Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Rimadyl Large Animal Solution for Injection is a clear, very pale straw coloured, sterile, aqueous solution for injection containing carprofen 5% w/v (50 mg/ml) with Ethanol 10% v/v as preservative.

Uses

Carprofen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and anti-pyretic properties. In young cattle (under 12 months of age) Rimadyl Large Animal Solution for Injection is indicated as adjunctive therapy for the control of acute inflammation associated with respiratory disease. The cause of the condition should be determined and treated with an appropriate antimicrobial.

In horses and ponies it is indicated for analgesic and anti-inflammatory action in musculo-skeletal disorders and after surgery.

Dosage and administration

In young cattle, the recommended dosage is 1.4 mg carprofen per kg (1 ml/35 kg) bodyweight once, administered subcutaneously or intravenously.

In horses and ponies the recommended dosage is 0.7 mg/kg (1 ml/70 kg) bodyweight by intravenous injection as a single dose. This can be repeated after 24 hours, or followed by therapy with an oral formulation such as Rimadyl Granules for 4 or 9 days (giving a total treatment course of 5 or 10 days), according to the duration of clinical signs. After this, further use should follow another clinical evaluation.

Contra-indications, warnings, etc

FOR INTRAVENOUS USE ONLY IN THE HORSE.

For specific information about the time which must elapse between treatment and competition, veterinary surgeons are advised to consult the authority responsible for the competition in question (e.g. the Jockey Club in the case of racing in the UK).

Do not exceed the stated dose or the duration of treatment.

Do not administer other 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 use in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding, or 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 cannot be avoided, animals may require a reduced dosage and careful clinical management.

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

In horses, concurrent administration of potential nephrotoxic drugs should be avoided.

Studies in cattle have suggested a transient nodule unassociated with heat or pain may form at the site of injection, although it is felt that this may be related to needle trauma rather than the product and has only been seen in a small number of animals.

In the absence of any specific studies in pregnant target animals, such use is not indicated.

There is no specific antidote for carprofen overdosage but general supportive therapy as applied to clinical overdosage with NSAIDs should be applied.

Avoid contact with skin and eyes. Wash off any splashes immediately with clean running water. Seek medical attention if irritation persists. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical attention immediately.

For animal treatment only.

Withdrawal period

Cattle (meat): 21 days.

Cattle (milk): not for use in cattle producing milk for human consumption.

Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

Pharmaceutical precautions

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

Following withdrawal of the first dose, use remainder of the product within 28 days. Discard unused material. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product.

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

Keep out of the reach of children.