Introduction

Merial Logo

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

A clear, sterile, aqueous solution for injection containing 100 mg/ml ketoprofen. Benzyl alcohol is added at 10 mg/ml as a preservative.

Uses

Ketoprofen is a potent, non-narcotic, non-steroidal anti-inflammatory agent with analgesic and anti-pyretic properties.

In the horse

KETOFEN 10% is indicated for the alleviation of inflammation and pain associated with musculo-skeletal disorders. It is also indicated for the alleviation of visceral pain associated with colic.

In cattle

KETOFEN 10% is indicated for:

The supportive treatment of parturient paresis associated with calving;

Reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate;

Improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy;

Reducing oedema of the udder associated with calving.

In pigs

KETOFEN 10% is indicated for:

Reducing the pyrexia and respiratory distress associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate.

The supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate.

Dosage and administration

Horse

For use in musculo-skeletal conditions, the recommended dosage is 2.2 mg/kg ketoprofen, i.e. 1 ml of KETOFEN 10% per 45 kg bodyweight, administered by intravenous injection once daily for up to 3 to 5 days.

For use in equine colic, the recommended dosage is 2.2 mg/kg (1 ml per 45kg) bodyweight, given by intravenous injection for immediate effect. A second injection may be given if colic recurs.

Cattle

The recommended dose is 3 mg/kg ketoprofen bodyweight, i.e. 1 ml of KETOFEN 10% per 33 kg bodyweight, administered by intravenous or deep intramuscular injection once daily for up to 3 days.

Pigs

The recommended dose is 3mg ketoprofen bodyweight, i.e. 1ml of KETOFEN 10% per 33kg bodyweight administered once by deep intramuscular injection.

Contra-indications, warnings, etc

For animal treatment only.

Avoid intra-arterial injection.

As the effects of ketoprofen on fertility, pregnancy or foetal health in horses have not been determined, KETOFEN 10% should not be administered to pregnant mares. KETOFEN 10% may be given to pregnant and lactating cattle and is indicated for use in lactating sows.

Do not administer to horses, cattle or pigs that have previously shown a hypersensitivity to ketoprofen.

In case of accidental self injection seek medical advice. Wash hands after use.

Avoid splashes on the skin and eyes. Irrigate thoroughly with water should this occur. If irritation persists seek medical advice.

Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

Do not exceed the stated dose or the duration of treatment. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use can not be avoided, animals may require a reduced dosage and careful management.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity.

Concurrent administration of nephrotoxic drugs should be avoided.

Withdrawal periods

Horses, cattle and pigs must not be slaughtered for human consumption during treatment.

There is no withholding period necessary for the milk of treated cattle.

Animals may be slaughtered for human consumption only after the following periods from the last treatment:-

Horses	Meat - 1 day
Cattle	Meat - following intravenous administration 1 day
	Meat - following intramuscular administration 4 days Milk - Zero days
Pigs	Meat - 4 days

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Keep out of the reach and sight of children. Following withdrawal of the first dose use the product within 28 days. Discard unused material safely.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

50ml, 100ml and 250ml glass bottles.

Further information

Following intravenous injection in the horse, the onset of musculo-skeletal anti-inflammatory activity occurs by 2 hours and reaches a peak at about 12 hours. It is still measurable 24 hours after each dose.

No clinical signs were observed when KETOFEN 10% was administered to horses at 5 times the recommended dose for 15 days, to cattle at 5 times the recommended dose for 5 days, or to pigs at 3 times the recommended dose for 3 days.

Horses have been found to tolerate intravenous dosages of ketoprofen of 2.2, 6.6 and 11.0 mg/kg once daily for 15 consecutive days (i.e. up to 5 times the recommended dose for three times the recommended duration) with no evidence of toxic effects.

Ketoprofen is similarly well tolerated in cattle, where doses of up to 15 mg/kg/day (5 times the recommended dose) for 5 consecutive days have been given without significant adverse effects. The product has been safely given to calves as young as 3 days of age, and to pregnant and lactating cattle.

Ketoprofen is well tolerated in pigs. Doses of 9mg/kg/day (3 times the recommended dose) for 3 consecutive days have been given with no significant adverse effects.

In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, there can be the possibility in certain individuals of gastric or renal intolerance.

KETOFEN 10% (ketoprofen), in common with other non-steroidal anti-inflammatories, is not permitted by the Racing Authorities of Great Britain & Ireland to be used at the time of racing. Ketoprofen or its conjugates can be detected in urine for up to 10 days after treatment (analytical sensitivity of 50 ng/ml). An interval of 15 days from cessation of treatment should ensure that the drug is undetectable in most horses.