Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Omeprazole
CP-Pharma Handelsgesellschaft mbH
QA02BC01
Omeprazole
400 mg/sachet
Gastro-resistant granules
POM: Prescription Only Medicine as defined in relevant national legislation
omeprazole
Authorised
2018-07-20
Health Products Regulatory Authority 20 July 2018 CRN000TW2 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equizol 400 mg gastro-resistant granules for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 5 g contains: ACTIVE SUBSTANCE: Omeprazole 400 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant granules White to beige spherical granules 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of gastric ulcers in horses. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance or any of the excipients. See section 4.5. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 20 July 2018 CRN000TW2 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals As the safety of the product has not been assessed in foals under 8 months of age or weighing less than 125 kg bodyweight, the use of the product is not recommended in these animals. 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 This product may cause adverse gastrointestinal effects or hypersensitivity (allergic) reactions if accidentally ingested, particularly by children. Do not eat or drink whilst handling or administering the product. Wash hands or any exposed skin after use. Any part-used sachets should be returned to the original carton and suitably stored to prevent access by children. In case of accid Lugege kogu dokumenti