Summary of product Characteristics

Vanguard Rabies

	Quantity/Dose
Active Constituents: Rabies Virus (Strain Flury LEP) (Inactivated, concentrated and purified rabies virus antigen * Based on Ph. Eur. serology test)	≥ 3.25 IU/ml of Rabies glycoprotein inducing ≥ 1.4 log10 IU/ml*
Adjuvant: Aluminium Hydroxide	1.7-2.1 mg

For full list of excipients, see section 6.1

Vanguard Rabies vaccine is a sterile opaque suspension for subcutaneous injection, with an off-white precipitate which readily resuspends on shaking.

Cats, dogs.

For the active immunisation of cats and dogs to prevent infection and mortality due to rabies.

An antibody response normally develops within 7-14 days after vaccination. Vaccinated animals should not be exposed to the risk of rabies infection for 14 days. The specific immune response confers immunity for up to 3 years.

Do not use in unhealthy animals.

Do not use in pregnant animals.

None.

Do not vaccinate animals for at least one month following the administration of immuno-suppressive drugs.

No special precautions apply.

As with all vaccines, occasional hypersensitivity may occur. In such cases, appropriate treatment, such as adrenalin, should be administered without delay.

In dogs, treatment with the vaccine produces oedematous swelling of up to 3.8 cm maximum diameter (5.4 cm³max. volume) at the site of injection. This swelling resolves with time and disappears by 21 days after treatment.

Treatment of cats with the vaccine produces a swelling of about 2-3 cm in diameter and raised by about 0.1 cm. at the site of injection. This swelling resolves with time and disappears by 24 hours after treatment. In some animals a fibrous nodule of 3 - 8 mm in diameter may develop at the site of injection 14 to 21 days after treatment. These nodules should resolve uneventfully over a period of 14 to 35days.

Do not use in pregnant animals

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Cats and dogs: 1 mL by subcutaneous injection.

VaccinationRegime:

1 mL dose.

Cats and dogs may be vaccinated from 3 months of age and should be re-vaccinated every three years

Cats: Treatment with a double dose of vaccine produces no systemic reaction. At the site of injection a swelling of about 2 - 3 cm in diameter and raised by about 0.2 cm occurs soon after treatment. This swelling disappears by 3 days after treatment. About 7 -21 days after treatment fibrous nodules may develop at the site of injection. These nodules should resolve uneventfully after a maximum of 35daysfollowing their appearance.

Dogs: Treatment with a double dose of vaccine produces no systemic reaction. At the site of injection oedematous swelling of up to 4.5 cm maximum diameter (9 cm³max. volume) occurs soon after treatment. This swelling disappears by 28 days after treatment.

Not applicable.

To stimulate active immunity against rabies.

ATCVet code:QI07AA02

Aluminium hydroxide

Neomycin sulphate

Do not mix with any other vaccine/immunological product.

Shelf life of the veterinary medicinal product as package for sale: 3 years

Shelf life after first opening the immediate packaging: use immediately

Store between +2° - +8°C.

Protect from light.

Do not freeze.

Single dose presentation (1mL) in a glass vial with bromobutyl rubber stopper and aluminium crimp seal. Printed cartons of 1 x 1 mL vial and 10 x 1 mL vials.

Not all pack sizes may be marketed.

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

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm42058/4162

Date:23 May 2000

Date: October 2015

Final information

In any animal population, there may be a number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon the correct storage and administration of the vaccine together with the animal’s ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, the presence of maternally derived antibodies, nutritional status, concurrent drug therapy and stress.

Pet Travel Scheme (PETS)

Animals intended for vaccination under the Pet Travel Scheme (PETS) must be identified by a permanently numbered microchip. This microchip number must be recorded on the record of dog and cat vaccination at the time of rabies vaccination.

Approved: 02 September 2015