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Equioxx

What is EQUIOXX?

EQUIOXX contains the active substance firocoxib in an oral paste for horses (8.2 mg/g). This medicine is the same as Previcox oral paste for horses, which is already authorised in the

European Union. The company that makes Previcox has agreed that its scientific data can be used for EQUIOXX.


What is EQUIOXX used for?

EQUIOXX is used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) and reduce the lameness that is associated with the disease in horses.


The dose is 0.1 mg firocoxib per kg bodyweight, given once a day. EQUIOXX is presented as a paste with a special syringe that allows the right amount of medicine to be drawn and given directly into the horse’s mouth. The duration of treatment will depend on the horse’s response, but should not exceed 14 days.


How does EQUIOXX work?

The active substance in EQUIOXX, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oxygenase-2 (COX-2)

inhibitors’ (or Coxibs). It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins, EQUIOXX helps reduce the symptoms of inflammation, including pain.


How has EQUIOXX been studied?

EQUIOXX has been studied in laboratory animals, as well as in horses that were treated in various veterinary practices/clinics across Europe (“clinical studies”).


Two multi-centre studies were conducted (one in the USA and one in Europe) to compare the efficacy, safety and acceptability of firocoxib under field conditions with that of phenybutazone (in the USA) or vedaprofen (in Europe). The studies looked at the


effectiveness of the medicine in improving lameness, pain on manipulation/palpation, joint swelling and ability to move.


What benefit has EQUIOXX shown during the studies?

EQUIOXX oral paste administered once daily for 14 days at a dose of 0.1 mg/kg improved clinical scores for lameness and soft tissue injuries in horses and also helped relieve pain and inflammation associated with osteoarthritis in horses.


What are the side-effects of EQUIOXX?

The side effects of EQUIOXX are typical for those seen with other medicines in this class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/diarrhoea or lethargy (unresponsiveness). These reactions are generally temporary and reversible when the

treatment is stopped.


EQUIOXX must not be administered with corticosteroids or other NSAIDs. Care should also be taken when used with medicines which have an effect on the kidney such as diuretics.


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

Wash hands after use of the product. Avoid contact with eyes and skin.

Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.


What is the time to allow before a horse can be slaughtered and the meat used for human consumption (withdrawal period)?

After the last day of treatment with EQUIOXX, horses should not be slaughtered for 26 days.

The use of EQUIOXX is not permitted in mares producing milk for human consumption.


Why has EQUIOXX been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of EQUIOXX exceed the risks for the treatment of relief of pain and inflammation in horses and recommended that EQUIOXX be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about EQUIOXX:

The European Commission granted the marketing authorisation valid throughout the European Union, for EQUIOXX to Merial on 25/06/2008. Information on the prescription status of this product may be found on the label/outer package.


This summary was last updated in June 2008.


European Medicines Agency

Veterinary Medicines


EMEA/V/C/142


EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUIOXX

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).


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