Sodium Chloride Injection BP 0.9%

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium chloride 0.9%;  ;  

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Sodium chloride 0.9%

Dosage:

0.9 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Sodium chloride 0.9%     Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Prescription type:

General sale

Manufactured by:

Salinen Austria AG

Therapeutic indications:

Sodium Chloride Injection BP 0.9% can be used as the vehicle for the restoration of electrolytes, as the vehicle for parenteral drug administration or as a sterile irrigation medium.

Product summary:

Package - Contents - Shelf Life: Ampoule, plastic, LDPE (PVC free) twist off 20mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, LDPE (PVC free) twist off 10mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, LDPE (PVC free) twist off 5mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, LDPE (PVC free) twist off 10mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2013-08-26

Patient Information leaflet

October
2021
Page 1
Change: Address change
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% if you
have

Summary of Product characteristics

Page 1 of 4
NEW ZEALAND DATA SHEET
1 SODIUM CHLORIDE INJECTION BP 0.9%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride is a white, crystalline powder or colourless crystals,
freely soluble in
water and practically insoluble in ethanol.
Sodium Chloride Injection BP 0.9% is a sterile, preservative-free
solution, pH 4.5-7.0
containing sodium chloride 0.9% in Water for Injections.
For full list of excipients see section 6.2
3 PHARMACEUTICAL FORM
Solution for Injection
4 CLINICAL PARTICULARS
4.1 THERAPUTIC 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 DOSE 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 dependant on the age, weight, clinical and fluid/electrolyte
condition of the
patient.
4.3 CONTRAINDICATIONS
Congestive heart failure
Severe renal impairment
Conditions of sodium retention and oedema
Liver cirrhosis
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Solutions containing sodium chloride should be used cautiously in
patients with
cardiovascular or renal disease, pregnancy associated hypertension,
pulmonary or
peripheral oedema, those receiving corticosteroids or corticotrophin
or any condition
associated with sodium retention.
Sodium chloride solutions should be used with caution in geriatric
patients and infants.
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.
Page 2 of 4
When used as a vehicle for