POTASSIUM CHLORIDE JUNO Potassium Chloride 1g/10mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium chloride, Quantity: 100 mg/mL

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

50 ampoules

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 04 NOVEMBER 2004 : 1.The treatment hypokalaemia.2. Treatment of digitalis intoxication. The IV route is indicated when the patient is unable to take potassium orally or if hypokalaemia is severe.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

Consumer Medicine Information
Juno Pharmaceuticals Pty Ltd
STERILE POTASSIUM CHLORIDE CONCENTRATE
Page: 1
POTASSIUM CHLORIDE JUNO
STERILE POTASSIUM CHLORIDE CONCENTRATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common questions people ask about
Sterile
Potassium
Chloride
Concentrate. It does not contain all
the information that is known about
Sterile
Potassium
Chloride
Concentrate.
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
Sterile
Potassium
Chloride
Concentrate against the benefits they
expect it will have for you.
If
you
have
any
concerns
about
being given this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
STERILE
POTASSIUM
CHLORIDE CONCENTRATE IS
FOR
Sterile
Potassium
Chloride
Concentrate
increases
levels
of
potassium in the blood. It is given to
patients
who
have
very
low
potassium levels or who are unable
to
take
tablets.
It
is
also
used
in
digoxin poisoning.
_ _
Your
doctor
will
have
explained
why
you
are
being
treated
with
Sterile
Potassium
Chloride
Concentrate.
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.
Sterile
Potassium
Chloride
Concentrate is not addictive.
BEFORE YOU ARE GIVEN
STERILE POTASSIUM
CHLORIDE CONCENTRATE
You may already have been given
Sterile
Potassium
Chloride
Concentrate. 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 USE IT _
STERILE
POTASSIUM
CHLORIDE
CONCENTRATE
MUST
BE
DILUTED
BEFORE
USE
ACCORDING
TO
THE
INSTRUCTIONS ON THE LABEL. IF THIS
CONCENTRATED
SOLUTION
HAS
NOT
BEEN DILUTED CORRECTLY AND MIXED
THOROUGHLY IT MUST NOT BE
USED.
YOU
SHOULD
NOT
BE
GIVEN
POTAS

Summary of Product characteristics

Australian Product Information
v0.1
Page | 1
AUSTRALIAN PRODUCT INFORMATION
POTASSIUM CHLORIDE JUNO
STERILE POTASSIUM CHLORIDE CONCENTRATE_ _
_ _
MUST BE DILUTED BEFORE ADMINISTRATION
1 NAME OF THE MEDICINE
The Australian Approved name is Potassium Chloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterile Potassium Chloride Concentrate is a sterile solution of
potassium chloride in Water for
Injections, containing no preservatives.
3 PHARMACEUTICAL FORM
Concentrated injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.The treatment of hypokalaemia.
2.Treatment of digitalis intoxication.
The IV route is indicated when the patient is unable to take potassium
orally or if hypokalaemia
is severe.
4.2 DOSE AND METHOD OF ADMINISTRATION
This product contains no antimicrobial preservative and should be used
in one patient on one
occasion only.
Sterile Potassium Chloride Concentrate is a concentrated solution and
must be diluted before
use. Sterile Potassium Chloride Concentrate is administered
intravenously only after dilution
in a large volume parenteral fluid.
The dose and rate of injection are dependent upon the individual
patient's condition.
THE USUAL MAXIMUM CONCENTRATION IS 40 mmol/L.
In patients whose serum potassium concentration is above 2.5 mmol/L,
the rate of infusion
should not exceed 10 mmol/hour. The total dose should not exceed 200
mmol/24 hours.
If urgent treatment is required (serum potassium concentration less
than 2 mmol/L with ECG
changes or paralysis), infuse potassium in a suitable concentration at
a rate of 40 mmol/hour,
Australian Product Information
v0.1
Page | 2
up to a rate of 400 mmol/24-hour period.
In critical states, potassium may be infused in saline (unless saline
is contraindicated) rather
than in glucose solutions, as the latter may decrease serum potassium
concentrations.
To reduce microbiological hazard, use as soon as practical after
dilution. If storage is
necessary, hold at 2-8°C for not more than 24 hours.
DILUENTS COMPATIBILITY
Potassiu