Uses
For active immunization of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Onset of immunity: 1 week
Duration of immunity: 12 months demonstrated by challenge
Dosage and administration
Subcutaneous use.
Vaccination dosing schedule:
Administer 1 dose (0.5 ml) of the vaccine to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Revaccination: every 12 months after the last vaccination
Before use allow the vaccine to reach room temperature.
Shake well before administration.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special precautions for use in animals:
Vaccinate only healthy rabbits.
Vaccination is recommended where RHDV2 is epidemiologically relevant.
Pregnancy and lactation: Laboratory studies in doe rabbits in the last third of gestation have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Pregnant does should be handled with special care to avoid stress and risk of abortion.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions (frequency and seriousness)
Very common: a transient temperature increase slightly above 40 ºC between two or three days following vaccination was observed very commonly during safety studies. This slight temperature increase resolves spontaneously without treatment by day 5 post-vaccination.
Very common: nodules or swellings (< 2cm) at the injection site were observed very commonly during safety studies. These local reactions may last 24 hours and gradually reduce and disappear without need for treatment.
Very rare: Lethargy and/or inappetence in the first 48 hours after injection may be observed very rarely based on post-authorisation pharmacovigilance reporting.
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)
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.
Overdose
No available data.
Withdrawal period
Zero days.