0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% sodium chloride 50 mL intravenous infusion

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 0.45 g

Available from:

B Braun Australia Pty Ltd

INN (International Name):

Sodium chloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous Infusion

Units in package:

20 x 50 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

The solutions are indicated for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. The solutions may also be used as solvents for intravenously administered drugs where compatibility has been established. 0.9% Sodium Chloride injection may also be used for irrigation of wounds and moistening of wound dressings. Compound Sodium Lactate Solution is particularly suitable for the replacement of extracellular fluid loss where isotonic dehydration is evident and in burn therapy.

Product summary:

Visual Identification: Clear to colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-04-16

Patient Information leaflet

NaCl, Glucose, Na Lactate Inf. CMI – Version 2.0 (August 2022)
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CONSUMER MEDICINE INFORMATION
B. BRAUN (AUSTRALIA) INTRAVENOUS REPLACEMENT FLUIDS
*
0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP
*
5% GLUCOSE INTRAVENOUS INFUSION BP
*
0.9% SODIUM CHLORIDE AND 5% GLUCOSE INFUSION BP
*
COMPOUND SODIUM LACTATE INFUSION BP (HARTMANN’S SOLUTION)
_THIS LEAFLET PROVIDES A SUMMARY OF SOME OF THE IMPORTANT THINGS YOU
NEED TO KNOW ABOUT _
_THIS MEDICINE. ONLY YOUR DOCTOR AND PHARMACIST ARE ABLE TO WEIGH UP
ALL THE RELEVANT FACTS _
_ABOUT THE USE OF THIS MEDICINE IN YOUR CONDITION AND YOU SHOULD
CONSULT THEM FOR FURTHER _
_DETAILS. MORE DETAILED AND TECHNICAL INFORMATION IS AVAILABLE ON
REQUEST FROM YOUR DOCTOR _
_OR PHARMACIST. _
The solutions described above are clear colourless solutions intended
for intravenous
infusion. They contain water and various electrolytes i.e. simple
chemicals such as sodium,
calcium, potassium etc. Some also contain glucose as a source of
energy.
COMPOSITION:
The solutions have the following formulations (g/L):
0.9%NACL
5% GLUCOSE
0.9% NACL AND
5% GLUCOSE
COMPOUND SODIUM
LACTATE
SODIUM CHLORIDE
9 g
---
9 g
6 g
GLUCOSE
---
50 g
50 g
---
POTASSIUM
CHLORIDE
---
---
---
0.4 g
CALCIUM CHLORIDE
---
---
---
0.27 g
SODIUM
LACTATE
(AS 50% SOLN)
---
---
---
3.12 g
Solutions containing 5% glucose provide 835kJ/L.
WHAT ARE THE PRODUCTS USED FOR?
Electrolyte replacement solutions are used to replace fluid
and electrolytes which have been lost from the body due to illness or
injury.
HOW DO THEY WORK?
The solution chosen by your doctor is infused slowly into a vein and
provides water as well as some or all of the following electrolytes:
sodium, chloride,
potassium and bicarbonate ions to replace those lost. The solution may
also contain glucose.
BEFORE USING THIS PRODUCT:
Please note that the solutions should not be used if the container
is found to be leaking or the solution is not clear.
* Tell your doctor if you have kidney or liver problems or if you have
high levels of
potassium in your bloo

Summary of Product characteristics

NaCl, Glucose, Sod. Lactate PI – Version 5.0 (12/08/2022)
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AUSTRALIAN PRODUCT INFORMATION
B. BRAUN (AUSTRALIA) INTRAVENOUS REPLACEMENT FLUIDS
*
0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP
*
5% GLUCOSE INTRAVENOUS INFUSION BP *
0.9% SODIUM CHLORIDE AND 5% GLUCOSE INFUSION BP *
COMPOUND SODIUM LACTATE INFUSION BP (HARTMANN’S SOLUTION)
1.
NAME OF THE MEDICINE
Sodium Chloride, Glucose, Sodium Lactate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solutions have the following formulations (g/L):
0.9% NACL
5% GLUCOSE
0.9% NACL AND
5% GLUCOSE
COMPOUND NA
LACTATE
SODIUM CHLORIDE
9g
---
9g
6g
GLUCOSE
---
50g
50g
---
POTASSIUM
CHLORIDE
---
---
---
0.4g
CALCIUM CHLORIDE
---
---
---
0.27g
SODIUM LACTATE
(AS 50% SOLN)
---
---
---
3.12g
and have the following content of electrolytes (mmol/L), total
osmolality and pH:
0.9% NACL
5% GLUCOSE
0.9% NACL AND
5% GLUCOSE
COMPOUND NA
LACTATE
SODIUM
154
---
154
131
CHLORIDE
154
---
154
111
POTASSIUM
---
---
---
5.4
CALCIUM
---
---
---
1.8
LACTATE
---
---
---
29
TOTAL OSMOLALITY
308
mOsm/L
278
mOsm/L
585
mOsm/L
278
mOsm/L
PH
4.5 – 7.0
3.5 - 5.5
3.5 - 5.5
5.0 - 7.0
Solutions containing 5% glucose provide 835 kJ/L.
NaCl, Glucose, Sod. Lactate PI – Version 5.0 (12/08/2022)
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3.
PHARMACEUTICAL FORM
B. Braun intravenous replacement solutions are clear to colourless
solutions intended
for intravenous infusion.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The
solutions
are
indicated
for
intravenous
fluid
therapy
designed
to
correct
deficiencies in hydration, electrolyte and energy levels. The
solutions may also be used
as
solvents
for
intravenously
administered
drugs
where
compatibility
has
been
established.
* 0.9% sodium chloride injection may also be used for irrigation of
wounds and
moistening of wound dressings
* Compound Sodium Lactate Solution is particularly suitable for the
replacement
of extracellular fluid loss where isotonic dehydration is evident and
in burn
therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage should be adjusted according to ind