SODIUM CHLORIDE 0.9% 4.5g/500mL injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 9 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous

Units in package:

500mL x 1

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid.

Product summary:

Visual Identification: Clear colourless liquid.; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-10-21

Patient Information leaflet

Sodium Chloride Injection
1
SODIUM CHLORIDE 0.9% INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SODIUM CHLORIDE 0.9% INJECTION?
Sodium chloride 0.9% contains the active ingredient sodium chloride.
Sodium
For more information, see Section 1. Why am I using Sodium Chloride
0.9% Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 0.9% INJECTION?
Do not use if you have ever had an allergic reaction to Sodium
Chloride 0.9% or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sodium Chloride 0.9% Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Chloride 0.9% and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SODIUM CHLORIDE 0.9% INJECTION?
•
Sodium Chloride 0.9% Injection will be given to you by your doctor or
specially trained nurse by infusion or drip
into the vein. They will decide what dose and how long you will
receive it for. This depends on your medical condition and
other factors.
•
More instructions can be found in Section 4. How do I use Sodium
Chloride 0.9% Injection? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 0.9% INJECTION?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Sodium Chloride 0.9% tell
your doctor immediately.
•
Remind any doctor, dentist or pharmacist or nurse you visit that you
have been given using Sodium
Chloride 0.9% Injection.
•
Before surgery, tell the surgeon or anaesthetist that you have been
given this medicine.
DRIVING OR USING
MACHINES
• Be careful driving or operating machinery until you

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SODIUM CHLORIDE 0.9 % FREEFLEX
(SODIUM CHLORIDE)
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterile isotonic solution of sodium chloride 9 g/L in Water for
Injections, containing no preservatives
(normal saline).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless liquid
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Normal saline can be used as the vehicle for many parenteral drugs and
as an electrolyte replenisher
for maintenance or replacement of deficits of extracellular fluid.
It can also be used as a sterile irrigation medium.
4.2
Dose and method of administration
The dosage of sodium chloride as a vehicle for parenteral drugs and as
an electrolyte replenisher
must be calculated after consideration of clinical and laboratory
data.
For use in one patient, on one occasion only. It does not contain
antimicrobials. Any unused portion
should be discarded. Care should be taken with intravenous technique
to avoid injection site
reactions and infections.
4.3
Contraindications
Sodium Chloride 0.9 % is contraindicated in patients with congestive
heart failure, severe renal
impairment,
conditions
of
sodium
retention
and
oedema,
liver
cirrhosis
and
irrigation
during
electrosurgical procedures.
4.4
Special warnings and precautions for use
Do not use unless the solution is clear. The entire contents of the
bag should be used promptly.
2
When used as a vehicle for intravenous drug delivery, the product
information document of such drugs
should
be
checked
prior
to
use
to
ensure
compatibility
with
the
sodium
chloride
solution.
Reconstitution instructions should be read carefully.
Excessive administration of sodium chloride causes hypernatraemia,
resulting in dehydration of internal
organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte
and acid/base balance may be
necessary. Congestive heart failure and pulmonary oedema may be
precipitated, particularly