Bimeprazol Oral Paste Syringe

PRESENTATION Smooth, homogeneous, tan-coloured oral paste.

INDICATIONS For the treatment and prevention of gastric ulcers in horses.

CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in mares producing milk for human consumption.

SPECIAL WARNINGS None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS Not recommended for animals under 4 weeks of age or weighing less than 70 kg body weight. Stress (including high performance training and competition), feeding, management and husbandry practices may be associated with the development of gastric ulceration in horses. Individuals responsible for the well-being of horses should consider reducing the ulcerogenic challenge by modifying husbandry practices to achieve one or more of the following: reduced stress, reduced fasting, increased intake of roughage and access to grazing.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT As this product may cause hypersensitivity, avoid direct contact with skin and eyes. Use impervious gloves and do not eat or drink when handling and administering the product. Wash hands or any exposed skin after use. In case of contact with eyes, wash immediately with clean running water and seek medical advice. Persons developing a reaction after contact with the product should avoid handling the product in future.

ADVERSE REACTIONS None known.

USE DURING PREGNANCY, LACTATION OR LAY Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect. In the absence of data during pregnancy and lactation, the use of Bimeprazol in pregnant and lactating mares is not recommended.

INTERACTIONS Omeprazole may delay the elimination of warfarin. No other interaction with medicines routinely used in the treatment of horses is expected, although interaction with drugs metabolised by liver enzymes cannot be excluded.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Bimeprazol is effective in horses of various breeds and under different management conditions; foals as young as four weeks of age, weighing over 70 kg and breeding stallions.

For oral administration. Treatment of gastric ulcers: one administration per day during 28 consecutive days at the dose rate of 4 mg omeprazole per kg body weight followed immediately by a dosage regimen of one administration per day during 28 consecutive days at the dose rate of 1 mg omeprazole per kg body weight, to reduce the recurrence of gastric ulcers during treatment. Should recurrence occur, re-treatment at a dose rate of 4 mg omeprazole per kg body weight is recommended. It is recommended to associate the treatment with changes of husbandry and training practices.

Prevention of gastric ulcers: one administration per day at the dose rate of 1 mg omeprazole per kg body weight. To deliver Bimeprazol at the dose of 4 mg omeprazole/kg, set the syringe plunger to the appropriate dose division for the horse's weight. Each full dose division on the syringe plunger delivers sufficient omeprazole to treat 100 kg body weight. The contents of one syringe will treat a 575 kg horse at the rate of 4 mg omeprazole per kg body weight. To deliver Bimeprazol at the dose of 1 mg omeprazole/kg, set the syringe plunger to the dose division equivalent to one quarter of the horse's body weight. At this dose, each full dose division on the syringe plunger will deliver sufficient omeprazole to treat 400 kg body weight. For example, to treat a horse weighing 400 kg, set the plunger to 100 kg. Replace cap after use

WITHDRAWAL PERIOD Meat and offal: 1 day. Not permitted for use in mares producing milk for human consumption.