SODIUM CHLORIDE

8). Monitoring of serum sodium is particularly important for hypotonic fluids. g. 4. 8). Recommended dosage: - For adults, older people and adolescents: 500 ml to 3 litres/24h, - For babies and children: 20 to 100 ml per 24 h and per kg of body weight, depending on 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.

Administration rate:

The infusion rate depends on the patient clinical conditions. It is usually: 40 ml/kg/24h for adults, older people and adolescents, - 5 ml/kg/h in average for paediatric patients but the value varies with age: - 6-8 ml/kg/h for infants, - 4-6 ml/kg/h for toddlers, - 2-4 ml/kg/h for schoolchildren.

Note:

Infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk). Children and schoolchildren: age ranges from about 2 years to 11 years. 45% Solution for Infusion is used as a diluent for injectable preparations of other medicinal products, the infusion rate will also be dictated by the nature and the dose regimen of the prescribed medicinal products.

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 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. Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens.

If an adverse event occurs the patient evaluated and appropriate countermeasures started. If needed the infusion should be stopped. 6.

45% Solution for Infusion. 2. 5). The following adverse reactions have not been reported with this product but may occur: • Hyperchloraemic metabolic acidosis • Infusion reactions, including hypotension, tremor, chills, urticaria, rash, and pruritus.

Adverse reactions may be associated to the medicinal products added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects. If an adverse event occurs the patient should be evaluated and appropriate countermeasures started, if needed the infusion should be stopped Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard

9% may result in hyponatraemia. 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.

The risk for hyponatraemia is increased, for example, • in children • in elderly patients • in women • in patients with hypoxemia • in patients with underlying central nervous system disease • postoperatively • in persons with psychogenic polydipsia in patients treated with medications that increase the risk of hyponatraemia (such as certain antiepileptic and psychotropic medications).

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.

Acute symptomatic hyponatraemic encephalopathy is considered a medical emergency. Hyponatraemia should be corrected at a calculated rate to prevent hyponatraemic encephalopathy. Rapid correction of hyponatraemia and hypernatremia is potentially dangerous (risk of serious neurologic complications).

Rapidly correcting hypernatremia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death. Dosage, rate, and duration of administration should be determined by a physician experienced in intravenous fluid therapy.

Fluid balance/renal function Use in patients with moderate renal impairment The product should be administered with particular caution to patients with moderate renal impairment. 45% Solution for Infusion may result in sodium retention.

45% Solution for Infusion can cause • Fluid and/or solute overload resulting in over hydration/hypervolemia and, for example, congested states, including central and peripheral oedema. • Clinically relevant electrolyte disturbances and acid-base imbalance.

In general; the risk of dilutional states is inversely proportional to the electrolyte concentrations in the solution and additions. The risk of solute overload causing congested states is directly proportional to the electrolyte concentration in the solution and its additions.

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.

45% Solution for Infusion should be used with particular caution, if at all, in patients with or at risk for: • Hypervolemia • Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as patients with - primary hyperaldosteronism, - secondary hyperaldosteronism associated with, for example, - hypertension, - congestive heart failure, - liver disease (including cirrhosis), - renal disease (including renal artery stenosis, nephrosclerosis) or - pre-eclampsia.

Medications that may increase the risk of sodium and fluid retention, such as corticosteroids. Infusion reactions Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with parenteral infusion of Sodium Chloride.

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 only be given after determination of serum sodium level. The infusion of hypotonic fluids together with the non-osmotic secretion of ADH may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death, therefore acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.

Geriatric population In older people, the risk for hyponatraemia is increased. 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.

45% Solution […]

The solution is contra-indicated in patient presenting: - Hyponatremia, hypochloremia, - Extracellular hyperhydration or hypervolemia, - Severe renal insufficiency (with oliguria/anuria), - Fluid and sodium retention, - Uncompensated cardiac failure, - General oedema and ascitic cirrhosis.

The contra-indications related to the added medicinal product should be considered.