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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/206131/2014

EMEA/V/C/002746

EPAR summary for the public

Vectra Felis

Dinotefuran / pyriproxyfen

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 Vectra Felis?

Vectra Felis is a veterinary medicine that contains two active substances: dinotefuran and pyriproxyfen. It is available as a spot-on solution in an applicator for use on cats.

What is Vectra Felis used for?

Vectra Felis is used on cats to treat and prevent flea infestations. Its actions last for one month, and it prevents fleas from hatching and developing for three months. It may also be used as part of a treatment strategy for flea allergy dermatitis (an allergic reaction to flea bites).

The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head. The responsible veterinarian should assess the need for repeat treatment and the appropriate time interval.

How does Vectra Felis work?

The active substances in Vectra Felis act as ectoparasiticides. This means that they kill parasites that live on the skin or in the fur of animals, such as fleas and ticks that feed on the animal's skin.

Dinotefuran is an insecticide which kills insects by acting on receptors called nicotinic acetylcholine receptors in their nervous system. Pyriproxyfen is an insect growth regulator which stops the flea life

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cycle by causing production of infertile eggs as well as by blocking the development of juvenile flea stages into adults.

How has Vectra Felis been studied?

The effectiveness of Vectra Felis against fleas was investigated in a large number of laboratory studies and in one field study.

The field study involved 129 cats with flea infestations that were treated once a month for three consecutive months either with Vectra Felis or with another spot-on product containing two different substances, fipronil and (S)-methoprene, that control fleas. The measure of effectiveness was reduction of flea counts.

What benefit has Vectra Felis shown during the studies?

The field study showed that Vectra Felis was as effective as the comparator product and reduced flea counts by 91% over the 84 day study period.

The study also showed that Vectra Felis was effective as an aid in the treatment of flea allergy dermatitis in cats.

What is the risk associated with Vectra Felis?

Temporary signs may be noticed at the site of application of the product, such as a wetness and a white colour, but these signs do not affect the safety or effectiveness of the product.

Cats may rarely show a slight scaling of their skin, temporary redness and itching or temporary hair loss at the application site. These usually disappear without any treatment.

For a full list of all side-effects reported with Vectra Felis, see the package leaflet.

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

If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin the skin should be washed with soap and water.

If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.

People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.

People must not handle treated cats for at least eight hours after application of the veterinary medicine. Treated cats should not be permitted to sleep with their owners, especially children, on the day of treatment.

Why has Vectra Felis been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vectra Felis exceed the risks for the approved indications and recommended that Vectra Felis be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Vectra Felis:

The European Commission granted a marketing authorisation valid throughout the European Union, for Vectra Felis on 6 June 2014. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in April 2014.

Vectra Felis

EMA/615923/2013

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