BAXTER Compound Sodium Lactate (Hartmann's Solution) 1000mL injection AHB2324

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

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

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

1000mL x 12

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

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 comparable with the solutions. This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code)

Product summary:

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

Authorization status:

Licence status A

Authorization date:

1994-04-21

Patient Information leaflet

CMI Mar14
BAXTER
Page 1 of 2
COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION
(HARTMANN’S SOLUTION)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
COMPOUND SODIUM LACTATE
INTRAVENOUS INFUSION
(HARTMANN’S SOLUTION). 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 IV
Infusion against the benefit
they expect it will have for you.
It does not take the place of
talking to your doctor, nurse or
pharmacist.
If you have any concerns about
taking this medicine, ask your
doctor, nurse or pharmacist.
WHAT HARTMANN’S SOLUTION
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.
BEFORE YOU ARE GIVEN
HARTMANN’S SOLUTION
_HARTMANN’S SOLUTION SHOULD _
_NOT BE GIVEN TO YOU_ _IF: _
•
you have an allergy to any
ingredient listed at the end
of this leaflet;
•
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.
_YOU MUST TELL YOUR DOCTOR IF _
_YOU: _
•
have heart problems;
•
have kidney problems
including kidney stones;
•
you have too much
potassium or calcium in your
blood that is not being
corrected with medication
•
have diabetes;
•
are taking any other
medicines including those
you can buy without a
prescription, in particular
digoxin (a medicine for heart
problem

Summary of Product characteristics

COMPOUND SODIUM LACTATE (HARTMANN’S)/ MODIFIED HARTMANN’S
SOLUTIONS (sodium chloride, sodium lactate, potassium chloride,
calcium chloride
dihydrate)
Version 1.1
1 of 11
AUSTRALIAN PRODUCT INFORMATION - COMPOUND SODIUM
LACTATE (HARTMANN’S) AND MODIFIED HARTMANN’S
SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Sodium chloride, sodium lactate, potassium chloride and calcium
chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLE 1: HARTMANN’S AND MODIFIED HARTMANN’S IV INFUSIONS
PRODUCT*
POTASSIUM
CHLORIDE
SODIUM
CHLORIDE
SODIUM
LACTATE
CALCIUM CHLORIDE
DIHYDRATE
OSMOLARITY
Α
MOSMOL/L
[Osmolality,
mOsmol/kg]
MODIFIED HARTMANN’S SOLUTION
Potassium Chloride 0.22%,
Sodium Chloride 0.6%,
Sodium Lactate 0.322% and
Calcium Chloride Dihydrate 0.027%
IV Infusion 1000 mL (AHB2954)
29.5 mmol/L
102.5 mmol/L
28.75 mmol/L
1.84 mmol/L
329
[304]
HARTMANN’S SOLUTION
Potassium Chloride 0.04%,
Sodium Chloride 0.6%,
Sodium Lactate 0.322% and
Calcium Chloride Dihydrate 0.027%
IV Infusion 500 mL (AHB2323)
2.7 mmol/
500 mL
51.35 mmol/
500 mL
14.36 mmol/
500 mL
0.92 mmol/
500 mL
280
[254]
Potassium Chloride 0.04%,
Sodium Chloride 0.6%,
Sodium Lactate 0.322% and
Calcium Chloride Dihydrate 0.027%
IV Infusion 1000 mL (AHB2324)
5.4 mmol/L
102.7 mmol/L
28.72 mmol/L
1.84 mmol/L
280
[254]
Osmolarity
α
is a calculated figure; whilst 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
Solution for intravenous infusion. Hartmann’s and Modified
Hartmann’s Intravenous (IV)
Infusion preparations are clear, colourless sterile, non-pyrogenic
solutions with pH of 5.0 –
7.0. No antimicrobial agent or buffer is included.
COMPOUND SODIUM LACTATE (HARTMANN’S)/ MODIFIED HARTMANN’S
SOLUTIONS (sodium chloride, sodium lactate, potassium chloride,
calcium chloride
dihydrate)
Version 1.1
2 of 11
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Hartmann’s and Modified Hartmann’s IV Infusions are indicated as a
sou