Purevax RCPCh FeLV (Attenuated feline rhinotracheitis herpesvirus...) – Package leaflet - QI06AX

Updated on site: 09-Feb-2018

Medication name: Purevax RCPCh FeLV
ATC: QI06AX
Substance: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox viru
Manufacturer: Merial

PACKAGE LEAFLET FOR:

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: MERIAL

29, avenue Tony Garnier 69007 Lyon

FRANCE

Manufacturer responsible for the batch release: MERIAL

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:

 

 

Lyophilisate:

≥ 104.9

CCID501

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) .......................................

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:

≥ 107.2

CCID501

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

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,

-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 have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.

The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis and feline leukaemia components.

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.

* less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports.

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 (1 ml) 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 rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila 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:

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

-subsequent revaccinations must be carried out: every year for the chlamydiosis and feline leukaemia components and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.

9.ADVICE ON CORRECT ADMINISTRATION

Use immediately after reconstitution.

10.WITHDRAWAL PERIOD

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.

12.SPECIAL WARNING(S)

Special precautions for use in animals: Use in healthy animals only.

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 in pregnant animals.

The use is not recommended during 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 Merial adjuvanted vaccine against rabies.

Overdose (symptoms, emergency procedures, antidotes):

No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, 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

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

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.

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.

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