Indications for use
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
Special warnings for each target species
Vaccinate healthy animals only.
High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product. To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop an adequate immune response against rabbit haemorrhagic disease following vaccination.
Special precautions for use
A transient temperature increase of 1 – 2°C can commonly occur. A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination. In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases. Serious hypersensitivity reactions, which may be fatal, may occur after vaccination in very rare cases. The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases. Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
The frequency of adverse reactions is defined using the following convention:
− very common (more than 1 in 10 animals treated displaying adverse reaction(s))
− common (more than 1 but less than 10 animals in 100 animals treated)
− uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
− very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
Can be used during pregnancy.
No safety study on the reproductive performance has been conducted in male rabbits (bucks). Therefore, the vaccination of breeding bucks is not recommended.
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.
Amounts to be administered and administration route
Administer one dose to rabbits from 5 weeks of age onwards.
Ensure that the lyophilisate is completely reconstituted before use.
Reconstituted product: off-pink or pink coloured suspension.
Single dose vial
Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent. Administer the total contents of the vial.
Multi-dose vial (50 doses)
Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent. Administer 0.2 ml per animal.
For proper reconstitution of the multi-dose vial, use the following procedure:
1. Add 1 - 2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
2. Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
3. Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
4. Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining at the end of this time should be discarded.
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after administration of a ten-fold overdose.