Butagran Equi for horses, 200mg/g, phenylbutazone , 20x5g sachets

Target species:

Equines.

Indications for use, specifying the target species:

The product is indicated for the treatment of musculoskeletal conditions where relief of pain and reduction of associated inflammation is required, for example, in claudication associated with osteoarthritis, bursitis, laminitis and soft tissue inflammation, particularly where continued mobility is considered desirable.

It is also of value in limiting post-operative inflammation, myositis and other soft tissue inflammation.

The product may be used as an antipyretic in situations where it is considered appropriate, for example, in viral respiratory infections.

Amounts to be administered and route of administration:

For oral administration.

For every 450 kg of body weight, the following dosage guide should be used, depending on the individual response:

Day 1: Two sachets or 10 g of product twice daily (equivalent to 4.4 mg phenylbutazone/kg body weight each time).

Days 2-4: One sachet or 5 g of product twice daily (equivalent to 2.2 mg phenylbutazone/kg body weight each time), followed by one sachet or 5 g of product daily (2.2 mg phenylbutazone/kg body weight daily) or every other day, as needed.

If no response is seen after 4-5 days, discontinue treatment. Hay may delay the absorption of phenylbutazone and therefore the onset of a clinical effect. It is recommended that hay not be administered immediately before or during administration of the product.

To facilitate administration, the product may be mixed with a limited amount of bran or oats.

Overdose (symptoms, emergency procedures, antidotes), if applicable:

Overdose may cause gastric and large intestinal ulceration and general enteropathy. Renal papillary lesions with renal failure may also occur. Subcutaneous edema, especially under the jaw, may become manifest due to loss of plasma proteins. There is no specific antidote. If signs of possible overdose appear, the animal should be treated symptomatically.

Adverse reactions (frequency and seriousness):

In common with other NSAIDs that inhibit prostaglandin synthesis, gastric and/or renal intolerance may occur. This is usually associated with overdose and such events are rare. Recovery usually occurs upon discontinuation of treatment and initiation of supportive symptomatic therapy

Ponies are very sensitive to gastric ulceration associated with this product, even at therapeutic doses (diarrhea, mouth ulceration and hypoproteinemia may also be observed).

Contraindications:

Do not use in animals with known hypersensitivity to the active ingredient.

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, in which there is a possibility of gastrointestinal ulceration or bleeding, or in which there are signs of blood dyscrasias.

Use during pregnancy or lactation:

Pregnancy:

Caution should be exercised if the product is administered to pregnant mares. Although no adverse effects associated with phenylbutazone on the fetus or maintenance of pregnancy have been reported in field use, definitive safety studies in mares have not been conducted. Phenylbutazone has been shown to be fetotoxic in experimental animal species at high dose levels.

Lactation:

The safety of the product in lactating mares has not been demonstrated. If the administration of phenylbutazone to pregnant or lactating mares is considered essential, the potential benefits should be weighed against the potential hazards to the mare and/or foal.

Use should be avoided around the time of parturition.

Special warnings for each target species:

The clinical effects of phenylbutazone may be evident for at least three days after cessation of therapy. This should be taken into account when examining horses for condition.

The FEI (International Equestrian Federation) considers phenylbutazone to be a prohibited substance, therefore it should not be administered for at least 8 days before competition.

Special precautions for use in animals:

Do not exceed the indicated dose as the therapeutic index of phenylbutazone is narrow.

Use in any animal less than 6 weeks of age or in elderly animals may involve additional risk. If such use cannot be avoided, animals may require close clinical attention. Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity. Provide a continuous supply of water throughout the treatment period to avoid dehydration. NSAIDs may cause inhibition of phagocytosis,

, therefore, in the treatment of inflammatory conditions associated with bacterial infections, appropriate concomitant antimicrobial therapy should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Wash hands after use.

Avoid contact with eyes. In case of accidental contact with eyes, rinse eyes with plenty of clear water. If irritation persists, seek medical advice. Care should be taken to avoid inhalation or ingestion of the powder. In case of accidental inhalation or ingestion, seek medical advice and show the product packaging.

Interactions with other medicinal products and other forms of interaction:

Concomitant administration of potentially nephrotoxic drugs should be avoided. Phenylbutazone is highly bound to plasma proteins. It may displace other highly protein-bound drugs, e.g. some sulfonamides, warfarin, or may itself be displaced to produce an increase in unbound pharmacologically active concentrations, which may cause toxic effects. Concomitant treatment with other therapeutic agents should be undertaken with caution because of the risk of metabolic interactions. Phenylbutazone may interfere with the metabolism of other drugs, e.g. warfarin, barbiturates, resulting in toxicity. There is evidence that the pharmacokinetics of penicillin and gentamicin products may be affected by the concomitant administration of phenylbutazone-containing products, with a possible reduction in therapeutic efficacy, as tissue penetration may be reduced. The distribution of other concomitantly administered drugs may also be affected.

Do not administer other NSAIDs concomitantly or within 24 hours of each other.

Phenylbutazone induces the activity of hepatic microsomal enzymes

Withdrawal period:

Not for use in horses intended for human consumption.

Treated horses can never be slaughtered for human consumption.