GastroGard 370 mg/g Oral Paste

None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
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 veterinary medicinal
product to animals:
As this product may cause hypersensitivity, avoid direct contact with skin and eyes.

Personal protective clothing consisting of impervious gloves should be worn when
handling the
product. 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 and show the label/leaflet to the physician.
Persons developing a reaction after contact with the product should avoid handling the
product in future.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Horses:
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
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 veterinary medicinal
product in pregnant and lactating mares is not recommended.
3.8 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.
3.9 Administration route and dosage
For oral administration.
Veterinary medicinal 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.
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 3.5.
Prevention of gastric ulcers: one administration per day at the dose rate of 1 mg
omeprazole per kg body weight.
To deliver veterinary medicinal 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 veterinary medicinal 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.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
No adverse events 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 adverse events 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 adverse events related to treatment were observed following daily use for 21 days at
an omeprazole dosage of 40 mg/kg in adult horses.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: 1 day.
Not authorised for use in mares producing milk for human consumption.
4.