Summary of medicine characteristics - Nobivac Myxo-RHD
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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 the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink coloured suspension.
4. CLINICAL PARTICULARS4.1 Target species
Rabbits.
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4.2 Indications for use, specifying the target species
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 (RHD) caused by classical RHD virus strains.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
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4.6 Adverse reactions (frequency and seriousness)
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, 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:
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– very common (more than 1 in 10 animals treated displaying adverse reactions)
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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).
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4.7 Use during pregnancy and lactation
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.
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.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Revaccinate annually.
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.
Multi-dose vial
| Solvent volume | 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 multi-dose vial, use the following procedure:
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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.
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2. Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
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3. Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for leporidae, 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.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate:
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
6.2 MajorIncompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
6.3 Shelf life
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Shelf-life of the solvent as packaged for sale:
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– 1 ml and 10 ml glass vials: 4 years.
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– 50 ml PET vials: 2 years.
Shelf-life after reconstitution according to directions: 4 hours.
6.4 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.
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6.5 Nature and composition of immediate packaging
Lyophilisate:
Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) vial of 50 ml closed with a halogenobutyl rubber stopper and aluminium cap.
Packaging:
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– Plastic box with 5 × 1 dose vial of vaccine and 5 × 1 ml vial of solvent.
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– Plastic box with 25 × 1 dose vial of vaccine and 25 × 1 ml vial of solvent.
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– Cardboard box with 10 × 50 doses vial of vaccine + cardboard box with 10 × 10 ml vial of solvent.
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– Cardboard box with 10 × 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 × 50 ml vial of solvent.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/11/132/001–004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 07/09/2011
Date of last renewal: 21/06/2016