Veraflox

pradofloxacin

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This 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 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 Veraflox?

Veraflox is a medicine that contains pradofloxacin. It is available as brownish tablets containing 15 mg, 60 mg or 120 mg pradofloxacin, and as a yellowish/beige-coloured oral suspension, containing 25 mg/ml pradofloxacin.

What is Veraflox used for?

Veraflox 15 mg tablets can be used in both cats and dogs. The 60-mg and 120-mg tablets are only for use for dogs, and Veraflox oral suspension is only for use in cats.

In dogs, Veraflox is used to treat some skin infections, including wound infections, and acute urinary-tract infections caused by certain specific bacteria. It can also be used in conjunction with dental treatment in dogs with severe gum infections.

In cats, Veraflox is used to treat acute infections of the upper respiratory tract caused by certain specific bacteria. In addition, the oral suspension can also be used to treat some skin infections, including wound infections and abscesses, caused by certain specific bacteria.

The dose and duration of treatment depend on the species of the animal being treated and its body weight, the nature and severity of the infection, and the animal’s response to the treatment. The standard dose for tablets is 3 mg pradofloxacin per kilogram body weight once a day. For the oral suspension it is 5 mg pradofloxacin per kilogram body weight once a day. For more information, see the package leaflet.

How does Veraflox work?

The active substance in Veraflox, pradofloxacin, belongs to a group of antibiotics called ‘fluoroquinolones’. Pradofloxacin works by blocking some of the enzymes that are important in allowing bacteria to make copies of their DNA. By blocking two enzymes called ‘DNA gyrase’ and ‘topoisomerase IV’, pradofloxacin stops the bacteria from growing and multiplying. The full list of bacteria against which Veraflox is active can be found in the summary of product characteristics (SmPC).

How has Veraflox been studied?

The company presented the results of studies looking at the effectiveness of Veraflox against a range of bacterial infections in cats and dogs. In dogs, the medicine was studied in some skin, urinary-tract and gum infections caused by certain specific bacteria. In cats, the medicine was studied in acute infections of the upper respiratory tract and also some skin infections caused by certain specific bacteria. In all of the studies the effectiveness of Veraflox was compared with antibiotics that are commonly used for the treatment of the infections studied (amoxicillin with or without clavulanic acid for the skin and urinary-tract infections, and clindamycin for the gum infections).

What benefit has Veraflox shown during the studies?

The studies showed that Veraflox was at least as effective as the comparator medicines in all indications. Veraflox is well tolerated in cats and dogs with mild transient gastro-intestinal disturbances, including vomiting, being observed only in rare cases.

What is the risk associated with Veraflox?

The most common side effects in dogs and cats are mild transient gastro-intestinal disturbances including vomiting, although these have only been observed rarely.

Veraflox must not be used in animals that may be hypersensitive (allergic) to fluoroquinolone antibiotics.

Veraflox must not be used in young growing dogs, in kittens below six weeks of age, in animals with joint problems caused by damage to the cartilage, or in animals with central-nervous-system disorders such as epilepsy. Veraflox must not be used in female animals that are pregnant or lactating.

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

Veraflox products can be harmful to children if they are accidentally swallowed. Therefore all products should be kept out of the reach and sight of children.

People who are hypersensitive (allergic) to quinolone antibiotics should avoid any contact with Veraflox.

People should ensure that Veraflox does not come into contact with their skin or eyes. In case of contact, rinse immediately with plenty of water. Do not eat, drink or smoke while handling Veraflox products. Wash hands after using these products.

If Veraflox is swallowed accidentally, seek medical advice immediately and show the package leaflet or the label to the doctor. For more information, see the package leaflet.

Why has Veraflox been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Veraflox exceed the risks for the treatment of certain specified infections in dogs and cats and recommended that Veraflox be given a marketing authorisation. More information on the benefit-risk balance can be found in the scientific discussion part of this EPAR.

Other information about Veraflox

The European Commission granted a marketing authorisation valid throughout the European Union for Veraflox to Bayer Animal Health GmbH on 12 April 2011. Information on the prescription status of this product can be found on the label / outer package.

Name Language First published Last updated
Veraflox : EPAR - Summary for the public BG = bălgarski 2011-07-18  
Veraflox : EPAR - Summary for the public ES = español 2011-07-18  
Veraflox : EPAR - Summary for the public CS = čeština 2011-07-18  
Veraflox : EPAR - Summary for the public DA = dansk 2011-07-18  
Veraflox : EPAR - Summary for the public DE = Deutsch 2011-07-18  
Veraflox : EPAR - Summary for the public ET = eesti keel 2011-07-18  
Veraflox : EPAR - Summary for the public EL = elliniká 2011-07-18  
Veraflox : EPAR - Summary for the public EN = English 2011-07-18  
Veraflox : EPAR - Summary for the public FR = français 2011-07-18  
Veraflox : EPAR - Summary for the public IT = italiano 2011-07-18  
Veraflox : EPAR - Summary for the public LV = latviešu valoda 2011-07-18  
Veraflox : EPAR - Summary for the public LT = lietuvių kalba 2011-07-18  
Veraflox : EPAR - Summary for the public HU = magyar 2011-07-18  
Veraflox : EPAR - Summary for the public MT = Malti 2011-07-18  
Veraflox : EPAR - Summary for the public NL = Nederlands 2011-07-18  
Veraflox : EPAR - Summary for the public PL = polski 2011-07-18  
Veraflox : EPAR - Summary for the public PT = português 2011-07-18  
Veraflox : EPAR - Summary for the public RO = română 2011-07-18  
Veraflox : EPAR - Summary for the public SK = slovenčina 2011-07-18  
Veraflox : EPAR - Summary for the public SL = slovenščina 2011-07-18  
Veraflox : EPAR - Summary for the public FI = suomi 2011-07-18  
Veraflox : EPAR - Summary for the public SV = svenska 2011-07-18  

This EPAR was last updated on 15/06/2017 .

Authorisation details

Product details

Product details for Veraflox
NameVeraflox
Agency product numberEMEA/V/C/000159
Active substance

pradofloxacin

International non-proprietary name (INN) or common name

pradofloxacin

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QJ01MA97



Publication details

Publication details for Veraflox
Marketing-authorisation holder

Bayer Animal Health GmbH
 

Revision5
Date of issue of marketing authorisation valid throughout the European Union12/04/2011

Contact address:

Bayer Animal Health GmbH
D-51368 Leverkusen
Germany

 

Product information

Product information

06/06/2017  Veraflox -EMEA/V/C/000159 -IAIN/0014

Name Language First published Last updated
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15
Veraflox : EPAR - Product Information SV = svenska 2011-07-18 2017-06-15

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
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  
Veraflox : EPAR - All Authorised presentations SV = svenska 2011-07-18  

Pharmacotherapeutic group

Antibacterials for systemic use, fluoroquinolones

Therapeutic indication

Dogs

Treatment of:

  • wound infections caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);
  • superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);
  • acute urinary-tract infections caused by susceptible strains of Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius);
  • as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp. and Prevotella spp.

Cats

Treatment of acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Veraflox : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-06-26 2017-06-15

Initial marketing-authorisation documents

Name Language First published Last updated
Veraflox : EPAR - Public assessment report SV = svenska 2011-07-18  
CVMP summary of positive opinion for Veraflox SV = svenska 2010-07-16 2011-02-11