Target species
Horses.
Indications for use, specifying the target species
For treatment and prevention of gastric ulcers in horses.
Contra-indications
Do not use in mares producing milk for human consumption.
Special warnings for each target species
None.
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 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 to animals
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 (frequency and seriousness)
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 GastroGard in pregnant and lactating mares is not recommended.
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
GastroGard is effective in horses of various breeds and under different management conditions; foals as young as four weeks 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 bodyweight 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 bodyweight, 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 (please see Special precautions for use in animals above).
Prevention of gastric ulcers: One administration per day at the dose rate of 1 mg omeprazole per kg bodyweight.
To deliver GastroGard 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 bodyweight. The contents of one syringe will treat a 575 kg horse at the rate of 4 mg omeprazole per kg bodyweight.
To deliver GastroGard at the dose of 1 mg omeprazole/kg, set the syringe plunger to the dose division equivalent to one quarter of the horse’s bodyweight. 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.
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 periods
Meat and offal: 1 day.
Not permitted for use in mares producing milk for human consumption.