Easotic (hydrocortisone aceponate /miconazole...) - QS02CA03
Updated on site: 09-Feb-2018
|Substance:||hydrocortisone aceponate /miconazole nitrate / gentamicin sulphate|
EPAR summary for the public
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 Easotic?
Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate. It is an ear drop suspension for dogs, that 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).
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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
Other information about Easotic:
The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20/11/2008. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in November 2008.