SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

POULVAC SHS VACCINE

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Attenuated Avian Pneumovirus, strain clone K: not less than 10^3.2 TCID₅₀, not more than 10^4.5 TCID₅₀per dose.

Excipient(s):

Gentamicin: a trace may be found

Excipients: qs 1 dose

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Freeze-dried powder for solution for oculonasal use and spray application.

4. CLINICAL PARTICULARS

4.1 Target species

Broiler chickens, one day of age.

4.2 Indications for use, specifying the target species

For active immunisation of broiler chickens to reduce clinical signs associated with infection with avian pneumovirus.

Immunity to challenge has been demonstrated 4 weeks after vaccination.

4.3 Contraindications

Do not vaccinate unhealthy birds.

Do not vaccinate laying birds.

4.4 Special warnings

None.

4.5 Special precautions for use

i. Special precautions for use in animals

In order to prevent risks of dissemination of the vaccine in the site, all the birds at the same site should be correctly vaccinated.

There is a possibility that the virus may be disseminated to other avian species and care should be taken to avoid contact with other birds.

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

If the vaccine is administered by spray, the eyes must be protected by safety goggles and the nose and mouth by a dust mask. A helmet with filtered air circulation may be used instead of goggles and a mask.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Do not use in chickens in lay.

4.8 Interaction with other medicinal products and other forms of interaction

Poulvac SHS Vaccine has been used in chickens in conjunction with Newcastle vaccine and Infectious Bronchitis vaccine from the same manufacturer at one day of age, with no adverse effects being noted. No information is available for the concurrent use of this product with other products. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.

4.9 Amounts to be administered and administration route

One dose per bird to be administered by spray, eye drop or nose drop.

Spray

The quantity of water depends on the method of administration:

Hand spray: 0.2 1/1000 birds

Knapsack spray: 0.5 1/1000 birds, if the birds are housed on the ground.

0.25 1/1000 birds, if the birds are housed in a battery.

Automatic spray equipment: 0.15-0.50 1/1000 birds (hatchery)

Eye drop/nose drop: 30-50 ml/1000 birds, 0.03-0.05 ml/eye or nostril.

If administered by spray, spray equipment, providing a droplet size of 0.12 - 0.15 mm has to be used (hand spray, knapsack spray, automatic spray equipment). The distance from the spraying head to the birds must be approximately 50 cm.

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

None.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against avian pneumovirus.

ATCVet Code:QI01CD01

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Gentamicin

D-Mannitol

Inositol

NZ Case Plus

Gelatin

6.2 Incompatibilities

Only disinfectant-free and/or antiseptic free materials should be used for the preparation of vaccine solution.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 20 months

Shelf-life after dilution or reconstitution according to directions: 4 hours

6.4. Special precautions for storage

Store at 2-8°C.

Protect from light.

Do not freeze.

6.5 Nature and composition of immediate packaging

Nature: Type I glass vial 1,000, 2,000 or 5,000 doses

Pack size: 10 x 1,000 / 2,000 or 5,000 doses

Content: Freeze-dried pellet

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

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4112

9. DATE OF FIRST AUTHORISATION

Date:14th January 1998

10. DATE OF REVISION OF THE TEXT

Date:November 2013

06 November 2013