Anivac Vhd Suspension For Injection For Rabbits
Revised: October 2015
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Anivac VHD Suspension for injection for rabbits (UK, IE)
CASTOREX Suspension for injection for rabbits (CZ,PL,FR)
CASTOREX vakcina A.U.V. Suspension for injection for rabbits (HU)
CALICIVAC Suspension for injection for rabbits (PT)
2. Qualitative and quantitative composition
One dose of vaccine (0.5 ml) contains:
Inactivated Rabbit Haemorrhagic Disease Virus strain RHDV PHB98 ……min. 1 PD90 *
Aluminium hydroxide gel ................................................................................. 1.3 mg
Formaldehyde ……………………………………………………………… 0.55 mg
Thiomersal ……………………………………………………………… 0.05 mg
For a full list of excipients, see section 6.1.
* Protective dose for minimum 90% of vaccinated animals
3. Pharmaceutical form
Suspension for injection.
Suspension of red-brown colour with easily shakeable sediment of inactivated RHDV adsorbed on aluminium hydroxide gel that forms 40-60% of the vaccine if left undisturbed.
4. Clinical particulars
4.1. Target species
4.2. Indications for use, specifying the target species
For active immunisation of rabbits to prevent mortality caused by RHD virus
Onset of immunity: 7 days
Duration of immunity: 1 year based on field data without controlled challenge
4.4. Special warnings for each target species
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies; therefore in situations where high antibody levels are expected the vaccination protocol should be planned accordingly.
4.5. Special precautions for use
Special precautions for use in animals
Do not vaccinate unhealthy animals.
It is recommended not to vaccinate in the later stages of pregnancy in order to avoid stress and handling of pregnant does.
Special precautions to be taken by the person administering the 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.
4.6. Adverse reactions (frequency and seriousness)
4.7. Use during pregnancy,lactation or lay
Can be used during pregnancy and lactation.
See section 4.5
4.8 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.
4.9. Amounts to be administered and administration route
The vaccine dose for all age categories is 0.5 ml.
1 dose of 0.5 ml per rabbit, administered subcutaneously, it is recommended to localise the site of administration to the lateral thoracic wall.
Primary vaccination: 1 injection in rabbits from the age of 10 weeks.
Booster: 1 injection every 12 months
With respect to the epizootological situation, it is possible to vaccinate rabbits younger than 10 weeks (but not earlier than at the age of six weeks) with subsequent revaccination 4 weeks after the first vaccination.
Shake well before and occasionally during administration.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
In laboratory studies in dwarf rabbits vaccinated with double dose a small swelling of approximately 5mm that disappeared up to 3 days was observed.
The effects of a double dose in pregnant rabbits have not been investigated.
4.11. Withdrawal periods
5. Immunological properties
To stimulate active immunity against rabbit haemorrhagic disease.
6.1. List of excipients:
Phosphate buffered solution (PBS)
Do not mix with any other veterinary medicinal products.
6.3. Shelf- life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 10 hours.
6.4. Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Protect from frost.
Once opened, store below 25°C.
6.5. Nature and composition of immediate packaging
Paper carton containing glass vial made of neutral borosilicate glass with high hydrolytic resistance (Type 1) closed with a rubber plug suitable for parenteral preparations and an aluminium cap.
Size of package:
10 x 1 dose (10 x 0.5 ml)
10 doses (5 ml) in one vial
20 doses (10 ml) in one vial
40 doses (20 ml) in one vial
Not all pack sizes will be marketed.
6.6. Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing authorisation holder
Pharmagal Bio, s. r. o.
949 01 Nitra
Marketing authorisation number
Date of first authorisation
17 October 2008
Date of revision of the text
Approved: 21 October 2015
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