Special Warning : אזהרת שימוש

4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Electrolyte balance
Hyponatraemia/Hypernatraemia
The infusion of solutions with sodium concentrations <0.9% 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).

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. 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. 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.

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. In such patients administration of Sodium Chloride 0.45% Solution for Infusion may result in sodium retention.

Risk of fluid and/or solute overload and electrolyte disturbances
Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride 0.45% 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.

Use in patients at risk for sodium retention, fluid overload and oedema Sodium Chloride 0.45% 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.

Other warnings
Osmolarity
Sodium Chloride 0.45% Solution for Infusion is hypotonic with an osmolarity of approximately 154 mOsmol/L.

Administration with blood products
Do not mix or administer Sodium Chloride 0.45% Solution for Infusion through the same administration set with whole blood or cellular blood components.

During long-term infusion, the doctor can decide to give you an appropriate nutritive supply.
As with all parenteral solutions, compatibilities should be checked when additives are used (see section 6.2).

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