Target species
Horses, cattle, pigs.
Indications
Horses:
- alleviation of inflammation and pain associated with musculoskeletal disorders;
- alleviation of visceral pain associated with colic.
Cattle:
- alleviation of pain (e.g. from pressure trauma) resulting from parturient paresis;
- reduction of the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate;
- improvement of the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy;
- alleviation of pain associated with udder oedema following calving;
- reduction of pain associated with lameness.
Pigs:
- reduction of the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate;
- supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate.
Contraindications
Do not use in cases of hypersensitivity to the active substance(s) or to any of the excipient(s).
Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.
Do not use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis, blood dyscrasia, impaired hepatic, cardiac or renal function.
Please refer to Use during pregnancy and lactation.
Special precautions for use in animals
Use in any animal 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.
The use of ketoprofen is not recommended in foals under the age of 15 days.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.
Avoid intra-arterial injection.
Do not exceed the stated dose or duration of treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection seek medical advice and show the package leaflet or the label to the physician.
People with known hypersensitivity to the active substance and/or benzyl alcohol should avoid contact with the product.
Avoid splashes on the skin and eyes. Wash the affected area thoroughly with water should this occur. If irritation persists seek medical advice.
Wash hands after use.
Adverse reactions
In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, cases of of gastric or renal intolerance have been observed very rarely.
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 1000 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
The safety of ketoprofen has been investigated in pregnant laboratory animals, (rats, mice and rabbits) and in cattle, and showed no teratogenic or embryotoxic effects.
The product may be given to pregnant and to lactating cattle, and to lactating sows.
As the effects of ketoprofen on the fertility, pregnancy or foetal health of horses have not been determined, the product should not be administered to pregnant horses.
As the safety of ketoprofen has not been assessed in pregnant sows, the product should be used in these cases according to a benefit/risk assessment by the responsible veterinarian.
Interactions
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. 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.
Amounts to be administered and administration route
Horse: intravenous use
For use in musculo-skeletal conditions, the recommended dosage is 2.2 mg ketoprofen/kg i.e. 1 ml of the product/45 kg body weight, administered once daily for up to 3-5 days.
For use in equine colic, the recommended dosage is 2.2 mg/kg (1 ml/45 kg) body weight, given for immediate effect. A second injection may be given if colic recurs.
Cattle: intravenous use or deep intramuscular use
The recommended dose is 3 mg ketoprofen/kg body weight, i.e. 1 ml of the product/33 kg body weight, administered once daily for up to 3 days.
Pigs: deep intramuscular use
The recommended dose is 3 mg ketoprofen/kg body weight, i.e. 1 ml of the product/33 kg body weight, administered once.
The stopper cannot be punctured more than 20 times.
Overdose
No clinical signs were observed when ketoprofen was administered to horses at 5 times the recommended dose (11 mg/kg) for 15 days, to cattle at 5 times the recommended dose (15 mg/kg/day) for 5 days, or to pigs at 3 times the recommended dose (9 mg/kg/day) for 3 days.
In cases of overdose, a symptomatic treatment is required.
Withdrawal periods
Cattle:
Meat and offal: following intravenous administration - 1 day; following intramuscular administration - 4 days
Milk: zero hours
Pigs:
Meat and offal: 4 days
Horses:
Meat and offal: 1 day
Milk: not authorized for use in lactating animals producing milk for human consumption.