Contraindications
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 case 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.
Adverse reactions
Cattles:
Common (more than 1 but less than 10 animals in 100 animals treated): | Injection site swelling1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactoid reaction2 |
1Slight and transient following subcutaneous administration
2May be serious (including fatal). If such reaction occurs, it should be treated symptomatically.
Pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactoid reaction1 |
1May be serious (including fatal). If such reaction occurs, it should be treated symptomatically.
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactoid reaction1 |
Undetermined frequency (cannot be estimated from the available data): | Injection site swelling2 |
1May be serious (including fatal). If such reaction occurs, it should be treated symptomatically.
2Transient, that resolves without intervention.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Special precautions for use
Special precautions for safe use in the target species:
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.
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.
Use during pregnancy and lactation
Cattle and pigs: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Overdose
In the case of overdose, symptomatic treatment should be initiated.
Withdrawal periods
Cattle: Meat and offal: 15 days, Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days. Not authorised for use in horses producing milk for human consumption