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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/73568/2007

EMEA/V/C/000032

EPAR summary for the public

Quadrisol

Vedaprofen

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).

What is Quadrisol?

Quadrisol is an oral gel presented in graduated multidose oral syringes that contain the active substance vedaprofen as 100 mg/ml (for horses).

What is Quadrisol used for?

Quadrisol is a pain killer (an anti-inflammatory and analgesic) used in horses.

In horses, Quadrisol 100 mg/ml oral gel is used to relieve pain and reduce inflammation due to problems with and injury to the muscles, bones and joints and also injuries to other non-bony areas of the body(so called soft tissue lesions) including the trauma caused by surgery. The oral gel can be given 3 hours or earlier before a surgical operation.

The dose, frequency, route, and length of treatment depends on the weight and type of animal and the condition to be treated. For details, please see the Package Leaflet.

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How does Quadrisol work?

Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). Vedaprofen blocks an enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins. Prostaglandins are substances that trigger pain, swelling and inflammation, and the action of Quadrisol reduces these responses.

How has Quadrisol been studied?

Quadrisol has been studied in laboratory animals, as well as specifically in horses treated in a number of veterinary practices/clinics ("clinical studies") across Europe.

Horse:

Quadrisol has been studied in a large number of horses with bone, muscle and other soft tissue and joint problems. The response of the horses to treatment was measured using the improvement in specific clinical scores for each condition studied. The efficacy of Quadrisol was compared with another similar product.

What benefit has Quadrisol shown during the studies?

Quadrisol oral gel improved the clinical scores for lameness and soft tissue injuries in horses. The response to treatment with Quadrisol was similar to the response to the other similar product.

What are the side effects of Quadrisol?

The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhea) and the kidneys or lethargy. In horses, skin rashes (urticaria) have been reported. All of these effects are reversible.

Quadrisol must not be administered in conjunction with other drugs that work in the same way (NSAIDs) or with other anti-inflammatory drugs such as the glucocorticosteroids.

Horses intended for racing and competition should be treated according to local requirements and appropriate precautions must be taken to ensure compliance with the official competition regulations. In case of doubt, it is advisable to test the urine.

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

Quadrisol has been developed especially for horses and is not intended for use in humans.

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 Quadrisol, horses should not be slaughtered for 12 days.

What is the time to allow before milk can be taken from the animal for human consumption?

The use of Quadrisol is not permitted in horses producing milk that is intended for human consumption.

Why has Quadrisol been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Quadrisol to reduce of inflammation and relieve pain caused by musculoskeletal disorders and trauma are greater than any risks associated with this treatment. CVMP recommended that Quadrisol should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Quadrisol:

The European Commission granted a marketing authorisation valid throughout the European Union, for Quadrisol on 4 December 1997. Information on the prescription status of this product may be found on the label of the carton box that contains the product.

This summary was last updated in: 04-2013.

Quadrisol

EMA/73568/2007

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