Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate
Tillotts Pharma GmbH
A06AD; A06AD65
Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate
110.44
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Marketed
2016-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER Vistaprep ® Powder for oral solution. Macrogol 3350, sodium chloride, sodium bicarbonate and potassium chloride. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Vistaprep is and what it is used for 2. What you need to know before you take Vistaprep 3. How to take Vistaprep 4. Possible side effects 5. How to store Vistaprep 6. Contents of the pack and other information 1. What Vistaprep is and what it is used for Vistaprep is a white powder for oral solution with a laxative effect. Vistaprep is used for bowel cleansing in preparation for the examination of the colon (colonoscopy) in adults over 18 years of age. 2. What you need to know before you take Vistaprep Do not take Vistaprep if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride saccharin sodium, orange flavour, lemon-lime flavour, colloidal anhydrous silica or any of the other ingredients of this medicine (listed in section6); if you have a bowel obstruction or suspected bowel obstruction, strictures or perforations in the gastrointestinal area, or if you are at risk of perforations in the gastrointestinal area; if you suffer from problems emptying your stomach or have a severe, highly inflammatory form of colitis (colon inflammation) and a severe, abnormally enlarged colon due to this colitis (toxic megacolon); if you have an impaired swallowing and gag reflex, or suffer from general weakness. Vistaprep should not be adminis Прочитать полный документ
Health Products Regulatory Authority 14 December 2020 CRN00C1CN Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vistaprep Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active substances: Macrogol 3350 105.000 g Sodium chloride 2.800 g Sodium bicarbonate 1.430 g Potassium chloride 0.370 g The electrolyte ion content of one sachet after preparation of 1,000 mL solution is equivalent to: Sodium 65 mmol/L Chloride 53 mmol/L Bicarbonate 17 mmol/L Potassium 5 mmol/L For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Appearance: white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VistaPrep is used for bowel cleansing in preparation for colonoscopy. VistaPrep is indicated in adults over 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For complete bowel cleansing, 3 up to a maximum of 4 litres of VistaPrep solution must be taken. 1 sachet corresponds to 1 L solution. _Paediatric population_ VistaPrep should not be used in children because the safety has not been established in this patient group. Method of administration The route of administration is for oral use. The solution is drunk in portions of 200 - 300 mL every 10 minutes until the rectal effluent is clear or 4 litres maximum have been drunk. Administration takes place over a period of about 4 hours, generally on the examination day. The total amount required can also be taken on the evening before, or a part taken on the evening before and the remaining amount on the morning of the examination day. Patients should consume no solid food for 2 to 3 hours prior to administration of VistaPrep until after the examination. Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6. For further directions for use see section 6.2 Incompatibilities. 4.3 CONTRAINDICATIONS Health Products Re Прочитать полный документ