Glycoprep-C

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Macrogol 3350 755.68 mg/g (prepared solution contains 6% w/w); Potassium chloride 10.55 mg/g; Sodium chloride 37.33 mg/g; Sodium sulfate 80.62 mg/g

Disponível em:

Fresenius Kabi New Zealand Limited

DCI (Denominação Comum Internacional):

Macrogols 755.68 mg/g (as Macrogol 3350 prepared solution contains 6% w/w)

Dosagem:

6% w/w

Forma farmacêutica:

Powder for oral solution

Composição:

Active: Macrogol 3350 755.68 mg/g (prepared solution contains 6% w/w) Potassium chloride 10.55 mg/g Sodium chloride 37.33 mg/g Sodium sulfate 80.62 mg/g Excipient: Ascorbic acid Aspartame Citric acid Lemon flavour QL58817

Unidades em pacote:

Sachet, aluminium foil, 70 g

Classe:

Restricted

Tipo de prescrição:

Restricted

Fabricado por:

Erca SpA

Indicações terapêuticas:

Glycoprep-C 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 colonic surgery.

Resumo do produto:

Package - Contents - Shelf Life: Sachet, aluminium foil, - 70 g - 2 years from date of manufacture stored at or below 25°C - Sachet, aluminium foil, - 210 g - 2 years from date of manufacture stored at or below 25°C

Data de autorização:

1996-06-06

Folheto informativo - Bula

Page 1 of 3
GLYCOPREP-C
®
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Glycoprep-C.
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 Glycoprep-C
against the benefits they expect 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 GLYCOPREP-C IS
USED FOR
Glycoprep-C
is
used
for
bowel
cleansing
in
conjunction
with
intravenous
pyelograms
(IVP),
abdominal
X-ray
examinations,
surgery and colonoscopy.
The
bowel
needs
to
be
clean
before your doctor can examine it
properly.
Glycoprep-C
produces
watery
stools
or
bowel
motions
within
about
an
hour
after
the
first
administration
and
after
4
hours
should produce a clear discharge.
THIS
MEDICINE
BELONGS
TO
A
GROUP
OF
MEDICINES
CALLED
BOWEL
PREPARATIONS.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
BEFORE YOU TAKE
GLYCOPREP-C
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE GLYCOPREP-C IF YOU
HAVE AN ALLERGY TO:

Any of the ingredients listed at
the end of this leaflet

Any
similar
medicines
to
Glycoprep-C
Some
symptoms
of
an
allergic
reaction may include:

Shortness of breath

Wheezing or difficulty breathing

Swelling
of
the
face,
lips,
tongue
or
other
parts
of
the
body

Skin rash, itching or hives
DO NOT TAKE GLYCOPREP-C IF YOU
HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS:

Phenylketonuria – Glycoprep-C
contains aspartame

Gastrointestinal blockage

Gastric
retention
-
problems
with
food
and
fluid
emptying
from your stomach

Bowel perforation

Toxic megacolon - very dilated
large intestine

A condition known as Paralytic
Ileus
where
the
small
bowel
does not work properly

Toxic
colitis
-
severe
inflammation
of
the
large
intestine

Severe d

Características técnicas

NEW ZEALAND DATA SHEET
Data Sheet – Glycoprep-C® powder - June 2019
Page 1 of 6
1 PRODUCT NAME
Glycoprep-C® powder 70 g sachet
Glycoprep-C® powder 210 g sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients 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.
Each 70 g or 210 g sachet contains macrogol 3350 (polyethylene glycol)
755.69 mg/g, sodium sulfate
(anhydrous) 80.62 mg/g, sodium chloride 37.33 mg/g, potassium chloride
10.55 mg/g, citric acid
12.77 mg/g, ascorbic acid 85.16 mg/g, aspartame 5.11 mg/g and lemon
flavour 12.77 mg/g.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for solution.
Glycoprep-C® powder for solution is a white crystalline powder packed
in a sachet containing 70 g or
210 g. When dissolved in water it produces a solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Glycoprep-C® is indicated for bowel emptying and cleansing by means
of total gastrointestinal tract
perfusion in preparation for gastrointestinal procedure (such as
colonoscopy, barium enema x-ray
examination), prior to intravenous pyelograms (IVP) or colonic
surgery.
4.2
Dose and method of administration
For Oral Use.
Glycoprep-C® is usually taken the day before the procedure. This may
be varied if considered
appropriate by the doctor.
Guidance for clinicians/doctors: Glycoprep-C® can be taken in the
evening prior to the procedure (if a
morning procedure) or on the morning of the procedure (if an afternoon
procedure).
On the day before the procedure
Patients should fast until after the procedure. Patients should only
drink recommended clear sugar
free fluids. During the day, patients should drink at least one