Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
omeprazole 370 mg/g
Norbrook Laboratories Limited
QA02BC01
Oral paste
omeprazole
Horses Non Food
2013-06-26
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 Read the complete document