SODIUM CHLORIDE 0.9 %w/v Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

B05XA03

INN (International Name):

SODIUM CHLORIDE

Dosage:

0.9 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Electrolyte solutions

Authorization status:

Authorised

Authorization date:

1988-06-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION
This leaflet will provide you with important information about your
medicine. Please read it 
carefully before your medicine is administered. The leaflet contains
a summary but not all of the 
information about Sodium Chloride 0.9% w/v Solution for Injection.
If you require any further 
information or if you are unsure about anything, ask your physician
or pharmacist.
ABOUT YOUR MEDICINE
Sodium Chloride 0.9% w/v Solution for Injection is a clear, colourless
sterile solvent for 
parenteral use. Each 1mI of this solvent contains 9mg of the active
ingredient, sodium chloride.
Each 1ml of sterile solution for injection contains 0.15millimoles of
Na+ and Cl- ions.
2ml of sterile solution for injection contains 0.3millimoles of Na+
and Cl- ions.
5ml of sterile solution for injection contains 0.75millimoles of Na+
and Cl- ions.
10ml of sterile solution for injection contains 1.5millimoles of Na+
and Cl- ions.
Other ingredients: Water for Injections and Hydrochloric Acid (for pH
adjustment).
_Pack sizes: _2ml, 5ml and 10ml in glass ampoules (packs of 10
ampoules). (Not all pack sizes 
may be marketed.)
_Type of medicine: _Sodium Chloride 0.9% w/v Solution for Injection
is an isotonic saline 
solution.
Being isotonic means that the body cells bathed in the solution will
neither shrink nor swell.
_Holder of Product Authorisation:_
Mercury Pharmaceuticals (Ireland) Ltd,
4045, Kingswood Road, City West Business Park, Co Dublin, Ireland
_Manufacturer: _Lomapharm Rudolf Lohmann GmbH KG, Langes Feld 5,
31860,
Emmerthal, Germany.
PA No.: 73/105/1 (2ml, 5ml and 10ml glass ampoules).
USES
Sodium Chloride 0.9% w/v Solution for Injection may be used to
prevent or to treat certain types 
of salt and fluid imbalances that may occur in the body.
The solution may be used to dilute or to prepare some drugs for
use. It may also be used for 
irrigation (e.g. to wash out wounds).
BEFORE YOU RECEIVE YOUR MEDICINE
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 0.9% w/v
Each ml contains 9 mg sodium chloride.
Each 1ml of sterile solution for injection contains 0.15 millimoles of Na
+
and Cl
-
ions.
Each 2ml of sterile solution for injection contains 0.3 millimoles of Na
+
and Cl
-
ions.
Each 5ml of sterile solution for injection contains 0.75 millimoles of Na
+
and Cl
-
ions.
Each 10ml of sterile solution for injection contains 1.5 millimoles of Na
+
and Cl
-
ions.
(equivalent to 150 millimoles of Na
+
and Cl
-
per litre)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. (Injection)
A clear colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in prophylactic and replacement therapy requiring the use of sodium chloride. Also for reconstitution and
dilution of certain drugs and as an irrigant.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous administration, or as appropriate to the reconstituted drug. In prophylaxis or replacement therapy of
extracellular fluid deficits, the intravenous route should be used and the dose is dependent upon the age, weight,
clinical state and degree of deficiency of the patient, and must be determined on an individual basis.
4.3 CONTRAINDICATIONS
Administration in congestive heart failure, in conditions of severe impairment of renal function or in oedema with
sodium retention.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administration should be carried out under regular and careful supervision and should be discontinued if adverse
reaction occurs.
No other medication or substance should be added to this solution unless compatibility is known.
The