SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of Veterinary Medicinal Product

Equipalazone 1 g Oral Powder

2. Qualitative and Quantitative Composition

Active substance per sachet

Phenylbutazone 1 g

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral powder.

White/cream powder.

4. Clinical Particulars

4.1 Target species

Horses and ponies.

4.2 Indications for use, specifying the target species

For the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of phenylbutazone can offer relief. Examples of conditions normally considered suitable for treatment with phenylbutazone include lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis, and in the reduction of post-surgical soft tissue reaction.

4.3 Contraindications

The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or the duration of treatment.

Do not administer with other non-steroidal anti-inflammatory agents concurrently or within 24 hours of each other.

Do not use in animals suffering from cardiac, hepatic or renal disease; where there is the possibility of gastrointestinal ulceration or bleeding; where there is evidence of a blood dyscrasia or of hypersensitivity to the product.

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

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.

Use in any animal under six weeks of age, or in aged animals, may involve additional risks. If such use cannot be avoided, animals may require a reduced dosage and special clinical management.

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

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

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

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 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.

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.

4.6 Adverse reactions (frequency and seriousness)

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

4.7 Use during pregnancy, lactation or lay

The safety of phenylbutazone in pregnancy has not been established. Use during pregnancy should be avoided whenever possible, particularly during the first trimester.

4.8 Interaction with other medicinal products and other forms of interaction

Some non-steroidal anti-inflammatory agents 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. Concurrent administration of potential nephrotoxic drugs (e.g. aminoglycoside antibiotics) should be avoided.

Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.

4.9 Amounts to be administered and administration route

For oral administration only.

The dosage should be adjusted according to the individual animal’s response, but the following may be taken as a guide:

Horses 450 kg (1000 lb) body weight: the contents of two sachets to be administered twice on day 1 of treatment (equivalent to 8.8 mg/kg/day) followed by the contents of 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) on alternate days.

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

For ease of administration mix the powder with a small quantity of feed.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The therapeutic index of phenylbutazone is low. In man, charcoal haemoperfusion in conjunction with dopamine has been used successfully to treat overdosage with phenylbutazone, but there is no experience of the use of this technique in the horse.

4.11 Withdrawal periods

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.

5. Pharmacological OR IMMUNOLOGICAL PROPERTIES

Phenylbutazone is a pyrazolone non-steroidal anti-inflammatory, analgesic and antipyretic agent.

ATC Vet Code: QM01AA01

5.1 Pharmacodynamic properties

Phenylbutazone acts by inhibiting the production of prostaglandins. Prostaglandins possess a wide variety of physiological properties, including those involved in the production of pain, inflammation and pyrexia. The main metabolite, oxyphenbutazone, possesses similar pharmacological properties.

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

5.2 Pharmacokinetic properties

Phenylbutazone is generally well absorbed following oral administration. The rate, but not the extent, of absorption may be affected due to binding of phenylbutazone to food and the contents of the gastrointestinal tract. Therefore, it is recommended that Equipalazone Powder is administered mixed with a small amount of dry bran or oats. Phenylbutazone is highly bound to plasma proteins.

6. Pharmaceutical Particulars

6.1 List of excipients

Acacia

Gelatin

Silicon dioxide

6.2 Incompatibilities

There are no known incompatibilities.

Equipalazone Powder should only be mixed with dry foodstuffs, to prevent premature solution of the encapsulation coat.

Shelf life of veterinary medicinal product as packaged for sale: 4 years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in a dry place.

6.5 Nature and contents of immediate packaging

Sachets of a paper/polyethylene outer layer and aluminium/polyethylene inner layer, in packs of 100 sachets (25 strips of four sachets) and of 32 sachets (8 strips of four sachets). Each sachet contains 1.5 g Equipalazone Powder.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

Dechra Limited

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire

BD23 2RW

United Kingdom

8. MARKETING AUTHORISATION NUMBERS

Vm 10434/4005

9. DATE OF LAST RENEWAL OF THE AUTHORISATION

Date: 26 August 2004

Date: November 2014

APPROVED 13/11/14