Compound Sodium Lactate Intravenous Infusion BP, Solution for Infusion (Hartmann’s Solution)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Sodium lactate solution; Calcium chloride dihydrate

Available from:

B. Braun Medical Limited

ATC code:

B05BB; B05BB01

INN (International Name):

Sodium chloride; Potassium chloride; Sodium lactate solution; Calcium chloride dihydrate

Dosage:

6/6.24/0.40/0.27 %v/v

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Marketed

Authorization date:

1983-04-01

Summary of Product characteristics

Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate Intravenous Infusion BP, Solution for Infusion
(Hartmann’s Solution)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution contains
Sodium Chloride 6.00 g
Sodium Lactate Solution (50% w/w) 6.24 g
(equivalent to sodium lactate, 3.12 g)
Potassium Chloride 0.40 g
Calcium Chloride Dihydrate 0.27 g
_Electrolyte concentrations:_
Sodium 131 mmol/l
Potassium 5 mmol/l
Calcium 2 mmol/l
Chloride 111mmol/l
Lactate 29 mmol/l
_Excipients_
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless, aqueous solution.
Theoretical osmolarity: 278 mOsm/l
Titration acidity: (to pH 7.4) < 1 mmol/l
pH: 5.0 - 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
● Fluid substitution under the conditions of undisturbed acid-base
balance or mild acidosis
● Isotonic and hypotonic dehydration
● Short-term intravascular volume replacement
● Vehicle solution for compatible electrolyte concentrates and
drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fluid balance, serum electrolytes and acid-base balance may need to be
monitored before and during administration, with
particular attention to serum sodium in patients with increased
non-osmotic vasopressin release (syndrome of inappropriate
antidiuretic hormone secretion, SIADH) and in patients co-medicated
with vasopressin agonist drugs, due to the risk of hospital
acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).
Monitoring of serum sodium is particularly important for hypotonic
fluids.
Compound Sodium Lactate Intravenous Infusion BP tonicity: 278 mOsm/l
Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 2 of 8
The infusion rate and volume depend on the age, weight, clinical
condition (e.g. burns, surgery, headinjury, infections), and
concomitant therapy should be determined by the consulting physician
experienced in paediatric intr