BAXTER Compound Sodium Lactate Solution and 5% Glucose 1000mL injection AHB2074

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glucose, Quantity: 50 g/L; sodium chloride, Quantity: 6 g/L; sodium lactate, Quantity: 3.22 g/L; potassium chloride, Quantity: 400 mg/L; calcium chloride dihydrate, Quantity: 270 mg/L

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1000ml x 1

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Compound Sodium Lactate Solution and 5% glucose is indicated as a source of water and electrolytes. It is also used in patients as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency. These solutions are indicated as methods of intravenous drug delivery, if the drugs are compatible with the solutions.

Product summary:

Visual Identification: Clear liquid; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-04-21

Patient Information leaflet

CMI Mar 2014
BAXTER
Page 1 of 3
COMPOUND SODIUM LACTATE (HARTMANN’S)
SOLUTION WITH GLUCOSE INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
COMPOUND SODIUM
LACTATE (HARTMANN’S)
SOLUTION WITH GLUCOSE
INTRAVENOUS (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 Hartmann’s Solution
with Glucose 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.
If you have any concerns
about taking this medicine,
ask your doctor or
pharmacist.
WHAT HARTMANN’S
SOLUTION WITH GLUCOSE
IV INFUSION IS USED FOR
This medicine is used to
replace and balance body
fluid and mineral salts that
may be lost for a variety of
medical reasons and also as
an energy source.
BEFORE YOU ARE GIVEN
HARTMANN’S SOLUTION
WITH GLUCOSE IV
INFUSION
_ _
_THE HARTMANN’S SOLUTION _
_WITH GLUCOSE IV INFUSION _
_SHOULD NOT BE GIVEN TO YOU _
_IF: _

you have an allergy to
any ingredient listed at
the end of this leaflet;

you have had an
allergic reaction to corn
or corn products. Some
of the symptoms of an
allergic reaction may
include skin rash,
peeling of the skin and
swelling of the face, lips
or tongue, causing
difficulty swallowing or
shortness of breath;

you have
congestive heart
failure (constant
wheezing,
shortness of
breath);

you have severely reduced
kidney function;

you have too much
sodium and chloride
in your blood that is
not being corrected
with medication

you have ischaemic stroke
or head trauma in the last
24 hours

it is intended to be
administered at the same
time and through the same
injection equipment as
blood preparations (citrate
anticoagulated /preserved
blood) or ceftriaxone, an
antibiotic (if a baby < 1
month of age is to be
treated, administration at
the same time as
ceftriaxone must never
occur)

the expiry date printed on
the pack has pa

Summary of Product characteristics

BAXTER HARTMANN’S & 5% GLUCOSE Intravenous Infusion
Version 1.2
1 of 14
AUSTRALIAN PRODUCT INFORMATION –
BAXTER COMPOUND SODIUM LACTATE (HARTMANN’S)
AND 5% GLUCOSE (SODIUM CHLORIDE, SODIUM
LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
DIHYDRATE, GLUCOSE) INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sodium chloride, sodium lactate, potassium chloride, calcium chloride
dihydrate and glucose.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Compound Sodium Lactate (Hartmann’s) and 5% Glucose
Intravenous (IV) Infusion
comprises sodium chloride (6 g/L), sodium lactate (3.22 g/L),
potassium chloride (0.4g/L),
calcium chloride dihydrate (0.27 g/L) and glucose (50 g/L) in Water
for Injections.
Hartmann’s and 5% Glucose IV Infusions are sterile, non-pyrogenic
solutions. There is no
antimicrobial agent or buffer added. They are
_hypertonic_
intravenous solutions (osmolality of
563 mOsm/kg) with pH of 4.0 - 6.5.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear liquid solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hartmann’s and 5% Glucose IV Infusion is indicated as a source of
water and electrolytes. It
is also used in patients as a source of bicarbonate in the treatment
of mild to moderate metabolic
acidosis associated with dehydration or associated with potassium
deficiency. These solutions
are indicated as methods of intravenous drug delivery, if the drugs
are compatible with the
solutions.
4.2
DOSE AND METHOD OF ADMINISTRATION
To be used as directed by the physician. The dosage, rate and duration
of administration of
Hartmann’s and 5% Glucose IV Infusion is to be individualised and
depend upon the indication
for use, the patient’s age, weight, concomitant treatments and
clinical condition, as well as
laboratory determinations and response.
The infusion rate should not exceed the patient’s ability to utilise
glucose in order to avoid
hyperglycaemia. The infusion rate of intravenous solutions containing
glucose should