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EPAR summary for the public
Live myxoma vectored RHD virus strain 009
This document is a summary of the European Public Assessment Report. Its purpose is to explain how
the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis
of the documentation provided, led to the recommendations on the conditions of use.
This document cannot replace a face-to-face discussion with your veterinarian. If you need more
information about your animal’s medical condition or treatment, contact your veterinarian. If you want
more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part
of the EPAR).
What is Nobivac Myxo-RHD?
Nobivac Myxo-RHD is a vaccine that contains live myxoma vectored RHD virus strain 009. It is
available as a lyophilisate (freeze-dried substance) and a solvent that are made up into a suspension
What is Nobivac Myxo-RHD used for?
Nobivac Myxo-RHD is used in rabbits aged five weeks or more to reduce number of deaths and clinical
signs due to myxomatosis (skin tumours caused by the myxoma virus) and to prevent death due to
rabbit haemorrhagic disease (RHD), a disease resulting in blood clot formation caused by the RHD
How does Nobivac Myxo-RHD work?
Nobivac Myxo-RHD, like all vaccines, works by ‘teaching’ the immune system (the body’s natural
defences) how to defend itself against a disease. It contains a weakened strain of the myxoma virus
which has been genetically modified so that it can produce a protein of the RHD virus. When it is given
to rabbits the immune system recognises the myxoma and RHD materials as ‘foreign’ and makes
antibodies against them. In the future, if the rabbits are exposed to any of the viruses, the immune
system will be able to respond more quickly. This will help to protect against the diseases.
How has Nobivac Myxo-RHD been studied?
Fifteen field and laboratory studies were carried out, in which rabbits vaccinated with Nobivac Myxo-
RHD were compared with unvaccinated rabbits to establish the onset and duration of immunity against
myxoma and RHD viruses.
What benefit has Nobivac Myxo-RHD shown during the studies?
The studies showed that Nobivac Myxo-RHD was effective in providing immunity against myxomatosis
and RHD three weeks after vaccination and that the immunty was still present after one year. Rabbits
that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies
against RHD virus in their blood and a lower death rate than unvaccinated rabbits.
What is the risk associated with Nobivac Myxo-RHD?
A temporary increase in body temperature of 1-2°C can occur. There may also be a small, painless
swelling at the injection site within the first two weeks after vaccination. The swelling will resolve
completely by the end of the third week.
What is the withdrawal period?
The withdrawal period is the time allowed after administration of the medicine and before the animal
can be slaughtered and the meat used for human consumption. The withdrawal period for Nobivac
Myxo-RHD is zero days.
Why has Nobivac Myxo-RHD been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of
Nobivac Myxo-RHD exceed the risks when used to reduce the number of deaths and clinical signs due
to myxomatosis and prevent death due to rabbit haemorrhagic disease. The Committee recommended
that Nobivac Myxo-RHD be given a marketing authorisation. The benefit-risk balance may be found in
the scientific discussion module of this EPAR.
Other information about Nobivac Myxo-RHD:
The European Commission granted a marketing authorisation valid throughout the European Union, for
Nobivac Myxo-RHD to Intervet International BV on 7 September 2011. Information on the prescription
status of this product may be found on the label/outer package.
This summary was last updated on 7 September 2011.
B. PACKAGE LEAFLET
Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
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
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of reconstituted vaccine contains:
Live myxoma vectored RHD virus strain 009:
*Focus Forming Units
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink coloured suspension.
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.
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 displaying adverse reactions during the course of one
common (more than 1 but less than 10 animals in 100 animals)
uncommon (more than 1 but less than 10 animals in 1,000 animals)
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform
your veterinary surgeon.
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
ADVICE ON CORRECT ADMINISTRATION
Ensure that the lyophilisate is completely reconstituted before use.
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the
total contents of the vial.
Number of vials of
to be added
Total number of
rabbits that can
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
4. Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining
at the end of this time should be discarded.
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.
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
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.
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.
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.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the
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.
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 http://www.ema.europa.eu/
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
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
- 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.