Omeproshield 370 mg/g Oral Paste for Horses

None.
4.5 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.

Revised May 2024
MA Split following NI AN: 01125/2023
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 veterinary
medicinal 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.
4.6 Adverse reactions (frequency and seriousness)
There are no known treatment-related clinical adverse effects.
4.7 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 the product in
pregnant and lactating mares is not recommended.
4.8 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.
4.9 Amounts to be administered and administration route
The product 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 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. Please see also the text under section 4.5

Revised May 2024
MA Split following NI AN: 01125/2023
Prevention of gastric ulcers: one administration per day at the dose rate of 1 mg
omeprazole per kg body weight.
To deliver the product 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 the product 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.
4.10 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.
4.11 Withdrawal period(s)
Horse:
Meat and offal: 1 day
Not authorised for use in mares producing milk for human consumption.
5.