Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Citric acid, anhydrous; Magnesium oxide, light; Sodium picosulfate
FERRING PHARMACEUTICALS PRIVATE LIMITED
A06A B58
12 g
POWDER, FOR SOLUTION
Citric acid, anhydrous 12 g; Magnesium oxide, light 3.5 g; Sodium picosulfate 10 mg
ORAL
Prescription Only
Ferring Pharmaceuticals (China) Co., Ltd.
ACTIVE
2013-01-30
63-I-SG-04.01; LAC: Approved on 23-Jan-2013 Drafted by VL dated 20-Feb-2013 PICOPREP ® DESCRIPTION White crystalline powder COMPOSITION Each sachet contains the following active ingredients: Sodium picosulfate 10.0 mg Magnesium oxide, light 3.5 g Citric acid, anhydrous 12.0 g List of excipients: Potassium hydrogen carbonate Sodium saccharin Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole PHARMACEUTICAL DOSAGE FORM Powder for oral solution in sachet INDICATIONS To clean the bowel prior to X-ray examination or endoscopy. To clean the bowel prior to surgery when judged clinically necessary (see Special Warnings and Precautions for Use regarding open colorectal surgery) DOSAGE AND ADMINISTRATION Route of administration: Oral A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration it is recommended to drink a sufficient amount of clear liquids whilst the effects of PICOPREP persist. Clear liquids may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or even coffee without milk. Directions for reconstitution: Reconstitute the PICOPREP powder right before each administration. Do not prepare the solution in advance. Reconstitute the contents of one sachet in a cup of water (approximately 150ml). Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink. Adults (including the elderly): (if the procedure is scheduled for the afternoon, it is recommended that the Split-Dose regimen should be used): SPLIT-DOSE REGIMEN (EVENING-BEFORE AND DAY OF THE PROCEDURE) The first PICOPREP sachet is taken the night before the procedure, and the sec Les hele dokumentet
PICPREP-I-SG-06.03 NAME OF THE MEDICINAL PRODUCT PICOPREP ® POWDER FOR ORAL SOLUTION QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Sodium picosulfate 10.0 mg Magnesium oxide, light 3.5 g Citric acid, anhydrous 12.0 g List of excipients: Potassium hydrogen carbonate Sodium saccharin Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole PHARMACEUTICAL FORM Powder for oral solution. White crystalline powder. THERAPEUTIC INDICATIONS To clean the bowel prior to X-ray examination or endoscopy. To clean the bowel prior to surgery when judged clinically necessary (see section Special Warnings and Precautions for Use regarding open colorectal surgery). POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults (including elderly): (if the procedure is scheduled for the afternoon, it is recommended that the Split Dosing regimen should be used): SPLIT DOSING REGIMEN (EVENING-BEFORE AND DAY OF THE PROCEDURE) The first PICOPREP ® sachet (see Method of Administration section below for reconstitution guidance) is taken the night before the procedure, and the second is taken the next day, in the morning prior to the procedure. _On the day before the procedure – 1 sachet: _ • The first reconstituted sachet is taken in the late afternoon/ evening (e.g. 5:00 to 9:00PM), followed by at least 5 x 250 ml drinks of clear liquids (not only water), spread over several hours _On the day of the procedure – 1 sachet: _ • The second reconstituted sachet is taken in the morning (5-9 hours before the procedure), followed by at least 3 x 250 ml drinks of clear liquids (not only water), spread over several hours • Clear liquids (not only water) may be consumed until 2 hours before the time of the procedure or DAY-BEFORE DOSING REGIMEN (EVENING-BEFORE THE PROCEDURE ONLY) The first PICOPREP ® sachet (see Method of Administration section below for reconstitution guidance) is taken in the afternoon or early evening and the second is Les hele dokumentet