Purevax RCPFeLV

Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Lyophilisate and solvent for suspension for injection.

Active substance(s)

Per 1 ml dose:

Freeze-dried pellet:

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ≥ 104.9 CCID50

Inactivated feline calicivirosis antigens (FCV 431 and G1 strains) ≥ 2.0 ELISA U.

Attenuated feline panleucopenia virus (PLI IV) ≥ 103.5 CCID50

Excipient:

Gentamicin, at most 23 μg

Solvent:

FeLV recombinant canarypox virus (vCP97) ≥ 107.2 CCID50

Uses

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 viral excretion; against feline panleucopenia to prevent mortality and reduce clinical signs; and against feline leukaemia to prevent persistent viraemia and reduce clinical signs of the disease. Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.

The duration of immunity is 1 year after the last (re)vaccination for rhinotracheitis, calicivirus and feline leukaemia components, and 3 years for panleucopenia component.

Dosage and administration

1 ml by subcutaneous injection after reconstitution of the freeze-dried pellet with the solvent, according to the following schedule:

Primary vaccination: First injection: from 8 weeks of age,

Second injection: 3 to 4 weeks later.

Revaccination: For all components one year after the primary vaccination course, then every year for the rhinotracheitis, calicivirosis and feline leukaemia components, and every three years for the panleucopenia component.

In the presence of high levels of maternally derived specific antibodies, the primary vaccination course should be delayed until 12 weeks of age.

Contra-indications, warnings, etc

For animal treatment only.

Do not use in pregnant animals. Use is not recommended during lactation.

Undesirable effects

Under 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.

Special precautions for use

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.

Interaction with other veterinary 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 (RABISIN). Do not mix with any other vaccine or immunological product.

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.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Use immediately after reconstitution.

Store and transport at 2°C - 8°C (in a refrigerator), protected from light. Do not freeze.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category

POM-V

Packaging Quantities

10 bottles of 1 dose of lyophilisate and 10 bottles of 1ml of solvent.

Further information

None.

Marketing authorisation number

EU/2/04/048/001.