PICO-SALAX Powder for Oral Solution

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

Anhydrous Citric Acid; SODIUM PICOSULFATE; MAGNESIUM OXIDE

Tilgængelig fra:

Ferring Sdn. Bhd.

INN (International Name):

Anhydrous Citric Acid; SODIUM PICOSULFATE; MAGNESIUM OXIDE

Enheder i pakken:

2sachet Sachets

Fremstillet af:

Ferring Pharmaceutical (China) Co., Ltd.

Produktets egenskaber

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