Horses.

Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.

Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders. Do not use in breeding, pregnant or lactating mares.

Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients.

None.

Do not use in animals less than 10 weeks. If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided. The recommended treatment dose and duration should not be exceeded.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water. Wash hands after use of the product. Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.

Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.

No data is available in horses, however, studies in other animals have shown embryo-foetotoxicity, malformations, delayed parturition and decreased pup survival. Therefore, do not use in breeding, pregnant or lactating animals.

Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.

Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should be observed. The treatment-free period should take into account the pharmacological properties of the medicinal products used previously.

Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.

Oral use.

Administer 0.1 mg firocoxib per kg bodyweight, once daily. Duration of treatment will be dependent on the response observed, but should not exceed 14 days.

To administer Equioxx at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to 600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.

To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.

Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the tongue.

Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose. Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema. The incidence of oral/skin lesions increases with increasing dose.

At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic treatment initiated.

Meat and offal: 26 days.

Do not use in mares producing milk for human consumption.