Target species
Horses
Indications for use, specifying the target species
For treatment and prevention of gastric ulcers in horses.
Contraindications
See section, "Special precautions for use"
Do not use in cases of hypersensitivity to the active substance or any of the excipients.
Special warnings for target species
The veterinarian should consider the need for performing relevant diagnostic tests before selection of the treatment dose rate.
Special precautions for use
Special precautions for use in animals
Not recommended for animals under 4 weeks of age or weighing less than 70 kg bodyweight.
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 wellbeing 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 veterinary medicinal product to animals
As this product may cause irritant and hypersensitivity reactions, 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 seek medical advice and avoid handling the product in future.
Adverse reactions (frequency and seriousness)
There are no known treatment-related clinical adverse effects.
In cases of hypersensitivity reactions, treatment should be discontinued immediately.
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect.
The safety of the product has not been assessed during pregnancy and lactation. The use of the product is not recommended in pregnant and lactating mares.
Interaction with other medicinal products and other forms of interaction
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
Omeprazole is effective in horses of various breeds and under different management conditions; foals as young as four weeks of age and 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 (1 division of the oral syringe/50 kg BW) 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 (1 division of the oral syringe/50 kg BW) is recommended.
It is recommended to associate the treatment with changes of husbandry and training practices.
Please see also the text under section, "Special precautions for use"
Prevention of gastric ulcers: one administration per day at the dose rate of 1 mg Omeprazole per kg body weight.
To deliver Omeprazole at the dose of 4 mg Omeprazole /kg, set the oral syringe plunger to the appropriate dose division for the horse’s weight. Each division on the oral syringe plunger delivers sufficient Omeprazole to treat 50 kg body weight. The contents of one oral syringe will treat a 700 kg horse at the rate of 4 mg Omeprazole per kg body weight.
To deliver Omeprazole at the dose of 1 mg Omeprazole /kg, set the oral syringe plunger to the dose division equivalent to one quarter of the horse’s body weight. For example, to treat a horse weighing 400 kg, set the plunger to 100 kg. At this dose, each division on the oral syringe plunger will deliver sufficient Omeprazole to treat 200 kg body weight.
Replace cap after use.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects related to treatment were observed following daily use for 91 days at Omeprazole dosages up to 20 mg/kg in adult horses and in foals older than 2 months.
No undesirable effects related to treatment (in particular no adverse effect on the semen quality or reproductive behaviour) were observed following daily use for 71 days at an Omeprazole dosage of 12 mg/kg in breeding stallions.
No undesirable effects related to treatment were observed following daily use for 21 days at an Omeprazole dosage of 40 mg/kg in adult horses.
Withdrawal period
Horse: Meat and offal: 1 day
Not authorised for use in mares producing milk for human consumption.