Patient leaflet - Nobivac Myxo-RHD Plus
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Live myxoma vectored RHD virus strain 009: 103.0 – 105.8 FFU
Live myxoma vectored RHD virus strain MK1899: 103.0 – 105.8 FFU
*Focus Forming Units
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
4.
INDICATION(S)
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
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 (maximum 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, 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 in very rare cases. 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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Rabbits.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
Primary vaccination:
Administer one dose to rabbits from 5 weeks of age onwards.
Revaccination:
Revaccinate annually.
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9. ADVICE ON CORRECT ADMINISTRATION
Ensure that the lyophilisate is completely reconstituted before use.
Reconstituted product: off-pink or pink coloured suspension.
Single-dose vial
Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent. Administer the total contents of the vial.
Multi-dose vial
Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent. Administer 0.2 ml per animal.
For proper reconstitution of the multidose vial, use the following procedure:
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1. Add 1 –2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
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2. Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
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3. Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
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4. Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining at the end of this time should be discarded.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Lyophilisate:
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
Solvent:
No special precautions for storage.
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.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product. To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
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.
Special precautions for use in animals:
Not applicable.
Pregnancy :
Can be used during 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 the administration of a ten-fold overdose.
Incompatibilities :
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION
The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses. As a consequence rabbits are immunised against myxoma virus and both classical and type 2 RHD virus.
The vector technology used to develop the vaccine strains allows the RHD virus components to be produced in vitro instead of using live rabbits for cultivation.
After infection with virulent field myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs. These scabs usually disappear within 2 weeks. The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
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– Plastic box with 5 × 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
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– Plastic box with 25 × 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
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– Cardboard box with 10 × 50 doses vials of vaccine; and cardboard box with 10 × 10 ml vials of solvent.