País: Israel
Idioma: inglés
Fuente: Ministry of Health
CITRIC ACID ANHYDROUS; MAGNESIUM OXIDE; SODIUM PICOSULFATE
FERRING PHARMACEUTICALS LTD
A09AB04
POWDER FOR SOLUTION
SODIUM PICOSULFATE 10 MG; CITRIC ACID ANHYDROUS 12 G; MAGNESIUM OXIDE 3.5 G
PER OS
Required
FERRING GmbH ,GERMANY
CITRIC ACID
CITRIC ACID
To clean the bowel Prior to X-ray examination, endoscopy or surgery.
2015-07-31
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Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT PICO - SALAX Orange PICO - SALAX Cranberry 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Sodium picosulfate 10.0mg Magnesium oxide, light 3.5g Citric acid, anhydrous 12.0g Each sachet also contains: Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium] Lactose (as a component of the orange flavour) For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution in sachet. White crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To clean the bowel prior to X-ray examination or endoscopy or surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including elderly): _ The two PICO - SALAX sachets are taken dependent on the planned time of the procedure: • The first reconstituted sachet is taken 10 to 18 hours before the procedure, followed by at least 5 x 250 ml drinks of clear liquids (not only water), spread over several hours • The second reconstituted sachet is taken 4 to 6 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 _ _ _Special populations _ Limited data is available for treatment of patients with low body weight (BMI less than 18). The rehydration regimen above has not been tested in such individuals and therefore monitoring of their hydration status is required and the regimen may need to be altered appropriately (see section 4.4). Page 2 of 9 _Pediatric population: _ A measuring spoon is provided with the product. It is recommended that a narrow flat edge, for example the back of a knife blade, is drawn across the top of a heaped measuring spoon to obtain a flat surface of the measure. This will give ¼ of a sachet (4 g powder) per spoonful. For the timing of dosing in children, refer to the instructions given for adults from 1 up to 2 years: first dose Leer el documento completo