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AstraZeneca

Purevax RCPCh FeLV
vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukeamia and feline Chlamydophila infections


PACKAGE LEAFLET:

Purevax RCPCh FeLV 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: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein

    GERMANY


    Manufacturer responsible for the batch release: Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes

    Rue de l'Aviation 69800 Saint Priest FRANCE


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection


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


    Per dose of 1 ml or 0.5 ml:


    Lyophilisate: Active substances:

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

    Attenuated feline panleucopenia virus (PLI IV) ............................................. 103.5 CCID501


    Excipient:

    Gentamicin, at most.......................................................................................... 34 µg


    Solvent:

    Active substance:

    FeLV recombinant canarypox virus (vCP97) .................................................. 107.2 CCID501


    1. cell culture infective dose 50%.

    2. egg infective dose 50%.


    Lyophilisate: homogeneous beige pellet.

    Solvent: clear colourless liquid with presence of cell debris in suspension.


  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,

    • against Chlamydophila felis infection to reduce clinical signs,

    • against feline panleucopenia to prevent mortality and clinical signs,

    • against leukaemia to prevent persistent viraemia and clinical signs of the related disease.


      Onsets of immunity: Rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components: 1 week after primary vaccination course.

      Feline leukaemia component: 2 weeks after primary vaccination course.


      Duration of immunity:

    • Rhinotracheitis, calicivirosis and panleucopenia components:1 year after primary vaccination course and 3 years after the last re-vaccination.

    • Chlamydophila felis and feline leukaemia components: 1 year after the last re-vaccination .


  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS


    Transient apathy and anorexia as well as hyperthermia (lasting usually for 1 or 2 days) were commonly observed during safety and field studies. A local reaction (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most was commonly observed during safety and field studies.


    A hypersensitivity reaction has been observed uncommonly in field studies, which may require appropriate symptomatic treatment.


    Emesis (mostly within 24 to 48 hours) has been observed in very rare cases based on post-marketing safety experience.


    Transient hyperthermia and lethargy, sometimes associated with lameness, have been observed 1 to

    3 weeks following booster vaccination in adult cats, in very rare cases, based on post marketing safety experience.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

    • common (more than 1 but less than 10 animals treated in 100 animals)

    • uncommon (more than 1 but less than 10 animals treated in 1,000 animals )

    • rare (more than 1 but less than 10 animals in 10,000 animals treated)

    • very rare (less than 1 animal in 10,000 animals treated, including isolated reports).


      If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Cats.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Subcutaneous route.


    After reconstitution of the lyophilisate with 0.5 ml or 1 ml of the solvent (depending on the presentation chosen) inject one dose of vaccine, 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 rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9 to 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:

    • the first revaccination must be carried out for all components one year after the primary vaccination course,

    • subsequent revaccinations:

      • Chlamydiosis and feline leukaemia components: every year.

      • Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.


  9. ADVICE ON CORRECT ADMINISTRATION


    Reconstitute gently the vaccine in order to obtain a uniform suspension with limited foam formation. Visual appearance after reconstitution: slightly yellow suspension with presence of cell debris in suspension.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children. Store and transport refrigerated (2 °C 8 °C). Protect from light.

    Do not freeze.

    Do not use this veterinary medicinal product after the expiry date, which is stated on the label after EXP Shelf life after reconstitution according to directions: use immediately.


  12. SPECIAL WARNING(S)


    Special warnings for each target species: Vaccinate healthy animals only.


    Special precautions for use in 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 insert 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.

    Pregnancy and lactation:

    Do not use during the whole pregnancy and lactation.


    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 Boehringer Ingelheim adjuvanted vaccine against rabies.

    No information is available on the safety and efficacy of this vaccine when used with any other

    veterinary medicinal product except the products mentioned above. 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):

    No effect other than those already mentioned in section on “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.


    Incompatibilities:

    Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    .


  15. OTHER INFORMATION


The feline leukaemia 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.

The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.


Plastic box containing:

10 x 1 dose of lyophilisate and 10 x 1 ml of solvent or 50 x 1 dose of lyophilisate and 50 x 1 ml of solvent or

10 x 1 dose of lyophilisate and 10 x 0.5 ml of solvent or

50 x 1 dose of lyophilisate and 50 x 0.5 ml of solvent. Not all pack sizes may be marketed.