Baxter 0.45% Sodium Chloride and 5% Glucose Intravenous Infusion 1000 mL bag (AHB6028)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glucose, Quantity: 50 g/L; sodium chloride, Quantity: 4.5 g/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

glucose,sodium chloride

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

1000 mL bag

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium Chloride and Glucose Intravenous Infusion is indicated for replenishing fluid losses, as an energy source and for restoration or maintenance of sodium and chloride ion concentrations. It may be used as a vehicle of drug delivery where intravenous delivery is appropriate and the drug is compatible with this solution.

Product summary:

Visual Identification: Clear, colourless or faintly straw-coloured solution, practically free from visible particles; Container Type: Bag; Container Material: PVC; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-04-20

Patient Information leaflet

SODIUM CHLORIDE AND GLUCOSE INTRAVENOUS INFUSION BP
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about the
Sodium Chloride & Glucose
Intravenous (IV) Infusion.
It does not contain all of
the available information. All
medicines have risks and
benefits. Your doctor has
weighed the risks of you
using Sodium Chloride &
Glucose IV Infusion against
the benefit they expect it will
have for you.
It does not take the place of
talking to your doctor or
pharmacist. If you have any
concerns about having this
medicine, ask your doctor or
pharmacist.
WHAT SODIUM CHLORIDE &
GLUCOSE IV INFUSION IS USED
FOR
A combination of glucose
and sodium chloride
infusion is used as a
source of energy and for
maintenance and
replacement of body fluid. It
can be used alone or in
combination with an
injectable nutrient
supplement in patients who
are unable to take fluids and
nutrients by mouth. The
glucose component provides
a source of energy. The
sodium chloride component
helps correct salt imbalance,
to help prevent dehydration
(the loss of too much water
from the body). An optimum
level of salts in circulation is
essential for life and good
health. Thus, the Glucose &
Sodium Chloride IV Inf
usion
is used to provide energy
and restore and maintain
fluid and salt levels in
patients where these are
depleted.
BEFORE YOU ARE GIVEN THE
SODIUM CHLORIDE & GLUCOSE
IV INFUSION
_THE SODIUM CHLORIDE & _
_GLUCOSE IV INFUSION MUST _
_NOT BE GIVEN TO YOU IF: _
•
You have had an allergic
reaction to corn or corn
products. Some of the
symptoms of an allergic
reaction may include skin
rash, peeling of the skin,
swelling of the face, lips or
tongue which may cause
difficulty swallowing or
shortness of breath.
•
you already have too much
glucose, lactate and/or
potassium in your blood,
that is not being correct with
medication, or you are not
passing urine
•
you are taking a
corticosteroid medication,
such as prednisone and
prednisolone.
•
you have pulmonary or
peripheral oedema, or heart
problems.

Summary of Product characteristics

Baxter Sodium Chloride and Glucose IV Infusion
Version 1.0
1 of 17
AUSTRALIAN PRODUCT INFORMATION –
BAXTER SODIUM CHLORIDE AND GLUCOSE
INTRAVENOUS INFUSION
(SODIUM CHLORIDE, GLUCOSE)
1
NAME OF THE MEDICINE
Sodium chloride and glucose.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Sodium Chloride and Glucose Intravenous (IV) Infusions are
sterile, nonpyrogenic
solutions, and are for single use in one patient on one occasion only.
The solution is clear,
colourless to faintly straw-coloured solution, practically free from
visible particles.
Baxter
Sodium Chloride and Glucose IV Infusions contain glucose and sodium
chloride in Water for
Injections. The concentrations of the active ingredients dissolved in
Water for Injections are
shown in Table 1 (see Section 6.5 Nature and Contents of Container).
They are iso-osmotic
as indicated by their osmolarity shown in Table 1, except AHB6028,
AHB1064 and AHB2026
are hypertonic solutions as indicated by the osmolarities: Sodium
Chloride 0.45% and Glucose
5% with osmolarity of 432 mOsmol /L, Sodium Chloride 0.9% and Glucose
5% IV Infusion
with osmolarity of 586 mOsmol/L, and Sodium Chloride 0.22% and Glucose
10% IV Infusion
with osmolarity of 630 mOsmol/L.
They do not contain an antimicrobial agent or added buffer, and have a
pH of 3.5 - 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baxter Sodium Chloride and Glucose IV Infusion is indicated for
replenishing fluid losses, as
an energy source and for restoration or maintenance of sodium and
chloride ion concentrations.
It may be used as a vehicle of drug delivery where intravenous
delivery is appropriate and the
drug is compatible with this solution.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIVE
To be used only as directed by the physician. The dosage, volume ,
rate and duration of
administration of Baxter Sodium Chloride and Glucose IV Infusion are
dependent on the age,
Baxter So