País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Anhydrous Citric Acid; SODIUM PICOSULFATE; MAGNESIUM OXIDE
Ferring Sdn. Bhd.
Anhydrous Citric Acid; SODIUM PICOSULFATE; MAGNESIUM OXIDE
2sachet Sachets
Ferring Pharmaceutical (China) Co., Ltd.
PROPOSED PACKAGING MATERIAL Code 63-I-MY-05.01 Size 204 mm x 297mm Submission ☐ NDA ☐ Renewal ☒ Variation change detail no.: PICPOW-14-002 CCDS 2013 Ver. 2.0 _ _ Code of previous version 63-I-MY-04.03 Changes Safety updates: section 4.2 – liquid intake, sec4.3, 4.4, 4.5, 4.6, and 4.8 – minor updates to align with CCDS. Dosage and posology follows US SPC – Lac 451 approved in 2013 Reference ☒ CCDS version: ☐ Core PIL version: ☒ SPC country/version/date: German April 2015, US Revision 10/2014 ☐ LAC no.: Name & Date JIWO, 10-JAN-2017 PICO-SALAX ® POWDER FOR ORAL SOLUTION DESCRIPTION White crystalline powder with a faint odour of orange. The faint flavour of orange can still be detected even after reconstitution. 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 Each sachet also contains: Potassium hydrogen carbonate 0.5g (equivalent to 5mmol (195mg) potassium) Lactose (as a component of the flavour) List of excipients: Potassium hydrogen carbonate Sodium saccharin Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole 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 PICO-SALAX ® , supplied as a powder, must be reconstituted with cold water right before its use. There are two dosing regimens, each requires two separate dosing times: • The preferred method is the “Split-Dose” method and consists of two separate doses: the first dose during the evening before the procedure and the second dose the next day, during the morning prior to the procedure. • The alternative method is the “Day Before” method and consists of two separate doses: the first dose during the afternoon or early evening before the pro Leia o documento completo