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Purevax RC

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Summary for the public


What is Purevax RC?

Purevax RC is a vaccine containing the following active substances:

  • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
  • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains).

Purevax RC is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.


What is Purevax RC used for?

Purevax RC is used to vaccinate cats from the age of 8 weeks against the following diseases:

  • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
  • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus).

The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection.

After Purevax RC has been made up, 1 ml is injected under the skin. The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later. If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age. The cat should be revaccinated for all components one year after the first vaccination course, then every year.


How does Purevax RC work?

Purevax RC is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Purevax RC contains small amounts of weakened or killed viruses that cause the diseases listed above.

When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. The antibodies will help to protect against the diseases caused by these viruses. When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.


How has Purevax RC been studied?

The effectiveness of Purevax RC has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus and calicivirus. In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection). They included young and adult cats of various breeds, but not young kittens. The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.


What benefit has Purevax RC shown during the studies?

In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above. In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection. In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly.


What is the risk associated with Purevax RC?

Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as 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, itching or oedema (swelling), which disappears within one or two weeks. For a full list of the side-effects reported with Purevax RC, see the Package Leaflet. Purevax RC 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 RC been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RC be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Purevax RC

The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC to MERIAL on 23 February 2005.

Authorisation details
Name: Purevax RC
EMEA Product number: EMEA/V/C/000091
Active substance: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)
INN or common name: Vaccine against feline viral rhinotracheitis and feline calicivirosis
Species: Cats
ATCvet Code: QI06AH
Marketing Authorisation Holder: Merial
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 23/02/2005
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 RC lyophilisate and solvent for suspension for injection
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of 1 ml:
    Lyophilisate
    Active substances:
    Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ......................................
    ≥
    10 4.9 CCID 50 1
    Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains) ..............................
    ≥
    2.0 ELISA U.
    Excipient:
    Gentamicin, at most....................................................................................................................... 16.5 µg
    Solvent:
    Water for injections......................................................................................................................q.s. 1 ml
    1 : cell culture infective dose 50%
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cats.
    4.2 Indications for use, specifying the target species
    Active immunisation of cats aged 8 weeks and older:
    -
    against feline viral rhinotracheitis to reduce clinical signs,
    -
    against calicivirus infection to reduce clinical signs and excretion.
    Onsets of immunity have been demonstrated 1week after primary vaccination course for
    rhinotracheitis and calicivirus components.
    The duration of immunity is 1 year after the last (re-)vaccination.
    4.3 Contraindications
    Do not use in pregnant animals.
    The use is not recommended during lactation.
    4.4 Special warnings
    None.
    2
    4.5 Special precautions for use
    Special precautions for use in animals
    Use only in healthy animals.
    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.
    4.6 Adverse reactions (frequency and seriousness)
    In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as
    hyperthermia (lasting usually for 1 or 2 days). A local reaction may occur (slight pain at palpation,
    itching or limited oedema) that disappears within 1 or 2 weeks at most.
    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 mixed with Merial
    non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with
    Merial adjuvanted vaccine against rabies.
    4.9 Amounts to be administered and administration route
    Inject by subcutaneous route one dose (1ml) of vaccine after reconstitution of the lyophilisate with the
    solvent, according to the following vaccination scheme:
    Primary vaccination course:
    - first injection: from 8 weeks of age,
    - second injection: 3 to 4 weeks later.
    Where high levels of maternal antibodies against R or C components are expected to be present (e.g.
    in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or
    with known or suspected previous exposure to the pathogen(s)), the primary vaccination course
    should be delayed until 12 weeks of age.
    Revaccination: every year.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed,
    except hyperthermia that may exceptionally last 5 days.
    4.11 Withdrawal period(s)
    Not applicable.
    3
    5. IMMUNOLOGICAL PROPERTIES
    ATCvet code: QI06AH08
    Vaccine against feline viral rhinotracheitis and feline calicivirosis.
    Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Sucrose
    Sorbitol
    Dextran 40
    Casein hydrolysate
    Collagen hydrolysate
    Dipotassium phosphate
    Potassium dihydrogen phosphate
    Potassium hydroxide
    Sodium chloride
    Disodium hydrogen orthophosphate
    Monopotassium phosphate anhydrous
    6.2 Incompatibilities
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administrated with Merial non-adjuvanted vaccine against feline leukaemia.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
    Shelf life after reconstitution: use immediately after reconstitution
    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 bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent,
    both closed with a butyl elastomer closure and sealed with an aluminium cap.
    Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent
    Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent
    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.
    4
    7.
    MARKETING AUTHORISATION HOLDER
    MERIAL
    29, avenue Tony Garnier
    69007 LYON
    FRANCE
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/04/051/001-002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    Date of first authorisation: 23/02/2005
    Date of last renewal: 15/01/2010
    10. DATE OF REVISION OF THE TEXT
    15/01/2010
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.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(s) of the biological active substance(s)
    Merial
    Laboratory of Lyon Porte des Alpes
    Rue de l’aviation
    69800 SAINT-PRIEST
    France
    Merial
    Laboratory of Lyon Gerland
    254, Avenue Marcel Mérieux
    69007 LYON
    France
    Name and address of the manufacturer responsible for batch release
    Merial
    Laboratory of Lyon Porte des Alpes
    Rue de l’aviation
    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
    Pack containing 10 bottles of lyophilisate and 10 bottles of solvent
    Pack containing 50 bottles of lyophilisate and 50 bottles of solvent
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax RC lyophilisate and solvent for suspension for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 1 ml:
    FHV (F2 strain) .................................................................................................................
    ≥
    10 4.9 CCID 50
    2.0 ELISA U.
    Gentamicin, at most....................................................................................................................... 16.5 µg
    ≥
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    PACKAGE SIZE
    Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml)
    Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
    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
    FCV (431 and G1 strains) ...............................................................................................
     
