Prepkit-C

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Citric acid 12.77 mg/g; Macrogol 3350 755.68 mg/g (as Macrogol 3350 prepared solution contains 6% w/w); Potassium chloride 10.55 mg/g; Sodium chloride 37.33 mg/g;  ; Sodium sulfate 80.62 mg/g; Citric acid 771.868 mg/g; Heavy magnesium oxide 225.128 mg/g; Sodium picosulfate 0.64 mg/g

Disponibbli minn:

Fresenius Kabi New Zealand Limited

INN (Isem Internazzjonali):

Citric acid 12.77 mg/g

Għamla farmaċewtika:

Combination

Kompożizzjoni:

Active: Citric acid 12.77 mg/g Macrogol 3350 755.68 mg/g (as Macrogol 3350 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 Lemon flavour QL58817 Active: Citric acid 771.868 mg/g Heavy magnesium oxide 225.128 mg/g Sodium picosulfate 0.64 mg/g Excipient: Aspartame

Unitajiet fil-pakkett:

Combination pack, Composite pack containing 1 x 70 g Glycoprep-C sachet and 2 x 15.5 g Picoprep sachets, 1 dose unit

Klassi:

Restricted

Tip ta 'preskrizzjoni:

Restricted

Manifatturat minn:

AMS Laboratories Pty Ltd

Indikazzjonijiet terapewtiċi:

Indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination

Sommarju tal-prodott:

Package - Contents - Shelf Life: Combination pack, Composite pack containing 1 x 70 g Glycoprep-C sachet and 2 x 15.5 g Picoprep sachets - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Sachet, laminate, 2 x 15.5 g Picoprep - 31 g - 36 months from date of manufacture stored at or below 30°C - Sachet, laminate, 1 x 70g Glycoprep-C - 70 g - 2 years from date of manufacture stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

2007-10-05

Fuljett ta 'informazzjoni

1 PREPKIT-C
®
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about Prepkit-C.
It
does
not
contain
all
the
information
that
is
known
about
Prepkit-C.
It
does
not
take
the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
will
have
weighed
the
risks
of
you
taking
Prepkit-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 PREPKIT-C IS USED
FOR
Prepkit-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.
Prepkit-C produces watery stools
or
bowel
motions
within
2
to
3
hours after the first administration
and
may
cause
frequent
loose
bowel motions during the night.
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
PREPKIT-C
_ _
_WHEN YOU MUST NOT TAKE IT _
DO
NOT
TAKE
PREPKIT-C
IF
YOU
HAVE AN ALLERGY TO:

Any of the ingredients listed at
the end of this leaflet

Any similar medicines to
Prepkit-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
PREPKIT-C
IF
YOU
HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS:

Gastrointestinal obstruction or
blockage

Gastric retention

A hole in the stomach, large
intestine or small intestine

Toxic megacolon, a type of
bloating

A condition known as Paralytic
Ileus where the small bowel
doesn’t work properly

Inflammation of the bowel

A body weight less than
20kg
CAUTION SHOULD BE EXERCISED
IN “AT RISK” PATIENTS

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
Data Sheet – Prepkit-C® powder for oral solution - June 2019
Page 1 of 7
WARNING:
Life threatening dehydration and / or electrolyte disturbances may
occur in “at risk” groups. See
Contraindications and Precautions.
1 PRODUCT NAME
Prepkit-C® (Combination pack)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in Glycoprep-C® Sachet Powder for Solution
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® Sachet Powder for Solution 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 Glycoprep-C® 70 g sachet contains macrogol 3350 (polyethylene
glycol) 52.9 g, sodium chloride
2.6 g, potassium chloride 740 mg, sodium sulfate (anhydrous) 5.6 g and
ascorbic acid 6.0 g. This
solution also contains citric acid (anhydrous), aspartame and
flavouring. Total sodium content 2.83 g.
Each PicoPrep® 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.
Prepkit-C® is a combination kit containing one sachet of
Glycoprep-C® 70 g powder for solution to
produce one litre of solution and two sachets of PicoPrep® 15.5 g
powder for solution. They both
contain dry white crystalline powders which, when dissolved in water,
produce solutions with a lemon
like taste.
4