Purevax RCPCh lyophilisate and solvent for suspension 10 Dose

Purevax RCPCh lyophilisate and solvent for suspension for injection (10 Dose).

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 Chlamydophila felis (905 strain) = 103.0 EID50

Attenuated feline panleucopenia virus (PLI IV) = 103.5 CCID50

Excipient:

Gentamicin, at most 28 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; against Chlamydophila felis infection to reduce clinical signs; 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, Chlamydophila felis and panleucopenia components.

The duration of immunity is 1 year after the last (re)vaccination for rhinotracheitis, calicivirus, and Chlamydophila felis, 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 chlamydiosis components, and every three years for the panleucopenia component.

Where high levels of maternal antibodies against R, C, P 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.

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.

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.

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 label to the physician.

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

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.