Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

Liquid oil adjuvanted vaccine containing a suspension of inactivated calicivirus of viral haemorrhagic disease strain 3116-AP.

Uses

For the active immunisation of rabbits to prevent mortality caused by viral haemorrhagic disease (VHD).

Onset of immunity: 6 days

Duration of immunity: 1 year

Dosage and administration

1 dose of 0.5 ml per rabbit, administered subcutaneously.

Primary vaccination: 1 injection in rabbits from the age of 5 weeks

Booster: 1 injection every 12 months

Mode of administration

Keep the vial at ambient temperature (approximately 25°C) for a few minutes before administration of the vaccine. Agitate the vial/bottle before use to obtain a homogenous emulsion. Once broached the contents of the vial must be used within a working day (8-10 hours).

Contra-indications, warnings, etc

Administration at 5 times the recommended dose caused a pink discolouration of the skin to be observed, which disappears spontaneously in a few hours.

Special precautions for use in animals

The vaccine is safe to use in pregnant females. However, pregnant females should be handled with the usual precautions. Only vaccinate healthy animals.

Special precautions to be taken by the person administering the medical product to animals

To the user:

This product contains mineral oil. Accidental injection/self–inoculation 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 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 further medical advice.

To the physician:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may result in ischaemic necrosis and 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.

Interaction with other medicinal products and others form of interaction

No information is available on safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.

Withdrawal periods

Rabbit: meat: 0 days

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store and transport between +2°C and +8°C. Do not freeze.

Once broached the contents of the vial must be used within, or discarded by the end of that working day (8 - 10 hours).

Legal category

POM-V

Packaging Quantities

Box of 1 glass vial (2.5 ml) of 5 doses

Further information

Nil

Marketing authorisation number

Vm 15052/4032.