Target species
Horses
Indications for use
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
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 cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
Special precautions for use in animals
Avoid use in any dehydrated, hypovolemic or hypotensive animals as there is a potential risk of renal toxicity.
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
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). The clinical signs were reversible.
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 in very rare cases and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
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 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy and lactation
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore do not use the product during pregnancy and lactation (see Contraindications).
Interactions
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Amounts to be administered and administration route
For oral use.
To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg body weight scale.
Shake vigorously at least 20 times before use.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Avoid introduction of contamination during use.
Overdose
In case of overdose symptomatic treatment should be initiated.
Withdrawal periods
Meat and offal: 3 days.
Not authorised for use in mares producing milk for human consumption.