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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/615923/2013

EMEA/V/C/002555

EPAR summary for the public

Vectra 3D

Dinotefuran / pyriproxyfen / permethrin

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 3D?

Vectra 3D is a veterinary medicine that contains three active substances: dinotefuran, pyriproxyfen and permethrin. It is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.

What is Vectra 3D used for?

Vectra 3D is used on dogs to treat and prevent flea and tick infestations and to repel sand flies, mosquitoes and stable flies. Its actions last for up to a month, and it prevents fleas from hatching and developing for two months. It may also be used as part of a treatment strategy for flea allergy dermatitis (an allergic reaction to flea bites).

The dose of Vectra 3D depends on the dog's body weight. The content of one full Vectra 3D applicator is applied directly to the dog's skin, after parting its fur, either in one or more spots on the back, depending on the dog's weight, or in a continuous line along the centre of the back from the base of the tail to the shoulder blades. Treatment can be repeated once a month.

How does Vectra 3D work?

The active substances in Vectra 3D 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.

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Dinotefuran and permethrin are insecticides which kill insects by acting on their nervous system by different mechanisms; permethrin also acts similarly on ticks. Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together they reinforce each other's action. Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.

How has Vectra 3D been studied?

The effectiveness of Vectra 3D against fleas, ticks, mosquitoes and flies was investigated in 24 laboratory studies and in two field studies.

One field study involved 485 dogs with flea and/or tick infestations that were treated once either with Vectra 3D or another spot-on product containing two other substances that control fleas and ticks, fipronil and (s)-methoprene. The measure of effectiveness was reduction of flea and tick counts.

A second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)-methoprene. The measure of effectiveness was reduction of flea counts.

What benefit has Vectra 3D shown during the studies?

The first field study showed that dogs treated with Vectra 3D had fleas reduced by 79% over the 4 week study period compared with a reduction of 57% for dogs treated with the other product. The study also showed a reduction of over 90% in the signs of flea allergy dermatitis in dogs treated with either Vectra 3D or the comparator product. The dogs treated with Vectra 3D had an average tick reduction of 94% compared with 97% in the control group over 4 weeks.

The second field study showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.

What is the risk associated with Vectra 3D?

Dogs may very rarely show short-lived redness, itching or other signs of discomfort at the application site. These usually disappear within 24 hours after administration. Dogs may very rarely vomit or have diarrhoea.

For a full list of all side-effects reported with Vectra 3D, see the package leaflet.

Vectra 3D must not be used on cats and they must not be allowed to groom dogs treated with the medicine, as it may cause harmful effects that could be fatal.

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

People applying the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.

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.

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

Why has Vectra 3D been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vectra 3D exceed the risks for the approved indications and recommended that Vectra 3D be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Vectra 3D:

The European Commission granted a marketing authorisation valid throughout the European Union, for Vectra 3D on 04/12/2013. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in October 2013.

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Vectra 3D

EMA/615923/2013