Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

A clear, sterile, aqueous solution for injection. Each ml contains 100 mg ketoprofen as active ingredient and 10 mg benzyl alcohol as preservative.

Uses

Ketoprofen is a non-steroidal anti-inflammatory drug belonging to the 2-arylpropionic acid group of NSAIDs. In addition to the anti-inflammatory effect, it also has an anti-pyretic and analgesic effect.

HORSE

Comforion vet is indicated for the anti-inflammatory and analgesic treatment of musculoskeletal disorders, and the alleviation of visceral pain associated with colic.

CATTLE

Comforion vet is indicated for the anti-inflammatory treatment of mammary gland disorders.

PIGS

Comforion vet is indicated for the reduction of pyrexia in respiratory tract disorders and in case of MMA-syndrome (mastitis, metritis, agalactia) in conjunction with antibiotic therapy.

Dosage and administration

Horses: 2.2 mg ketoprofen/kg bodyweight (1 ml/45 kg bodyweight) by IV injection once daily for up to 3 days. For use in equine colic, the recommended dosage is 2.2 mg/kg (1 ml/45 kg) bodyweight, given by intravenous injection for immediate effect. A subsequent dose may be given only after a thorough re-examination.

Cattle: 3 mg ketoprofen/kg bodyweight (1 ml/33 kg bodyweight) by IV or deep IM injection once daily for up to 3 days.

Pigs: 3 mg ketoprofen/kg bodyweight (1 ml/33 kg bodyweight) by deep IM injection once daily for up to 3 days.

Contra-indications, warnings, etc

Do not administer to horses, cattle or pigs that have previously shown a hypersensitivity to ketoprofen or any of the excipients in the product.

Use is contra-indicated in animals suffering from severe hepatic, renal or cardiac insufficiency, gastro-intestinal ulceration, heavy bleeding or evidence of blood dyscrasia. Use with caution in dehydrated or hypotensive animals.

Other NSAIDs should not be used concomitantly or within 24 hours from administration of the product. Competition at plasma protein binding sites may lead to intoxication. Concurrent administration with diuretics, anticoagulant therapy and nephrotoxic drugs should be avoided. Repeated intramuscular injections may cause mild transient irritation. Due to the mechanism of action of ketoprofen (inhibition of prostaglandin synthesis), gastric and intestinal irritation or ulceration or renal intolerance may occur.

Avoid intra-arterial injections.

Do not exceed the recommended dose or duration of treatment.

The use of ketoprofen is not recommended in foals under the age of 15 days . 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 safety of ketoprofen has been investigated in pregnant laboratory animals (rats, mice, rabbits) and cattle. No adverse effects were noted. As the safety of ketoprofen has not been assessed in pregnant mares or sows, the product should be used in these cases only according to the benefit/risk assessment by the responsible veterinarian.

Do not mix with other veterinary medicinal products.

Withdrawal period

Meat: 4 days. Milk: zero days.

Operator warnings

Avoid splashes to the skin and eyes. If accidental skin or eye contact occurs, irrigate thoroughly with water. In case of accidental self-injection, seek medical advice.

Pharmaceutical precautions

For animal treatment only. Keep out of reach of children. Do not store above 30 °C. Do not freeze. Keep the vial in the outer carton. After first opening, the product should be used within 10 days. When the vial is broached for the first time, the date on which any product remaining in the vial should be discarded should be calculated. A statement of the in-use shelf-life of the product is given on this package insert. This discard date should be written in the space provided on the label.

Legal category

POM-V

Packaging Quantities

100 ml glass bottle

Further information

Ketoprofen is rapidly absorbed after intramuscular administration. The measured maximum plasma concentration at 30 minutes from a single dose injection is 16.3 mg/ml in pigs and 9.7 mg/ml in cattle. Ketoprofen binds approximately 95 % to plasma proteins and its bioavailability after intramuscular administration is 80-100 %. The plasma half life is approximately 1 hour in horses, 2.5 hours in cattle and 2-3 hours in pigs. 90 % of the dose is eliminated in urine primarily as metabolites. Elimination from synovial fluid is delayed.

Ketoprofen is a prohibited substance under international equine competition rules. Treatment with should be stopped for a suitable time prior to competing.

Marketing authorisation number

Vm 06043/4000.