Trifexis

spinosad / milbemycin oxime

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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 Trifexis and what is it used for?

Trifexis is a veterinary medicine used to treat and prevent flea infestations in dogs. Trifexis is only to be used when there is also a need for one or more of the following:

  • to prevent heartworm disease (roundworms that infect the heart and blood vessels and are
    transmitted by mosquitoes);
  • to prevent lungworm disease (transmitted by eating slugs or snails);
  • to treat gut infections by other types of worms (the nematodes hookworm, roundworm and whipworm).

Trifexis may also be used as part of a treatment strategy for the control of flea allergy dermatitis (an allergic reaction to flea bites).

Trifexis contains two active substances, spinosad and milbemycin oxime.

How is Trifexis used?

Trifexis should be given with food or immediately after feeding; the dose (the number of tablets of particular strengths to use) depends on the bodyweight of the dog. For the appropriate strength of tablet and number of tablets to be given, see the dosage table in the package leaflet.

In areas where heartworm infection is known to occur, treatment should be given at monthly intervals, starting one month before the time of year when mosquitoes and fleas are present until at least one month after the last exposure to mosquitoes. Trifexis should not be given for more than six consecutive months in any one year.

In areas where heartworm infection does not occur, dogs may be given a single dose of Trifexis to prevent seasonal fleas when infections with gut worms have been diagnosed. Subsequent flea prevention should be with a different product containing a single active substance.

In areas where lungworm infection is known to occur, Trifexis should be given at monthly intervals during the time of year when snails/slugs and fleas are present until at least one month after last exposure to slugs and snails. Trifexis should not be given for more than six consecutive months in any one year.

How does Trifexis work?

One of the active substances in Trifexis, spinosad, interferes with receptors in the fleas’ nervous system (nicotinic acetylcholine receptors), resulting in subsequent paralysis and death of the fleas. 

The second active substance, milbemycin oxime, causes paralysis and death of worms by interfering with the way signals are passed between nerve cells in the parasites’ nervous system.

Trifexis can prevent flea infestation for up to four weeks after a single administration because it kills adult fleas and reduces egg production.

What benefits of Trifexis have been shown in studies?

For prevention and treatment of flea infestations, a field study was conducted in which 178 dogs were treated with Trifexis and 88 dogs were treated with another flea medicine containing selamectin. The study showed a 90% reduction in flea count in 97% and 89% of Trifexis-treated dogs at days 14 and 30 respectively, compared with 86% and 73% in the selamectin-treated dogs.

For treatment of gut worm infections the company submitted data from a field study involving a total of 229 dogs. Trifexis-treated dogs were compared to dogs treated with milbemycin oxime alone. The measure of effectiveness was based on the proportion of dogs with at least a 90% reduction in the number of worm eggs in their faeces. The study showed the success rate with Trifexis against gut worms to be comparable to the success rate with milbemycin oxime alone.

For prevention of heartworm disease in three laboratory studies, dogs aged 4 to 9 months were artificially infected with European strains of heartworm and then treated with Trifexis at different times after infection. Treatment with Trifexis was compared with a dummy treatment containing no active substance. The studies showed that a single treatment 30 days after infection gave 100% prevention for one strain, but three consecutive monthly treatments were needed for the other less susceptible heartworm strains.

For prevention of lungworm disease, two laboratory studies were conducted in dogs which were artificially infected with European strains of lungworm and then treated with Trifexis 30 days later. The studies showed that a single treatment 30 days after infection gave 95% protection.

What are the risks associated with Trifexis?

Trifexis must not be used in puppies less than 14 weeks of age.

Vomiting in the first 48 hours after treatment is common (seen in up to 1 in 10 animals). In most cases it is mild and short lived without requiring treatment. Other common side effects include lethargy (sluggishness), decreased appetite, diarrhoea, pruritus (itching), dermatitis (inflammation of the skin) and reddening of the skin and ear.

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

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

Accidental ingestion may cause side effects.

If the medicine is accidentally ingested, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Hands should be washed after handling the product.

Children must not come into contact with Trifexis.

Why is Trifexis approved?

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

Other information about Trifexis

The European Commission granted a marketing authorisation valid throughout the EU, for Trifexis on 19/09/2013.

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

Name Language First published Last updated
Trifexis : EPAR - Summary for the public BG = bălgarski 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public ES = español 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public CS = čeština 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public DA = dansk 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public DE = Deutsch 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public ET = eesti keel 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public EL = elliniká 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public EN = English 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public FR = français 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public IT = italiano 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public LV = latviešu valoda 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public LT = lietuvių kalba 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public HU = magyar 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public MT = Malti 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public NL = Nederlands 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public PL = polski 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public PT = português 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public RO = română 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public SK = slovenčina 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public SL = slovenščina 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public FI = suomi 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public SV = svenska 2013-10-17 2017-04-10
Trifexis : EPAR - Summary for the public HR = Hrvatski 2013-10-17 2017-04-10

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Trifexis
NameTrifexis
Agency product numberEMEA/V/C/002635
Active substance

spinosad / milbemycin oxime

International non-proprietary name (INN) or common name

spinosad / milbemycin oxime

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QP54AB51



Publication details

Publication details for Trifexis
Marketing-authorisation holder

Eli Lilly and Company Limited

Revision3
Date of issue of marketing authorisation valid throughout the European Union19/09/2013

Contact address:

Eli Lilly and Company Limited
Elanco Animal Health
Priestly Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

Product information

Product information

17/02/2017  Trifexis -EMEA/V/C/002635 -II/0008

Name Language First published Last updated
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10
Trifexis : EPAR - Product Information HR = Hrvatski 2013-10-17 2017-04-10

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
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  
Trifexis : EPAR - All Authorised presentations HR = Hrvatski 2013-10-17  

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents – endectocides

Therapeutic indication

For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently:

  • prevention of heartworm disease (L3, L4 Dirofilaria immitis);
  • prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum;
  • treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult, L5) and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Trifexis : EPAR - Public assessment report HR = Hrvatski 2013-10-17  
CVMP summary of positive opinion for Trifexis HR = Hrvatski 2013-07-19