Introduction

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

Free flowing white/cream powder for oral administration, containing 1 g micro-encapsulated Phenylbutazone per sachet.

Preservative: Sodium Paracombin 0.15 % w/w

Uses

Equipalazone 1 g Oral Powder is indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of Phenylbutazone can offer relief, for example, in lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis, and in the reduction of post-surgical soft tissue reaction.

Dosage and administration

For oral administration only. Dependent on individual response, but as a guide:

Horses: 450 kg (1000 lb) body weight:

Two sachets to be administered twice on day one (equivalent to 8.8 mg/kg/day) followed by one sachet twice daily for four days (4.4 mg/kg/day), then one sachet daily or on alternate days sufficient to keep the horse comfortable (2.2 mg/kg/day).

Ponies: 225 kg (500 lb) body weight:

One sachet (4.4 mg/kg/day) on alternate days.

Adjust dose according to body weight.

Discontinue treatment if no response is evident after four to five days treatment.

Equipalazone 1 g Oral Powder should be mixed with a small quantity of feed.

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.

Do not use 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 any animal 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 animal as there is a risk of increased 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.

Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given NSAIDs.

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

Response to long-term therapy should be monitored at regular intervals by a veterinary practitioner.

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

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

Do not store above 25°C. Store in a dry place. Keep out of the reach and sight of children.

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

Boxes of 32 and 100 sachets.

Further information

When mixed with a concentrate feed, the product was shown to be palatable to horses.

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.

Marketing authorisation number

Vm 10434/4005.