One dose to chickens at 7 to 28 days of age. A second vaccination should be administered at 7 to 10 days after the first vaccination.

Broilers: Vaccination may be carried out from one day of age by spray or drinking water.

Depending on the level of field virus present, repeat administration of the vaccine may be required. For the use of the vaccine in specific circumstances, consult a Veterinary Surgeon or Fort Dodge Animal Health Technical Staff.

Nipple-drinking systems are not an appropriate method of vaccine delivery for 1-3 day old chicks.

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.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.

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

5.Avoid exposure of the vaccine suspension to sunlight.

6.Water used for drinking water administration of a live virus vaccine must be non-chlorinated and contain as few as possible metal ions.

Coarse Spray

This method is for day old broiler chicks only and may be used in the hatchery or on farm.

NB Ensure that birds are neither overheated nor chilled following coarse spray.

1.Use a suitable sprayer and restrict use for vaccine only. If the Falcon 5S sprayer (5 litre capacity) is used, replace the standard nozzle on this sprayer with a flat fan tip model –Lurmark tip –colour coded pink –reference no. 01F80. A black plastic lance adaptor will also be needed for this nozzle. The Cooper Pegler Knapsack sprayer, model CP3 is already equipped with the plastic lance adaptor, but the Lurmark flat fan tip nozzle should be fitted.

2.Pump sprayer up to 2 atmospheres and do not allow the pressure to drop below 1 atmosphere, when it should be recharged back to 2.

3.Use 1 litre (1,000 ml) of room temperature water per 1,000 chicks, allowing 15–20 seconds per 150 chick box. Spray the sides of the box first from a height of 12–18". Ensure no water spillage by rotating the sprayer end to spray into the box at each turn. The operator may need to stand on a box to correctly spray two chick boxes at the right angle. Hold birds in boxes for approximately 30–45 minutes following vaccination. 500/750 ml has also been used with success. Ensure the temperature of the holding area is 70–80°F and draught free, to avoid chilling.

4.Whilst Poulvac Bursine 2 is very resistant to low levels of chlorine, copper and organic matter etc, it is advisable to use good quality water, eg deionised water. Treat water with milk powder, if necessary, but ensure that there are no particles which may block the spray nozzle.

5.Consult Fort Dodge Animal Health for further advice on the application of Poulvac Bursine 2 to day old broiler chicks in an automated sealed cabinet in the hatchery.

Correct administration:

Use clean vaccination materials.

Avoid exposing the reconstituted vaccine to heat and/or direct sunlight.

Contact with disinfectants makes the vaccine ineffective.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not vaccinate unhealthy birds.

Do not use in birds in lay or within 4 weeks before the onset of the laying period.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other, except Poulvac IB H120, administered to broilers at one-day of age, where this vaccine is authorised. It is therefore recommended that no other vaccine than this should be administered within 7 days before or after vaccination with Poulvac Bursine 2.

Do not mix with any other vaccine or immunological product.

Adverse Reactions:

Occasionally local and/or general reactions after administration of the vaccine can be observed. Reactions are usually transient.

Poulvac Bursine 2 is an invasive vaccine. It produces increasing bursal damage on bird to bird passage and this is accompanied by a degree of immunosuppression.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Special warnings:

The virus of the vaccine will spread to unvaccinated birds.

Maternally-derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly.

Very virulent gumboro virus can breakthrough higher maternal antibody levels than vaccine virus.

Field infection is capable therefore of reaching birds before vaccine has a chance to take. 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.

If spray vaccination is applied, the user must at least protect their eyes with safety goggles and nose and mouth with a dust mask. A helmet with filtered air circulation may be used instead.

Withdrawal period: Zero days.

Pharmaceutical precautions

Store and transport refrigerated (2°C to 8°C).

Keep out of the reach and sight of children.

Protect from light.

Once broached, use contents immediately.

Legal category

POM-V

Packaging Quantities

The lyophilised vaccine is bottled in Type I Borosilicate glass vials with fluted butyl rubber stoppers containing 1000, 2500, 5000 or 10,000 doses.

Pack sizes: 10 x 1000, 2500, 5000 and 10,000 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 01596/4215