Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
ASCORBIC ACID; MACROGOLS; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
B05XA31
POWDER FOR SOLUTION
POTASSIUM CHLORIDE 1.015 G; SODIUM ASCORBATE 5.9 G; MACROGOLS 100 G; SODIUM CHLORIDE 2.691 G; SODIUM SULFATE ANHYDROUS 7.5 G; ASCORBIC ACID 4.7 G
PER OS
Required
NORGINE LIMITED UK
ELECTROLYTES IN COMBINATION WITH OTHER DRUGS
ELECTROLYTES IN COMBINATION WITH OTHER DRUGS
For bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology.
2016-01-31
Norgine Item No.: Proof No.: Change Control No.: Product Name (including flavour): Date: Market: Component Type: Manufacturing Site: Technical Drawing No.: Dimensions (mm): Pharmacode: Material Number: Va iable data p ompts info mation: Schawk Job No.: Profile Technical Info Pre-printed (as part of artwork) Printed on-line 10070408 3 MVP_2021_12_20_290; MVP_2021_10_22_01 17/08/2023 Israel - - PIL HENGOED NOR-LFT77-V2 UNFOLDED 210 x 640mm FOLDED 210 x 40mm 730 N/A N/A 108920016 / 403360344 0313 MOVIPREP Black :لمشت ةيفاضإ ةيبناج ضارعأ :10 نيب نم دحاو مدختسم نم رثكأ ىدل رهظت ضارعأ - ا ً دج ةعئاش ةيبناج ضارعأ .ةنوخس ,نايثغ ,جرشلا ةحتف يف ملاآ ,ءيس ماع روعش ,بعت ,نطبلا يف خافتنا ,نطبلا يف ملاآ :10 نيب نم دحاو مدختسم ىتح ىدل رهظت ضارعأ - ةعئاش ةيبناج ضارعأ .ةريرعشق ,شطع ,مضه تابوعص ,تا ّ ؤيقت ,سأر ملاآ ,راود ,مونلا يف لكاشم ,عوج :100 نيب نم دحاو مدختسم ىتح ىدل رهظت ضارعأ - ةعئاش ريغ ةيبناج ضارعأ .دبكلا لمع فئاظو تاصوحف جئاتن يف تارييغت ,علبلا يف تابوعص ,ةحار مدع :)دعب اهعويش ديدحت ّ متي مل ضارعأ ( فورعم ريغ اهعويش هيبناج ضارعأ تابرض( بــلقلا ناــقفخ وأ مـ ـظتنم رـ ـيغ بــلق مـ ـظن ,مدــلا طـ ـغض يــف تــقؤم عاــفترا ,)ءاــعمأ تازاــغ( نـ ـطبلا يــف تازاــغ ةــضفخنم موــيدوص بــسن ,)ؤــيقتلل دوــهجمب ماــيقلا( حاــجنلا نود ؤــيقتلا ةــلواحم ,فاــفج ,)كــبلق تاــقدب رعــشت ,بــلق يــف طوــبه لــثم مدــلا يــف حلاــملأا تايوتــسم يــف تارــييغتو )تاــبون( تاــجلاتخا Aqra d-dokument sħiħ
1 PRESCRIBING INFORMATION 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 1 contains the following active substances: Macrogol 3350 100g Sodium sulfate anhydrous 7.500g Sodium chloride 2.691g Potassium chloride 1.015g SACHET 2 contains the following active substances: Ascorbic acid 4.700g Sodium ascorbate 5.900g 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 56.5 mmol/L Excipient(s) with known effect: This product contains 0.233g of aspartame per sachet 1. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Free flowing white to yellow powder in Sachet 1. Free flowing white to light brown powder in Sachet 2. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moviprep is indicated for bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology. 2 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 1 ’ and one ‘sachet 2 ’ 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 and timing is dependent on whether the clinical procedure is conducted with or without general anaesthesia as specified below: FO Aqra d-dokument sħiħ