Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Omeprazole
Boehringer Ingelheim Vetmedica GmbH
QA02BC01
Omeprazole
370 milligram(s)/gram
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
omeprazole
Authorised
2015-03-13
Health Products Regulatory Authority 06 March 2020 CRN009673 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Omeproshield 370 mg/g 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 the 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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 administering the product. Wash hands or any exposed skin after use. In case of contact with eyes, wash immediately with clean running water and seek medical advice. Persons developing a reaction after contact with the product should avoid handling the product in future. Health Products Regulatory Authority 06 March 2020 CRN009673 Page 2 of 4 4.6 ADVE Perskaitykite visą dokumentą