    10. EXPIRY DATE
    EXP (mm/yyyy)
    Use immediately after reconstitution.
    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/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml)
    EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    11
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Lyophilisate bottle
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax RC lyophilisate 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
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP (mm/yyyy)
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Solvent bottle
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Purevax RC solvent
    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
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP (mm/yyyy)
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    13
     
    B. PACKAGE LEAFLET
    14
    PACKAGE LEAFLET FOR:
    Purevax RC
    Lyophilisate and solvent for 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 RC
    Lyophilisate and solvent for suspension for injection.
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Per dose of 1 ml:
    Lyophilisate
    Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ......................................
    ≥
    10 4.9 CCID 50 1
    Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains) .....................
    ≥
    2.0 ELISA U.
    Excipient:
    Gentamicin, at most....................................................................................................................... 16.5 µg
    Solvent:
    Water for injection .......................................................................................................................q.s. 1 ml
    1 : cell culture infective dose 50%
    4.
    INDICATION(S)
    Active immunisation of cats aged 8 weeks and older:
    -
    against feline viral rhinotracheitis to reduce clinical signs,
    -
    against calicivirus infection to reduce clinical signs and excretion.
    Onsets of immunity have been demonstrated 1 week after primary vaccination course for
    rhinotracheitis and calicivirus components.
    The duration of immunity is 1 year after the last (re-)vaccination.
    15
    5.
    CONTRAINDICATIONS
    Do not use in pregnant animals.
    The use is not recommended during lactation.
    6.
    ADVERSE REACTIONS
    In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as
    hyperthermia (lasting usually for 1 or 2 days). A local reaction may occur (slight pain at palpation,
    itching or limited oedema) that disappears within 1 or 2 weeks at most.
    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
    Inject by subcutaneous route one dose (1ml) of vaccine after reconstitution of the lyophilisate with the
    solvent, according to the following vaccination scheme:
    Primary vaccination course:
    - first injection: from 8 weeks of age,
    - second injection: 3 to 4 weeks later.
    Where high levels of maternal antibodies against R or C components are expected to be present (e.g.
    in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or
    with known or suspected previous exposure to the pathogen(s)), the primary vaccination course
    should be delayed until 12 weeks of age.
    Revaccination: every year.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Use immediately after reconstitution.
    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and
    administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the
    same day but not mixed with Merial adjuvanted vaccine against rabies.
    10. WITHDRAWAL PERIOD(s)
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    16
    Store and transport refrigerated (2
    °
    C – 8
    °
    C)
    Protect from light.
    Do not freeze.
    12. SPECIAL WARNING(S)
    Use only in healthy animals.
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Do not use in pregnant animals.
    The use is not recommended during lactation.
    No effect other than those already mentioned in section “Adverse reactions” have been observed after
    the administration of several doses, except hyperthermia that may exceptionally last 5 days.
    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
    15/01/2010
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.europa.eu/
    15. OTHER INFORMATION
    Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent
    Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent
    Not all pack sizes may be marketed.
    To be supplied only on veterinary prescription.
    17


    Source: European Medicines Agency


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