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Poulvac Bursa Plus, Oral solution following reconstitution of the freeze-dried vaccine in water, for chickens

Name of the product in other countries:
Poulvac Bursa (DK)
Poulvac Bursa Plus vakcina A.U.V. (HU)

1 M. Nishizawa et al., Evaluation of anatomopathological, serological, immunological responses and protection in broilers vaccinated with live infectious bursal disease vaccines. Arq. Inst. Biol., São Paulo, v.74, n.3, p.219-226, jul.set., 2007

Description

Lyophilisate for suspension in drinking water.
Appearance: brownish tablets.

Active IngredientsPer dose
Live infectious Bursal Disease Virus, strain V877
* 50% egg infective dose		102.2 – 103.4EID50

INDICATIONS

For the active immunisation of chickens with maternal antibody levels of ≤ 500 ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
The onset of immunity has been shown by challenge from 14 days after vaccination and the duration of immunity is 32 days.

CONTRAINDICATIONS

Do not vaccinate sick birds.
Do not use in infected flocks showing clinical signs.

ADVERSE REACTIONS

The administration of a single dose to 10-day old chickens causes lymphocyte depletion in the bursa of Fabricius (in 75-100% of the follicles). Lymphocyte repopulation is observed from 21 days post vaccination onwards. At 28 days post vaccination there is still depletion remaining (25-75 % of follicles). As a consequence vaccination with Poulvac Bursa Plus may induce immunosuppression.
After administration of a 10x overdose, no other adverse reactions are observed..

TARGET SPECIES

Chickens from 10 days of age.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

One dose per chicken to be administered with drinking water from10 days of age.
Make sure that all conduit pipes, tubing, troughs, drinkers etc are thoroughly clean and free of any trace of disinfectants, detergents, soap, etc.
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 maybe 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.
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 (low-fat skimmed milk powder, < 1% fat, 2-4 grams per litre) or skimmed milk (1 litre per 40 litres of water) is recommended where this is not possible to increase the stability of the virus.
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 container and stir well before mixing with more water in a 10-litre container 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, e.g. 10 litres would be needed for 1,000 10-day old chickens.
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.
Administer the dissolved vaccine to birds immediately after dilution.
Avoid exposure of the vaccine suspension to sunlight.
Avoid stress in the birds around vaccination.

WITHDRAWAL PERIOD

Zero days.

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 21 months.
Shelf life after reconstitution according to directions: use within 4 hours.

SPECIAL STORAGE PRECAUTIONS

Store and transport at +2°C to +8°C.
Protect from light.
Do not freeze

SPECIAL WARNINGS

Use only in flocks with maternal antibody levels of ≤ 500 ELISA units. The optimum day of vaccination is calculated according to the Kouwenhoven’s formula (see Special precautions for use in animals).
Due to its residual pathogenicity to the bursae the vaccine should be used only in case of outbreaks of very virulent IBDV strains.
Special precautions for use in animals
Use carefully as Poulvac Bursa Plus spreads from bird to bird and may also spread to nearby flocks. Reversion to virulence studies conducted at the laboratory level demonstrated that there is no increase in virulence after 5 passages in chickens. However, it is recommended to avoid spreading, especially to laying birds.
The optimum age for vaccination may be determined with the following method:
Determine the ELISA∗ antibody titres against Gumboro Disease in 20 chickens of 1 day of age.
For each result, calculate the square root.
Calculate the average square root for all data (M).
The age for vaccination (J) is calculated with the formula:

*Method valid for data collected with the Idexx FlockChek®: Anti-IBD assay kit.

Whatever the vaccination day calculation reaches, do not vaccinate birds less than 10 days of age.
Do not use in laying or breeding hens.
Interaction with vaccination against Newcastle Disease has been studied. No significant interference in protection against Newcastle Disease virus virulent challenge is observed in birds vaccinated at 10 days of age with Poulvac Bursa Plus and 7 days later with a live Newcastle disease vaccine. However, a statistically lower serological response to Newcastle Disease virus was observed in birds vaccinated with Poulvac Bursa Plus. As a consequence a transient immunodepression following vaccination with Poulvac Bursa Plus cannot be excluded.
No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Special precautions to be taken by the person administering the medicinal product to animals
Wash and disinfect hands and equipment after vaccination.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

OTHER INFORMATION

ATCVet Code:QI01AD09
Nature and composition of immediate packaging
Vial: Type I (Ph. Eur.) glass bottles.
Closure: Type I (Ph. Eur.) butyl rubber stoppers sealed with aluminium overseal.
Pack Sizes:
1 x 1000, 1 x 2000, 1 x 5000, 10 x 1000, 10 x 2000 or 10 x 5000 doses.
Not all pack sizes may be marketed.
A Member State may, in accordance with its national legislation, prohibit the import, possession, sale, supply and/or use of Poulvac Bursa [Plus] on the whole or part of its territory if it is established that the disease to which the product is intended to confer immunity is largely absent from the territory in question.

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