País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Omeprazole
Norbrook Laboratories (Ireland) Limited
QA02BC01
Omeprazole
370 milligram(s)/gram
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
omeprazole
Authorised
2020-05-29
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Peptaleve 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. 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 and prevention of gastric ulcers in horses. 4.3. CONTRAINDICATIONS See section 4.5 Do not use in cases of hypersensitivity to the active substance or any of the excipients. 4.4. SPECIAL WARNINGS FOR TARGET SPECIES The veterinarian should consider the need for performing relevant diagnostic tests before selection of the treatment dose rate. 2 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 wellbeing 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. 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 seek medical advice and avoid handling the product in future. 4.6. ADVERSE REACTIONS (FREQUEN Leia o documento completo