• For use in prophylactic and replacement therapy, requiring the use of isotonic saline solution.
• In the reconstitution, dilution and making up of certain drugs.
• As a saline irrigant.
• As a priming fluid for hemodialysis procedures and to initiate and terminate blood transfusions.

For parenteral use. (For intravenous, intramuscular or subcutaneous use.)
In the prophylaxis or replacement therapy of extracellular fluid deficits, the dosage of Sodium Chloride 0.9% w/v is dependent on the age, weight, clinical status and degree of deficiency, and must be determined on the individual basis.

Sodium Chloride 0.9% w/v should be administered with caution to patients with congestive cardiac failure, pre-eclampsia, impaired renal function or oedema with sodium retention. Care is also required with administering this solution to very young or to elderly patients. Pseudohyponatraemia is a condition in which spuriously low concentrations of sodium are found when plasma sodium is measured by conventional methods. It may occur when there is an abnormally high concentration of large molecules and hence an abnormally low percentage of plasma water. This may occur in hyperlipaemia and hyperproteinaemia and has also been reported in patients with diabetes mellitus. Correct values may be obtained by referring the concentration to plasma water.

Concomitant administration of other sodium salts, may contribute to the sodium load. Only use as a pharmaceutical diluent where indicated in the manufacturer’s literature.

The solution is physiological saline and may be used during pregnancy and lactation.

None known.

Injudicious intravenous saline therapy (e.g. post-operative and in patients with impaired cardiac or renal function) may cause hypernatraemia. Osmotically induced water shift decreases intracellular volume, resulting in dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage. General adverse effects of sodium chloride excess in the body include: nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivary and lachrymal secretions, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. Excess chloride in the body may cause a loss of bicarbonate, with an acidifying effect. With judicious use of intravenous saline therapy these side effects can be avoided. If administered sub-cutaneously, any addition to the isotonic solution could render it hypertonic and cause pain at the site of injection.

- To reports any side effect(s):

• Saudi Arabia:

• Other GCC States:

Injudicious intravenous saline therapy (e.g. post-operatively or in patients with impaired cardiac or renal function) may cause hypernatraemia. Osmotically induced water shift decreases intracellular volume, resulting in dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage. General adverse effects of sodium chloride excess in the body include: nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivary and lachrymal secretions, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. Excess chloride in the body may cause a loss of bicarbonate, with an acidifying effect. With judicious use of intravenous saline therapy these side effects can be avoided.

ATC code 1: B05XA03 – Sodium chloride, Electrolyte solutions.
ATC code 2: B05CB01 – Sodium chloride, Salt solutions.
The principal determinant of the effective osmolality of the extracellular fluids (and also of the intracellular fluids, since they remain in osmotic equilibrium with the extracellular fluids) is the extracellular fluid sodium concentration. The reason for this is that sodium is the most abundant positive ion of the extracellular fluid. Negative ion concentrations of the body fluids are adjusted to equal those of the positive ions by renal acid-base control mechanisms. Furthermore, glucose and urea, the most abundant of the non-ionic osmolar solutes in extracellular fluids, normally only represent about 3% of the total osmolality. Therefore, in effect, the extracellular fluid sodium ion concentration controls over 90% of the effective osmotic pressure of the extracellular fluid. Sodium Chloride remains the most important single salt for prophylaxis or replacement therapy of deficits of extracellular fluid. Volume contraction, whether isotonic, hypotonic or hypertonic, may seriously impair the circulation (cardiac output falls and microcirculation is compromised) and prompt infusion of isotonic sodium chloride solution is indicated.

The homeostatic mechanisms involved in maintaining constant ion concentrations are well described in standard text books of physiology and biochemistry and are not, therefore, included here.

No further information other than that which is included in the Summary of Product Characteristics.

Water for injection.
Nitrogen gas.

The addition of sodium chloride to mannitol 20 or 25% may cause precipitation of the mannitol.

Do not store above 30°C.
Do not refrigerate or freeze.
Keep the ampoules in the outer carton.

Before use, ensure that the container is undamaged and the contents clear in appearance. After use, discard any remaining solution.