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Clinical particulars
Target species
Horses.
Indications for use, specifying the target species
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.
Contraindications
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
In order to minimise risk of intolerance, the product should be mixed into muesli feed.
This product is only for use in horses weighing between 500 and 600 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported. In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in horses is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Do not administer concurrently with glucocorticoids, other NSAIDs or with anti-coagulant agents.
Amounts to be administered and administration route
In-feed use.
To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days. The product should be added to 250 g of muesli feed, prior to feeding.
Each sachet contains one dose for a horse weighing between 500 and 600 kg and the dose must not be divided into smaller doses.
Avoid introduction of contamination during use.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose symptomatic treatment should be initiated.
Withdrawal period
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.