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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/899251/2011

EMEA/V/C/002234

EPAR summary for the public

Activyl Tick Plus

Indoxacarb and 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 Activyl Tick Plus?

Activyl Tick Plus is a veterinary medicine that contains the active substances indoxacarb and permethrin. It is available as a 'spot-on' solution in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of different weights (75 mg/240 mg, 150 mg/480 mg,

300 mg/960 mg, 600 mg/1920 mg and 900 mg/2880 mg).

What is Activyl Tick Plus used for?

Activyl Tick Plus is used to treat flea infestations in dogs. It may also kill certain types of ticks if they are present when the medicine is applied. It can be used as part of a treatment strategy for flea allergy dermatitis (FAD), an itchy skin disease which can affect dogs.

The appropriate dose is determined by the dog's body weight. The contents of a full pipette are applied directly to the skin between the shoulder blades, after parting the fur. For larger dogs it can be applied in up to four different spots along the back from the shoulders to the base of the tail.

How does Activyl Tick Plus work?

The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas that live on the skin or in the fur of animals. After application, indoxacarb and permethrin are consumed by the insects (indoxacarb is converted in their gut into an active form).

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Together, the active form of indoxacarb and permethrin interfere with the parasites' nervous system, causing paralysis and death. Permethrin also acts as a mild repellent.

How has Activyl Tick Plus been studied?

The effectiveness of Activyl Tick Plus against fleas was investigated in laboratory studies and in three field studies. One field study involved 230 dogs where Activyl Tick Plus was compared with fipronil (another ectoparasiticide), where the medicines were given every four weeks for 84 days. The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals.

What benefit has Activyl Tick Plus shown during the studies?

Both treatments reduced flea and tick numbers to almost zero by the end of the study period.

What is the risk associated with Activyl Tick Plus?

The main side effects seen with Activyl Tick Plus are transitory scratching, erythema (reddening of the skin) and hair loss at the application site. These effects usually resolve without treatment. The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue. This is normal and will generally resolve within a couple of days.

Activyl Tick Plus must not be used in cats. It must not be used in dogs which are known to be hypersensitive (allergic) to indoxacarb, permethrin or to any of the other ingredients.

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

Users should not eat, drink or smoke while handling the medicine. They should wash their hands immediately after use. People known to be hypersensitive to indoxacarb or permethrin should avoid contact with the product. If Activyl Tick Plus is accidentally spilled into eyes, it should be rinsed off with water. The medicine is highly flammable and should be kept away from possible sources of ignition. To protect children, the medicine should be kept in its sachet until use, and the used pipette should be disposed of immediately.

Why has Activyl Tick Plus been approved?

The CVMP considered that the medicine was effective in eliminating flea infestations and controling and preventing new flea and tick infestations for up to three to four weeks after treatment. The Committee also noted that Activyl Tick Plus combined two active substances thereby reducing the need to use two different products against flea and tick infestations.

The CVMP therefore concluded that the benefits of Activyl Tick Plus exceed the risks and recommended that it be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Activyl Tick Plus:

The European Commission granted a marketing authorisation valid throughout the European Union, for Activyl Tick Plus to Intervet International BV on 09/01/2012. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 09/01/2012.

Activyl Tick Plus EMA/899251/2011