SODIUM CHLORIDE INJECTION 0.9% 5 mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 9 mg/mL

Available from:

Interpharma Pty Ltd

INN (International Name):

sodium chloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous, Intramuscular, Subcutaneous

Units in package:

50 ampoules

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium Chloride Injection BP 0.9% 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.

Product summary:

Visual Identification: Clear, colourless; Container Type: Ampoule; Container Material: PP; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-12-22

Patient Information leaflet

1
SODIUM CHLORIDE INJECTION BP 0.9% CMI V1.0 July 2020
SODIUM CHLORIDE INJECTION BP
0.9%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Chloride
Injection BP 0.9%. 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 being
given Sodium Chloride Injection
BP 0.9% 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.
You may need to read it again.
WHAT SODIUM
CHLORIDE INJECTION
BP 0.9% IS USED FOR
Sodium Chloride Injection BP
0.9% is used to replace lost body
fluids and salts. Other medicines
which are given by injection or by
drip may be diluted with Sodium
Chloride Injection BP 0.9%.
Sodium Chloride Injection BP
0.9% can also be used as a sterile
irrigation solution.
Your doctor will have explained
why you are being given Sodium
Chloride Injection BP 0.9%.
FOLLOW
ALL
DIRECTIONS
GIVEN
TO
YOU
BY YOUR
DOCTOR
CAREFULLY.
THEY
MAY
DIFFER
FROM
THE
INFORMATION
CONTAINED
IN
THIS
LEAFLET.
Your doctor may prescribe this
medicine
for
another
use.
Ask
your
doctor
if
you
want
more
information.
Sodium
Chloride
Injection
BP
0.9% is not addictive.
BEFORE YOU ARE
GIVEN SODIUM
CHLORIDE
INJECTION BP 0.9%
You may already have been
given Sodium Chloride Injection
BP 0.9%.Your doctor will have
considered the situation carefully
and decided to use it. However, if
any of the following applies to
you, tell your doctor
immediately.
_WHEN YOU MUST NOT _
_BE GIVEN IT _
SODIUM CHLORIDE INJECTION BP
0.9% WILL ONLY BE USED IF THE
SOLUTION IS CLEAR, THE PACKAGE IS
UNDAMAGED AND THE USE BY
(EXPIRY) DATE MARKED ON THE
PACK HAS NOT BEEN PASSED.
YOU SHOULD NOT BE GIVEN SODIUM
CHLORIDE INJECTION BP 0.9% IF
YOU ARE PREGNANT OR
BREASTFEEDING UNLESS YOUR DOCTOR
SAYS IT IS SAFE. ASK YOUR DOCTOR
ABOUT THE RISKS AND BENEFITS
INVOLVED.
You should not be given Sodium
Chloride Injection BP 0.9% i

Summary of Product characteristics

SODIUM CHLORIDE INJECTION BP 0.9% INTERPHARMA PI-V 1.0 (Sep 2020)
Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION – SODIUM CHLORIDE
INJECTION BP 0.9%
1
NAME OF THE MEDICINE
Sodium Chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride Injection BP 0.9%is a sterile, preservative-free
solution, containing
sodium chloride 0.9% w/w in Water for Injections.
3
PHARMACEUTICAL FORM
Injection, solution
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sodium Chloride Injection BP 0.9% 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
D
OSE AND METHOD OF ADMINISTRATION
To be used as directed by a physician.
Parenteral drug products should be inspected prior to administration
for particulate matter
and discolouration. Sodium Chloride Injection BP 0.9% does not contain
any antimicrobial
preservatives. Care should be taken with intravenous technique to
avoid injection site
reactions and infections.
Dosage is dependent on the age, weight, clinical and fluid/electrolyte
condition of the
patient.
4.3
C
ONTRAINDICATIONS
•
Congestive heart failure
•
Severe renal impairment
•
Conditions of sodium retention and oedema
•
Liver cirrhosis
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Solutions containing sodium chloride should be used cautiously in
patients with
cardiovascular or renal disease, pregnancy associated hypertension,
pulmonary
SODIUM CHLORIDE INJECTION BP 0.9% INTERPHARMA PI-V 1.0 (Sep 2020)
Page 2 of 6
or peripheral oedema, those receiving corticosteroids or
corticotrophin or any
condition associated with sodium retention.
•
Excessive administration of sodium chloride solution may result in
hypernatraemia, resulting in dehydration of internal organs,
hypokalaemia and
acidosis. Monitoring of fluid, electrolyte and acid-base balance may
be
necessary
•
When used as a vehicle for intravenous drug delivery, the Product
Information
document of