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Date: Saturday, May 18, 2024 14:02

Release 3.107
Poulvac Bursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For poultry
Active ingredient: Vaccine Antigens
Product:Poulvac® Bursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens
Product index: Poulvac Bursine 2
Poultry - meat: Zero days
Poultry - eggs: Zero days
Incorporating:
Presentation
Infectious Bursal Disease virus strain Lukert ≥104.3 TCID50* per dose.
*TCID50 = 50% tissue culture infective dose
Uses
For the active immunisation of broilers and future layers/breeders to reduce clinical signs caused by Infectious Bursal Disease virus.
Dosage and administration
Coarse spray or in drinking water use.
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
Upon reconstitution, light peach to a tan-brownish suspension depending on volume of water added.
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 only contain vaccine water. 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. 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.
Contra-indications, warnings, etc
Vaccinate healthy animals only.
Do not use in birds in lay and within 4 weeks before the start of the laying period.
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 one-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.
Do not mix with any other veterinary medicinal product.
Adverse Reactions
Local and/or general reactions after administration of the vaccine can be observed very rarely. 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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects, even those not already listed above or you think that the medicine has not worked, please inform your veterinary surgeon.
Special warnings
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 vaccine virus can spread to in contact birds.
Care should be taken to ensure that the vaccine virus does not spread to unvaccinated birds. It is recommended to vaccinate all chickens on a site at the same time. Cleaning and disinfection of the premises is advisable between flocks.
Withdrawal period
Zero days.
User warning
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. It is recommended to wash and disinfect hands and equipment after vaccinating.
Pharmaceutical precautions
Store and transport refrigerated (2°C to 8°C).
Protect from light.
Shelf-life after reconstitution according to directions: 4 hours.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Pack sizes: 10 x 1000, 2000, 2500, 5000 and 10,000 doses.
Not all pack sizes may be marketed.
Further information
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 42058/4099
Significant changes
GTIN
GTIN description:10 x 1000 dose:
GTIN:08714015011785
GTIN description:10 x 5000 dose:
GTIN:08714015012386
GTIN description:10 x 10000 dose:
GTIN:08714015011808