Each dose of reconstituted vaccine contains:
Active substance: Live myxoma vectored RHD virus strain 009: =103.0 and =106.1 FFU*.
*Focus Forming Units.
Excipients: For a full list of excipients, see section “Pharmaceutical Particulars”.
Lyophilisate and solvent for suspension for injection.
Indications for use
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
Special warnings for each target species
Special precautions for use
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.
User warnings: None.
A transient temperature increase of 1-2°C can 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.
Use during pregnancy, lactation or lay
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy. No safety study on the reproductive performance has been conducted in male rabbits (bucks).Therefore, the vaccination of breeding bucks is not recommended.
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.
Amounts to be administered and administration route
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
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.
50 dose vial
Number of vials of freeze-dried vaccine to be added
Total number of rabbits that can be vaccinated
For proper reconstitution of the multidose vial, use the following procedure:
•Add 1-2 ml of Nobivac Myxo RHD solvent to the 50 dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
•Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo RHD solvent vial.
•Ensure that the resulting vaccine suspension in the Nobivac Myxo RHD solvent vial is properly mixed.
•Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining at the end of this time should be discarded.
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.
Pharmacotherapeutic group: live viral vaccine, ATCvet code: QI08AD.
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. 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.
Hydrolysed gelatine, Pancreatic digest of casein, Sorbitol, Disodium phosphate dihydrate, Potassium dihydrogen phosphate and Water for injections.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Shelf-life of the solvent as packaged for sale: 1 ml and 10 ml Glass vials: 4 years.
50 ml PET vials: 2 years.
Shelf-life after reconstitution according to directions: 4 hours.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.
Solvent (50 ml PET vial): Store in a refrigerator (2°C - 8°C). Do not freeze.
Solvent (1 ml and 10 ml glass vial): No special precautions for storage. Do not freeze.
Lyophilisate: Glass vial of 1 or 50 doses with a halogenobutyl rubber stopper and aluminium cap.
Solvent: Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) bottle of 50 ml with a halogenobutyl rubber stopper and aluminium cap.
Packaging: Box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Box with 10 x 50 doses vial of vaccine.
2 Boxes with 1 x 50 ml vial of solvent.
Box with 10 x 10 ml vial of solvent.
Not all pack sizes may be marketed.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Intervet International B.V. NL
EU/2/11/132/001 – 004.
7 September 2011
7 September 2011
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