Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use
Fluid balance/renal function
Use in patients with (severe) renal impairment
Sodium Chloride 0.9% should be administered with particular caution to patients with or at risk of severe renal impairment. In such patients, administration of Sodium Chloride 0.9% may result in sodium retention. (See “Use in patients at risk for sodium retention, fluid overload and oedema” below; for additional considerations).

Risk of fluid and/or solute overload and electrolyte disturbances
Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride 0.9% 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.

In general, the risk of dilutional states (retention of water relative to sodium) is inversely proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions. Conversely, the risk of solute overload causing congested states (retention of solute relative to water) is directly proportional to the electrolyte concentrations of Sodium Chloride 0.9% 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).
Hyponatraemia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) 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.

Children, women in the fertile age and patients with reduced cerebral compliance (e.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.

Use in patients at risk for sodium retention, fluid overload and oedema Sodium Chloride 0.9% 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.
• Iatrogenic hyperchloraemic metabolic acidosis (e.g., 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.
• 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 infusion of Sodium Chloride 0.9 %. 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 hypernatraemia 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.
For information on preparation of the product and additives, please see section 6.6.
This medicinal product contains 354 mg sodium per 100 ml, equivalent to 17.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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