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Purevax Rabies

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Summary for the public


What is Purevax Rabies?

Purevax Rabies is a vaccine that contains rabies recombinant canarypox virus (vCP65). Purevax Rabies is a liquid suspension for injection.


What is Purevax Rabies used for?

Purevax Rabies is used to vaccinate cats from 12 weeks of age to protect against rabies infection.
A 1 ml dose of Purevax Rabies is injected under the skin. The first injection should be given in cats aged at least 12 weeks. Protection starts at the latest four weeks after the injection and lasts for a year. The cats should be revaccinated every year.


How does Purevax Rabies work?

Purevax Rabies is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. The vaccine strain vCP65 in Purevax Rabies is a ‘carrier’ canarypox virus that has been given a gene that makes it able to produce part of a rabies virus called ‘glycoprotein G’. The canarypox viruses do not spread or multiply in the cats but they do produce the glycoprotein G of the rabies virus.

When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to rabies, and this helps to protect against mortality due to rabies infection.


How has Purevax Rabies been studied?

A number of studies, including laboratory studies and field trials, were performed in kittens and cats looking at Purevax Rabies used either on its own or together with other cat vaccines, for primary and booster vaccination. The main measure of effectiveness was the ability of the vaccine to trigger immunity against rabies.

When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to rabies, and this helps to protect against mortality due to rabies infection.


What benefit has Purevax Rabies shown during the studies?

The laboratory studies showed that Purevax Rabies can give protection against rabies, and that the protection lasts for up to a year. The field trials showed that the vaccine is safe, and that it triggers a significant increase of anti-rabies antibodies. The vaccine can boost the immune response in cats that have received primary vaccination with another rabies vaccine.


What is the risk associated with Purevax Rabies?

Occasionally, cats will develop temporary slight apathy (loss of interest in surroundings) and mild anorexia (loss of appetite) or hyperthermia (elevated body temperature) lasting for one or two days. There may be a local reaction at the injection site, with slight pain on touching or oedema (swelling) which disappears within one or two weeks at most. For a full list of the side-effects reported with Purevax Rabies, see the package leaflet.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Canarypox recombinants such as those contained in Purevax Rabies are known to be safe for humans. Transient mild local or general adverse reactions related to the injection itself may be observed. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.


Why has Purevax Rabies been approved?

The CVMP concluded that the benefits of Purevax Rabies outweigh the risks for the active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection, and recommended that Purevax Rabies be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.


Other information about Purevax Rabies:

The European Commission granted a marketing authorisation valid throughout the European Union, for Purevax Rabies to MERIAL on 18.02.2011. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Purevax Rabies
EMEA Product number: EMEA/V/C/002003
Active substance: vCP65 virus
INN or common name: Rabies recombinant canarypos virus (vCP65)
Species: Cats
ATCvet Code: QI06AD
Marketing Authorisation Holder: Merial
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 18/02/2011
Contact address:
Merial
29 avenue Tony Garnier
69007 Lyon
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax Rabies suspension for injection
    2. QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 1 ml contains:
    Active substance:
    Rabies recombinant canarypox virus (vCP65)
     10 6.8 FAID* 50
    For a full list of excipients, see section 6.1.
    3. PHARMACEUTICAL FORM
    Suspension for injection.
    4. CLINICAL PARTICULARS
    4.1 Target species
    Cats.
    4.2 Indications for use, specifying the target species
    Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
    Onset of immunity: 4 weeks after the primary vaccination course.
    Duration of immunity: 1 year.
    4.3 Contraindications
    None.
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    Special precautions for use in animals
    Only healthy animals should be vaccinated.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse
    reactions related to the injection itself may be observed transitorily. In case of accidental self-injection,
    seek medical advice immediately and show the package leaflet or the label to the physician.
    2
    *Fluorescent assay infectious dose 50%
    4.6 Adverse reactions (frequency and seriousness)
    Transient and slight apathy may occur, as well as occasionally mild anorexia or hyperthermia (above
    39.5 °C), lasting usually 1 or 2 days. Most of these reactions appeared during the 2 days following the
    vaccine injection.
    A transient local reaction may occasionally occur (pain at palpation, limited swelling that may become
    nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2
    weeks at most.
    Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic
    treatment.
    4.7 Use during pregnancy, lactation or lay
    The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
    4.8 Interaction with other medicinal products and other forms of interaction
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
    Based on currently available efficacy data showing a risk of interference, the administration of
    MERIAL non-adjuvanted vaccine against feline leukaemia is not recommended within 14 days before
    or after vaccination with this vaccine.
    4.9 Amounts to be administered and administration route
    Subcutaneous use.
    Administer one dose of 1 ml according to the following vaccination scheme:
    Primary vaccination : 1 injection from 12 weeks of age,
    Revaccination : annual.
    Pet Travel Scheme: experience has shown that some vaccinated animals, while protected, may not
    show the 0.5 IU/ml antibody titre required by some countries. Veterinary surgeons may wish to
    consider two vaccinations. The best time for a blood sample to be taken is around 28 days after
    vaccination.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No adverse reactions other than those already mentioned in section 4.6 have been observed after the
    administration of 10 doses. The reactions may last longer.
    4.11 Withdrawal period
    Not applicable.
    5. IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Other immunologicals for cats, ATC vet code: QI06AX.
    3
    The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of
    rabies virus. After inoculation, the virus expresses the protective protein, but does not replicate in the
    cat. As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
    6 PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Potassium chloride
    Sodium chloride
    Potassium dihydrogen phosphate
    Disodium phosphate dihydrate
    Magnesium chloride hexahydrate
    Calcium chloride dihydrate
    Water for injections
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
    Once broached, use immediately.
    6.4 Special precautions for storage
    Store and transport refrigerated (2 C-8 C).
    Protect from light.
    Do not freeze.
    6.5 Nature and composition of immediate packaging
    Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
    Box of 10 or 50 vials of 1 dose.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant
    approved for use by the competent authorities.
    7. MARKETING AUTHORISATION HOLDER
    MERIAL
    29 avenue Tony Garnier
    F-69007 LYON
    FRANCE
    4
    8. MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/117/001
    EU/2/10/117/002
    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    18/02/2011
    10. DATE OF REVISION OF THE TEXT
    18/02/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5
    ANNEX II
    A.
    MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    6
    A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l’Aviation
    F-69800 SAINT PRIEST
    FRANCE
    MERIAL
    Laboratoire Lyon Gerland
    254, rue Marcel Mérieux
    F-69007 Lyon
    FRANCE
    Name and address of the manufacturer responsible for batch release
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l’Aviation
    F-69800 SAINT PRIEST
    FRANCE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Not applicable.
    7
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8
    A. LABELLING
    9
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Box of 10 vials of suspension for injection
    Box of 50 vials of suspension for injection
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax Rabies suspension for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Rabies recombinant canarypox virus (vCP65) ...............................................................  10 6.8 FAID* 50
    *Fluorescent assay infectious dose 50%
    3.
    PHARMACEUTICAL FORM
    Suspension for injection.
    4.
    PACKAGE SIZE
    10 vials of 1 ml
    50 vials of 1 ml
    5.
    TARGET SPECIES
    Cats.
    6.
    INDICATION
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    Subcutaneous use.
    Read the package leaflet before use
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNING, IF NECESSARY
    Read the package leaflet before use.
    10
     
