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Nobivac Myxo-RHD
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009


PACKAGE LEAFLET


Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

    The Netherlands


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    Each dose of reconstituted vaccine contains:


    Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU*


    *Focus Forming Units


    Lyophilisate: off-white or cream-coloured pellet. Solvent: clear colourless solution.

    Reconstituted product: off-pink or pink coloured suspension.


  4. INDICATION(S)


    For active immunisation of rabbits to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.


    Onset of immunity: 3 weeks. Duration of immunity: 1 year.


  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS


    A transient temperature increase of 1 - 2° C can commonly occur. A small, non-painful swelling (max. 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination. In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur. In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination. In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination. Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.

    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals treated displaying adverse reactions)

    • 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).


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Rabbits.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.


    Revaccinate annually.


  9. ADVICE ON CORRECT ADMINISTRATION


Ensure that the lyophilisate is completely reconstituted before use.


Single-dose vial

Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.


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Multi-dose vial Solvent Volume


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Number of vials of freeze-dried vaccine to be added


Injection volume


Total number of rabbits that can be vaccinated

10 ml 1 0.2 ml 50

50 ml 5 0.2 ml 250


For proper reconstitution of the multidose vial, use the following procedure:


  1. Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.

  2. Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.

  3. Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.

  4. Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining at the end of this time should be discarded.


  1. WITHDRAWAL PERIOD(S)


    Zero days.


  2. SPECIAL STORAGE PRECAUTIONS

    Keep out of the sight and reach of children.

    Vaccine: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light. Solvent:

    • Glass vial (1 ml or 10 ml): No special precautions for storage.

    • PET vial (50 ml): Store in a refrigerator (2 °C – 8 °C). Do not freeze.


      Do not use this veterinary medicinal product after the expiry date which is stated on the label. Shelf-life after reconstitution according to directions: 4 hours


  3. SPECIAL WARNING(S)


    Special precautions for use in animals: Vaccinate only healthy rabbits.

    Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination.


    Pregnancy:

    Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy.


    Fertility:

    No safety study on the reproductive performance has been conducted in male rabbits (bucks). Therefore, the vaccination of breeding bucks is not recommended.


    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 (symptoms, emergency procedures, antidotes):

    In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.


    Incompatibilities:

    Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.


  4. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.


  5. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    .

  6. OTHER INFORMATION


    To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.

    The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus. As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.


    The vector technology used to develop the vaccine strain allows the RHD virus component to be produced in vitro instead of using live rabbits for cultivation.


    After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs. The scabs usually disappear within 2 weeks after the small swellings have been observed. These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.


    • Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.

    • Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.

    • Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.

    • Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.


Not all pack sizes may be marketed.