European Medicines Agency Veterinary Medicines

EMEA/V/C/143

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LEUCOFELIGEN FELV/RCP EPAR summary for the public

What is Leucofeligen FeLV/RCP?

Leucofeligen FeLV/RCP is a vaccine for cats. It is available as two vials, one containing a white powder pellet and one containing a liquid. The powder contains live attenuated (weakened) feline viruses: feline calicivirus (strain F9), viral rhinotracheitis virus (strain F2) and feline panleucopenia virus (strain LR 72). The liquid contains a protein of feline leukaemia virus (FeLV). The contents of the two vials are mixed together before use to make up a suspension for injection.

What is Leucofeligen FeLV/RCP used for?

Leucofeligen FeLV/RCP is used to vaccinate cats from eight weeks of age against the following diseases:

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

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

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

•    feline leukaemia (an illness affecting the immune system caused by a retrovirus).

The vaccine helps to reduce the signs of these diseases. It can also help to reduce excretion of feline viral rhinotracheitis viruses, to prevent a fall in white blood cell counts in feline panleucopenia and to prevent FeLV remaining in the blood.

Leucofeligen FeLV/RCP is given to kittens as two injections under the skin. The first injection is given when the kitten is about eight weeks old, and the second three/four weeks later. Afterwards, cats need a booster injection every year.

How does Leucofeligen FeLV/RCP work?

Leucofeligen FeLV/RCP is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Leucofeligen FeLV/RCP contains small amounts of the three types of weakened virus listed above and protein from the FeLV called ‘envelope p45 protein’. The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant DNA technology’.

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When a cat is given the vaccine, the immune system recognises the weakened viruses and the FeLV proteins as ‘foreign’ and makes antibodies against them. In the future, the cat’s immune system will be able to produce antibodies more quickly when it is exposed to the viruses. The antibodies will help to protect against the diseases caused by these viruses. When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection. The vaccine also contains an ‘adjuvant’ (a compound containing aluminium) to stimulate a better protective immune response.

How has Leucofeligen FeLV/RCP been studied?

Because Leucofeligen FeLV/RCP is made up of two vaccines that have been available in the European Union (EU) since the 1980s (Feligen RCP and Leucogen), the company used data from studies carried out with these vaccines to support the use of Leucofeligen FeLV/RCP. Leucofeligen FeLV/RCP has been examined in two main ‘field’ studies involving kittens aged eight to nine weeks. The main measure of effectiveness was the presence of antibodies against the viruses in the vaccinated kittens’ blood. Further studies were carried out under laboratory conditions to confirm the other benefits of vaccination.

What benefit has Leucofeligen FeLV/RCP shown during the studies?

The studies showed that Leucofeligen FeLV/RCP provided protection against the diseases listed above. In addition, it reduced the excretion of feline viral rhinotracheitis viruses, prevented a fall in white blood cell counts in feline panleucopenia and prevented FeLV from remaining in the blood.

What is the risk associated with Leucofeligen FeLV/RCP?

A temporary small nodule (hard swelling) may appear at the site of injection. This usually resolves on its own within three to four weeks. This reaction is reduced after subsequent injections. In rare cases, there may be pain on being touched, sneezing or conjunctivitis (eye inflammation). These resolve without any treatment. The temporary usual signs following vaccination, such as increased temperature, apathy (listlessness) and digestive problems such as abdominal discomfort may also be seen following vaccination. For a full list of all side effects reported with Leucofeligen FeLV/RCP, see the Package Leaflet.

Leucofeligen FeLV/RCP should not be used in pregnant cats. Its use is not recommended in cats nursing kittens.

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.

Why has Leucofeligen FeLV/RCP been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucofeligen FeLV/RCP exceed the risks for the active immunisation of cats from eight weeks of age against the diseases listed above. The Committee recommended that Leucofeligen FeLV/RCP be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Leucofeligen FeLV/RCP:

The European Commission granted a marketing authorisation valid throughout the European Union, for Leucofeligen FeLV/RCP to Virbac S.A. on 25 June 2009. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 25 June 2009.

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