PicoPrep

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Citric acid 771.868 mg/g; Heavy magnesium oxide 225.128 mg/g; Sodium picosulfate 0.64 mg/g;  

MAH:

Fresenius Kabi New Zealand Limited

INN:

Citric acid 771.868 mg/g

dosage:

0.64 mg/g

pharmaceutical_form:

Powder for oral solution

composition:

Active: Citric acid 771.868 mg/g Heavy magnesium oxide 225.128 mg/g Sodium picosulfate 0.64 mg/g   Excipient: Aspartame

units_in_package:

Sachet, laminate, 2 x 15.546g, 2 dose units

class:

Restricted

prescription_type:

Restricted

manufactured_by:

AMS Laboratories Pty Ltd

leaflet_short:

Package - Contents - Shelf Life: Sachet, laminate, 2 x 15.546g - 2 dose units - 36 months from date of manufacture stored at or below 30°C - Sachet, laminate, 3 x 15.546g - 3 dose units - 36 months from date of manufacture stored at or below 30°C

authorization_date:

1999-07-13

PIL

CMI FOR PICOPREP 

October 2010

Filename:PicCMI261010-cleanmarked Page 1 of 4 
Change: Company name change 
PICOPREP 

Sodium Picosulfate Powder for Oral Solution  

CONSUMER MEDICINE INFORMATION 

WARNING 
Serious 
dehydration 
and/or 
electrolyte  disturbance  may  occur  in 
some “at risk” Patients. 
Please  read  the  section  headed 
“Before you take PicoPrep” 

WHAT IS IN THIS LEAFLET? 

This  leaflet  answers  some  common 
questions  about  PicoPrep.  It  does 
not 
contain 
all 
the 
available 
information.  It  does  not  take  the 
place  of  talking  to  your  doctor  or 
pharmacist.  All  medicines  have  risks 
and  benefits.  Your  doctor  has 
weighed  the  risks  of  you  taking 
PicoPrep 
against 
the 
expected 
benefits it will have for you. 

IF  YOU  HAVE  ANY  CONCERNS  ABOUT 
TAKING  THIS  MEDICINE,  ASK  YOUR 
DOCTOR  OR  PHARMACIST.  KEEP  THIS 
LEAFLET WITH THE MEDICINE.  You may 
need to read it again 

WHAT  PICOPREP  IS  USED 
FOR? 

PicoPrep  is  used  to  remove  the 
bowel  contents  and  cleanse  it  prior 
to  the  doctor’s  examination  or 
surgery.  It  enables  your  doctor  to 
see  inside  easily.  It  is  sometimes 
used  to  clear  the  colon  before  a 
special  x-ray  of  the  kidneys.  It  does 
this  by  acting  in  the  intestine  and 
colon  causing  a  watery  stool  or 
bowel  motion  which  removes  the 
bowel  contents.  This  may  be  a  little 
uncomfortable  but  is  necessary  for 
the examination. 
It 
depends 
on 
what 
type 
of 
examination  you  are  having  as  to 
what  procedure  is  to  be  used.  One 
type  is  that  a  special  instrument  is 
insert

SPC

NEW ZEALAND DATA SHEET
Data Sheet – PicoPrep® powder for oral solution - June 2019
Page 1 of 6
WARNING
LIFE-THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR
IN “AT
RISK” GROUPS. SEE CONTRAINDICATIONS AND PRECAUTIONS.
1 PRODUCT NAME
PicoPrep® powder 15.5 g sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are:
•
sodium picosulfate has a chemical formula of C
18
H
13
NNa
2
O
8
S
2
,H
2
O, a MW of 499.4 and a CAS
No. 10040-45-6 (anhydrous)
•
magnesium oxide - heavy, has a chemical formula of MgO, a MW of 40.3
and a CAS No.
1309-48-4;
•
citric acid which has a chemical formula of C
6
H
8
O
7,
a MW of 192.1 and a CAS No. 77-92-9.
Each sachet contains sodium picosulfate 10 mg, magnesium oxide 3.5 g,
citric acid anhydrous 12.0 g
and aspartame 36 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for oral solution.
PicoPrep® powder for oral solution is a white crystalline powder
packed in sachets each containing
15.546 g. When dissolved in water it produces a solution with a mild
citric acid taste.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
PicoPrep® is indicated for bowel emptying and cleansing by means of
total gastrointestinal tract
perfusion in preparation for gastrointestinal examination (such as
colonoscopy, barium enema x-ray
examination), prior to intravenous pyelograms (IVP) or surgery.
4.2
Dose and method of administration
Information for Patients
The first bowel motion should occur approximately 2 to 3 hours after
commencing dose. Onset may
be sooner in individual patients. This action cleanses the bowel
before examination. It should be
prepared and taken according to the directions on the box or in the
Dosage and Administration
section.
No food or drink should be taken for at least six (6) hours before the
examination.
It is important that the patient follow the recommended dosing
schedule and take adequate fluids to
ensure hydration.
NEW ZEALAND DATA SHEET
Data Sheet – PicoPrep® powder for or