INDICATIONS

Sodium Chloride (0.9%) Intravenous Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

CONTRAINDICATIONS

The use of Sodium Chloride Intravenous Infusion requires careful evaluation of risks and benefits by the attending physician. It must not be used in the following conditions unless the physician has determined that potential benefits outweigh risks:

• congestive heart failure
• severe impairment of renal function,
• clinical states in which there exists oedema with sodium retention.

PRECAUTIONS

General

Clinical evaluation and appropriate laboratory determinations are essential to monitor renal function, changes in fluid balance, electrolyte concentration and acid-base balance.

Sodium Chloride Intravenous Infusion may cause fluid and/or solute overload. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary oedema is directly proportional to the electrolyte concentration administered.

Thus, caution should be exercised in patients with hypertension, heart failure, cerebral oedema, renal disease, pulmonary or peripheral oedema, pre-eclampsia, liver cirrhosis, conditions associated with sodium retention, and in geriatric patients, and infants.

Sodium Chloride Intravenous Infusion should be used with caution in patients receiving corticosteroids or corticotropin, because of potential sodium retention.

Its use may result in electrolyte abnormalities, including hypokalemia and hyperkalaemia.

Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous.

Use in lactation

Following intravenous administration, a fraction of sodium and chloride ions is expected to be excreted into human milk. However, at physiological concentrations, neither of these ions is known to have adverse effects on a breastfeeding baby.

Interactions with other drugs

Sodium Chloride Intravenous Infusion should not be administered simultaneously with blood products through the same administration set, because of the possibility of pseudo-agglutination or haemolysis. The container label for this product bears the statement: do not administer simultaneously with blood.

If Sodium Chloride (0.45% or 0.9%) Intravenous Infusion is used as a vehicle for a drug delivery, a thorough review of the Product Information document(s) of such drug(s) should be made to ensure that no incompatibility might occur. Salting out, ie., a precipitation of organic base drug may occur in the presence of salt.