Sodium Chloride 0.9%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE

Available from:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

ATC code:

B05CB01

INN (International Name):

SODIUM CHLORIDE 9 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SODIUM CHLORIDE 9 mg/ml

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Withdrawn

Authorization date:

2007-10-25

Patient Information leaflet

             
SODIUM CHLORIDE INJECTION/DEMO 
0,9% & 15% 
STERILE SOLUTION FOR INJECTION  
FREE OF PYROGENS 

COMPOSITION: 
_ACTIVE INGREDIENT:_
 Sodium Chloride 
_EXCIPIENT:_
 Water for Injection 
PHARMACEUTICAL FORM: 
Solution for Injection 
CONTENT IN ACTIVE INGREDIENT: 
0.9%:
 Each ml contains 9mg of Sodium Chloride equivalent to 0.154 mEq Na
+
 and 0.154 mEq Cl
- 
15%:
 Each ml contains 150mg of Sodium Chloride equivalent to 2.565 mEq
Na
+
 and 2.565 mEq Cl
-

DESCRIPTION – PACKAGING: 
Sodium Chloride Injection/DEMO 0.9% is a clear colorless aqueous
solution in polypropylene ampoules 
of 5 and 10 ml. 
Sodium Chloride Injection/DEMO 15% is a clear colorless aqueous
solution in polypropylene ampoules 
of 10 ml. 
LICENSE HOLDER AND MANUFACTURER: 
DEMO SA, 21
st
 Km Nat. Road Athens-Lamia14568, Athens, Greece 
GENERAL INFORMATION: 
Sodium Chloride is the principal salt involved in the maintenance of
plasma and 
other tissue tonicity, influencing thus water and electrolyte
balance. In patients who are not suffering from 
dehydration an excess of sodium chloride has a salt diuretic effect,
while in cases of dehydration it acts 
as a source of water and electrolytes. 
INDICATIONS: 
The isotonic solution is used for dissolving drugs which must be
administered 
intramuscularly or intravenously. 
The hypertonic solution is used as an additive in parenteral fluid
therapy. 
CONTRAINDICATIONS: 
Acute heart and renal failure. 
OVERDOSE:
 General undesirable effects of Sodium excess include nausea,
vomit, diarrhoea, abdominal 
cramps, thirsty, reduced saliva excretion and flow tears,
ephidrosis, fever, tachycardia, hypertension, 
kidney deficiency, peripheral and pneumonic edema, breath pause,
headache, dizziness, hyperkinetic, 
hyperexcitability, inability, muscle
spasms and inflexibility, comma and death. Long-term
administration 
or quick infusion of large volumes of Sodium
chloride injection/DEMO 0.9% solution for IV infusion may 

Summary of Product characteristics

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

SODIUM CHLORIDE 0.9 % 
1.  COMMERCIAL NAME OF PHARMACEUTICAL PRODUCT 
Sodium chloride 0.9%. 
2.  COMPOSITION IN ACTIVE INGREDIENTS (PER ML) 
Sodium chloride 
9 mg 
3.  PHARMACOTECHNICAL  FORM 
Solution for Injection and Solvent for Parenteral use. 
4.  CLINICAL INFORMATION 
4.1  INDICATIONS 
For parenteral restoration of sodium ion in patients with
restricted oral intake. Sodium 
replacement is specifically indicated in patients with
hyponatremia or low salt syndrome. Sodium 
chloride may also be added to compatible carbohydrate solutions such
as dextrose in water to 
produce electrolytes. 
Sodium chloride injections are also indicated as pharmaceutical
aids and diluents for the infusion 
of compatible drug additives.  
The isotonic solution Sodium Chloride 0.9% (normal saline) restores
both water and sodium 
chloride losses. Other indications for parenteral 0.9% saline
include: Diluting or dissolving drugs 
for IV, IM or SC injection, flushing of IV catheters, extracellular
fluid replacement, treatment of 
metabolic alkalosis in the presence of fluid loss and mild
sodium depletion, as a priming solution 
in hemodialysis procedures and to initiate and terminate blood
transfusions without hemolyzing 
red blood cells. 
4.2  DOSAGE AND ADMINISTRATION 
ROUTE OF ADMINISTRATION: Intravenous or Intramuscular. 

DOSAGE: The amount administered is adjusted according to frequent
measurements of serum Na
+

and Cl
-
. The dosage is individualized. Frequent laboratory
determinations and clinical evaluation 
are essential to monitor changes in fluid balance, blood glucose and
electrolytes. 
In the average adult, daily requirements of sodium and chloride are
met by the infusion of 1L of 
0.9% sodium chloride (154mEq each of sodium and chloride). Fluid
administration should be 
based on calculated maintenance or replacement fluid requirements. 
The isotonic solution is most commonly used. Rarely the hyper