Contraindications
Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Do not use in animals suffering from gastrointestinal lesions, haemorrhagic diathesis, impaired hepatic, renal or cardiac function.
Do not use with other NSAID drugs concurrently or within 24 hours of each other.
Special warnings
Treatment of piglets with ketoprofen before castration reduces post-operative pain for 1 hour. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.
Treatment of calves with ketoprofen before dehorning reduces post-operative pain. Ketoprofen alone will not provide adequate pain relief during the dehorning procedure. To obtain pain relief during dehorning co-medication with an appropriate local anaesthetic is needed.
Special precautions for use
Special precautions for safe use in the target species:
Avoid intra-arterial injection. Do not exceed recommended dose or period of treatment. Special care should be taken when administering the veterinary medicinal product to animals with severe dehydration, hypovolaemia and hypotension as there is a potential risk of increased renal toxicity.
The use of ketoprofen is not recommended in foals under the age of 15 days. Use in animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful management. See section 'Use during pregnancy, lactation or lay' regarding the use of the veterinary medicinal product in pregnant mares and sows.
Sufficient drinking water must be supplied at all times during treatment. In colic, a subsequent dose may be given only after a thorough re-examination.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to ketoprofen or benzyl alcohol should avoid contact with the veterinary medicinal product.
Avoid splashes on the skin and eyes. Rinse thoroughly with water should this occur. If irritation persists seek medical advice. Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses, cattle, pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction, Anaphylaxis1. |
Undetermined frequency (cannot be estimated from the available data): | Gastrointestinal irritation2, Gastric ulceration2, Small intestine ulcer2; Renal disorder2; Injection site irritation3; Inappetence4. |
1 Anaphylaxis may be life-threatening and should be treated symptomatically.
2 Due to the mechanism of action of NSAIDs (inhibition of prostaglandin synthesis).
3 Transient, caused by intramuscular injections.
4 Only in pigs, due to repeated administration, reversible.
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.
Use during pregnancy, lactation or lay
Pregnancy:
The safety of ketoprofen has been investigated in pregnant laboratory animals and cattle and no adverse effects were noted. The veterinary medicinal product can be used in pregnant cows.
In absence of studies on pigs use only according to the benefit-risk assessment by the responsible veterinarian. Do not use in pregnant mares. Lactation: Can be used in lactating cows.
Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product must not be administered in conjunction with, or within 24 hours of administration of other NSAIDs and glucocorticoids. Concurrent administration of diuretics, nephrotoxic drugs and anticoagulative drugs should be avoided.
Ketoprofen is highly bound to plasma proteins, and may displace or be displaced by other highly protein bound medicines, such as anticoagulants with the possibility of consequent toxic effects due to the unbound fraction of the drug. Due to the fact that ketoprofen may inhibit platelet aggregation and cause gastrointestinal ulceration, it should not be used with other medicines that have the same profile of adverse drug reactions.
Withdrawal periods
Meat and offal:
Horses: 1 day (24 hours)
Cattle: i.v. 1 day (24 hours), i.m 3 days (72 hours)
Pigs: 4 days
Milk (cattle): Zero hours
Not authorised for use in mares producing milk for human consumption.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdose with NSAIDs can lead to gastrointestinal ulceration, loss of proteins, hepatic and renal impairment. In tolerance studies performed in pigs up to 25 % of the animals treated at three times the maximum recommended dose (9 mg/kg) for three days or at the recommended dose (3 mg/kg) for triple the maximum recommended time (9 days) showed erosive and/or ulcerative lesions in both the aglandular (pars oesophagica) and glandular parts of the stomach. Early signs of toxicity include loss of appetite and pasty faeces or diarrhoea. If overdose symptoms are observed, symptomatic treatment should be initiated. The occurrence of ulcers is dose dependent to a limited extent.