देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Macrogol '3350'; Sodium sulfate anhydrous; Sodium bicarbonate; Sodium chloride; Potassium chloride
Forum Health Products Ltd
A06AD
Macrogol '3350'; Sodium sulfate anhydrous; Sodium bicarbonate; Sodium chloride; Potassium chloride
59gram ; 5.685gram ; 1.685gram ; 1.465gram ; 742.5mg
Powder for oral solution
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01060500; GTIN: 5012748052017
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KLEAN-PREP 69G SACHET POWDER FOR ORAL SOLUTION Macrogol 3350, Sodium sulphate anhydrous, Sodium bicarbonate, Sodium chloride 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. 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. This includes any possible side effects not listed in this leaflet. See Section 4. If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000 and for Medical Information: 01895 826 606 WHAT IS IN THIS LEAFLET: 1. What Klean-Prep is and what it is used for 2. What you need to know before you take Klean-Prep 3. How to take Klean-Prep 4. Possible side effects 5. How to store Klean-Prep 6. Contents of the pack and other information 1. WHAT KLEAN-PREP IS AND WHAT IS IT USED FOR Klean-Prep is dissolved in water, it is a bowel cleansing agent. This means it flushes everything out of your intestines (gut) through a laxative action so that they are completely empty and clean. You are taking Klean-Prep because you are going to have one of these procedures : Colonoscopy Barium enema Gut surgery For all of these, it is important that your gut is clean so the procedure is more likely to be a success. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLEAN-PREP DO NOT TAKE KLEAN-PREP if you suspect or your doctor suspects: you are allergic (hypersensitive) to the active substances or any of the other ingredients of Klean-Prep (listed in section 6). you have a blockage of the gastrointestinal obstruction or perforation of the wall of the 2 bowel you have ileus (loss of muscle tone in the gut) you have ga पूरा दस्तावेज़ पढ़ें
OBJECT 1 KLEAN PREP 69G, SACHET POWDER FOR ORAL SOLUTION Summary of Product Characteristics Updated 10-Oct-2016 | Norgine Limited 1. Name of the medicinal product KLEAN-PREP 69g, sachet powders for oral solution. 2. Qualitative and quantitative composition Each sachet of Klean-Prep contains the following active ingredients: Macrogol 3350 59.000 g Anhydrous Sodium Sulfate 5.685 g Sodium Bicarbonate 1.685 g Sodium Chloride 1.465 g Potassium Chloride 0.7425 g The content of electrolyte ions per sachet when made up to one litre of water is as follows: Sodium 125 mM Sulfate 40 mM Chloride 35 mM Bicarbonate 20 mM Potassium 10 mM For the full list of excipients, see 6.1. 3. Pharmaceutical form Powder for oral solution. A whitish powder which, when dissolved in water, gives a clear, colourless solution for oral administration. 4. Clinical particulars 4.1 Therapeutic indications For colonic lavage prior to diagnostic examination or surgical procedures requiring a clean colon, e.g. colonoscopy, barium enema or colonic resection. 4.2 Posology and method of administration ADULTS: Each sachet should be dissolved in 1 litre of water. The usual dose is up to 4 sachets taken at a rate of 250 ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician. The solutions from all 4 sachets should be drunk within 4 to 6 hours. Alternatively, administration may be divided, for example, taking 2 sachets during the evening before the examination, and the remaining 2 sachets on the morning of the examination. If administration is by nasogastric tube, the usual rate should be 20 to 30 ml/minute. CHILDREN: There is no recommended dosage. Renal patients: No dosage adjustment need be made. 4.3 Contraindications Do not use in patients with known or suspected: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - gastrointestinal obstruction or perforation - ileus - gastric retention - toxic colitis and toxic megacolon - congestive cardiac fai पूरा दस्तावेज़ पढ़ें