PHEBRA SODIUM CHLORIDE 0.9% (450mg/50mL) injection BP vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 9 mg/mL

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intramuscular, Intravenous

Units in package:

50mL x 10

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 01 JAN 1991 : 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.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

Sodium Chloride 0.9%
solution for injection V03
1
SODIUM CHLORIDE 0.9%
SOLUTION FOR 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%?
Sodium Chloride 0.9% contains the active ingredient sodium chloride.
Sodium Chloride 0.9% is used to replace lost body fluids
and salts, dilute other medicines, and/or act as a sterile liquid for
washing wounds, nasal passages or during surgery.
For more information, see Section 1. Why am I using Sodium Chloride
0.9%? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 0.9%?
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%? 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%?
•
Sodium Chloride Injection 0.9% must only give by a doctor or
healthcare professional. 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%? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 0.9%?
THINGS YOU
SHOULD DO
•
If you become pregnant while being given Sodium Chloride 0.9%, tell
your doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given Sodium Chloride
0.9%.
•
Before surgery, tell the surgeon or anaesthetist that you have been
given this medicine.
DRIVING OR

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information - Sodium Chloride 0.9% Solution for
Injection
Page 1 of 7
Version 04
SODIUM CHLORIDE 0.9%
(SODIUM CHLORIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sodium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 9 mg sodium chloride equivalent to 0.15 mmol sodium
ions and 0.15 mmol chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Sodium Chloride 0.9% is an isotonic solution for injection. pH 4.5 to
8.0
.
Osmolality of 296 mOsm/L.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prophylaxis of heat prostration or muscle cramps, chloride deficiency
due to diuresis or salt restriction, prevention
or treatment of extracellular volume depletion.
PARENTERAL
Sodium Chloride 0.9% (isotonic) is used to restore sodium chloride
losses; to dilute or dissolve drugs for
intravenous (IV), intramuscular (IM), or subcutaneous (SC) use;
flushing of IV catheters; extracellular fluid
replacement; priming solution for haemodialysis; initiate and
terminate blood transfusions so red blood cells will
not haemolyse; metabolic alkalosis when there is fluid loss and mild
sodium depletion.
TOPICAL OR IRRIGATION
Relief of inflamed, dry, or crusted nasal membranes or as a topical
irrigating or flush solution.
4.2
D
OSE 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.
Use in one patient on one occasion only and discard. Contains no
antimicrobial preservative. Solutions containing
visible, solid particles must not be used.
4.3
C
ONTRAINDICATIONS
•
Congestive heart failure
•
Severe renal impairment
•
Conditions of sodium retention and oedema
PRODUCT INFORMATION
SODIUM CHLORIDE 0.9%
SOLUTION FOR INJECTION
Australian Product Information - Sodium Chloride 0.9% Solution for
Injection
Page 2 of 7
Version 04
•
Liver cirrhosis
•
Irrigation during electrosurgical proced