Posatex

orbifloxacin / mometasone furoate / posaconazole

  • Email
  • Help

About

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 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 United States. 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, sexes and weights.

What benefit has Posatex shown during the studies?

Posatex at the recommended dose and following seven 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 June 2008. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Posatex : EPAR - Summary for the public BG = bălgarski 2008-07-01  
Posatex : EPAR - Summary for the public ES = español 2008-07-01  
Posatex : EPAR - Summary for the public CS = čeština 2008-07-01  
Posatex : EPAR - Summary for the public DA = dansk 2008-07-01  
Posatex : EPAR - Summary for the public DE = Deutsch 2008-07-01  
Posatex : EPAR - Summary for the public ET = eesti keel 2008-07-01  
Posatex : EPAR - Summary for the public EL = elliniká 2008-07-01  
Posatex : EPAR - Summary for the public EN = English 2008-07-01  
Posatex : EPAR - Summary for the public FR = français 2008-07-01  
Posatex : EPAR - Summary for the public IT = italiano 2008-07-01  
Posatex : EPAR - Summary for the public LV = latviešu valoda 2008-07-01  
Posatex : EPAR - Summary for the public LT = lietuvių kalba 2008-07-01  
Posatex : EPAR - Summary for the public HU = magyar 2008-07-01  
Posatex : EPAR - Summary for the public MT = Malti 2008-07-01  
Posatex : EPAR - Summary for the public NL = Nederlands 2008-07-01  
Posatex : EPAR - Summary for the public PL = polski 2008-07-01  
Posatex : EPAR - Summary for the public PT = português 2008-07-01  
Posatex : EPAR - Summary for the public RO = română 2008-07-01  
Posatex : EPAR - Summary for the public SK = slovenčina 2008-07-01  
Posatex : EPAR - Summary for the public SL = slovenščina 2008-07-01  
Posatex : EPAR - Summary for the public FI = suomi 2008-07-01  
Posatex : EPAR - Summary for the public SV = svenska 2008-07-01  

This EPAR was last updated on 11/06/2013 .

Authorisation details

Product details

Product details for Posatex
NamePosatex
Agency product numberEMEA/V/C/000122
Active substance

orbifloxacin / mometasone furoate / posaconazole

International non-proprietary name (INN) or common name

orbifloxacin / mometasone furoate / posaconazole

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQS02CA91

Publication details

Publication details for Posatex
Marketing-authorisation holder

Intervet International BV

Revision7
Date of issue of marketing authorisation valid throughout the European Union23/06/2008

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

14/05/2013  Posatex -EMEA/V/C/000122 -R/0018

Name Language First published Last updated
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11
Posatex : EPAR - Product Information SV = svenska 2009-10-13 2013-06-11

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
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  
Posatex : EPAR - All Authorised presentations SV = svenska 2008-07-01  

Pharmacotherapeutic group

Otologicals

Therapeutic indication

Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Posatex : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-10-16 2013-06-11

Initial marketing-authorisation documents