Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE PH. EUR.
Norbrook Laboratories Limited
QA02BC01
OMEPRAZOLE PH. EUR.
370 mg/g
Oral Paste
POM
Equine
Omeprazole
Alimentary Tract Preparation
Authorised
2013-07-26
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 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _2_ _6_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _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, in Les hele dokumentet