Purevax RCP
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 16.5 μg
Solvent:
Water for injections q.s. 1 ml
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; and against feline panleucopenia to prevent mortality and reduce clinical signs. Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components.
The duration of immunity is 1 year after the last (re)vaccination for rhinotracheitis and calicivirus, 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 primary vaccination, then every year for the rhinotracheitis and calicivirosis 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.
Interaction with other veterinary medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial PUREVAX non-adjuvanted vaccine against feline leukaemia and/or 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/2/04/052/001.