국가: 영국
언어: 영어
출처: HMA (Heads of Medicines Agencies)
omeprazole 37 %
Merial Animal Health Ltd
QA02BC01
Oral paste
omeprazole
Horses Females
2011-06-13
Revised: December 2009 AN: 01095/2009 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 TARGET SPECIES None._ _ Revised: December 2009 AN: 01095/2009 4.5 SPECIAL PRECAUTIONS FOR USE i) 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. ii) Special precautions to be taken by the person admini 전체 문서 읽기