BAXTER POTASSIUM CHLORIDE 40 mmol and 0.9% SODIUM CHLORIDE 100 mL intravenous infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium chloride, Quantity: 29.8 g/L; sodium chloride, Quantity: 9 g/L

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

potassium chloride,sodium chloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

100mL x 48 bags

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; Container Material: PVC; Container Life Time: 9 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-04-13

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 & 0.9% SODIUM CHLORIDE Intravenous Infusion
40mmol/100mL
Version 2
1 of 10
AUSTRALIAN PRODUCT INFORMATION –
BAXTER POTASSIUM CHLORIDE AND 0.9% SODIUM
CHLORIDE 40MMOL/100ML (POTASSIUM CHLORIDE,
SODIUM CHLORIDE) INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Potassium chloride and sodium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 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 1below. 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 product is a hypertonic solution.
TABLE 1: BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV LNFUSION
CODE NO
NAME OF THE ACTIVE COMPONENTS &
CONCENTRATIONS %(MMOL/CONTAINER) OSMOLARITY
Α (MOSMOL/L)
ARTG/
AUSTR
PACK SIZE
(ML)
AHB6053
Potassium Chloride 2.98% (40) &
Sodium Chloride 0.9% (15.4)
1100.0 (1100)
159380
100
Osmolarity
α
is a calculated figure; in dilute condition, osmolarity is
approximately the same as osmolality.
AHB6053 (40mmol/100mL) is significantly hypertonic. The figures in the
brackets are osmolality (mOsmol/kg).
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 is
indicated as a source of
water and to restore electrolyte balance as required by the patient's
clinical condition, such as
hypokalaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
To be used as directed by the physician for intravenous use only. The
dosage of the Baxter
Potassium Chloride and Sodium Chloride IV Infusion is dependent upon
the age, weight,
clinical and biological (acid-base balance) condition of the patient
as well as laboratory
BAXTER POTASSIUM CHLORIDE & 0.9% SODIUM CHLORIDE Intravenous Infusion
40m