Procox

emodepside / toltrazuril

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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 Procox?

Procox is an antiparasitic medicine that contains two active substances, emodepside and toltrazuril. It is available as an oily suspension, containing 0.9 mg/ml emodepside and 18 mg/ml toltrazuril.

What is Procox used for?

Procox is used to treat dogs that are infected, or that the veterinary surgeon suspects of being infected, with two types of parasite at the same time, roundworms and coccidia. The full list of roundworms and coccidia against which Procox is effective can be found in the summary of product characteristics (SmPC).

Procox is given as a single treatment. The dose depends on the body weight of the dog being treated.

The standard dose of the oral suspension is 0.5 ml per kg bodyweight.

How does Procox work?

The two active substances in Procox interact with different parts of the parasites' systems. Emodepside interferes with certain specific receptors in the nervous systems of roundworms, which results in their subsequent paralysis and death. Toltrazuril interferes with the enzymes needed by the coccidia to produce energy. As a result it is able to kill the parasites at all stages of their development.

How has Procox been studied?

The company presented the results of studies across Europe in dogs looking at the effectiveness of Procox against the specified roundworms and coccidia. The studies included dogs of various ages, different breeds and weights, which were naturally infected, or could become infected, with parasitic gastrointestinal roundworms or coccidia.

The effectiveness of Procox against roundworms was studied by looking at the number of worm eggs passed out in the animal’s faeces after a single treatment with the recommended dose, and compared with a medicine (containing milbemycin oxime and praziquantel) commonly used for the treatment of these roundworm infections.

The effectiveness of the product in coccidial infections was studied by looking at the number of oocysts (egg-like structures that mature into the infective stage of the parasite) passed out in the animal’s faeces. One study compared Procox with sulfadimethoxine in the treatment of coccidiosis and the other with no treatment in the prevention of the disease.

What benefit has Procox shown during the studies?

The studies showed that Procox was superior to the comparator medicines or placebo in all studies. Procox is well tolerated in dogs with mild, transient, gastrointestinal disturbances, including vomiting, being observed.

What is the risk associated with Procox?

The most common side effects in dogs are slight and temporary digestive system disorders such as vomiting or loose stools.

Procox must not be used in puppies under two weeks of age or in dogs or puppies weighing less than 0.4 kg. The product must also not be used in cases of hypersensitivity (allergy) to either of the active substances or to any of the other ingredients.

It is not recommended to use Procox in young puppies of Collie or related breeds since it has not been investigated whether these dogs are more sensitive to treatment with emodepside.

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

The person administering Procox should avoid contact with his or her skin or eyes. If accidental exposure occurs, the eyes should be rinsed immediately with plenty of water, or the skin washed with soap and water. People should not eat, drink or smoke while handling Procox, and should wash their hands after use.

If Procox is swallowed accidentally, medical advice should be sought immediately and the package leaflet or label shown to the doctor. For more information, see the package leaflet.

Why has Procox been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Procox outweigh the risks when used for the approved indications and recommended that Procox be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Procox

The European Commission granted a marketing authorisation valid throughout the European Union for Procox on 20 April 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Procox : EPAR - Summary for the public BG = bălgarski 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public ES = español 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public CS = čeština 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public DA = dansk 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public DE = Deutsch 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public ET = eesti keel 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public EL = elliniká 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public EN = English 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public FR = français 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public IT = italiano 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public LV = latviešu valoda 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public LT = lietuvių kalba 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public HU = magyar 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public MT = Malti 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public NL = Nederlands 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public PL = polski 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public PT = português 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public RO = română 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public SK = slovenčina 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public SL = slovenščina 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public FI = suomi 2011-05-05 2013-06-13
Procox : EPAR - Summary for the public SV = svenska 2011-05-05 2013-06-13

This EPAR was last updated on 12/09/2016 .

Authorisation details

Product details

Product details for Procox
NameProcox
Agency product numberEMEA/V/C/002006
Active substance

emodepside / toltrazuril

International non-proprietary name (INN) or common name

emodepside / toltrazuril

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQP52AX60

Publication details

Publication details for Procox
Marketing-authorisation holder

Bayer Animal Health GmbH

Revision10
Date of issue of marketing authorisation valid throughout the European Union20/04/2011

Contact address:

Bayer Animal Health GmbH
D-51368 Leverkusen
Germany

Product information

Product information

05/09/2016  Procox -EMEA/V/C/002006 -IAIN/0017

Name Language First published Last updated
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12
Procox : EPAR - Product Information SV = svenska 2011-05-05 2016-09-12

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
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  
Procox : EPAR - All Authorised presentations SV = svenska 2011-05-05  

Pharmacotherapeutic group

Antiparasitic product

Therapeutic indication

For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated:

Roundworms (nematodes)

  • Toxocara canis (mature adult, immature adult, L4);
  • Uncinaria stenocephala (mature adult);
  • Ancylostoma caninum (mature adult).

Coccidia

  • Isospora ohioensis complex;
  • Isospora canis.

Procox is effective against the replication of Isospora and also against the shedding of oocysts. Although treatment will reduce the spread of infection, it will not be effective against the clinical signs of infection in already infected animals.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Procox : EPAR - Scientific Discussion SV = svenska 2011-05-05  
CVMP summary of positive opinion for Procox SV = svenska 2011-02-11