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Purevax FeLV

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Summary for the public


What is Purevax FeLV?

Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97). Purevax FeLV is presented as a suspension for injection.


What is Purevax FeLV used for?

Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus. The vaccine is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.

A 1 ml dose of Purevax FeLV is injected under the skin. The first injection should be given in cats aged at least eight weeks, with a second injection three to five weeks later. Immunity starts at the latest two weeks after the second injection and lasts for a year. The cats should be revaccinated every year.


How does Purevax FeLV work?

Purevax FeLV is a vaccine. Vaccines work by priming the immune system (the body’s natural defences) how to defend itself against diseases. Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology’. The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.

When a cat is given the vaccine, the immune system recognises the FeLV proteins as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the FeLV. The antibodies will help to protect against the disease caused by the virus. Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus: A, B and C.


How has Purevax FeLV been studied?

The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV. In the field, efficacy has been studied in one main study of kittens aged eight weeks or older, in which the effects of Purevax FeLV were compared with those of another vaccine against FeLV. The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV. In all trials, the main measure of effectiveness was the presence of antibodies against the virus and infectious FeLV in the vaccinated kittens’ blood.


What benefit has Purevax FeLV shown during the studies?

Purevax FeLV vaccine provided protection against FeLV infection. The first evidence of FeLV infection occurred after six weeks in only a few of the kittens vaccinated with Purevax FeLV. Infection was seen from four weeks in non-vaccinated animals.


What is the risk associated with Purevax FeLV?

A temporary small nodule (hard lump) may appear at the site of injection. This usually disappears within one to four weeks. Temporary lethargy (listlessness) and hyperthermia (increased body temperature) may occur for one day, exceptionally for two days. For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet. Purevax FeLV should not be used in pregnant cats.


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

In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.


Why has Purevax FeLV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Purevax FeLV

The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000. The marketing authorisation was renewed on 18 April 2005. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Purevax FeLV
EMEA Product number: EMEA/V/C/000056
Active substance: FeLV recombinant canarypox virus (vCP97)
INN or common name: Vaccine against feline leukaemia
Species: Cats
ATCvet Code: QI06AD
Marketing Authorisation Holder: Merial
Revision: 5
Date of issue of Market Authorisation valid throughout the European Union: 13/04/2000
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 FeLV suspension for injection
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 1 ml contains:
    Active substance
    FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 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 of 8 weeks of age or older against feline leukaemia for the prevention of
    persistent viraemia and clinical signs of the related disease.
    Onset of immunity:2 weeks after primary vaccination course.
    Duration of immunity:1 year after the last vaccination.
    4.3 Contraindications
    Do not use in pregnant animals.
    The use is not recommended during lactation.
    4.4 Special warnings
    None
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate only healthy animals.
    It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
    Vaccination of FeLV positive cats is of no benefit.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    2
    4.6 Adverse reactions (frequency and seriousness)
    A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4
    weeks.
    Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
    In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate
    symptomatic treatment.
    4.7 Use during pregnancy, lactation or lay
    Do not use in pregnant animals.
    The use is not recommended during 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 administered the
    same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and rabies components).
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial
    non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis,
    panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with
    Merial adjuvanted vaccine against rabies.
    4.9 Amounts to be administered and administration route
    Subcutaneous use
    Administer one dose of 1ml according to the following schedule:
    Basic vaccination :
    first injection: from 8 weeks of age,
    second injection: 3 to 5 weeks later.
    Revaccination :
    annual
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No undesirable effect has been observed after the administration of several doses except those
    mentioned in the “Adverse reactions” section.
    4.11 Withdrawalperiod(s)
    Not applicable
    5.
    IMMUNOLOGICAL PROPERTIES
    ATC vet code: QI06AD
    Vaccine against feline leukaemia.
    The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
    Under field conditions, only sub-group A is infective and immunisation against sub-group A provides
    full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but
    does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline
    leukaemia virus.
    3
    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
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administered with Merial non-adjuvanted vaccine range (various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 2 years
    Use immediately after broaching.
    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
    Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with
    an aluminium cap.
    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 or by
    appropriate channels approved for use by the competent authorities.
    7.
    MARKETING AUTHORISATION HOLDER
    MERIAL
    29 avenue Tony Garnier
    F-69007 LYON
    FRANCE
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/019/005-007
    4
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    Date of first authorisation: 18/04/2005
    Date of last renewal: 22/03/2010
    10 DATE OF REVISION OF THE TEXT
    22/03/2010
    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.
    MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) 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. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance(s)
    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
    {NATURE/TYPE}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax FeLV suspension for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
    3.
    PHARMACEUTICAL FORM
    Suspension for injection
    4.
    PACKAGE SIZE
    10 x 1-ml suspension (10 doses)
    20 x 1-ml suspension (20 doses)
    50 x 1-ml suspension (50 doses)
    5.
    TARGET SPECIES
    Cats
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous use.
    8.
    WITHDRAWAL PERIOD
    Not applicable
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10
     
    10. EXPIRY DATE
    EXP (mm/yy)
    Use immediately after broaching
    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/2/00/019/005 10 doses: 1-ml suspension (10 bottles)
    EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles)
    EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    11
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax FeLV suspension for injection
    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(S) OF ADMINISTRATION
    Subcutaneous use
    5.
    WITHDRAWAL PERIOD
    Not applicable
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12
     
    B. PACKAGE LEAFLET
    13
    PACKAGE LEAFLET FOR:
    Purevax FeLV
    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
    Manufacturing authorisation holder responsible for batch release
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l’Aviation
    F-69800 SAINT PRIEST
    FRANCE
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax FeLV
    Suspension for injection
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each dose of 1ml contains:
    FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
    4.
    INDICATION(S)
    Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of
    persistent viraemia and clinical signs of the related disease.
    Onset of immunity: 2 weeks after primary vaccination course.
    Duration of immunity:1 year after the last vaccination.
    5.
    CONTRAINDICATIONS
    Do not use in pregnant animals. The use is not recommended during lactation.
    6.
    ADVERSE REACTIONS
    A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4
    weeks
    Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
    14
    In exceptional circumstances 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 1ml - according to the following schedule:
    Basic vaccination :
    first injection: from 8 weeks of age,
    second injection: 3 to 5 weeks later.
    Revaccination :
    annual
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Shake well before use.
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administered with Merial non-adjuvanted vaccine range (various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
    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.
    Use immediately after broaching.
    Do not use after the expiry date stated on the label.
    12. SPECIAL WARNING(S)
    Vaccinate only healthy animals.
    It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
    Vaccination of FeLV positive cats is of no benefit.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Safety and efficacy data are available which demonstrate that this vaccine can be administered the
    same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral
    rhinotracheitis, calicivirosis, panleukopenia and rabies components).
    15
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial
    non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis,
    panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with
    Merial adjuvanted vaccine against rabies.
    No undesirable effect has been observed after the administration of several doses except those
    mentioned in the “Adverse reactions” section.
    Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine
    range.
    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 or by
    appropriate channels approved for use by the competent authorities.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    22/03/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    http://www.ema.europa.eu
    15. OTHER INFORMATION
    Vaccine against feline leukaemia.
    The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
    Under field conditions, only sub-group A is infective and immunisation against sub-group A provides
    full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but
    does not replicate in the cat. As a consequence, the vaccine induces an immune status against feline
    leukaemia virus.
    Plastic box containing 10, 20 or 50 bottles
    Not all pack sizes may be marketed.
    16


    Source: European Medicines Agency


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