HALF STRENGTH COMPOUND SODIUM LACTATE IV INFUSION %v/v Solution for Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE

Disponível em:

Baxter Healthcare Limited

DCI (Denominação Comum Internacional):

SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE

Dosagem:

%v/v

Forma farmacêutica:

Solution for Infusion

Status de autorização:

Withdrawn

Data de autorização:

2008-03-31

Características técnicas

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Half Strength Compound Sodium Lactate Intravenous Infusion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
This provides 66mmol/l Na
+
, 2.7mmol/l K
+
, 1mmol/l Ca
2+
, 56mmol/l Cl
-
and 14mmol/l Lactate.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Sterile, non-pyrogenic, clear, colourless, aqueous solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Half Strength Compound Sodium Lactate Intravenous Infusion is indicated for prophylactic and replacement therapy
requiring the use of Sodium Chloride and Lactate, with minimal amounts of Calcium and Potassium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
DOSAGE
The dosage is dependant upon the age, weight and clinical condition of the patient.
4.2.2
ADMINISTRATION
The solution is for administration by intravenous infusion.
4.3 CONTRAINDICATIONS
Half Strength Compound Sodium Lactate Intravenous Infusion is contraindicated in patients with congestive heart
failure, severe impairment of renal function or oedema with Sodium retention. It is also contraindicated in patients with
liver disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.4.1
Administration should be carried out under regular and careful surveillance; plasma electrolyte levels should be
monitored during use.
4.4.2
This fluid should be administered with great care to patients with renal insufficiency.
4.4.3
Do not administer unless solution is clear and container undamaged.
Sodium Lactate
1.61
g/l
Potassium Chloride
200
mg/l
Sodium Chloride
3.0
g/l
Calcium Chloride Dihydrate
135
mg/l
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/08/2006_
_CRN 2023805_
_page number: 1_
4.4.4
Discontinue infusion