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Danilon Equidos Sachets

Danilon Equidos Sachets

Danilon Equidos comes in sachets of yellow, odourless granules to add to the food of horses. It has to be prescribed by your vet and is used to treat pain and inflammation associated with osteoarthritis, degenerative joint disease, musculo-skeletal injuries and conditions such as bursitis and laminitis. One sachet is an adequate starting dose for a 240kg pony. A horse weighing 480kg needs two sachets on the first day. On the following three days a half dose is all that is required, and then afterwards this dose can be given daily or on alternate days, depending on the response. A scoop is provided within the carton to enable half sachets to be measured out for more accurate dosing of different sized equines. Danilon Equidos should not be given to any equine which might go for human consumption in future. It is also a prohibited substance under international equine competition rules. Treatment with Danilon should be stopped for a suitable time before competing to allow the drug to clear.

Description

Presentation

Sachets containing 10 g of yellow, odourless granules for top dressing. Each sachet contains 1.5 g of Suxibuzone (microencapsulated). Also contains quinoline yellow (E104)

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. When added to a portion of feed the product will be accepted by most horses. Ensure free access to drinking water during treatment. Do not exceed the stated dose or duration of treatment. Dosage should be kept to a minimum for alleviation of symptoms.

Horses

For a 480 kg horse: administer 2 sachets twice daily for 2 days (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 (equivalent to 3.1 mg suxibuzone/kg/day) or on alternate days or 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 on alternate days. Thereafter, reduce the dose to the minimum dose necessary for a satisfactory clinical response.

Further administration advice

For administration of less than one sachet, use the measuring scoop provided. One full level scoop contains 5 g granules (equivalent to 1/2 sachet) and up to the green line level contains 2.5 g granules (equivalent to 1/4 sachet). 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. 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.

Do not administer to horses prior to taking part in a competition. See Further Information section.

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. Do not restrict the consumption of water during treatment.

After continued 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 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.

NSAIDs can inhibit phagocytosis and hence, in the 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. (sulphonamides, warfarin) or may itself be displaced to produce an increase of non-bound pharmacologically active concentrations which could lead to toxic effects. 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.

For animal treatment only. Keep out of the reach and sight of children

Pharmaceutical precautions

After opening a sachet re-seal as well as possible between doses. Once opened, use within 7 days. This medicinal product does not require any special storage conditions

Legal category

POM-V

Packaging Quantities

Carton with 18 or 60 laminated opaline/aluminium polyethylene sachets containing 10 g granules. A 5g scoop (when level) with a 2.5g increment is provided.

Further information

Do not administer to horses prior to taking part in a competition

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; these active metabolites produce suxibuzone's therapeutic effect.

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 Holder (if different from distributor)

Laboratorios Dr. ESTEVE, S.A.

Avda. Mare de Deu de Montserrat, 221

08041 - Barcelona

Spain

Marketing authorisation number

Vm 08498/4000.

GTIN (Global Trade Item No)

Danilon Equidos 1.5g Granules for top dressing 10g sachets x 60

05420036900337

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