BAXTER 0.9% SODIUM CHLORIDE 9g/L injection BP bag AHB1324

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 9 g/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Sodium chloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

1 x 1L

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 9 October 2002: Sodium Chloride (0.9%) Intravenous Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-04-21

Patient Information leaflet

Sodium Chloride CMI Oct 2013
Page 1 of 3
Baxter
SODIUM CHLORIDE IV INFUSION
_Sodium Chloride Intravenous Infusion BP _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some
common questions about
Sodium Chloride IV Infusion.
It does not contain all of 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
prescribed Sodium Chloride
IV infusion for you in the
knowledge that the benefits
outweigh any possible risks.
If you have any concerns,
ask your doctor or
pharmacist.
KEEP THIS LEAFLET.
You may need to read it
again.
WHAT SODIUM
CHLORIDE IV INFUSION
IS USED FOR
Human body weight is about
60% water, which contains
various mineral salts and
other elements. Sodium
chloride is one of the main
mineral salts in the body
fluid. An optimum level of
salts in circulation is
essential for good health.
Sodium Chloride IV Infusion
is used for treatment of fluid
loss and to restore sodium
chloride balance.
It is used in the treatment of
patients who are unable to
take fluids and nutrients by
mouth.
It is also used for dilution of
other medicines before
injection into the body.
BEFORE YOU ARE GIVEN
SODIUM CHLORIDE IV
INFUSION
_SODIUM CHLORIDE IV _
_INFUSION SHOULD NOT BE _
_GIVEN TO YOU IF: _
_ _
•
you have congestive heart
failure.
•
you have ischaemic stroke,
or
•
you have severe renal
insufficiency
Also, the product should not
be used if the expiry date
printed on the bottom of the
bag has passed or if the
packaging is torn or shows
any signs of tampering.
_YOU MUST TELL YOUR _
_DOCTOR IF YOU: _
_ _
•
have heart disease
•
have any other illness,
especially the following:
kidney disease, liver
disease, swelling of the
hands, ankles or feet, or
breathlessness
•
are taking any prescription
medicine, or even non-
prescription medicines
•
If you are receiving
corticosteroids or
corticotrophin
•
have ever had an allergic
reaction to sodium chloride
injection
•
are pregnant
•
are breast

Summary of Product characteristics

BAXTER SODIUM CHLORIDE (0.45%, 0.9%, 3%) Intravenous Infusion
Version 1.3
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AUSTRALIAN PRODUCT INFORMATION –
BAXTER 0.45%, 0.9% OR 3% SODIUM CHLORIDE
(SODIUM CHLORIDE) INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Sodium Chloride Intravenous (IV) Infusion preparations are
sterile, non-pyrogenic
solutions of sodium chloride in Water for Injections. The preparations
do not contain an
antimicrobial agent or added buffer, and have a pH of 4.0 – 7.0.
Baxter Sodium Chloride 0.9% IV Infusion is isotonic, Baxter Sodium
Chloride 3% IV Infusion
is hypertonic and Baxter Sodium Chloride 0.45% IV Infusion is
hypotonic as indicated by their
osmolarities. The concentration of sodium chloride in each preparation
and their osmolarities
are shown in Table 1 (see
section 6.5 Nature and Contents of Container).
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 0.9% IV Infusion is indicated for extracellular
fluid replacement
and in the management of metabolic alkalosis in the presence of fluid
loss, and for restoring
or maintaining the concentration of sodium and chloride ions.
•
Hypertonic Baxter Sodium Chloride 3% IV Infusion is used in the
management of severe
sodium chloride depletion when electrolyte restoration is required.
•
Hypotonic Baxter Sodium Chloride 0.45% IV Infusion is mainly used as a
hydrating agent
solution.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIVE
Baxter Sodium Chloride IV Infusion is for intravenous infusion.
To be used as directed by the doctor.
BAXTER SODIUM CHLORIDE (0.45%, 0.9%, 3%) Intravenous Infusion
Version 1.3
2 of 13
Dosage, rate, and duration of administration are to be individualised
and depend upon the
indication for use, the patient’s age, weight, clinical condition,
and concomitant treatment, and
on the patient’s clinical and laboratory response to tre