COMPOUND SODIUM LACTATE (HARTMANN'S) 250 mL solution for injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium chloride dihydrate, Quantity: 67.5 mg; sodium chloride, Quantity: 1.5 g; sodium lactate, Quantity: 792.5 mg; potassium chloride, Quantity: 100 mg

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

calcium chloride dihydrate,potassium chloride,sodium chloride,sodium lactate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous

Units in package:

20 bags, 35 bags, 30 bags, 40 bags

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Compound Sodium Lactate (Hartmann's Solution) is used:,? for intravenous fluid and electrolyte replacement,? as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency,? as a vehicle for intravenous drug delivery, if the drugs are compatible with the solutions.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-03-12

Patient Information leaflet

CMI FOR COMPOUND SODIUM LACTATE (HARTMANN’S)
JUL 2018
1
COMPOUND SODIUM LACTATE
(HARTMANN’S) SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
about
Compound
Sodium
Lactate
(Hartmann’s). It does not contain
all the information. It does not take
the place of talking to your doctor.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
being
given
Compound
Sodium
Lactate
(Hartmann’s) against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT COMPOUND
SODIUM LACTATE
(HARTMANN’S) IS USED
FOR
Compound
Sodium
Lactate
(Hartmann’s)
is
used
to
replace
body fluid and mineral salts that
may be lost for a variety of medical
reasons.
It
is
especially
suitable
when the losses result in too much
acid being present in the blood.
YOUR
DOCTOR
MAY
HAVE
PRESCRIBED IT FOR ANOTHER REASON.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
BEFORE YOU ARE GIVEN
COMPOUND SODIUM
LACTATE (HARTMANN’S)
_WHEN YOU SHOULD NOT BE GIVEN _
_IT _
COMPOUND
SODIUM
LACTATE
(HARTMANN’S)
SHOULD
NOT
BE
GIVEN;

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;

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 on the bottom of
the bag has passed, or if
the
packaging
is
torn
or
shows
any
signs
of
tampering.
For
use
in
one
patient
on
one
occasion only.
It may have no effect at all, or
worse

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION- COMPOUND
SODIUM LACTATE (HARTMANN'S SOLUTION)
1 NAME OF MEDICINE
Calcium chloride dihydrate, potassium chloride, sodium chloride and
sodium lactate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Compound Sodium Lactate (Hartmann’s) contains Sodium Lactate (3.17
g/L), Sodium
Chloride (6.0 g/L), Potassium Chloride (400 mg/L) and Calcium Chloride
Dihydrate (270
mg/L).
The total amount of electrolytes per litre are: sodium 131 mmol,
potassium 5 mmol, chloride
112 mmol, calcium 2 mmol, bicarbonate (as lactate) 28 mmol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Injection for intravenous infusion.
The osmolality is approximately 255 mOsm/kg water. The solution is
isotonic, sterile, non-
pyrogenic and does not contain antimicrobial agent or added buffers.
The pH range is 5.0 to
7.0. Compound Sodium Lactate (Hartmann's) Solution for Injection is
also known as
Ringer’s Lactate.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Compound Sodium Lactate (Hartmann's) is used:
•
for intravenous fluid and electrolyte replacement
•
as a source of bicarbonate in the treatment of mild to moderate
metabolic acidosis
associated with dehydration or associated with potassium deficiency
•
as a vehicle for 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 doctor. The dosage of Compound Sodium
Lactate
(Hartmann’s) is dependent upon the age, weight and clinical
conditions of the patient as well
as laboratory determinations.
Parenteral drug products should be inspected visually for particulate
matter and
discolouration prior to administration.
Contains no antimicrobials. For use in one patient on one occasion
only. Discard any
unused portion. Care should be taken with intravenous administration
technique to avoid
administration site reactions and infection.
Do not administer Compound Sodium Lactate (Hartmann’s) unless the
solution is clear and
the seals are