BAXTER 0.224% POTASSIUM CHLORIDE and 5% GLUCOSE 1000mL injection AHB1174

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glucose, Quantity: 50 g/L; potassium chloride, Quantity: 2.24 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 Potassium Chloride in Glucose (5%) Intravenous Infusion is indicated for replenishing fluid losses, as an energy source and for restoration or maintenance of potassium and chloride ion concentrations. This is also an alternative route of administration for the patients who are unable to take potassium orally or if hypokalaemia is severe. It may be used as a vehicle of drug delivery where intravenous delivery is appropriate and the drug is compatible with this solution.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-30

Patient Information leaflet

Baxter
Page 1 of 2
POTASSIUM CHLORIDE IN GLUCOSE 5% INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
POTASSIUM CHLORIDE IN
GLUCOSE 5 % INTRAVENOUS (IV)
INFUSION. It does not contain all
of the available information.
All medicines have risks and
benefits. Your doctor has
prescribed Potassium Chloride
in Glucose IV Infusion for you in
the knowledge that the benefits
outweigh any possible risks. It
does not take the place of
talking to your doctor, nurse or
pharmacist.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING THIS MEDICINE,
ASK YOUR HEALTH CARE
PROFESSIONAL.
WHAT POTASSIUM CHLORIDE
IN GLUCOSE IV INFUSION IS
USED FOR
Potassium Chloride in Glucose
IV Infusion is used to replace
and maintain body fluid and
mineral salts such as potassium
chloride that may be lost for a
variety of medical reasons.
Potassium Chloride in Glucose
IV Infusion is especially suitable
when the losses result in
depletion of the body’s stores of
potassium. Glucose is used by
the body as a source of energy.
BEFORE YOU ARE GIVEN THE
POTASSIUM CHLORIDE IN
GLUCOSE IV INFUSION
_POTASSIUM CHLORIDE IN _
_GLUCOSE IV INFUSION SHOULD _
_NOT BE GIVEN TO YOU IF YOU _
_HAVE: _
•
had an allergic reaction to
corn or corn products (as
glucose is produced from
cornstarch). Some of the
symptoms of an allergic
reaction may include skin
rash, peeling of the skin,
swelling of the face, lips or
tongue, which may cause
difficulty swallowing or
shortness of breath.
•
already too much glucose in
your blood that is not being
corrected with medication
•
congestive heart failure
(constant wheezing,
shortness of breath)
•
had a stroke
•
you have liver disease or
•
severe kidney problems (not
passing urine)
•
untreated Addison’s disease
•
severe burns across your
body
Also, the product should not be
used if the expiry date printed
on the bottom of the bag has
passed, or if the packaging is
torn or shows any signs of
tampering.
_YOU MUST TELL YOUR DOCTOR IF _
_YOU:_
•
have heart

Summary of Product characteristics

BAXTER POTASSIUM CHLORIDE AND GLUCOSE Intravenous Infusion
Version 2.0
1 of 16
AUSTRALIAN PRODUCT INFORMATION –
BAXTER POTASSIUM CHLORIDE (0.15% OR 0.224%) AND
5% GLUCOSE (POTASSIUM CHLORIDE, GLUCOSE)
INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Potassium chloride and glucose.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Potassium Chloride and Glucose Intravenous (IV) Infusions are
sterile, non-pyrogenic
solutions.
The concentrations of
the active ingredients dissolved in 1 litre of water for
injections are shown in Table 1 below. They do not contain
antimicrobial agent or added buffer
and have a pH of 3.5 – 6.5. Their osmolarities are in the upper
level of the isotonic range as
listed in Table 1.
TABLE 1: BAXTER POTASSIUM CHLORIDE AND GLUCOSE IV INFUSION
PREPARATIONS
CODE NO
NAME AND QUANTITY OF THE ACTIVE
COMPONENTS [ENERGY (KJ/L)]
OSMOLARITY
Α
(MOSMOL/L)
ARTG
PACK SIZE*
(ML)
AHB1134
Potassium Chloride 0.15% (20 mmol/L)
and Glucose 5% (278 mmol/L)
[835 kJ/L]
317 (318)
19465
1000
AHB1174
Potassium Chloride 0.224% (30 mmol/L)
and Glucose 5% (278 mmol/L)
[835 kJ/L]
340 (338)
19469
1000
Osmolarity
Α
is a calculated figure, whilst figures in the bracket are
approximately Osmolality (mOsmol/kg).
1 gram of glucose provides 16.7 kiloJoules (kJ) of energy.
*
_Not all packs 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
Baxter Potassium Chloride and Glucose IV Infusion is indicated for
replenishing fluid losses,
as an
energy source and for restoration or maintenance of potassium and
chloride ion
concentrations.
This is also an alternative route of administration for the patients
who are
unable to take potassium orally or if hypokalaemia is severe.
It may be used as a vehicle of drug delivery where intravenous
delivery is appropriate and the
drug is compatible with this solution.
BAXTER POTASSIUM CHLORIDE AND GLUCOSE Intravenous Infusion
Version 2.0
2 of