POTASSIUM CHLORIDE 20 mmol in SODIUM CHLORIDE 0.9% 500 mL injection for intravenous infusion bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium chloride, Quantity: 3 g/L; sodium chloride, Quantity: 9 g/L

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

500 mL x 10, 500 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

A source of water and to restore electrolyte balance as required by a patient's clinical condition, such as hypokalaemia

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: PE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-02-28

Patient Information leaflet

CMI for Potassium Chloride in Sodium Chloride Intravenous Infusion
201
9
1.3.2 - CMI clean
Page 1 of 3
POTASSIUM CHLORIDE IN SODIUM CHLORIDE INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fresenius Kabi
Potassium Chloride in Sodium
Chloride IV Infusion. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Potassium
Chloride in Sodium Chloride IV
Infusion against the benefits they
expect it will have for you.
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 POTASSIUM
CHLORIDE IN SODIUM
CHLORIDE INTRAVENOUS
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.
Disorders of potassium levels 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
POTASSIUM CHLORIDE IN
SODIUM CHLORIDE
INTRAVENOUS INFUSION
_WHEN YOU MUST NOT BE GIVEN IT _
POTASSIUM CHLORIDE IN SODIUM
CHLORIDE SOLUTION IV INFUSION
MUST NOT BE GIVEN IF YOU HAVE:
•
documented hyperkalaemia,
hyperchloremia or
hypernatremia.
•
potassium retention or high
potassium levels in the blood
•
heart disease
•
kidney problems
•
in

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
1
NAME OF THE MEDICINE
Potassium Chloride and Sodium Chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of Fresenius Kabi’s Potassium Chloride in Sodium
Chloride Intravenous Infusion
contains either 0.15% w/v (1.5 g/L, 20 mmol/L) or 0.3% w/v (3 g/L, 40
mmol/L) potassium
chloride, as well as 0.9% w/v (9 g/L, 154 mmol/L) sodium chloride, as
the active ingredients.
Fresenius Kabi’s Potassium Chloride in Sodium Chloride Intravenous
Infusions have a pH of
4.5–7.0 and osmolarity of 348 mOsm/L (0.15 % potassium chloride/0.9
% sodium chloride
product) and 388 mOsm/L (0.3% potassium chloride/0.9% sodium chloride
product). The
0.15 % w/v solution is isotonic and the 0.3% w/v solution is
hypertonic.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Injection, intravenous infusion.
Fresenius Kabi’s Potassium Chloride in Sodium Chloride Intravenous
Infusion is a clear
colourless preservative free solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
A source of water and to restore electrolyte balance as required by a
patient's clinical
condition, such as hypokalaemia.
POTASSIUM CHLORIDE 10 MMOL IN SODIUM CHLORIDE 0.9% 500 ML INJECTION
FOR
INTRAVENOUS INFUSION
POTASSIUM CHLORIDE 20 MMOL IN SODIUM CHLORIDE 0.9% 500 ML INJECTION
FOR
INTRAVENOUS INFUSION
POTASSIUM CHLORIDE 20 MMOL IN SODIUM CHLORIDE 0.9% 1000 ML INJECTION
FOR
INTRAVENOUS INFUSION
POTASSIUM CHLORIDE 40 MMOL IN SODIUM CHLORIDE 0.9% 1000 ML INJECTION
FOR
INTRAVENOUS INFUSION
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
To be used as directed by the physician for intravenous use only. The
choice of the specific
Fresenius Kabi’s Potassium Chloride in Sodium Chloride Intravenous
Infusion formulation,
dosage, volume, rate and duration of administration is dependent upon
the age, weight, clinical
and biological (acid-base balance) condition of the patient,
concomitant therapy and laboratory
determinations. Additional electrolyte supplementation may be
indicated according