Versiguard Rabies 1Dose 1ml

Uses
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.
Onset of immunity
14-21 days after primary vaccination.
Duration of immunity
Dogs: At least three years following the primary vaccination course.
Cats, cattle, pigs, sheep, goats, horses and ferrets: At least one year after primary vaccination, and two years after booster vaccinations.
Dosage and administration
Shake the vial before use.
A single dose inoculation of 1 ml is sufficient irrespective of age, weight or breed of animal.
Dogs: Administer by subcutaneous injection.
All other species: Administer by subcutaneous or intramuscular injection.
Primary vaccination
Animals of all target species can be vaccinated from 12 weeks of age. Primary vaccination is with a single dose of vaccine.
Revaccination
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 EU, 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.
Use as solvent for the Versican Plus range
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 a slight opalescence. The mixed vaccines should be injected immediately via the subcutaneous route.
Co-administration with Vanguard canine range
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.
Contra-indications, warnings, etc
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.
Following subcutaneous administration in all target species, in very rare cases a transient swelling may occur at the injection site. The swelling may reach a maximum diameter of up to 10 mm, and in rare cases be associated with mild discomfort. These reactions usually resolve within 10 days.
Following intramuscular administration in any other target species than dogs, transient mild pain (which in rare cases may be associated with swelling) may very rarely occur at the site of injection. The swelling may reach a maximum diameter of up to 2 cm. These reactions usually resolve within 7 days.
As with any vaccine, very rarely hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
-common (more than 1 but less than 10 animals in 100 animals)
-uncommon (more than 1 but less than 10 animals in 1,000 animals)
-rare (more than 1 but less than 10 animals in 10,000 animals)
-very rare (less than 1 animal in 10,000 animals, including isolated reports).
Local reactions after subcutaneous vaccination with an overdose tended to be larger (up to 12 mm in diameter) than after a standard dose.
In dogs, safety and efficacy data 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 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 other than vaccines of the Vanguard range containing CDV, CAV, CPV, CPiV and Leptospira or the Versican Plus range containing CDV, CAV, CPV and/or CPiV.
In other target species, there is 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.
Withdrawal period
Dogs, cats, ferrets: Not applicable.
Cattle, pigs, sheep, goats, horses: Zero days.
User warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pharmaceutical precautions
Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.
Shelf-life after first opening the container: 10 hours.
For animal treatment only.
Keep out of the sight and reach of children.
Legal category
Legal category:POM-V
Packaging quantities
Packs with 1 x 1 ml, 10 x 1 ml or 10 x 10 ml vials.
Not all pack sizes may be marketed.
Further information
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.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.