Moviprep

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

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Download Vara einkenni (SPC)
27-09-2022

Virkt innihaldsefni:

Macrogol 3350 100 g;  ; Potassium chloride 1.015 g; Sodium chloride 2.691 g; Sodium sulfate 7.5 g;  ; Ascorbic acid 4.7 g;  ; Sodium ascorbate 5.9 g;  

Fáanlegur frá:

CARSL Consulting

INN (Alþjóðlegt nafn):

Macrogol 3350 100 g

Lyfjaform:

Powder for oral solution

Samsetning:

Active: Macrogol 3350 100 g   Potassium chloride 1.015 g Sodium chloride 2.691 g Sodium sulfate 7.5 g   Excipient: Acesulfame potassium Aspartame Lemon flavour V3938-1N1 Active: Ascorbic acid 4.7 g   Sodium ascorbate 5.9 g  

Einingar í pakka:

Sachet, laminate, Paper/LDPE/Al/LDPE: 2 x sachet A & 2 x sachet B, 2 dose units

Tegund:

Restricted

Gerð lyfseðils:

Restricted

Framleitt af:

Union Carbide Corporation

Ábendingar:

Moviprep is used for bowel cleansing prior to any clinical procedure requiring a clean bowel e.g., bowel endoscopy, lower gastrointestinal radiology or digestive tract surgery.

Vörulýsing:

Package - Contents - Shelf Life: Sachet, laminate, Paper/LDPE/Al/LDPE: 2 x sachet A & 2 x sachet B - 2 dose units - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2006-07-03

Upplýsingar fylgiseðill

                                Moviprep Consumer Medicine Information – May 2023
- 1 -
MOVIPREP
®
POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium
chloride and potassium chloride.
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Moviprep powder for oral solution.
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.
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 MOVIPREP IS USED FOR
Moviprep is a type of medicine called a bowel preparation.
It makes your bowels clean so that they are ready for
examination or surgery. Moviprep works by emptying the
contents of your bowels, so you should expect to have lots
of watery bowel movements.
Moviprep is a lemon flavoured powder contained in four
sachets. There are two large sachets (Sachet A) and two
small sachets (Sachet B). You need all of these for one
treatment.
Moviprep is intended for adults (18 years of age and
older), including the elderly, before any clinical procedure
that needs a clean bowel.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN RECOMMENDED FOR YOU.
BEFORE YOU TAKE MOVIPREP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MOVIPREP:

if
you
are
allergic
(hypersensitive)
to
the
active
ingredients
or
any
of
the
other
ingredients
of
Moviprep (listed in ‘Product Description’)

if you have a blockage in your intestine (gut)

if you have an opening in the wall of your stomach or
bowel (bowel perforation)

if
you
experience
problems
with
food
and
fluid
emptying from your stomach (gastric retention)

if you have paralysis of the gut (this often happens
after an operation to the abdomen)

if you suffer from phenylketonuria. This is a hereditary
inability of the body to use a particular amino acid.
Moviprep
contains
aspartame,
a
source

                                
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Vara einkenni

                                MOVIPREP DataSheet – July 2022
Page 1 of 8
NEW ZEALAND DATASHEET
1 PRODUCT NAME
MOVIPREP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sachet A contains the following active ingredients:
Macrogol 3350
100 g
Sodium sulfate anhydrous
7.500 g
Sodium chloride
2.691 g
Potassium chloride
1.015 g
Sachet B contains the following active ingredients:
Ascorbic acid
4.700 g
Sodium ascorbate 5.900 g
The concentration of electrolyte ions when both sachets are made up to
one litre of
solution is as follows:
Sodium
181.6 mmol/l (of which not more than 56.2 mmol is absorbable)
Sulfate
52.8 mmol/l
Chloride
59.8 mmol/l
Potassium
14.2 mmol/l
Ascorbate
56.5 mmol/l
Contains aspartame.
The complete treatment contains 8.4 g of sodium and 1.2 g of
potassium.
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
MOVIPREP is an oral powder for solution consisting of a free-flowing
white to yellow
powder in Sachet A and a free-flowing white to light brown powder in
Sachet B.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For bowel cleansing prior to any clinical procedure requiring a clean
bowel, e.g., bowel
endoscopy, lower gastrointestinal tract radiology or digestive tract
surgery.
4.2 Dose and method of administration
ADULTS AND ELDERLY:
A course of treatment consists of two litres of MOVIPREP. It is
strongly recommended that
patients also drink a further one litre of clear liquid to prevent
them from feeling thirsty and
becoming dehydrated.
“Clear liquids” include:
•
water,
•
clear soup,
•
tea or coffee without milk or non-dairy creamer,
•
all of the following liquids which are not coloured red or purple:
fruit juices
without pulp, carbonated and non-carbonated soft drinks, fruit
flavoured cordials.
MOVIPREP DataSheet – July 2022
Page 2 of 8
Note: patients should not drink anything coloured red or purple.
A litre of MOVIPREP consists of one 'Sachet A' and one 'Sachet B'
dissolved together in
water to make a one litre solution. The reconstituted solution should
be drunk over a period
of one to two hours. This process sh
                                
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