Prepkit Orange

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Macrogol 3350 52.9 g;  ; Potassium chloride 740mg; Sodium chloride 2.6 g; Sodium sulfate 5.6 g; Citric acid 12.2 g; Magnesium carbonate monohydrate 7.4 g; Sodium picosulfate 10.3mg

Tilgjengelig fra:

Fresenius Kabi New Zealand Limited

Legemiddelform:

Combination

Sammensetning:

Active: Macrogol 3350 52.9 g   Potassium chloride 740mg Sodium chloride 2.6 g Sodium sulfate 5.6 g Excipient: Ascorbic acid Colloidal silicon dioxide Orange flavour FACB076 Sweetener sweetesse 97 Active: Citric acid 12.2 g Magnesium carbonate monohydrate 7.4 g Sodium picosulfate 10.3mg Excipient: Orange flavour FACB076 Sweetener sweetesse 97

Resept typen:

Restricted

Indikasjoner:

PREPKIT ORANGE 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 colorectal surgery, in adults 18 years and over.

Produkt oppsummering:

Package - Contents - Shelf Life: Combination pack, Composite pack containing 1 x 70 g Glycoprep Orange sachet and 2 x 20 g Picoprep Orange sachets - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from moisture - Sachet, laminate, 2 x 20 g Picoprep Orange - 40 g -   - Sachet, laminate, 1 x 70 g Glycoprep Orange - 70 g -  

Autorisasjon dato:

2020-01-21

Informasjon til brukeren

Page 1 of 5
PREPKIT ORANGE™
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE
This leaflet answers some of the
common
questions
people
ask
about PREPKIT ORANGE. It does
not
contain
all
the
available
information. It does not take the
place
of
talking
to
your
doctor,
prescriber or pharmacist.
Ask
your
doctor,
prescriber
or
pharmacist:

if there is anything you do not
understand in this leaflet,

if you are worried about taking
your medicine, or

to obtain the most up-to-date
information.
All
medicines
have
risks
and
benefits. Your doctor, prescriber or
pharmacist will have weighed the
risks
of
you
taking
PREPKIT
ORANGE against the benefits they
expect it will have for you.
Pharmaceutical companies cannot
give
you
medical
advice
or
an
individual diagnosis.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE KIT
IS USED FOR
THIS MEDICINE BELONGS TO A
GROUP
OF
MEDICINES
CALLED
BOWEL PREPARATIONS.
PREPKIT
ORANGE
is
used
to
remove the bowel contents and
cleanse it prior to gastrointestinal
examination (such as colonoscopy,
barium enema x-ray examination),
prior
to
intravenous
pyelograms
(IVP)
or
colorectal
surgery,
in
adults 18 years and over.
PREPKIT
ORANGE
contains
GLYCOPREP
ORANGE
and
PICOPREP ORANGE sachets.
GLYCOPREP
ORANGE
contains
macrogol 3350, which acts as a
laxative in the intestine. Macrogol
3350
works
by
causing
excess
water to remain in your stool and
stimulates bowel movements.
PICOPREP
ORANGE
contains
sodium
picosulfate
and
magnesium citrate, which both act
as laxatives in the intestine.
Sodium picosulfate works by being
broken down by intestinal bacteria
and then acting on the lining in
your intestine to stimulate bowel
movements.
Magnesium citrate works similarly
to
GLYCOPREP
ORANGE
by
causing excess water to remain in
your
stool
and
stimulates
bowel
movements.
This
results
in
watery
stool
or
bowel motions which removes the
bowel
contents
and
ensures
the
bowel
is
clean
before
the
examination or pro

Preparatomtale

NEW ZEALAND DATA SHEET
Page 1 of 7
WARNING:
LIFE THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR
IN
“AT RISK” GROUPS. SEE SECTION 4.3 CONTRAINDICATIONS AND 4.4
SPECIAL WARNINGS
AND PRECAUTIONS FOR USE.
1 PRODUCT NAME
PREPKIT ORANGE
™
(Combination pack)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in GLYCOPREP ORANGE
®
are:

macrogol 3350 has a chemical formula of HOCH
2
[CH
2
OCH
2
]m. CH
2
OH (where ‘m’
equals 45 to 70).

sodium chloride has a chemical formula of NaCl, a MW of 58.44 and a
CAS No.
7647-14-5.

potassium chloride has a chemical formula of KCl, a MW of 74.6 and a
CAS No.
7447-40-7.

sodium sulfate has a chemical formula of Na
2
SO4, a MW of 142.0 and a CAS No.
7757-82-6.
The active ingredients in PICOPREP ORANGE
®
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 carbonate hydrate, has a chemical formula of MgCO
3
•H
2
O, a MW of
102.3 and a CAS No. 23389-33-5;

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.
PREPKIT ORANGE™ is a medicine kit containing one (1) GLYCOPREP
ORANGE
®
70 g
sachet and two (2) PICOPREP ORANGE
®
20 g sachets.
Each PICOPREP ORANGE
®
sachet contains sodium picosulfate 10.3 mg, magnesium
carbonate hydrate 7.4 g and citric acid 12.2 g, as the active
ingredients.
Each GLYCOPREP ORANGE
®
70 g sachet contains macrogol 3350 (polyethylene glycol)
52.9 g, potassium chloride 740 mg, sodium chloride 2.6 g, and sodium
sulfate 5.6 g, as
active ingredients. Total sodium content in the 70 g sachet is 2.86 g.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
PREPKIT ORANGE™ is a medicine kit containing one (1) GLYCOPREP
ORANGE
®
70 g
sachet and two (2) PICOPREP ORANGE
®
20 g sachets.
GLYCOPREP ORANGE
®
sachet: Powder for solution. For oral use.
GLYCOPREP ORANGE
®
contains 70 g of a white to creamy yellow powder which when
disso