Sodium Chloride 3% I.V. Injection is indicated as a source of water and electrolytes.

For Parenteral use.
As directed by a physician. Dosage is to be individualized according to patient need.

Sodium Chloride 3% I.V. Injection is strongly hypertonic and may cause vein damage.
Sodium Chloride 3% I.V. Injection should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
In patients with diminished renal function, administration of Sodium Chloride 3% I.V. Injection may result in sodium retention.
Acid – base balance should be evaluated clinically.

Caution must be exercised in the administration of Sodium Chloride 3% I.V. Injection to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during the administration of Sodium Chloride 3% I.V. Injection. Administration of Sodium Chloride 3% I.V. Injection may, therefore, result in decreased lithium levels.

Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride 3% I.V. Injection. It is also not known whether Sodium Chloride3% I.V. Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride 3% I.V. Injection should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted present in human milk. Because many drugs are excreted present in human milk, caution should be exercised when Sodium Chloride 3% I.V. Injection is administered to a nursing woman.

None known.

The following adverse reactions have not been reported but may occur:

• hyperchloremic metabolic acidosis,
• hypersensitivity reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus,

If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the solution for examination if deemed necessary.

- To reports any side effect(s):

• Saudi Arabia:

• Other GCC States:

Excessive administration of Sodium Chloride 3% I.V. Injection may lead to hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral edema and death) and sodium overload (which can lead to central and/or peripheral edema).

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.

None known.

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.