SODIUM CHLORIDE INTRAVENOUS

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 The solution is for administration by intravenous infusion through a sterile and non-pyrogenic administration set, using aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

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 seal is intact. Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the solution. Administer immediately following the insertion of infusion set. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism.

Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Additives may be introduced before infusion or during infusion through the injection site. 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) • Hyperchloremic metabolic acidosis • Hyponatraemia, which may be symptomatic. Hyponatraemia may occur when normal free water excretion is impaired.

(eg 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.

, during intravenous volume resuscitation) • Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as patients with o primary hyperaldosteronism, o secondary hyperaldosteronism, associated with, for example, - hypertension, - congestive heart failure, - liver disease (including cirrhosis), - renal disease (including renal artery stenosis, nephrosclerosis) or pre- eclampsia.

9 %. These have been characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Stop the infusion immediately if signs or symptoms of these reactions develop. Appropriate therapeutic countermeasures should be instituted as clinically indicated.

Specific patient groups The consulting physician should be experienced in this product’s use and safety in these special populations that are especially sensitive to rapid changes in serum sodium levels. Rapid correction of hyponatraemia and hypernatremia is potentially dangerous (risk of serious neurologic complications).

See section “Hyponatraemia/hypernatraemia” above. Paediatric population Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes.

Repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level. Geriatric population When selecting the type of infusion solution and the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

6. As with any prolonged intravenous infusion, venous irritation and thrombophlebitis may occur at the injection site. When used in conjunction with cell separator procedures, there is a risk of air embolism or haemolysis. A donor should not be subjected to this procedure more frequently than once in a 48 hour period, twice in 7 days or 24 times a year.

3. Contra-Indications This product must be used with caution in patients with an impaired ability to handle sodium such as organic heart disease especially with a history of congestive heart failure, patients with renal insufficiency, cirrhosis of the liver, cardiopulmonary diseases or patients receiving salt retaining steroids.

When used in conjunction with cell separator procedures, the solution is contraindicated in those patients where adequate anticoagulation cannot be achieved.