Glucose 5% Solution for Infusion

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Osta kohe

Laadi alla Infovoldik (PIL)
20-06-2018
Laadi alla Toote omadused (SPC)
14-11-2018

Toimeaine:

glucose monohydrate, Ph Eur

Saadav alates:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Rahvusvaheline Nimetus):

glucose monohydrate, Ph Eur

Ühikuid pakis:

250ml mL; 500ml mL; 1000ml mL

Valmistatud:

FRESENIUS KABI DEUTSCHLAND GMBH

Infovoldik

                                PART I
PACKAGE INSERT FOR
MALAYSIA
Page: 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE 5% W/V INTRAVENOUS INFUSION B.P.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What is GLUCOSE 5% W/V and what it is used for
2.
Before you receive GLUCOSE 5% W/V
3.
How you are given GLUCOSE 5% W/V
4.
Possible side effects
5.
How to store GLUCOSE 5% W/V
6.
Further information
1. WHAT GLUCOSE 5% W/V IS AND WHAT IT IS USED FOR
Glucose 5% w/v is a sterile, clear solution, non coloured to slightly
yellow
It is used for
the situations:
-
Rehydration when there is loss of water greater than loss of sodium
chloride and other
osmoles.
-
Prevention of dehydration.
-
Vehicle for other medicines during the preoperative, peroperative and
immediate
postoperative periods.
-
Prevention and treatment of ketosis during malnutrition.
2. BEFORE YOU RECEIVE GLUCOSE 5% W/V
YOU SHOULD NOT RECEIVE GLUCOSE 5% W/V
if you suffer from:
-
Water overload.
-
Glucose intolerance.
.
CARE SHOULD BE TAKEN WHEN BEING ADMINISTERED WITH GLUCOSE 5% W/V.
WARNINGS
-
Use a slow infusion rate because of the risk of undesirable osmotic
diuresis.
-
Before use, check that the solution is clear and that the container
and its stopper are
undamaged ; any damage or partially used container must be discarded.
PRECAUTIONS FOR USE
-
Monitor clinical and laboratory (blood and urine) parameters, in
particular
water/sodium balance, blood glucose, urinary glucose and acetone,
plasma potassium
and plasma phosphate.
-
If necessary, provide parenteral supplements of insulin and potassium.
PART I
PACKAGE INSERT FOR
MALAYSIA
Page: 2
-
In diabetics, monitor blood and urinary glucose and possibly adjust
the dosage
of insulin.
-
Do not administer blood simultaneously using the 
                                
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Toote omadused

                                FRESENIUS
KABI
GLUCOSE
50/0
_solution _
_for _
_infusion _
Clear
solution,
non
coloured
to
slightly
yellow
•
Pharmacodynamics
&
Pharmacokinetics
_Pharmacodynamics _
PLASMA
SUBSTITUTES
AND
SOLUTIONS
FOR
INFUSION/CARBOHYDRATES
The
pharmacological
properties
of
the
medicinal
product
are
those
of
glucose.
The
caloric
intake
is
200
kcalll
i.e.
836
kJII.
This
solution
also
provide
water
intake
without
ionic
intake.
_Pharmacokinetics _
Glucose
is
metabolised
in
carbonic
gas
and
water.
•
Indication
_I _
Usage
This
medicine
is
indicated
in
the
following
situations:
Rehydration
when
there
is
loss
of
water
greater
than
loss
of
sodium
chloride
and
other
osmoles.
Prevention
of
dehydration.
Vehicle
for
other
medicines
during
the
preoperative,
peroperative
and
immediate
postoperative
periods.
Prevention
and
treatment
of
ketosis
during
malnutrition.
•
Dose
_I _
Use
instruction.
Recommended
dose
&
Route
of administration
Intravenous
infusion
by
peripheral
or
central
vein.
Posology
is
to
be
adapted
according
to
patient's
clinical
status,
body
weight,
diet
and
any
possible
other
treatments.
Infusion
rate
must
not
exceed
a
volume
corresponding
to
0.5
g
of
glucose
per
minute.
•
Contraindication
Administration
of
this
medicine
is
contraindicated
in
the
following
cases:
Water
overload.
Glucose
intolerance.
•
Warnings
and
precautions
_Special _
_warnings: _
Use
a
slow
infusion
rate
because
of
the
risk
of
undesirable
osmotic
diuresis.
Before
use,
check
that
the
solution
is
clear
and
that
the
container
and
its
stopper
are
undamaged;
any
damage
or
partially
used
container
must
be
discarded.
_Precautions _
_for _
_use: _
Monitor
clinical
and
laboratory
(blood
and
urine)
parameters,
in
particular
water/sodium
balance,
blood
glucose,
urinary
glucose
and
acetone,
plasma
potassium
and
plasma
phosphate.
If
necessary,
provide
parenteral
supplements
of
insulin
and
potassium.
In
diabetics,
monitor
blood
and
urinary
glucose
and
possibly
adjust
the
dosage
of
insulin.
Do
not
administer
blood
simultaneously
using
the
same
infusion
kit
because
                                
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