MiPet Easecto

sarolaner

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This is a summary of the European public assessment report (EPAR) for MiPet Easecto.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use MiPet Easecto.

For practical information about using MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is MiPet Easecto and what is it used for?

MiPet Easecto is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs. After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks. MiPet Easecto can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites). It contains the active substance sarolaner. For further information, see the package leaflet.

This medicine is the same as Simparica, which is already authorised in the EU. The company that makes Simparica has agreed that its scientific data can be used for MiPet Easecto (‘informed consent’).

How is MiPet Easecto used?

MiPet Easecto is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription. The appropriate strength tablet should be used according to the dog’s weight.

For treatment of tick and flea infestations MiPet Easecto should be given once every month throughout the flea and/or tick season for optimal control.

For treatment of sarcoptic mange, MiPet Easecto is given monthly for two consecutive months.

For treatment of demodectic mange MiPet Easecto should be given once a month for at least three months. Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. As other conditions contribute to demodectic mange, any underlying diseases should also be treated.

For treatment of ear mite infestations a single dose should be given.

For further information, see the package leaflet.

How does MiPet Easecto work?

The active substance in MiPet Easecto, sarolaner acts as an ‘ectoparasiticide’. This means that it kills parasites that live on the skin or in the fur of animals, such as fleas, ticks and mites. In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog’s blood. Sarolaner kills these parasites that have ingested the dog’s blood by acting on their nervous system. It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters). This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites. Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog’s environment.

What benefits of MiPet Easecto have been shown in studies?

The effectiveness of MiPet Easecto against fleas was investigated in a field study in dogs infested with at least five live fleas. 189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad. MiPet Easecto was as effective as spinosad in reducing flea counts for up to 90 days after treatment.

A field study was conducted in dogs infested with at least three live attached ticks. 122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks. MiPet Easecto was as effective as fipronil in reducing tick counts for up to 90 days after treatment.

Another study involved dogs infested with sarcoptic mange. 53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid. MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.

In a study involving dogs with ear mite infestation, 283 dogs were treated with MiPet Easecto and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment). Dogs with live mites on day 30 after initial treatment received a second treatment. For MiPet Easecto the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments. MiPet Easecto was as effective as moxidectin/imidacloprid.

In a study with 98 dogs with demodectic mange, 63 dogs were treated with MiPet Easecto monthly for up to six months and 35 dogs received moxidectin/imidacloprid. MiPet Easecto was as effective as moxidectin/imidacloprid and the percentage of MiPet Easecto-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.

What are the risks associated with MiPet Easecto?

Side effects with MiPet Easecto are not common. However, the following side effects are seen in less than 1 dog in 10,000:mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions. These signs usually resolve without treatment.

Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.

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

Safety information has been included in the summary of product characteristics and the package leaflet for MiPet Easecto, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

The tablets should be kept in the original package until use in order to prevent children directly accessing the medicine.

Hands should be washed after handling the medicine. If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.

Why is MiPet Easecto approved?

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

Other information about MiPet Easecto

The European Commission granted a marketing authorisation valid throughout the EU for MiPet Easecto on 31 January 2018.

This authorisation was based on the authorisation granted to Simparica in 2015 (‘informed consent’).

The full EPAR for MiPet Easecto can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
MiPet Easecto : EPAR - Summary for the public BG = bălgarski 2018-02-23  
MiPet Easecto : EPAR - Summary for the public ES = español 2018-02-23  
MiPet Easecto : EPAR - Summary for the public CS = čeština 2018-02-23  
MiPet Easecto : EPAR - Summary for the public DA = dansk 2018-02-23  
MiPet Easecto : EPAR - Summary for the public DE = Deutsch 2018-02-23  
MiPet Easecto : EPAR - Summary for the public ET = eesti keel 2018-02-23  
MiPet Easecto : EPAR - Summary for the public EL = elliniká 2018-02-23  
MiPet Easecto : EPAR - Summary for the public EN = English 2018-02-23  
MiPet Easecto : EPAR - Summary for the public FR = français 2018-02-23  
MiPet Easecto : EPAR - Summary for the public IT = italiano 2018-02-23  
MiPet Easecto : EPAR - Summary for the public LV = latviešu valoda 2018-02-23  
MiPet Easecto : EPAR - Summary for the public LT = lietuvių kalba 2018-02-23  
MiPet Easecto : EPAR - Summary for the public HU = magyar 2018-02-23  
MiPet Easecto : EPAR - Summary for the public MT = Malti 2018-02-23  
MiPet Easecto : EPAR - Summary for the public NL = Nederlands 2018-02-23  
MiPet Easecto : EPAR - Summary for the public PL = polski 2018-02-23  
MiPet Easecto : EPAR - Summary for the public PT = português 2018-02-23  
MiPet Easecto : EPAR - Summary for the public RO = română 2018-02-23  
MiPet Easecto : EPAR - Summary for the public SK = slovenčina 2018-02-23  
MiPet Easecto : EPAR - Summary for the public SL = slovenščina 2018-02-23  
MiPet Easecto : EPAR - Summary for the public FI = suomi 2018-02-23  
MiPet Easecto : EPAR - Summary for the public SV = svenska 2018-02-23  
MiPet Easecto : EPAR - Summary for the public HR = Hrvatski 2018-02-23  

This EPAR was last updated on 23/02/2018 .

Authorisation details

Product details

Product details for MiPet Easecto
NameMiPet Easecto
Agency product numberEMEA/V/C/004732
Active substance

sarolaner

International non-proprietary name (INN) or common name

sarolaner

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53BE03


Publication details

Publication details for MiPet Easecto
Marketing-authorisation holder

Zoetis Belgium SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union31/01/2018

Contact address:

Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

31/01/2018  MiPet Easecto -EMEA/V/C/004732

Name Language First published Last updated
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - Product Information HR = Hrvatski 2018-02-23  

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
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  
MiPet Easecto : EPAR - All Authorised presentations HR = Hrvatski 2018-02-23  

Pharmacotherapeutic group

Ectoparasiticides for systemic use

Therapeutic indication

For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus,Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks.

For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).

For the treatment of sarcoptic mange (Sarcoptes scabiei).

For the treatment of ear mite infestations (Otodectes cynotis).

For the treatment of demodicosis (Demodex canis).

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
MiPet Easecto : EPAR - Public assessment report HR = Hrvatski 2018-02-23  
CVMP summary of positive opinion for MiPet Easecto HR = Hrvatski 2017-10-06  

Authorised

This medicine is approved for use in the European Union