Indications for use, specifying the target species
For active immunisation of rabbits from 10 weeks of age, to reduce mortality due to rabbit haemorrhagic disease caused by classical (RHDV1) and type 2 (RHDV2) virus strains.
Onset of immunity: 1 week.
Duration of immunity: 1 year.
Vaccinate healthy animals only.
No information is available on the use of the vaccine in seropositive animals, including animals with maternally derived antibodies. Thus, in situations where a high level of antibodies is expected, the vaccination scheme must be adjusted accordingly.
The efficacy of the vaccine in animals younger than 10 weeks of age has not been demonstrated.
Special precautions for use
Special precautions for use in animals
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Very common: a temporary increase in body temperature of up to 1.6°C can be observed one day after vaccination.
Very common: immunization may be followed by a limited local reaction (subcutaneous nodule, the size of which was up to 10 mm in diameter in the double dose study) which may be palpable for at least 52 days and which disappears without treatment.
Serious hypersensitivity reactions which may be fatal have been reported very rarely from post marketing pharmacovigilance reporting. Lethargy and/or inappetence have been reported very rarely in the first 48 hours after injection, from post marketing pharmacovigilance reporting
Use during pregnancy, lactation or lay
During a field trial, no case of abortion was noted after administration of the vaccine to pregnant animals.
Use only according to the benefit-risk assessment by the responsible veterinarian.
The influence of the vaccination on the fertility of rabbits has not been investigated.
Interaction with other medicinal products and other forms of interaction
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
One dose (0.5 ml) per subcutaneous injection per animal.
Primary vaccination: from the 10th week of age.
Apply usual aseptic conditions.
Shake gently before and occasionally during administration to maintain a homogeneous suspension.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those referenced under Adverse reactions have been observed after administration of a double dose of vaccine.