国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE POTASSIUM CHLORIDE SODIUM CHLORIDE SODIUM CITRATE
Galen Limited
1/40/50/50 MG/5ml
Oral Solution
1998-11-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diarrest Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS: Each 5ml contains: EQUIVALENT TO APPROXIMATELY: For excipients see 6.1. 3 PHARMACEUTICAL FORM Oral Solution Straw coloured liquid with a cream soda/orange odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: As an adjunct in the management of acute diarrhoea together with appropriate fluid and electrolyte replacement. In the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis; as an adjunct to specific measures such as corticosteroids and sulphasalazine. Use in these conditions should be under specialist supervision. In the adjunctive short-term control of post surgical diarrhoea, including ileostomy. Children: For the occasional use in the control of intractable diarrhoea under specialist supervision. Since persistent diarrhoea may be an indicator of a potentially serious condition, the underlying cause must always be investigated. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration. Loperamide hydrochloride 1.0 mg Potassium chloride 40.0 mg Sodium chloride 50.0 mg Sodium citrate 50.0 mg Potassium 0.5 mmol/5 ml Sodium 1.4 mmol/5 ml Chloride 1.4 mmol/5 ml IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/06/2006_ _CRN 2024590_ _page number: 1_ Diarrest Oral Solution administration should be accompanied by an adequate daily fluid intake. If no improvement in the condition of the patient is seen within two days of commencing treatment then further investigation into the underlying cause of the diarrhoea should be performed. ADULTS, THE ELDERLY AND CHILDREN OVER 12 阅读完整的文件