Sodium Chloride 0.9%w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05XA03

INN (International Name):

Sodium chloride

Dosage:

0.9 percent weight/volume

Pharmaceutical form:

Solution for infusion

Therapeutic area:

sodium chloride

Authorization status:

Not marketed

Authorization date:

2003-08-22

Patient Information leaflet

4750-2_Mise en page 1 11/09/15 16:24 Page1
Premature or term infants may retain an excess of sodium due to
immature renal
Do not throw away any medicines via wastewater or household waste. Ask
your
PACKAGE LEAFLET: INFORMATION FOR THE USER
function. In premature or term infants, repeated infusions of sodium
chloride
should therefore only be given after determination of the serum sodium
level.
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
-
The physician should judge the incompatibility of an additive drug
with the 0.9%
sodium chloride solution by checking for any possible change in colour
and/or
possible formation of precipitate, insoluble complex or crystals.
-
Before adding any drug, check that the pH range in which it is
effective is the
same as that of 0.9% sodium chloride solution (pH = 4.5 – 7.0).
-
Please refer to the drug’s package insert.
-
When any drug is added to the 0.9% sodium chloride solution, the
mixture must
be administered immediately.
INSTRUCTIONS FOR USE AND HANDLING
Do not use unless the solution is clear and free from particles and
the container
is undamaged.
Discard any damaged or partially used container.
Use in aseptic conditions.
Precautions when using bags:
-
do not use an air entry.
-
flush the infusion system in order to avoid any passage of air.
-
do not connect in series since the residual of the first container
might be
carried on by the solution coming from the second container, with the
risk of
air embolism.
-
for single use only; do not reconnect partially used container.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT
SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION CONTAINS
The active
substance is :
Sodium chloride
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 g/l
Sodium:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
154 mmol/l
Chloride:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
154 mmol/l
Osmolality:
. . . . . . . . . . . . . . . . . . . . . . .
290 mosmol/k

Summary of Product characteristics

Health Products Regulatory Authority
01 May 2019
CRN008S7Q
Page 1 of 4
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 or17.1 mmolof
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 dic