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EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCPCH EPAR summary for the public

What is Purevax RCPCh?

Purevax RCPCh is a vaccine containing the following active substances:

•    attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),

•    inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),

•    attenuated Chlamydophila felis (905 strain),

•    attenuated feline panleucopenia virus (PLI IV).

•

Purevax RCPCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.

What is Purevax RCPCh used for?

Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:

•    feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),

•    feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),

•    chlamydiosis (a flu-like illness caused by the bacterium C. felis),

•    feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus).

The vaccine helps to reduce the symptoms of the diseases. It also helps to reduce viral excretion in case of calicivirus infection. It can also prevent death due to panleucopenia.

After Purevax RCPCh has been made up, 1 ml is injected under the skin. The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later. If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age. The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis, and every three years for panleucopenia.

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How does Purevax RCPCh work?

Purevax RCPCh is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.

When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria. The antibodies will help to protect against the diseases caused by these viruses or bacteria. When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.

How has Purevax RCPCh been studied?

The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus, C. felis or parvovirus. In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection). They included young and adult cats of various breeds, but not young kittens. The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.

What benefit has Purevax RCPCh shown during the studies?

In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above. In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses. It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study. In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.

What is the risk associated with Purevax RCPCh?

Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days. There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks. For a full list of the side-effects reported with Purevax RCPCh, see the Package Leaflet.

Purevax RCPCh should not be used in pregnant cats.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor. The vaccine should not be handled by people with a weak immune system. If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.

Why has Purevax RCPCh been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCPCh be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Purevax RCPCh:

The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh to MERIAL on 23 February 2005.

This summary was last updated on 25 January 2008.

©EMEA 2008 3/3