SODIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Fresenius Kabi Limited

ATC code:

B05XA03

INN (International Name):

SODIUM CHLORIDE

Dosage:

0.9 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

sodium chloride

Authorization status:

Not Marketed

Authorization date:

2003-08-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9%w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium
chloride:...............................................................................
9 g/l
Each ml contains 9 mg sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and non coloured solution_._
Sodium:..................................................................................
154 mmol/l
Chloride:................................................................................
154 mmol/l
Osmolality:.......................................................................
290 mosmol/kg
Osmolarity:.........................................................................
308 mosmol/l
pH between 4.5 and 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in the following situations:
-
Treatment of sodium depletion.
-
Treatment of isotonic extracellular dehydration.
-
Treatment of hypovolaemia.
-
Vehicle or diluent of compatible drugs for parenteral administration
of medicines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By intravenous infusion using sterile equipment and aseptic method.
1 g of sodium chloride corresponds to 394 mg or 17.1 mEq or 17.1 mmol
of sodium ion.
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium depletion is:
-
FOR ADULTS : 500 ml to 3 Liters/24 h
-
FOR BABIES AND CHILDREN : 20 to 100 ml per 24 h and per kg of body
weight,
depending of the age and the total
body mass.
The infusion rate depends on the patient’s clinical condition.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of medicinal product to
be administered.
When Sodium Chloride
0.9 %,
solution for infusion,
is used as a diluent for injectable preparations of other drugs,
the
dosage and the infusion rate will be principally dictated by the
nature and the dose regimen of the prescribed drug
H
E
A