PICOPREP Powder for Oral Solution

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Citric acid, anhydrous; Magnesium oxide, light; Sodium picosulfate

Доступно од:

FERRING PHARMACEUTICALS PRIVATE LIMITED

АТЦ код:

A06A B58

Дозирање:

12 g

Фармацеутски облик:

POWDER, FOR SOLUTION

Састав:

Citric acid, anhydrous 12 g; Magnesium oxide, light 3.5 g; Sodium picosulfate 10 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Ferring Pharmaceuticals (China) Co., Ltd.

Статус ауторизације:

ACTIVE

Датум одобрења:

2013-01-30

Информативни летак

63-I-SG-04.01; LAC: Approved on 23-Jan-2013
Drafted by VL dated 20-Feb-2013
PICOPREP
®
DESCRIPTION
White crystalline powder
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
List of excipients:
Potassium hydrogen carbonate
Sodium saccharin
Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic
acid and butylated hydroxyanisole
PHARMACEUTICAL DOSAGE FORM
Powder for oral solution in sachet
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
A low residue diet is recommended on the day prior to the hospital procedure. To
avoid dehydration it is recommended to drink a sufficient amount of clear liquids
whilst the effects of PICOPREP persist. Clear liquids may include water, clear
soup, fruit juice without pulp, soft drinks, tea and/or even coffee without milk.
Directions for reconstitution:
Reconstitute the PICOPREP powder right before each administration. Do not
prepare the solution in advance. Reconstitute the contents of one sachet in a cup
of water (approximately 150ml). Stir for 2-3 minutes, the solution should now
become an off-white, cloudy liquid with a faint odour of orange. Drink the solution.
If it becomes warm, wait until it cools sufficiently to drink.
Adults (including the elderly):
(if the procedure is scheduled for the afternoon, it is recommended that the
Split-Dose regimen should be used):
SPLIT-DOSE REGIMEN (EVENING-BEFORE AND DAY OF THE PROCEDURE)
The first PICOPREP sachet is taken the night before the procedure, and the
sec

Карактеристике производа

PICPREP-I-SG-06.03
NAME OF THE MEDICINAL PRODUCT
PICOPREP
® POWDER FOR ORAL SOLUTION
QUALITATIVE AND QUANTITATIVE 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
List of excipients:
Potassium hydrogen carbonate
Sodium saccharin
Natural, spray dried orange flavour which contains acacia gum,
lactose, ascorbic acid and butylated
hydroxyanisole
PHARMACEUTICAL FORM
Powder for oral solution.
White crystalline powder.
THERAPEUTIC INDICATIONS
To clean the bowel prior to X-ray examination or endoscopy.
To clean the bowel prior to surgery when judged clinically necessary
(see section Special Warnings and
Precautions for Use regarding open colorectal surgery).
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (including elderly):
(if the procedure is scheduled for the afternoon, it is recommended
that the Split Dosing regimen should be
used):
SPLIT DOSING REGIMEN (EVENING-BEFORE AND DAY OF THE PROCEDURE)
The first PICOPREP
®
sachet (see Method of Administration section below for reconstitution
guidance)
is taken the night before the procedure, and the second is taken the
next day, in the morning prior to
the procedure.
_On the day before the procedure – 1 sachet: _
•
The first reconstituted sachet is taken in the late afternoon/ evening
(e.g. 5:00 to 9:00PM),
followed by at least 5 x 250 ml drinks of clear liquids (not only
water), spread over several hours
_On the day of the procedure – 1 sachet: _
•
The second reconstituted sachet is taken in the morning (5-9 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
or
DAY-BEFORE DOSING REGIMEN (EVENING-BEFORE THE PROCEDURE ONLY)
The first PICOPREP
®
sachet (see Method of Administration section below for reconstitution
guidance)
is taken in the afternoon or early evening and the second is