Suspension for injection.

The visual appearance is as follows: slightly pink suspension, which might contain fine sediments.

Each 1 ml dose contains:

Inactivated rabies virus, strain SAD Vnukovo-32 > 5 IU*

* IU – international units.

Aluminium hydroxide 2.0 mg.

Thiomersal 0.1 mg.

For the active immunisation of dogs, cats, cattle, pigs, sheep, goats, horses and ferrets (12 weeks of age and older) to prevent infection and mortality caused by rabies virus.

14-21 days after primary vaccination.

Dogs: three years following the primary vaccination course.

Cats, cattle, pigs, sheep, goats, horses and ferrets: one year after primary vaccination, and two years after booster vaccinations.

Shake the vial before use.

Dosage: A single dose of 1 ml is sufficient irrespective of age, weight or animal species.

Dogs: administer by subcutaneous injection.

All other species: administer by subcutaneous or intramuscular injection.

Animals of all target species can be vaccinated from 12 weeks of age. Primary vaccination is with a single dose of vaccine.

Dogs: a single dose of Versiguard Rabies should be given every 3 years. Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged. In case of travelling to risk areas or outside the UK, veterinary surgeons may wish to give additional rabies vaccinations to ensure that the vaccinated dogs have an antibody titre ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).

Cats, cattle, pigs, sheep, goats, horses and ferrets: animals should be revaccinated with one dose of vaccine 1 year after primary vaccination.

After the first booster vaccination (administered 1 year after primary vaccination), animals should be revaccinated every 2 years with one dose of vaccine.

The contents of a single vial of Versican Plus vaccine should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent). Once mixed, the contents of the vial should appear a pink/red or yellowish colour with light opalescence. The mixed vaccines should be injected immediately via the subcutaneous route.

To mix both products, Vanguard vaccines should be reconstituted according to their SPCs. The reconstituted vial will be well shaken and then mixed with 1 ml of Versiguard Rabies either in the Versiguard Rabies vial or the syringe. Versiguard Rabies should be well shaken before use. The mixed vaccines should be gently shaken and then administered immediately by subcutaneous injection.

Vaccinate healthy animals only.

Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus.

Do not use in cases of hypersensitivity to the adjuvant or to any of the excipients.

1Transient, following subcutaneous administration which may reach up to 10 mm in diameter and in rare cases be associated with mild discomfort. Usually resolves within 10 days.

2Appropriate treatment should be administered without delay.

1Mild and associated with injection site swelling.

2Transient.

∙ following intramuscular administration may reach up to 2 cm in diameter and usually resolves within 7 days.

∙ following subcutaneous administration may reach up to 10 mm in diameter and usually resolves within 10 days. In rare cases may be associated with mild discomfort.

3Appropriate treatment should be administered without delay.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.

Safety and efficacy data are available which demonstrate that this vaccine can be administered subcutaneously on the same day as any other vaccine from the Vanguard range (Vanguard 7, Vanguard Plus 7, Vanguard Plus 5, Vanguard Plus 5L, Vanguard Pup, Vanguard Puppy, Vanguard CPV, Vanguard CPV +L, Vanguard DA2Pi, Vanguard DA2Pi+L, Vanguard Lepto ci where approved), either mixed or at different sites. The duration of immunity for the Vanguard range when used with Versiguard R has not been established.

After concurrent or mixed administration of Versiguard Rabies and the Vanguard canine range, vaccinated dogs may have a transient swelling (up to 6 cm) at the injection site and a transient swelling of the sub-mandibular and/or pre-scapular lymph nodes at the injection site 4 hours after vaccination. These signs resolve within 24 hours.

In dogs, safety and efficacy data are available which demonstrate that this vaccine can also be used as the solvent for the live vaccines of the Versican Plus range (Versican Plus DHPPi, DHP, DP, P and Pi) and administered subcutaneously in dogs.

After mixed administration with the Versican Plus range vaccinated dogs may commonly have a transient swelling (up to 5 cm) at the injection site. The swelling can occasionally be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination. In rare cases gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible.

Do not mix with any other veterinary medicinal product except those mentioned in the section above.

No information 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.

Can be used during pregnancy.

The vaccine has not been extensively tested in lactating animals. However, the limited data that are available indicate that administration of the vaccine to lactating animals will not be associated with an increased incidence of adverse reactions.

Dogs, cats, ferrets: Not applicable.

Cattle, pigs, sheep, goats, horses: Zero days.

In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Store in a refrigerator (2 °C - 8 °C). Do not freeze. Protect from light.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the container: 10 hours.

For animal treatment only.

Keep out of the sight and reach of children.

The vaccine is supplied in type I (1 ml or 10 ml) glass vials complying with Ph. Eur., sealed with a bromobutyl rubber stopper and aluminium cap.

Cardboard box of 1 vial of 1 ml.

Plastic box of 10 vials of 1 ml or 10 ml.

Not all pack sizes may be marketed.

The vaccine stimulates active immunity in the target species against rabies.

As required by the European Pharmacopoeia, efficacy was demonstrated by challenge in dogs and cats, and by serology in the other target species. One year after primary vaccination, 100% of dogs and cats vaccinated via either the subcutaneous or intramuscular routes were protected against challenge. Two years after booster vaccination, protection rates against challenge were 92% of cats vaccinated via either the subcutaneous or intramuscular routes. Three years after primary vaccination, 96% of dogs vaccinated by subcutaneous route were protected against challenge. Protection rates against challenge in dogs and cats, and serology results for the other target species, comply with the efficacy criteria of the European Pharmacopoeia for inactivated rabies vaccine at both the one-year, two-year and three-year assessments.

Medicines should not be disposed of via wastewater

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

GB: Vm 42058/5113

NI: Vm 42058/3013