SODIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Baxter Healthcare Limited

ATC code:

B05XA03

INN (International Name):

SODIUM CHLORIDE

Dosage:

0.9 %w/v

Pharmaceutical form:

Intravenous Inf Solution

Prescription type:

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

Therapeutic area:

sodium chloride

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

Sodium Chloride Intravenous Infusion BP 0.9% w/v
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or nurse.
•
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
This medicine is called Sodium Chloride
Intravenous Infusion BP 0.9% w/v (Viaflex
container), but will be referred to as Sodium 0.9
Infusion throughout the remainder of this leaflet.
What is in this leaflet
1. What Sodium 0.9 Infusion is and what it is
used for
2. What you need to know before you are given
Sodium 0.9 Infusion
3. How you will be given Sodium 0.9 Infusion
4. Possible side effects
5. How to store Sodium 0.9 Infusion
6. Contents of the pack and other information
1. What Sodium 0.9 Infusion Is And What It Is
Used For
Sodium 0.9 Infusion is a solution of sodium chloride
in water.
Sodium chloride is a chemical substance (often
called “salt”) found in the blood.
Sodium 0.9 Infusion is used to treat:
•
a loss of body water (dehydration)
•
a loss of sodium from the body (sodium
depletion)
Situations that may cause sodium chloride and
water loss include:
•
when you cannot eat or drink, due to
illness or after surgery
•
pronounced sweating due to high fever
•
extensive skin loss, as can occur in
severe burns.
Sodium 0.9 infusion may also be used to deliver or
to dilute other medicines for infusion.
2. What You Need to Know Before You Are Given
Sodium 0.9 Infusion
Do NOT receive Sodium 0.9 Infusion if you are
suffering from any of the following conditions
•
higher levels of chloride in the blood than
normal (hyperchloraemia)
•
higher levels of sodium in the blood than
normal (hypernatraemia).
•
your blood is being pumped slower than normal
(heart failure)
•
severely reduced kidney function
•
fluid build up in your b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each litre contains 9.0 g (0.9% w/v) sodium chloride.
This provides 150 mmol/l Sodium and 150 mmol/l Chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
Clear, colourless solution, free from visible particles.
pH: 4.0-7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For
use in prophylactic and replacement
therapy requiring the use of
sodium chloride or
as
a vehicle for
the
reconstitution and administration of intravenous medications.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, older people and children:_
Doses may be expressed in terms of mEq or mmol of sodium, mass of
sodium, or mass of sodium salt (1 g NaCl = 394
mg, 17.1 mEq or 17.1 mmol of Na and Cl).
The dosage, rate and duration of administration is to be
individualised as determined by several factors including age,
weight, clinical condition, concomitant treatment and in particular
the patient's hydration state, clinical and laboratory
response to treatment. Fluid balance and plasma electrolyte
concentrations must be monitored during treatment.
Recommended dosage
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium depletion is:
•
For adults : 500 ml to 3 litres/24h
•
For babies and children: 20 to 100 ml per 24h and per kg of body
weight, depending of the age and the total
body mass.
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 % is used as a diluent for injectable
preparations of other drugs, the dosage and the infusion
rate will also be dictated by the nature and the dose regimen of the
prescribed drug.
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