Introduction

Dechra

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

A sterile, aqueous solution for injection, containing Phenylbutazone 200 mg/ml.

Preservative: Benzyl Alcohol 1.5 % v/v.

Uses

Equipalazone 200 mg/ml Solution for Injection is indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of Phenylbutazone can offer relief against inflammation, pain and lameness.

Dosage and administration

Horses: 450 kg (1000 lb) body weight:

Maximum 10 ml (4.4 mg Phenylbutazone/kg).

Ponies: 225 kg (500 lb) body weight:

Maximum 5 ml (4.4 mg Phenylbutazone/kg)

Equipalazone 200 mg/ml Solution for Injection should be administered by slow intravenous injection as a single dose, which may be followed if necessary by oral Phenylbutazone therapy commencing 24 hours after the injection.

In acute cases and in hospitalised animals, Equipalazone 200 mg/ml Solution for Injection may be administered once daily for not more than five consecutive days.

Contra-indications, warnings, etc

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.

The therapeutic index of Phenylbutazone is low.

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

There is a risk of irritancy if the injection is accidentally inoculated under the skin during intravenous injection.

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.

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 to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.

Use in animals less than six 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 animals as there is a risk of increased renal toxicity.

Concurrent administration of potentially nephrotoxic drugs should be avoided.

It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.

Use during pregnancy should be avoided whenever possible, particularly during the first trimester.

Operator warnings: The product should be handled with care at all times to reduce the risk of accidental ingestion, skin contact or self-injection. If accidental skin or eye contact occurs, the site should be washed immediately with water. If the product is self-injected or ingested, seek medical advice and show the product packaging.

Advice to doctors: gastric lavage (emesis in children) should be performed urgently. Charcoal haemoperfusion has also been shown to be beneficial. Treatment should then be administered symptomatically.

General precautions: For animal treatment only.

NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections, appropriate concurrent antimicrobial therapy should be instigated.

Rarely, collapse following intravenous injection has been reported. The product should be injected slowly over as long a period as is reasonably practical. At the first signs of intolerance, the administration of the injection should be interrupted.

Withdrawal period: 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

Store between +2 and +8°C. Protect from light. Keep out of the reach and sight of children.

Once the vial is broached, following withdrawal of the first dose use the product within 28 days. Discard unused material.

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

Legal category

POM-V

Packaging Quantities

Multidose vials of 50 ml.

Further information

The clinical effect of Phenylbutazone can be evident for at least three days following cessation of administration. This should be borne in mind when examining horses for soundness.

Some authorities (including the Jockey Club) regard Phenylbutazone as a "prohibited substance" under the rules of competition. Therefore, use of this product in a competition horse should be in accordance with the recommendations/advice of the relevant competition authorities.

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and Ireland.

Manufacturers: Ashton Pharmaceuticals Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR, UK.

Produlab Pharma B.V., Forellenweg 16, 4941 SJ Raamsdonksveer, The Netherlands.