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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.
Do not use in cases of hypersensitivity to the adjuvant or to any of the excipients.
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Injection site swelling1
Hypersensitivity reaction2
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.
Cats, cattle, pigs, sheep, horses and ferrets:
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Injection site pain1, Injection site swelling2
Hypersensitivity reaction3
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.
Dogs
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.
Other target species
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.
Pregnancy and lactation
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.