Easotic

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

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This is a summary of the European public assessment report (EPAR). 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 Easotic?

Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate. It is an ear-drop suspension for dogs, which is white in colour. It is available in a 10-ml bottle.

What is Easotic used for?

Easotic is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa). It is given once a day for five days. The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle. The inside of the ear should be cleaned and dried before treatment and any excess hair cut away.

How does Easotic work?

Ear infections in dogs can be caused by bacteria or fungi. They often lead to the ear(s) being inflamed (red, swollen and itchy). Two of the active substances in Easotic, miconazole nitrate and gentamicin sulphate, work against the cause of the infection, while the third one, hydrocortisone aceponate, works on the inflammation.

Hydrocortisone aceponate is a glucocorticosteroid, which is a type of substance that helps to reduce inflammation and itching. Miconazole nitrate is an antifungal that works by preventing the formation of ergosterol, which is an important part of fungal cell walls. Without ergosterol, the fungus is killed or prevented from spreading. Gentamicin sulphate is an antibiotic that belongs to the group aminoglycosides. It acts by preventing bacteria making proteins. This stops the bacteria growing, resulting in their death.

How has Easotic been studied?

Easotic has been studied in dogs in both laboratory and field trials. One large field trial was conducted in different centres throughout Europe. In the study, the effectiveness of Easotic was compared with that of ear drops containing three similar active substances in dogs with acute or recurrent bacterial or fungal ear infections. Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.

What benefit has Easotic shown during the studies?

When used at the recommended dose for five days, Easotic was as effective as the comparator medicine in improving the symptoms of ear infection (redness, swelling, ear discharge and discomfort). The medicine was well-tolerated.

What is the risk associated with Easotic?

Mild reddening of the ear has been seen in around 2% of dogs. The use of ear preparations may be associated with damage to hearing. This is usually temporary and happens primarily in older dogs.

Easotic must not be used in dogs that may be allergic to the active substances or any of the other ingredients, if the eardrum is perforated, at the same time as other medicines that can harm the ear, or in dogs with a parasite infection called generalised demodecosis (mange). For a full list of all side-effects reported with Easotic, see the package leaflet.

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

If accidental skin or eye contact occurs, wash immediately with lots of water. If a person accidentally takes the medicine or eye irritation occurs, seek medical advice immediately and show the package leaflet or the label to a doctor.

Why has Easotic been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Easotic exceed the risks for the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis, and recommended that Easotic be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Easotic

The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20 November 2008. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Easotic : EPAR - Summary for the public BG = bălgarski 2008-11-27  
Easotic : EPAR - Summary for the public ES = español 2008-11-27  
Easotic : EPAR - Summary for the public CS = čeština 2008-11-27  
Easotic : EPAR - Summary for the public DA = dansk 2008-11-27  
Easotic : EPAR - Summary for the public DE = Deutsch 2008-11-27  
Easotic : EPAR - Summary for the public ET = eesti keel 2008-11-27  
Easotic : EPAR - Summary for the public EL = elliniká 2008-11-27  
Easotic : EPAR - Summary for the public EN = English 2008-11-27  
Easotic : EPAR - Summary for the public FR = français 2008-11-27  
Easotic : EPAR - Summary for the public IT = italiano 2008-11-27  
Easotic : EPAR - Summary for the public LV = latviešu valoda 2008-11-27  
Easotic : EPAR - Summary for the public LT = lietuvių kalba 2008-11-27  
Easotic : EPAR - Summary for the public HU = magyar 2008-11-27  
Easotic : EPAR - Summary for the public MT = Malti 2008-11-27  
Easotic : EPAR - Summary for the public NL = Nederlands 2008-11-27  
Easotic : EPAR - Summary for the public PL = polski 2008-11-27  
Easotic : EPAR - Summary for the public PT = português 2008-11-27  
Easotic : EPAR - Summary for the public RO = română 2008-11-27  
Easotic : EPAR - Summary for the public SK = slovenčina 2008-11-27  
Easotic : EPAR - Summary for the public SL = slovenščina 2008-11-27  
Easotic : EPAR - Summary for the public FI = suomi 2008-11-27  
Easotic : EPAR - Summary for the public SV = svenska 2008-11-27  

This EPAR was last updated on 14/11/2017 .

Authorisation details

Product details

Product details for Easotic
NameEasotic
Agency product numberEMEA/V/C/000140
Active substance

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

International non-proprietary name (INN) or common name

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QS02CA03






Publication details

Publication details for Easotic
Marketing-authorisation holder

Virbac

Revision6
Date of issue of marketing authorisation valid throughout the European Union20/11/2008

Contact address:

Virbac 
1ère Avenue 2065 m L.I.D.
06516 Carros
France

Product information

Product information

06/10/2017  Easotic -EMEA/V/C/000140 -IB/0010

Name Language First published Last updated
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14
Easotic : EPAR - Product Information SV = svenska 2009-04-24 2017-11-14

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
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18
Easotic : EPAR - All Authorised presentations SV = svenska 2008-11-27 2012-09-18

Pharmacotherapeutic group

Otologicals – Corticosteroids and anti-infectives in combination

Therapeutic indication

Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole, in particular Malassezia pachydermatis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Easotic : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-04-24 2017-11-14

Initial marketing-authorisation documents