GASTROGARD 37% W/W ORAL PASTE FOR HORSES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-01-2017
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Active ingredient:
OMEPRAZOLE
Available from:
Merial Animal Health Limited
ATC code:
QA02BC01
INN (International Name):
OMEPRAZOLE
Dosage:
37 Per Cent
Pharmaceutical form:
Oral Paste
Prescription type:
POM
Therapeutic group:
Equine - Food
Therapeutic area:
Omeprazole
Therapeutic indications:
Alimentary Tract Preparation
Authorization status:
Authorised
Authorization date:
2004-11-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GastroGard 37% w/w oral paste for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Omeprazole:…………………………………………370 mg
EXCIPIENTS:
Yellow Iron Oxide (E 172)…………………………….2 mg
For a 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.
4.3 CONTRAINDICATIONS
Do not use in mares producing milk for human consumption.
See section 4.5.i.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 19/12/2016_
_CRN 7025205_
_page number: 1_
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 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 administ
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