SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AviPro_® PRECISE

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

1 dose contains min. 10³ and max 10 ^4,5 EID₅₀ * live IBD (Infectious Bursal Disease)-Virus, strain LC 75.

Host system: embryonated SPF-eggs

* EID₅₀= 50% egg-infectious dose: the virus titre required to cause infection in 50% of the inoculated embryos

Excipient(s):

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension

Appearance: rose to red brown pellet

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (from 7 days old)

4.2 Indications for use, specifying the target species

For active immunisation of susceptible chickens against Infectious Bursal Disease (IBD/Gumboro).

The vaccine reduces clinical signs of IBD and severe bursal lesions.

Onset of immunity: 14 days

Duration of immunity demonstrated by challenge 28 days, antibodies may last up to 15 weeks.

4.3 Contraindications

Do not vaccinate unhealthy birds

4.4 Special warnings <for each target species>

None

4.5 Special precautions for use

The vaccine may spread to unvaccinated chickens, since it is excreted via the faeces for at least 9 days. Avoid spreading to laying hens.

To reduce infection pressure before the onset of immunity, litter should be removed and chicken housing cleaned between rearing cycles.

Ensure that the drinking water is cold, clean, and free from detergents and disinfectants to ensure the viability of the vaccine.

Live attenuated viral vaccine, do not spray or spill.Wash and disinfect hands and equipment after vaccinating.

On day 7 post vaccination moderate generalised lymphocyte depletion is seen in the majority of birds. Lymphocyte repopulation occurs after day 7 post vaccination and by day 28 post vaccination only mild necrosis remains in some birds.

4.7 Use during lay

Not to be used for birds in lay.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before of after vaccination with the product.

4.9 Amounts to be administered and administration route

One dose (min. 10³ EID₅₀) should be administered per animal by drinking water from the age of 7 days onwards.

The determination of the vaccination date is dependant on a number of factors including status of maternal antibodies, type of bird, infection pressure, housing and management conditions.

Maternally derived antibodies (MDA) potentially interfere with the take of live IBD vaccines. The optimum age for vaccination therefore depends on both, the level of MDA against IBD in the flock and the capability of the vaccine to take in face of these MDA (“break-through-titre”). A high homogenicity of the flock MDA levels is important to define the timing of vaccination and guarantees the better take of the vaccine. To predict the age, when MDA have sufficiently decreased to allow effective vaccination it is advised, to test serum samples of at least 24 chicks by serology and apply the “Deventer Formula” for intermediate vaccines. For chicks from fully vaccinated or field virus infected breeders this may be at 14 days or more. Serologically negative birds may be vaccinated from day 7.

A further vaccination 7 days after the first may be necessary particularly in flocks where antibody levels vary widely between birds (i.e. CV greater than 30%), or stock originates from different sources.

Broilers: