Equinor Oral Paste for Horses
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-09-2013
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Active ingredient:
omeprazole 370 mg/g
Available from:
Norbrook Laboratories Limited
ATC code:
QA02BC01
Pharmaceutical form:
Oral paste
Therapeutic group:
omeprazole
Therapeutic area:
Horses Non Food
Authorization date:
2013-06-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equinor 370 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral paste.
A yellow to tan oily paste
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of gastric ulcers and the prevention of recurrence of gastric ulcers.
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
The veterinarian should consider the need for performing relevant diagnostic tests before selection of the treatment
dose rate.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/07/2013_
_CRN 7013031_
_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 irritant and hypersensitivity reactions, avoid direct contact with skin and eyes. U
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