Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

Sachets containing 10 g of granules. Each sachet contains 1.5 g of Suxibuzone (microencapsulated).

Uses

Danilon Equidos is a non-steroidal anti-inflammatory drug for treatment of pain and inflammation associated with musculoskeletal conditions in the horse eg. osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation.

Dosage and administration

For oral administration added to a small amount of feed. Ensure free access to drinking water during treatment.

Horses

For a 480 kg horse: administer 2 sachets twice daily for 2 days. This is equivalent to 12.5 mg suxibuzone/kg/day.

Follow by administering 1 sachet twice daily for 3 days (equivalent to 6.25 mg suxibuzone/kg/day).

Thereafter, administer 1 sachet daily or on alternate days, in order to achieve the desired clinical response (equivalent to 3.1 mg suxibuzone/kg/day). Thereafter, reduce the dose to the minimum dose necessary for a satisfactory clinical response.

Ponies

Administer half the recommended dose for horses. Adjust the dose carefully according to bodyweight. For a 240 kg pony: administer 1 sachet daily for 2 days (equivalent to 6.25 mg of suxibuzone/kg/day).

Follow by administering ½ sachet daily for 3 days (equivalent to 3.1 mg of suxibuzone/kg/day) or 1 sachet daily on alternate days. Thereafter, reduce the dose to the minimum dose necessary for a satisfactory clinical response.

Further administration advice

For administration of half sachets, use the measuring scoop provided. One level scoop contains 5 g granules. Hay, as part of the diet, may delay the absorption of suxibuzone and so the onset of the clinical effect. It is advisable not to feed hay immediately prior to, or with Danilon Equidos. If no clinical response is evident after 4-5 days of treatment, discontinue treatment and reconsider the diagnosis.

Contra-indications, warnings, etc

Do not use in horses intended for human consumption.

Do not administer to animals with renal, hepatic or cardiac disorders, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Avoid use in dehydrated, hypovolemic or hypotensive animals as there is an increased risk of renal failure.

After continuous use, or when used at high doses, gastro-intestinal changes may occur. Occasionally, blood dyscrasias and renal alterations may be found, especially in animals with restricted access to drinking water.

Use in very young (less than 12 weeks) or aged animals may involve additional risk. Ensure accurate assessment of dose to body weight and closely monitor clinical response.

Studies have not been carried out in the horse to establish safe use during pregnancy and lactation.

All NSAIDs can inhibit phagocytosis and hence, during treatment of inflammatory conditions associated with bacterial infections, appropriate antimicrobial treatment should also be used.

In case of accidental continuous overdose, the following symptoms may occur: thirst, depression, anorexia and weight loss; gastro intestinal disorders (irritation, ulcers, diarrhoea and faecal blood); altered blood profiles and haemorrhages; hypoproteinaemia with ventral oedema causing hemoconcentration, hypovolemic shock and circulatory collapse; renal failure and fluid retention.

If signs of intolerance appear, discontinue administration and apply symptomatic treatment.

A slow intravenous infusion of a solution of sodium bicarbonate, which leads to urine alkalinisation, increases the clearance of the product..

Interactions

Suxibuzone and its metabolites may be highly bound to plasma proteins and compete with other highly bound drugs eg. sulphonamide, warfarin. Concurrent administration of other highly bound drugs will lead to an increase of non-bound plasma concentrations, which may lead to toxic effects. Drug compatability must be closely monitored when adjunctive therapy is required.

Do not administer concurrently with other NSAIDs or within 24 hours of other NSAIDs.

Concurrent administration of potentially nephrotoxic drugs should be avoided.

Operator warnings

Wear suitable gloves. Wash hands after use. Use in a well-ventilated area. Avoid inhaling any dust when opening sachet and mixing with feed. In case of accidental contact with eyes, wash immediately with plenty of clean water. In case of accidental ingestion, seek medical advice immediately.

Pharmaceutical precautions

When using ½ sachets: after opening a sachet use the contents within 7 days and reseal between doses. Discard unused product 7 days after first opening. For animal treatment only. Keep out of the reach of children.

Legal category

POM-V

Packaging Quantities

Carton with 18 or 60 polyethylene lined sachets containing 10 g granules.

Further information

Suxibuzone is a prohibited substance under international equine competition rules. Treatment with Danilon Equidos should be stopped for a suitable time prior to competing. Follow RCVS guidance on elimination times for various anti-inflammatory drugs. Suxibuzone is a NSAID with anti-inflammatory, antipyretic and analgesic properties and low ulcerogenic potential. Its mechanism of action is based on the inhibition of cyclo-oxygenase. The therapeutic effects are mainly due to the inhibition of the biosynthesis of prostaglandins, which act as peripheral mediators of pain and trigger the synthesis of endogenous pyrogens and mediators in the inflammatory process. It also inhibits platelet aggregation. After oral administration, suxibuzone is readily absorbed and it is metabolized by the hepatic microsomal system producing phenylbutazone, oxyphenbutazone and γ - hydroxyphenylbutazone. As happens with other NSAIDs, the duration of the clinical response is much longer than the plasma half-life. Significant concentrations of both active metabolites are found in synovial fluid for at least 24 hours after administration.

Marketing authorisation number

Vm 08498/4000.