Activyl Tick Plus

indoxacarb / permethrin

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This 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 summary 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 and what is it used for?

Activyl Tick Plus is a veterinary medicine used in dogs to treat:

  • flea infestations and can be used as part of a treatment strategy for flea allergy dermatitis (FAD), an itchy skin disease which can affect dogs;
  • tick infestations

Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.

Activyl Tick Plus contains the active substances indoxacarb and permethrin.

For further information, see the package leaflet.

How is Activyl Tick Plus used?

The medicine, available as a spot-on solution, is given as a single application to the dog’s skin . The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights. For very small and small dogs the full content of a pipette appropriate for the dog’s weight is applied to the skin between the shoulder blades, after parting the fur. For larger dogs the content can be applied in two (medium dogs), three (large dogs) or four (very large dogs) different spots along the back from the shoulders to the base of the tail. The medicine can only be obtained with a prescription.

How does Activyl Tick Plus work?

The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas and ticks that may be found on the skin or in the fur of animals. After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form). Together, the active form of indoxacarb and permethrin interfere with the parasites’ nervous system, causing paralysis and death. Permethrin also acts as a repellent and so helps prevent sand flies from settling and taking a blood meal.

What benefits of Activyl Tick Plus have been shown in studies?

The effectiveness of Activyl Tick Plus against fleas and ticks 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 12 weeks. The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals. Both treatments reduced flea and tick numbers to almost zero by the end of the study period.

The effectiveness of Activyl Tick Plus against sand flies was shown in two laboratory studies. The main measure of effectiveness was the repellant effect against sandflies as measured by the number of fed female sand flies. In one study Activyl Tick Plus showed repellant activity of above 95% at 1 day after treatment falling to 92% at 3 weeks after treatment. In the other study Activyl Tick Plus showed repellant activity of 98% at 2 days after treatment falling to 86% at 3 weeks.

What are the risks associated with Activyl Tick Plus?

The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) 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.

Fleas, ticks and sand flies might still be able to transmit any diseases which they may be carrying.

For the full list of restrictions, see the package leaflet.

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

People should not eat, drink or smoke while handling the medicine. Protective gloves should be worn when handling or applying Activyl Tick Plus to dogs. Hands should be washed immediately after use and any product in contact with the skin should be washed off immediately with soap and water. People who are 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 should be applied in a well-ventilated area and treated dogs should not be handled until the application site is dry. 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. On the day of treatment, children must not handle treated dogs and the dogs should not be allowed to sleep with their owners especially children.

If adverse reactions occur medical advice should be sought and the package leaflet shown to the doctor.

Why is Activyl Tick Plus approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Activyl Tick Plus’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Activyl Tick Plus:

The European Commission granted a marketing authorisation valid throughout the EU for Activyl Tick Plus on 9 January 2012.

For more information about treatment with Activyl Tick Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Activyl Tick Plus : EPAR - Summary for the public BG = bălgarski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public ES = español 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public CS = čeština 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public DA = dansk 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public DE = Deutsch 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public ET = eesti keel 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public EL = elliniká 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public EN = English 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public FR = français 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public IT = italiano 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public LV = latviešu valoda 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public LT = lietuvių kalba 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public HU = magyar 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public MT = Malti 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public NL = Nederlands 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public PL = polski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public PT = português 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public RO = română 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public SK = slovenčina 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public SL = slovenščina 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public FI = suomi 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public SV = svenska 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Summary for the public HR = Hrvatski 2012-01-24 2017-09-06

This EPAR was last updated on 13/09/2017 .

Authorisation details

Product details

Product details for Activyl Tick Plus
NameActivyl Tick Plus
Agency product numberEMEA/V/C/002234
Active substance

indoxacarb / permethrin

International non-proprietary name (INN) or common name

indoxacarb / permethrin

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53AC54



Publication details

Publication details for Activyl Tick Plus
Marketing-authorisation holder

Intervet International BV

Revision5
Date of issue of marketing authorisation valid throughout the European Union09/01/2012

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

Product information

24/05/2017  Activyl Tick Plus -EMEA/V/C/002234 -II/0008

Name Language First published Last updated
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06
Activyl Tick Plus : EPAR - Product Information HR = Hrvatski 2012-01-24 2017-09-06

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  
Activyl Tick Plus : EPAR - All Authorised presentations HR = Hrvatski 2012-01-24  

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents

Therapeutic indication

Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis. The product has persistent acaricidal efficacy for up to 5 weeks against Ixodes ricinus and up to 3 weeks against Rhipicephalus sanguineus. One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Activyl Tick Plus : EPAR - Public assessment report HR = Hrvatski 2012-01-24  
CVMP summary of positive opinion for Activyl Tick Plus HR = Hrvatski 2011-11-11