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Contra-indications, warnings, etc
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.
Withdrawal periods
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
Adverse reactions
Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (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.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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).
Precautions for use in animals
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 is a potential risk of increased renal toxicity.
User warnings
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.
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 this species is not recommended during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Overdose
In the case of overdose symptomatic treatment should be initiated.