Compound Sodium Lactate (Hartmanns)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Calcium chloride dihydrate 0.2684 mg/mL; Potassium chloride 0.4 mg/mL; Sodium chloride 6 mg/mL; Sodium lactate 3.33 mg/mL (Formed in process from Lactic acid + Sodium hydroxide)

Available from:

Baxter Healthcare Ltd

INN (International Name):

Calcium chloride dihydrate 0.2684 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Calcium chloride dihydrate 0.2684 mg/mL Potassium chloride 0.4 mg/mL Sodium chloride 6 mg/mL Sodium lactate 3.33 mg/mL (Formed in process from Lactic acid + Sodium hydroxide) Excipient: Water for injection

Units in package:

Bag, plastic, Solu-pac, 500 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Baxter Healthcare Pty Ltd

Therapeutic indications:

Compound Sodium Lactate (Hartmanns) infusion solution 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. This solution is indicated as a method of intravenous drug delivery, if the drugs are compatible with the solution

Product summary:

Package - Contents - Shelf Life: Bag, plastic, - 500 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, - 1000 mL - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1974-08-22

Summary of Product characteristics

NEW ZEALAND DATA SHEET
COMPOUND SODIUM LACTATE (HARTMANNS) Data Sheet 23 May 2019
Page 1 of 13
Baxter Healthcare Ltd
1 COMPOUND SODIUM LACTATE (HARTMANNS), (solution for infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Compound Sodium Lactate (Hartmanns) infusion solution
Product
Potassium
chloride
Sodium
chloride
Sodium
lactate
Calcium
chloride
dihydrate
Osmolarity
α
mOsmol/L
[Osmolality,
mOsmol/kg]
Compound Sodium Lactate (Hartmanns) IV infusion 500mL (AHB2323)
Potassium chloride
0.04%,
Sodium chloride
0.6%,
Sodium lactate
0.322% and
Calcium chloride
dihydrate
0.027%
2.7mmol/
500mL
51.35mmol/
500mL
14.36mmol/
500mL
0.92mmol/
500mL
280 [254]
Compound Sodium Lactate (Hartmanns) IV infusion 1000mL (AHB2324)
Potassium chloride
0.04%,
Sodium chloride
0.6%,
Sodium lactate
0.322% and
Calcium chloride
dihydrate
0.027%
5.4mmol/L
102.7mmol/L
28.72mmol/L
1.84mmol/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.
3 PHARMACEUTICAL FORM
Solution for infusion.
Appearance
COMPOUND SODIUM LACTATE (HARTMANNS), an intravenous (IV) infusion
preparation, is a clear,
colourless, sterile, non‐pyrogenic solution.
COMPOUND SODIUM LACTATE (HARTMANNS) is an isotonic intravenous
solution with pH of 5.0 – 7.0.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
COMPOUND SODIUM LACTATE (HARTMANNS) infusion solution 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.
This solution is indicated as a method of intravenous drug delivery,
if the drugs are compatible with
the solution.
NEW ZEALAND DATA SHEET
COMPOUND SODIUM LACTATE (HARTMANNS) Data Sheet 23 May 2019
Page 2 of 13
Baxter Healthcare Ltd
4.2
Dose and method of administration
To be used as directed by the physician. The dosage of COMPOUND SODIUM
LACTATE (HARTMANNS)
infusion solution is dep