Posatex
European Medicines Agency Veterinary Medicines
EMEA/V/C/122
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
POSATEX
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 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 Posatex?
Posatex contains three active substances: orbifloxacin, mometasone furoate monohydrate and posaconazole. Posatex is an ear drop suspension, white to off white in colour. It is available in three pack sizes; 8.8, 17.5 and 35.1 ml bottles for dogs.
What is Posatex used for?
Posatex is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa). It is given once a day for seven days. The number of ear drops to use depends on the weight of the dog and varies from two to eight. The inside of the ear should be cleaned and dried before treatment.
How does Posatex 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 Posatex, orbifloxacin and posaconazole, work against the cause of the infection, while the third one, mometasone furoate monohydrate, works on the inflammation.
Orbifloxacin is an antibiotic that belongs to the group fluoroquinolones. It works by blocking an enzyme called ‘DNA gyrase’, which is important in allowing bacteria to make copies of their DNA. By blocking DNA gyrase, orbifloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death. Posaconazole is an antifungal that belongs to the group triazoles. It 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. Mometasone furoate monohydrate is a steroid, which is a type of substance that helps to reduce inflammation.
How has Posatex been studied?
Posatex has been studied in dogs in both laboratory and field trials. Two large field trials were conducted one in Europe and one in the USA. In both studies the effectiveness of Posatex was compared with that of ear drops containing three similar active substances. Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
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What benefit has Posatex shown during the studies?
Posatex at the recommended dose and following 7 days of treatment was as effective as the comparator medicine in improving the symptoms (redness, swelling, ear discharge, discomfort) of ear infections in dogs with acute or recurrent bacterial or fungal infections. The ear drop suspension is easy to apply by the owner and therefore increased success in the treatment of an ear infection can be expected when the medicinal product is used as directed.
What is the risk associated with Posatex?
Mild reddening of the ear has been observed. The use of ear preparations may be associated with damage to hearing, usually temporary and primarily in older dogs.
For a full list of all side-effects reported with Posatex, see the Package Leaflet.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
This veterinary medicine has been developed especially for dogs and is not for use in humans. If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor. If accidental skin contact occurs, wash immediately with lots of water.
Why has Posatex been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Posatex exceed its risks for the treatment of acute otitis externa and acute exacerbations of recurrent otitis externa in dogs and recommended that Posatex be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Posatex:
The European Commission granted a marketing authorisation valid throughout the European Union, for Posatex to S-P Veterinary, United Kingdom on 23/06/2008. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in June 2008.
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