Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
SODIUM PICOSULFATE MAGNESIUM OXIDUM LEVE CITRIC ACID
Laboratorios Casen-Fleet S.L.U.
SODIUM PICOSULFATE MAGNESIUM OXIDUM LEVE CITRIC ACID
Powder for Oral Solution
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CitraFleet, Powder for oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet (15.08 g) contains the following active ingredients: Each sachet also contains 5 mmol (or 195 mg) potassium (see section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution, in sachet White crystalline powder with a lemon flavour . 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration: Oral_ A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration during treatment with CitraFleet, it is recommended to drink approximately 250 ml per hour, of water or other clear fluid while the washout effect persists. _Directions for reconstitution_: Refer to section 6.6. _Adults (including the elderly) aged 18 years and over:_ One sachet reconstituted in water as directed, taken before 8 am on the day before the procedure. Second sachet 6 to 8 hours later. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients of the product, congestive cardiac failure, severe dehydration, hypermagnesaemia,gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites , acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro- intestinal obstruction or perforation. Sodium picosulfate 10.0 mg Light magnesium oxide 3.5 g Citric acid anhydrous 10.97 g IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/05/ Pročitajte cijeli dokument