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:

Active substances:

Inactivated Rabbit Haemorrhagic Disease Virus strain RHDV PHB98 ……min. 1 PD₉₀ *

Adjuvant:

Aluminium hydroxide gel ................................................................................. 1.3 mg

Excipients:

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

Rabbit.

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

4.3. Contra-indications

None.

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)

None.

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

Zero days.

5. Immunological properties

ATCvet: QI08AA01

To stimulate active immunity against rabbit haemorrhagic disease.

6.1. List of excipients:

Formaldehyde

Thiomersal

Phosphate buffered solution (PBS)

6.2. Incompatibilities

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.

Pharmagal Bio, s. r. o.

Murgašova 5

949 01 Nitra

Slovak Republic

Vm 33225/4000

17 October 2008

October 2015

Approved: 21 October 2015