BAXTER POTASSIUM CHLORIDE 20 mmol and 0.9% SODIUM CHLORIDE 1000 mL intravenous infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium chloride, Quantity: 1.5 g/L; sodium chloride, Quantity: 9 g/L

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

1000mL x 12

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

The Baxter Potassium Chloride and Sodium Chloride Intravenous Infusion is indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bag

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

POTASSIUM CHLORIDE AND SODIUM CHLORIDE INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS LEAFLET? _
This leaflet answers some common questions about the Baxter POTASSIUM
CHLORIDE AND
SODIUM CHLORIDE INTRAVENOUS INFUSION [POTASSIUM CHLORIDE AND SODIUM
CHLORIDE IV
INFUSION]. It does not contain all of the available information. All
medicines have risks and
benefits. Your doctor has weighed the risks of you using Baxter
POTASSIUM CHLORIDE AND
SODIUM CHLORIDE IV INFUSION against the benefit they expect it will
have for you. It does not
take the place of talking to your doctor or pharmacist.
This medicine is likely to be used while you are at a clinic or in
hospital, and will be stored in the
pharmacy or on the ward.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
_WHAT BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV INFUSION IS
USED FOR? _
A combination of potassium chloride and sodium chloride salts in an
infusion is intended for
maintenance and replacement of body fluid. It can be used alone or in
combination with an
injectable nutrient supplement in patients who are unable to take
fluids and nutrients by mouth.
An optimum level of salts in circulation, such as potassium and
sodium, etc, is essential for life
and good health. Disorder of potassium level in the circulation may
affect transmission of nerve
impulses in various organs such as heart, muscle and gastrointestinal
muscles. Thus, the
Sodium Chloride and Potassium Chloride IV Infusion is used for
replenishing fluid in the
treatment of patients who need restoring and maintaining of fluid and
salt in the system.
_BEFORE YOU ARE GIVEN THE BAXTER POTASSIUM CHLORIDE AND SODIUM
CHLORIDE IV INFUSION _
THE BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV INFUSION SHOULD
NOT BE GIVEN TO
YOU IF YOU HAVE:

documented hyperkalaemia, hyperchloremia or hypernatremia.

potassium retention or high potassium levels in the blood

heart disease

kidney problems

increased acidity in the blood

haemolysis

Summary of Product characteristics

BAXTER POTASSIUM CHLORIDE & SODIUM CHLORIDE Intravenous Infusion
10 mmol/100 mL, 20 mmol/1000 mL, 30 mmol/1000 mL and 40 mmol/1000 mL
Version 1.2
1 of 14
AUSTRALIAN PRODUCT INFORMATION –
BAXTER POTASSIUM CHLORIDE AND SODIUM
CHLORIDE 10 MMOL/100 ML, 20 MMOL/1000 ML,
30 MMOL/1000 ML AND 40 MMOL/1000 ML (POTASSIUM
CHLORIDE, SODIUM CHLORIDE) INTRAVENOUS
INFUSION
1
NAME OF THE MEDICINE
Potassium chloride and sodium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Potassium Chloride and Sodium Chloride Intravenous (IV)
Infusion is a sterile, non-
pyrogenic solution. The amounts of potassium chloride and sodium
chloride dissolved in Water
for Injections are shown in Table 1 below. Hydrochloric acid may be
added for pH adjustment.
They do not contain an antimicrobial agent or added buffer, and have a
pH of 4.0 - 7.0. The
products are isotonic solutions except for Potassium chloride 30 mmol
and 0.9% Sodium
chloride and Potassium chloride 40 mmol and 0.9% Sodium chloride,
these are hypertonic
solutions.
TABLE 1: BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV INFUSION
PREPARATIONS
CODE NO*
NAME OF THE ACTIVE COMPONENTS &
CONCENTRATIONS % (MMOL/CONTAINER)
OSMOLARITY
Α
(MOSMOL/L)
ARTG
PACK SIZE
(ML)
AHB6008
Potassium Chloride 0.75% (10) &
Sodium Chloride 0.29% (5)
300 (300)
159379
100 x 48
AHB1764
Potassium Chloride 0.15% (20) &
Sodium Chloride 0.9% (154)
348 (348)
19466
1000 x 12
AHB1274
Potassium Chloride 0.224% (30) &
Sodium Chloride 0.9% (154)
368 (368)
19470
1000 x 12
AHB6034
Potassium Chloride 0.298% (40) &
Sodium Chloride 0.9% (154)
388 (388)
225806
1000 x 1
α
Osmolarity
is a calculated figure; in dilute condition, osmolarity is
approximately the same as osmolality. The
figures in the brackets are osmolality (mOsmol/kg).
*
_Not all codes are marketed_
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear colourless solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The Baxter Potassium Chloride and Sodium Chloride IV Infusion