Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sachet A-macrogol (macrogol 3350), sodium sulfate, sodium chloride, potassium chloride; sachet B-ascorbic acid, sodium ascorbate
Norgine Limited
sachet A-macrogol (macrogol 3350), sodium sulfate, sodium chloride, potassium chloride; sachet B-ascorbic acid, sodium ascorbate
sachet A-100g+7.5g+2.691g+1.015g
powder for oral solution
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Moviprep, powder for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The ingredients of Moviprep are contained in two separate sachets. SACHET A contains the following active substances: Macrogol 3350 100 g Sodium sulfate anhydrous 7.500 g Sodium chloride 2.691 g Potassium chloride 1.015 g SACHET B contains the following active substances: Ascorbic acid 4.700 g Sodium ascorbate 5.900 g The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows: Sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable) Sulfate 52.8 mmol/L Chloride 59.8 mmol/L Potassium 14.2 mmol/L Ascorbate 29.8 mmol/L Excipient(s) with known effect: This product contains 0.233 g of aspartame per sachet A. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. Free flowing white to yellow powder in Sachet A. Free flowing white to light brown powder in Sachet B. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moviprep is indicated in adults for bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND OLDER PEOPLE _ A course of treatment consists of two litres of Moviprep. It is strongly recommended that one litre of clear liquid, which may include, water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk, is also taken during the course of treatment. _ _ A litre of Moviprep consists of one 'sachet A' and one 'sachet B' dissolved together in water to make one litre of solution. The reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second litre of Moviprep to complete this course. This course of treatment can be taken either as divided or as single doses as specified below: 1. Divided doses: one litre of Moviprep in the evening before and one litre of Moviprep Прочитать полный документ