Ketofen 1%

Introduction

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

Uses

Ketoprofen is a potent, non-steroidal anti-inflammatory and anti-pyretic analgesic.

KETOFEN 1% is indicated for the relief of pain and inflammation associated with musculo-skeletal and other painful disorders in the dog and cat.

Dosage and administration

The recommended dosage is 2 mg ketoprofen per kg bodyweight i.e. 1 ml/5 kg bodyweight, once daily for up to 3 consecutive days.

KETOFEN 1% may be given by the subcutaneous, intramuscular or intravenous route in the dog, and by the subcutaneous route in the cat.

If preferred after one injection of KETOFEN 1% treatment may be followed on the next day with KETOFEN® Tablets and continued on successive days for up to 4 days (i.e. up to 5 days in total).

Contra-indications, warnings, etc

For animal treatment only. Do not exceed the stated dose or the duration of treatment. Do not use in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding or, where there is evidence of a blood dyscrasia. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Do not use in animals known to be hypersensitive to the active substance. Do not administer with diuretics or anticoagulants. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. 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 clinical management. Although local tolerance is not a problem, perivenous injection should be avoided. Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs (e.g. aminoglycoside antibiotics) should be avoided. Do not mix with other substances in the same syringe. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in patients given non-steroidal anti-inflammatory drugs. Do not administer to pregnant animals. Some signs of digestive intolerance (vomiting and diarrhoea) have been observed in certain rare cases. They rapidly disappear when treatment is stopped. Slight transient swelling or local oedema is occasionally observed after sub-cutaneous or intramuscular injection. The product is well tolerated by dogs and cats when administered at twice the recommended dose. Do not exceed the stated dose or duration of treatment. In case of accidental self injection seek medical advice. Wash hands after use. Avoid contact with the skin and splashes to the eyes. Irrigate with copious amounts of water as necessary.

Pharmaceutical precautions

Do not store above 25°C. Protect from light.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur, the product should be discarded.

Keep out of the reach and sight of children.

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

Legal category

POM-V

Packaging Quantities

Vials of 20 ml.

Further information

Ketoprofen is a derivative of phenylpropionic acid, and belongs to the non-steroidal anti-inflammatory group of drugs.

Marketing authorisation number

Vm 08327/4073.