Each chewable tablet contains:
Active substance: Firocoxib 57 mg
Horses (450-600 kg)
Indications for use, specifying the target species
Alleviation of pain and inflammation associated with osteoarthiritis and reduction of associated lameness in horses.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, caridac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals (see section 4.7).
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Special precautions for use
Special precautions for us in animals
Do not exceed the recommended dosage.
For safe and effective use, this product should only be administered to horses in the weight range 450-600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and who the package leaflet or the label to the physician.
Wash hands after use of the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals treated displaying adverse reaction(s))
•common (more than 1 but less than 10 animals in 100 animals treated)
•uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
•rare (more than 1 but less than 10 animals in 10,000 animals treated)
•very rare (less than 1 animals in 10,000 animals, including isolated reports treated)
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product for us in breeding, pregnant or lactating horses has not been established. Laboratory studies in laboratory animals have shown evidence of embryofoetotoxicity, malformations, delayed parturition and decreased pup survival. Do not use in breeding, pregnant or lactating animals.