Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Glucose 50% is a hypertonic solution. In the body, however, glucose-containing fluids can become extremely hypotonic due to rapid glucose metabolisation.

Depending on the tonicity of the solution, the volume and the rate of infusion and depending on the patient's underlying clinical condition and capability to metabolise glucose, intravenous administration of glucose can cause electrolyte disturbances and, most importantly, hypo-osmotic or hyperosmotic hyponatraemia.

Hyponatraemia:
Patients with non-osmotic vasopressin release (e.g., in acute illness, pain, postoperative stress, infections, burns and CNS disorders), patients with cardiac, hepatic and renal disorders, and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia following infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema), characterised 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 of childbearing potential and patients with reduced cerebral compliance (e.g., meningitis, intracranial bleeding and cerebral contusion) are at particular risk of severe, life- threatening brain swelling caused by acute hyponatraemia.

Care must be taken in case of increased serum osmolarity.

Blood glucose levels must be monitored according to metabolic condition and administered amount.
Monitoring of the electrolyte and acid-base balance and of potassium levels is necessary.

Solutions containing glucose must not be administered simultaneously with stored blood through the same infusion equipment, as pseudoagglutination may occur (see section 6.2).

Paediatric population

There is an increased risk of hyperglycaemia in neonates, particularly in premature infants with a low birth weight. To prevent possible long-term undesirable effects in such cases, adequate glycaemic control is necessary by means of close monitoring during treatment with a solution containing glucose.

The solution must be administered with particular caution to prevent a possible fatal overdose of intravenous fluid in neonates.

Effects on Driving

4.7   Effects on ability to drive and use machines
Glucose 50% has no or negligible influence on the ability to drive and use machines.