Revised: February 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For one dose of vaccine:
Calicivirus of rabbit hemorrhagic disease 1 PD100*
Strain 3116-AP (suspension of inactivated virus)
Mineral oil 104.125 mg
Thiomersal 0.05 mg
Excipient q.s. 1 dose of 0.5 ml
* Protective Dose 100% tested in rabbits.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for injection.
4. CLINICAL PARTICULARS
4.2 Indications for use
For active immunisation of rabbit to prevent mortality caused by RHD virus
Onset immunity: 6 days
Duration of Immunity: 1 year
4.4 Special precautions for use
4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals
i. Special precautions for use in animals
Handle pregnant females with the usual precautions.
ii. Special precautions for the person administering the veterinary medicinal product to animals
To the user:
This 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 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.
This 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 ischeamic 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.
4.6 Adverse reactions
A local inflammatory reaction at the point of injection may appear, resulting in a sclerous cicatricial granuloma, which may persist for a period of at least 28 days in the fat cells.
4.7 Use during pregnancy and lactation
The vaccine can be used during pregnancy, and lactation.
4.8 Interaction with other medicaments 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.
4.9 Amount to be administered and administration route
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.
Where intensive breeding under commercial farming conditions is undertaken it is recommended to vaccinate breeding does every 6 to 12 months, depending of the turnover and the sanitary situation of the farm.
MODE OF ADMINISTRATION: Keep the vial/bottle at ambient temperature (approximately 25°C) a few minutes before the administration of the vaccine. Agitate the vial/bottle before use, to obtain a homogeneous emulsion. The content of the vial must be used in a working day (8 -10 hours).
Administration at 5 times the recommended dose caused, a pink colour of the skin to be observed, which disappeared spontaneously in a few hours.
Reactions following administration of an overdose are similar to but larger than those indicated in section 4.6.
4.11 Withdrawal period
5. Immunological particulars
To stimulate active immunity against rabbit haemorrhagic disease
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium diphosphate anhydrous
Potassium dihydrate phosphate
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life of the veterinary product as packaged for sale:2 years
Shelf-life after reconstitution: 8-10 hours.
6.4 Special precautions for storage
Store and transport between + 2°C and + 8°C.
Do not freeze.
6.5 Nature and contents of container
Nature of the immediate packaging:
. Type I or type II glass vial/bottle
. Stopper of bromobutyl rubber
. Aluminium capsule
Presentations intended for the sale:
- Box of 1 glass vial/bottle (2,5 ml) of 5 doses
- Box of 1 glass vial/bottle (5 ml) of 10 doses
- Box of 10 glass vial/bottle (5 ml) of 10 doses
- Box of 1 glass vial/bottle (10 ml) of 20 doses
- Box of 10 glass vial/bottle (10 ml) of 20 doses
- Box of 1 glass vial/bottle (20 ml) of 40 doses
- Box of 2 glass vial/bottle (20 ml) of 40 doses
- Box of 10 glass vial/bottle (20 ml) of 40 doses
- Box of 1 glass vial/bottle (100 ml) of 200 doses.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
7. NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE AUTHORIZATION HOLDER
Ceva Animal Health Limited
Unit 3, Anglo Office Park
White Lion Road
8. MARKETING AUTHORISATION NUMBERS
9. DATE OF FIRST AUTHORISATION
Date:22 September 2006
10. DATE OF REVISION OF THE TEXT
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