SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

PoulvacBursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances per dose:

Infectious bursal Disease virus strain Lukert: 10^4.3– 10^5.5TCID₅₀

Excipients:

For a full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension.

Brown to reddish brown lyophilisate.

Upon reconstitution, light peach to a tan-brownish suspension depending on volume of water added.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (broilers and future layers/breeders).

4.2 Indications for use, specifying the target species

For the active immunization of broilers, and future layers/breeders to reduce clinical signs caused by Infectious Bursal Disease virus.

4.3 Contraindications

Do not vaccinate unhealthy birds.

4.4 Special warnings for each target species

Maternally-derived antibodies (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 Infectious Bursal Disease 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 Infectious Bursal Disease control programme involving hygiene, biosecurity, management, stocking density and disinfection, etc. Overwhelming levels of field virus may overcome vaccinal immunity.

The virus of the vaccine will spread to unvaccinated birds.

4.5 Special precautions for use

Special precautions for use in animals

It is recommended to vaccinate all chickens on a site at the same time.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

4.6 Adverse reactions (frequency and seriousness)

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

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

4.7 Use during pregnancy, lactation or lay

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

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except for the concurrent use with Poulvac IB H120 administered to broilers at 1 day of age. A decision to use this vaccine before or after any other veterinary medicinal product, besides Poulvac IB H120, therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

Vaccination schedule:

Future layers/breeders:

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:

Administer via spray or drinking water.

One dose to chickens from 1 day of age.

Depending on the level of field virus present, repeat administration of the vaccine may be required at 7 to 10 days after the first vaccination. If not vaccinated at day old, it is recommended to determine the date of first vaccination according to the level of maternally derived antibodies (MDAs).Nipple-drinking systems are not an appropriate method of vaccine delivery for 1-3 day old chicks.

Reconstitution of vaccine:

Fill a container with an appropriate amount of preferably cold, fresh, non-chlorinated water that is free from metal-ions. Chlorine at levels as low as 1 ppm is known to have a detrimental effect on vaccine virus stability, therefore it’s recommended for drinking water application to add low-fat skimmed milk powder (i.e. < 1% fat, 2–4 grams per litre) or skimmed milk (20–40 ml per litre of water) to the water to prolong the life of the virus in the vaccine suspension. Only skimmed milk should be used, as the fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy. After mixing, the solution should be allowed to stand for 15–30 minutes before adding the vaccine.

Remove the cap of the vaccine vial. Open the vaccine vial under water and dissolve thoroughly in the container. Empty the vaccine vial completely by rinsing the vial and the stopper in the water.

Administer to birds immediately after dilution.

Avoid exposure of the vaccine suspension to sunlight.

Drinking water:

Make sure that all conduit pipes, tubing, troughs, drinkers etc are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc. Contact with disinfectants makes the vaccine ineffective.

Allow water to be consumed so that levels in drinkers are minimal before vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. It may be necessary to withhold water prior to vaccination in order to ensure that all birds drink during the vaccination period. Ideally, vaccine should be administered in the volume of water consumed by the birds in up to 3 hours. The aim is to give every bird one dose of vaccine. As a general rule, apply reconstituted vaccine to chlorine-free 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, e.g. 10 litres would be needed for 1,000 10-day old chickens. If in doubt, measure water intake the day before administering vaccine.

Coarse Spray:

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

Use clean vaccination materials only. No disinfectants or other substances impairing the performance of the live vaccine should be used in the sprayer.

Dilute and administer the reconstituted vaccine at a rate of one dose of reconstituted vaccine per bird, according to the directions of your specific coarse spray vaccination equipment. The recommended volume for 1 dose is between 0.1 and 0.5 ml. The spraying distance should be between 30 and 80 cm above the animals in order to ensure an even distribution and the recommended droplet size is greater than 100 µm.

Turn off ventilation during vaccination.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No reactions other than those reported following a single dose are expected after an overdose.

4.11 Withdrawal period(s)

Zero days

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against Infectious Bursal Disease virus (Gumboro Disease).

The vaccine contains the live intermediate IBDV strain Lukert.

ATCvet code: QI01AD09 Pharmacotherapeutic group: Live viral vaccines

Environmental properties

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pharmatone

Bacto-peptone

Sucrose

N-Z Amine type YT

Glutamic Acid Sodium Salt

6.2 Incompatibilities

Do not mix with any other vaccine or immunological product.

6.3 Shelf life

Shelf-life as packaged for sale: 27 months

Shelf-life after reconstitution: 4 hours

6.4. Special precautions for storage

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

Protect from light.

6.5 Nature and composition of immediate packaging

Nature: Hydrolytic Type I glass (Ph. Eur.) vial

Closure: Type I butyl rubber (Ph. Eur.) stoppers.

Pack sizes: 10 x 1000, 2500, 5000 and 10,000 doses.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4099

9. DATE OF FIRST AUTHORISATION

21 March 1994

10. DATE OF REVISION OF THE TEXT

15 October 2015

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 15/10/2015