COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
SODIUM CHLORIDE POTASSIUM CHLORIDE SODIUM LACTATE SOLUTION CALCIUM CHLORIDE DIHYDRATE
Available from:
B. Braun Medical Limited
Dosage:
500ml,1000 %v/v
Pharmaceutical form:
Solution for Infusion
Authorization date:
1983-04-01
Summary of Product characteristics
PART II
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 contain
Sodium Chloride
6.00 g
Sodium Lactate Solution (50% m/m)
6.24 g
Potassium Chloride
0.40 g
Calcium Chloride Dihydrate
0.27 g
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless, sterile and non-pyrogenic aqueous solution.
_Each litre provides:_
_Electrolytes:_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in prophylactic and replacement therapy requiring the use of sodium chloride and lactate, with minimum
amounts of calcium and potassium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Recommended dosage_
The dosage of Compound Sodium Lactate Intravenous Infusion BP depends on age, weight and clinical condition of
the patient.
Flow rate: up to 5 ml per kg body weight per hour, corresponding to 1.7 drops per kg body weight per minute.
_Children and the elderly_
According to individual requirements.
Sodium
131
mmol/l
Potassium
5
mmol/l
Calcium
2
mmol/l
Chloride
111
mmol/l
Lactate
29
mmol/l
Theoretical osmolarity:
278
mOsm/l
Titration acidity: (to pH 7.4)
< 1
mmol/l
pH:
5.0 - 7.0
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/11/2008_
_CRN 2058101_
_page number: 1_
_Route of administration_
Intravenous infusion.
4.3 CONTRAINDICATIONS
Compound Sodium Lactate Intravenous BP infusion must not be administered to patients in states of hyperhydration,
with circulatory overload, respiratory alkalosis, cardiac and liver disease.
This container contains a significant volume of air. To avoid risk of air embolism, this product must not be
administered by pressure infusion.
4.4 SP
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