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.
Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteriods 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 medicinal products should therefore 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 medicinal products should be avoided as there might be an increased risk of renal toxicity.
Amounts to be administered and administration route
Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Duration of treatment will be dependent on the response observed, but should not exceed 14 days.
One tablet should be administered with a small amount of food in a bucket or direct by hand, presenting the tablet combined with a small amount of food or with a treat in the palm of the hand.
After administration, it is recommended to examine the buccal cavity to ensure that the tablet has been adequately swallowed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
At high dosages and prolonged treatement (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.
The incidence of oral/skin lesions increases with increasing dose.
Meat and offal: 26 days
Not authorized for use in animals producing milk for human consumption.