GastroGard 370 mg/g oral paste

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Merial Animal Health Limited

ATC code:

QA02BC01

INN (International Name):

Omeprazole

Dosage:

370 milligram(s)/gram

Pharmaceutical form:

Oral paste

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

omeprazole

Therapeutic indications:

Alimentary Tract Preparation

Authorization status:

Authorised

Authorization date:

2004-11-19

Summary of Product characteristics

Health Products Regulatory Authority
14 June 2018
CRN000Y38
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GastroGard 370 mg/g oral paste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Omeprazole:…………………………………………370 mg
EXCIPIENTS:
Yellow Iron Oxide (E 172)…………………………….2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral paste.
Smooth homogeneous yellow to yellow-tan paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and prevention of gastric ulcers in horses.
4.3 CONTRAINDICATIONS
Do not use in mares producing milk for human consumption. See section
4.5.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
14 June 2018
CRN000Y38
Page 2 of 6
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.
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 husbandrypractices 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 A