Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Oral powder for addition to feed. 1 gram of powder contains 5 mg of dembrexine hydrochloride monohydrate.

Uses

For the symptomatic treatment of acute, sub-acute and chronic respiratory diseases of the upper and lower respiratory tract in horses, where an abnormal amount of mucus of increased viscosity is present. Dembrexine reduces the viscosity of respiratory mucus by fragmenting the sputum fibre network, and increasing pulmonayr surfactant and respiratory compliance.

Dosage and administration

For oral administration in the food at a dose of 0.3 mg active ingredient per kg bodyweight twice daily.

Adult horses (500 kg) receive 30 grams of powder twice daily in the food. This corresponds to 6 level measures twice daily (measure enclosed in the pack).

For small horses, ponies and foals the dose is administered pro rata according to the bodyweight ie, at a rate of 2 measures/170 kg.

Add to the feed immediately prior to administration. Discard any remaining medicated feed.

An improvement in clinical signs is usually seen within five days. Treatment should be continued until complete remission occurs (usually a total period of 12 to 14 days) but should not exceed 28 days. The horse's condition should be reassessed after this period before any further treatment is proposed.

In cases complicated by the presence of micro-organisms or where pyrexia is present, the simultaneous use of suitable chemotherapeutic agents is recommended.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to the active ingredient. Care/precaution should be taken when using this product to avoid skin contact, eye contact and/or inhalation of the dust. Medical advice should be sought if you feel unwell after using this product.

Withdrawal period

Animals must not be slaughtered for human consumption during treatment. Horses may be slaughtered for human consumption only after 1 day from the last treatment.

Sputolosin has not been tested in pregnant mares, however, reproduction studies using dembrexine in laboratory animals show no teratogenic effect. Where Sputolosin has been administered to pregnant mares, no adverse effects have been reported. Unused product and containers should be disposed of in accordance with national requirements.

For animal treatment only.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

Screw top polythene container with polyethylene seal insert containing 420 grams, with 5 g measuring scoop.

Further information

Nil.

Marketing authorisation number

Vm 00015/4018.