Procox
Authorised
This medicine is authorised for use in the European Union
emodepside / toltrazuril
MedicineVeterinaryAuthorised
Overview
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information: T/0029
25/01/2021
Product details
- Name of medicine
- Procox
- Active substance
- emodepside
- toltrazuril
- International non-proprietary name (INN) or common name
- emodepside
- toltrazuril
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP52AX60
Pharmacotherapeutic group
Antiparasitic products, insecticides and repellentsTherapeutic 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.
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