Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Treatment of calves with the veterinary medicinal product 20 minutes before dehorning reduces post-operative pain. The veterinary medicinal product alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.
Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
In case of overdose, symptomatic treatment should be initiated.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Injection site swelling1; anaphylactoid reaction2.
1 Following subcutaneous injection, slight and transient.
2 May be serious (including fatal) and should be treated symptomatically
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Injection site swelling1; anaphylactoid reaction2.
1 Following subcutaneous injection, slight and transient.
2 May be serious (including fatal) and should be treated symptomatically
Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued, and the advice of a veterinarian should be sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
This veterinary medicinal product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Withdrawal Periods
Cattle:
Meat and offal: 15 days.
Milk: 5 days.
Horses:
Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.