    10. EXPIRY DATE
    EXP (month/year)
    Once broached, use immediately.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2 C-8 C).
    Protect from light.
    Do not freeze.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    MERIAL
    29, avenue Tony Garnier
    F-69007 LYON
    FRANCE
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/117/001
    (10 vials)
    EU/2/10/117/002
    (50 vials)
    17. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    11
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Vial
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax Rabies
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Read the package leaflet before use.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose
    4.
    ROUTE OF ADMINISTRATION
    Subcutaneous use
    5.
    WITHDRAWAL PERIOD
    Not applicable.
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP (month/year)
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    12
     
    B. PACKAGE LEAFLET
    13
    PACKAGE LEAFLET FOR
    Purevax Rabies suspension for injection
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder :
    MERIAL
    29, avenue Tony Garnier
    F-69007 Lyon
    France
    Manufacturer for the batch release :
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l'Aviation
    F-69800 Saint Priest
    France
    2. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax Rabies suspension for injection
    3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each dose of 1 ml contains:
    Rabies recombinant canarypox virus (vCP65) ..............................................................  10 6.8 FAID* 50
    *Fluorescent assay infectious dose 50%
    4. INDICATION(S)
    Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
    Onset of immunity: 4 weeks after the primary vaccination course.
    Duration of immunity: 1 year.
    5. CONTRAINDICATIONS
    None
    6. ADVERSE REACTIONS
    Transient and slight apathy may occur, as well as occasionally mild anorexia or hyperthermia (above
    39.5 °C), lasting usually 1 or 2 days. Most of these reactions appeared during the 2 days following the
    vaccine injection
    A transient local reaction may occasionally occur (pain at palpation, limited swelling that may become
    nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2
    weeks at most.
    14
    Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic
    treatment.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7. TARGET SPECIES
    Cats
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Subcutaneous use.
    Administer one dose of 1 ml according to the following vaccination scheme:
    Primary vaccination course : 1 injection from 12 weeks of age,
    Revaccination : annual.
    9. ADVICE ON CORRECT ADMINISTRATION
    Once broached, use immediately.
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administered with MERIAL’s non-adjuvanted vaccine range (various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components).
    Based on currently available efficacy data showing a risk of interference, the administration of
    MERIAL non-adjuvanted vaccine against feline leukaemia is not recommended within 14 days before
    or after vaccination with this vaccine.
    Pet Travel Scheme: experience has shown that some vaccinated animals, while protected, may not
    show the 0.5 IU/ml antibody titre required by some countries. Veterinary surgeons may wish to
    consider two vaccinations. The best time for a blood sample to be taken is around 28 days after
    vaccination.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2 C-8 C).
    Protect from light.
    Do not freeze.
    Do not use after the expiry date which is stated on the label.
    12. SPECIAL WARNING(S)
    Only healthy animals should be vaccinated.
    The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
    15
    No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been
    observed after the administration of 10 doses. The reactions may last longer.
    Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse
    reactions related to the injection itself may be observed transitorily. In case of accidental self-injection,
    seek medical advice immediately and show the package leaflet or the label to the physician.
    Do not mix with any other veterinary medicinal product except MERIAL’s non-adjuvanted vaccine
    range mentioned in the section “Advice on correct administration”.
    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
    18/02/2011
    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
    Vaccine against rabies infection.
    The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of
    rabies virus. After inoculation, the virus expresses the protective protein, but does not replicate in the
    cat. As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
    Box of 10 vials of 1 dose.
    Box of 50 vials of 1 dose.
    Not all pack sizes may be marketed.
    16


    Source: European Medicines Agency


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