Certifect (fipronil /amitraz /(S)-methoprene) - QP53AX65
Updated on site: 09-Feb-2018
|Substance:||fipronil /amitraz /(S)-methoprene|
- What is Certifect?
- How does Certifect work?
- How has Certifect been studied?
- What benefit has Certifect shown during the studies?
- What is the risk associated with Certifect?
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
- Why has Certifect been approved?
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
What is Certifect?
Certifect is a medicine that contains three active substances, fipronil,
What is Certifect used for?
Certifect is used in dogs to treat and prevent infestations with ticks and fleas, and to treat infestations with chewing lice. The medicine can be used in the management of flea allergy dermatitis (an allergic reaction to flea bites).
The content of one full Certifect pipette (appropriate to the dog’s weight) is applied directly to the dog’s skin, after parting its fur, in two separate spots (halfway down the back of the neck, and at the base of the neck). Treatment should be repeated every month throughout the tick and/or flea seasons.
How does Certifect work?
The active substances in Certifect act as ‘ectoparasiticides’. This means that they kill parasites that live on the skin or in the fur of animals, such as ticks, fleas and lice. Both fipronil and amitraz kill adult parasites while
© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
which results in uncontrolled activity of the central nervous system and death of these parasites. Amitraz stimulates the nervous system of ticks, leading to hyperactivity and death of the ticks. (S)- Methoprene is absorbed into flea eggs or larvae, where it stops their development.
How has Certifect been studied?
The effectiveness of Certifect against ticks and fleas was investigated in both laboratory and field studies. In the main field study, dogs of various breeds, age groups, gender and different weights were treated with either Certifect or a similar
What benefit has Certifect shown during the studies?
The studies showed that the effect of Certifect is comparable to that of the combination of fipronil with
What is the risk associated with Certifect?
Dogs may show some temporary reactions at the site of application (skin discolouration, hair loss, itching or redness). Dogs may lack energy, show lack of muscle coordination, vomit, have a loss of appetite, diarrhoea, salivate, have blood sugar levels higher than normal, be more sensitive to stimulation, and have a slow heartbeat or slow breathing. These signs generally resolve without treatment and within one day.
For a full list of all side effects reported with Certifect, see the package leaflet.
Certifect must not be used on sick (e.g. with systemic diseases such as diabetes, or with a fever) or recovering animals.
Certifect must not be used on rabbits and cats.
Certifect should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
This medicine can cause skin sensitisation and allergic reactions, and people with known allergy to any of the ingredients should avoid contact with the pipette contents. Gloves are recommended. Contact with the application site should be avoided. Children should not be allowed to play with the treated dogs until the application site is dry. The medicine should be applied in a
Why has Certifect been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Certifect outweigh the risks for the approved indications and recommended that Certifect be given a marketing authorisation. The
Other information about Certifect:
The European Commission granted a marketing authorisation valid throughout the European Union, for Certifect on 6 May 2011. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in September 2013.