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Leucogen

European Medicines Agency Veterinary Medicines

EMEA/V/C/144

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LEUCOGEN

EPAR summary for the public

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR)._


What is Leucogen?

Leucogen is a vaccine for cats that contains a protein of feline leukaemia virus (FeLV). Leucogen is available as a suspension for injection.

What is Leucogen used for?

Leucogen is used to vaccinate cats from eight weeks of age against feline leukaemia (an illness affecting the immune system caused by a retrovirus). It is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.

Leucogen 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 Leucogen work?

Leucogen is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Leucogen contains small amounts of a 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’.

When a cat is given the vaccine, the immune system recognises the FeLV protein as ‘foreign’ and makes antibodies against it. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to FeLV. The antibodies will help to protect against the disease caused by the virus. When exposed to the virus later in life, the cat will either not become infected or have a much less serious infection.

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How has Leucogen been studied?

Because Leucogen has been available in the European Union (EU) since 1988, and is also used as part of a multivalent vaccine called Leucofeligen FeLV/RCP, the company used data from studies carried out with these vaccines to support the use of Leucogen.

Two main ‘field’ studies involved kittens aged eight to nine weeks, the first using Leucogen and the second using Leucofeligen FeLV/RCP. The main measure of effectiveness was the presence of antibodies against FeLV in the vaccinated kittens’ blood. Further studies were carried out under laboratory conditions to show that vaccination prevented FeLV from remaining in the blood.

What benefit has Leucogen shown during the studies?

The studies showed that Leucogen provided protection against FeLV infection. Vaccination on two occasions with three to four weeks between injections prevented FeLV from remaining in the blood and prevented the signs of FeLV infection.

What is the risk associated with Leucogen?

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 Leucogen, see the Package Leaflet. Leucogen 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 Leucogen been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucogen exceed the risks for the active immunisation of cats from eight weeks of age against feline leukaemia, and recommended that Leucogen be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Leucogen:

The European Commission granted a marketing authorisation valid throughout the EU for Leucogen to Virbac S.A. on 17 June 2009. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 17 June 2009.

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