Sodium Chloride 0.9% w/v Intravenous Infusion BP

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Sodium chloride

Verfügbar ab:

Baxter Healthcare Limited

ATC-Code:

B05BB; B05BB01

INN (Internationale Bezeichnung):

Sodium chloride

Dosierung:

0.9 percent weight/volume

Darreichungsform:

Solution for infusion

Verschreibungstyp:

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

Therapiebereich:

Solutions affecting the electrolyte balance; electrolytes

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2003-01-10

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION BP
Active substance: sodium chloride
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.
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
This medicine is called Sodium Chloride 0.9% w/v Intravenous Infusion
BP, but will be referred to as
Sodium 0.9 Infusion throughout the remainder of this leaflet.
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)
If a medicine has been added to Sodium 0.9 Infusion, the Package
Leaflet of the added medicine must be
consulted to determine whether or n

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Intravenous Infusion BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride:
9.0 g/l
Each ml contains 9 mg sodium chloride.
mmol/l:
Na
+
: 154
Cl
-
: 154.
pH: 4.5-7
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium chloride 0.9% intravenous infusion is indicated for:
o
Treatment of isotonic extracellular dehydration.
o
Treatment of sodium depletion.
o
Vehicle or diluent of compatible drugs for parenteral administration.
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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