Target Species
Rabbits.
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.
Contraindications
None.
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
Not applicable.
Operator warnings
Not applicable.
Adverse Reactions
Rabbits:
Common (1 to 10 animals / 100 animals treated): | Hyperthermia1, Injection site swelling.2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site necrosis3, injection site scab3, injection site crust3, injection site hair loss3. Hypersensitivity reaction4. Myxomatosis5. Anorexia, lethargy. |
1 Transient temperature increase of 1 – 2 °C
2 A small, non-painful swelling (maximum 2 cm diameter) within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination.
3 In pet rabbits.
4 Sometimes fatal.
5 Mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
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 the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy:
Can be used during pregnancy.
Fertility:
No safety study on the reproductive performance has been conducted in male rabbits (bucks). Therefore, the vaccination of breeding bucks is not recommended.
Interactions
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
Subcutaneous use.
Primary vaccination:
Administer one dose to rabbits from 5 weeks of age onwards.
Revaccination:
Revaccinate annually.
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.
Overdose
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.
Withdrawal periods
Zero days.