Land: Verenigd Koninkrijk
Taal: Engels
Bron: VMD (Veterinary Medicines Directorate)
Betamethasone
Norbrook Laboratories Limited
amendedS
Betamethasone
Expired
Revised: July 2010 ATCVet code amended SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norbet 0.25 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains 0.25 mg Betamethasone. EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet A small white circular, tablet with convex faces and a break-line. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Norbet Tablets are specifically indicated for the treatment of canine allergic dermatoses. 4.3 CONTRAINDICATIONS Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES During a course of treatment the situation should be reviewed frequently by close veterinary supervision. See all warnings 4.5 and 4.6. 1 Revised: July 2010 ATCVet code amended 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Anti-inflammatory corticosteroids such as betamethasone are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long-term use should therefore generally be kept to the minimum necessary to control symptoms. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with eyes. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-Pituitreal-Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adren Lees het volledige document