Product Description

Butagran Equi is indicated for use in non-food producing horses to manage pain and inflammation associated with a range of musculoskeletal and soft tissue conditions. The powder is vanilla flavoured for ease of administration and may be mixed with a limited quantity of bran or oats if required.

For Horses:

Treatment of musculoskeletal conditions requiring pain relief and reduction of inflammation — including lameness associated with osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation, particularly where continued mobility is considered desirable

Limiting post-surgical inflammation, myositis and other soft tissue inflammation

Use as an anti-pyretic where clinically indicated, for example in viral respiratory infections

Which Animals Can Use Butagran Equi 200 mg/g Oral Powder?

Butagran Equi is licensed for use in non-food producing horses only. It must not be used in horses intended for human consumption, or in mares producing milk for human consumption. It is not recommended for animals under 6 weeks of age without careful veterinary assessment. Always use only under the direction of your vet, who will confirm your horse's passport status and suitability before prescribing.

Available Strengths & Sizes

Please order the exact strength and pack size as specified on your veterinary prescription.

Note: Not all pack sizes may be marketed at all times. Each 5 g sachet contains 1 g of phenylbutazone.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. Dosage is adjusted according to the horse's body weight and individual clinical response. Refer to the dispensing label and product package leaflet for the full dosing schedule and administration instructions. Do not exceed the prescribed dose or treatment duration, and do not administer hay immediately before or during dosing as this may delay absorption and onset of effect.

Contraindications

Source: SPC Section 3.3

Do not use in horses with known hypersensitivity to the active substance phenylbutazone or to any of the excipients (glucose monohydrate, hypromellose, butter vanilla flavour)

Do not use in animals suffering from cardiac (heart) disease

Do not use in animals suffering from hepatic (liver) disease

Do not use in animals suffering from renal (kidney) disease

Do not use where there is a possibility of gastrointestinal ulceration or bleeding

Do not use where there is evidence of a blood dyscrasia (blood cell disorder)

Not for use in horses intended for human consumption

Not for use in mares producing milk for human consumption

Storage & Handling

Store below 25°C. Keep sachets in the outer carton. Once the sachet is opened, use immediately — there is no shelf life after opening. Keep out of reach of children and animals at all times. Shelf life of the product as packaged for sale is 3 years.

Do not mix with any other veterinary medicinal product.

Dispose of unused product or waste materials via appropriate take-back schemes in accordance with local requirements. Do not dispose of via wastewater.

Withdrawal periods:

Not for use in horses intended for human consumption

Not for use in mares producing milk for human consumption

Treated horses must never be slaughtered for human consumption; the horse must be declared as not intended for human consumption under national horse passport legislation

Important Warnings

Source: SPC Sections 3.4 & 3.5

Animal precautions:

Do not exceed the stated dose — the therapeutic index of phenylbutazone is low and overdosing may result in gastric and large intestinal ulceration, enteropathy, renal papillary damage and subcutaneous oedema

The clinical effects of phenylbutazone can persist for at least three days after cessation of therapy; this should be borne in mind when examining horses for soundness

Use in animals under 6 weeks of age or in aged animals may involve additional risk; if such use cannot be avoided, careful clinical management is required

Avoid use in any dehydrated, hypovolaemic or hypotensive horse as there is a potential risk of increased renal toxicity; ensure water is readily available throughout treatment

NSAIDs can inhibit phagocytosis; in inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be initiated

Ponies are particularly sensitive to phenylbutazone adverse effects, including blood dyscrasia, gastric ulceration, diarrhoea, oral ulceration and hypoproteinaemia, even at therapeutic doses

Use in pregnancy: foetotoxic effects have been recorded in experimental species at high doses; use only after benefit/risk assessment by the attending veterinarian; avoid use around the time of parturition

Use in lactation: safety has not been established; use only after benefit/risk assessment by the attending veterinarian

Human safety warnings:

This product may cause hypersensitivity (allergic) reactions in persons sensitised to phenylbutazone — avoid contact with skin and eyes

People with known hypersensitivity to phenylbutazone must avoid contact with this product

If symptoms such as skin rash develop following exposure, seek medical advice and show the physician this warning; swelling of the face, lips or eyes, or difficulty breathing, are serious symptoms requiring urgent medical attention

The product can be irritating to the skin and eyes; avoid eye contact; in the event of accidental eye contact, irrigate immediately with plenty of clean water; if irritation persists, seek medical advice

Avoid inhaling or ingesting the powder; in the event of accidental inhalation or ingestion, seek medical advice immediately and show the package leaflet or label to the physician

Wash any exposed skin and hands thoroughly after use

Drug interactions:

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

Avoid concurrent administration of potentially nephrotoxic drugs

Phenylbutazone may displace or be displaced by highly protein-bound drugs including sulphonamides and warfarin, leading to increased pharmacologically active concentrations and potential toxicity

Phenylbutazone may interfere with the metabolism of warfarin and barbiturates

Concurrent use may reduce the therapeutic efficacy of penicillin and gentamicin products

Phenylbutazone induces hepatic microsomal enzyme activity; concurrent therapy with other therapeutic agents should be undertaken with caution

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 28365/4004 (Source: VMD Product Information Database — MA holder: Dopharma Research B.V.; GB distributor: Bimeda, Division of Cross Vetpharm Group (UK) Ltd)