Nobivac Myxo-RHD

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Staðsetning

  • Fáanlegt í:
  • Nobivac Myxo-RHD
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  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Rabbits
  • Lækningarsvæði:
  • Immunologicals
  • Ábendingar:
  • For active immunisation of rabbits from five 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.
  • Vörulýsing:
  • Revision: 3

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/002004
  • Leyfisdagur:
  • 07-09-2011
  • EMEA númer:
  • EMEA/V/C/002004
  • Síðasta uppfærsla:
  • 31-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/632740/2011

EMEA/V/C/002004

EPAR summary for the public

Nobivac Myxo-RHD

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

for injection.

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

virus.

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.

Nobivac Myxo-RHD

EMA/632740/2011

Page 2/2

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.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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:

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 displaying adverse reactions during the course of one

treatment)

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.

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.

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

0.2 ml

50 ml

0.2 ml

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.

10.

WITHDRAWAL PERIOD

Zero days.

11.

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

12.

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.

13.

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.

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 http://www.ema.europa.eu/

15.

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.