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Purevax RCCh
vaccine against feline viral rhinotracheitis, feline calicivirosis and feline Chlamydophila infections

14

Medicinal product no longer authorised


PACKAGE LEAFLET FOR:


Purevax RCCh

Lyophilisate and solvent for suspension for injection.


authorised

  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 THE VETERINARY MEDICINAL PRODUCT


    no

    Purevax RCCh

    Lyophilisate and solvent for suspension for injection.


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    Per dose of 1ml:


    Lyophilisate:

    Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains) ..................... 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) .................................................................... 103.0 EID502

    Medicinal

    Excipient:

    Gentamicin, at most.......................................................................................................................... 28 µg


    Solvent:

    Water for injection .......................................................................................................................q.s. 1 ml


    1: cell culture infective dose 50%

    2: egg 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,

    • against Chlamydophila felis infection to reduce clinical signs.

      Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.


      authorised

      The duration of immunity is 1 year after the last (re-)vaccination.


  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.

    In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats. The reaction was transient

    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

    veterinary surgeon.


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  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,

      Medicinal

    • second injection: 3 to 4 weeks later.

    Where high levels of maternal antibodies against R, C or Ch components are expected to be present

    (e.g. in kittens of 9-12 weeks of age born 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


    Not applicable.


    authorised

  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.


  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.

    This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products. If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.


    Do not use in pregnant animals.

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    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.


    Medicinal

  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) https://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.