SODIUM CHLORIDE

1 mmol of Na and Cl). 8). Monitoring of serum sodium is particularly important for hypotonic fluids. g. 4. 8). Recommended dosage The recommended dosage for treatment of isotonic extracellular dehydration and sodium depletion is: • For adults: 500 ml to 3 litres/24h • For babies and children: 20 to 100 ml per 24h and per kg of body weight, depending of the age and the total body mass.

The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered. 9% is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will also be dictated by the nature and the dose regimen of the prescribed drug.

Method of administration For intravenous infusion. The product should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless solution is clear, free from visible particles and the bag is intact.

6. Additives may be introduced before infusion or during infusion through the injection port. 6.

The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data. 2. 5). The following adverse reactions have not been reported with this product but may occur: • Hypernatraemia (eg.

when administered to patients with nephrogenic diabetes insipidus or high nasogastric output) • Hyperchloraemic metabolic acidosis • Hyponatraemia, which may be symptomatic. Hyponatraemia may occur when normal free water excretion is impaired.

g. SIADH or postoperative). General adverse effects of sodium excess are described in section

9% should be administered with particular caution to patients with or at risk of severe renal impairment. 9% may result in sodium retention. 9% can cause: • Fluid and/or solute overload resulting in overhydration/hypervolemia and, for example, congested states, including central and peripheral oedema.

• Clinically relevant electrolyte disturbances and acid-base imbalance. 9% and its additions. 9% and its additions. Special clinical monitoring is required at the beginning of any intravenous infusion. Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

9% should be used with particular caution, if at all, in patients with or at risk for: • Hypernatraemia. Rapidly correcting hypernatraemia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death.

• Hyperchloraemia • Metabolic acidosis, which may be worsened by prolonged use of this product, especially in patients with renal impairment. • Hypervolaemia such as congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease.

The solution is contraindicated in patients presenting hypernatremia or hyperchloremia. The contraindications related to the added medicinal product should be considered.