0.9% SODIUM CHLORIDE INTRAVENOUS

For intravenous infusion under medical supervision. Single use only. The pathophysiological response to dehydration, to electrolyte loss and to sodium chloride infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy.

Fluid replacement therapy should be administered with caution to very young and elderly patients. The volume of isotonic saline solution needed to replenish fluid deficits varies with age, body weight, complementary treatment and severity of the clinical condition.

The dose and rate of administration are subject to clinical and laboratory assessment in each case.

9% sodium chloride infusion may lead to fluid and electrolyte imbalances such as metabolic acidosis, hypokalaemia, sodium retention, hypertension, tachycardia, oedema and gastrointestinal effects. Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site.

In the event of adverse reaction, stop infusion immediately. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Electrolytes should be monitored prior to and during infusion.

Sodium chloride infusion solution should be administered with caution to : - patients with conditions of impaired sodium excretion such as impaired renal function, cardiac failure, cardio-pulmonary disease, peripheral or pulmonary oedema, hypertension, cirrhosis of the liver, pre-eclampsia, severe hepatic insufficiency; hypernatremia - patients receiving drugs which may promote salt retention, and - very young and to elderly patients who have reduced capacity to compensate for fluctuations in fluid and electrolyte balance.