Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

General
20% w/v Glucose Intravenous Infusion BP is a hypertonic solution. In the body,
however, glucose containing fluids can become physiologically hypotonic due to rapid glucose metabolisation (see section 4.2).

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

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 (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain 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, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia has been reported to worsen ischaemic brain damage and impair recovery.

Application of hyperosmolar glucose solutions in patients with damaged haematoencephalic barrier may lead to increase of intracranial/intraspinal pressure.

Glucose infusions should not be started before existing fluid and electrolyte deficiencies like hypotonic dehydration, hyponatraemia and hypokalaemia have adequately been corrected.

This solution should be used with caution in patients with
- Hypervolaemia
- Renal insufficiency
- Cardiac insufficiency
- Increased serum osmolarity
- Known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

Unstable metabolism (e.g. postoperatively or after injuries, hypoxia, organ insufficiencies) impairs oxidative metabolism of glucose and may lead to metabolic acidosis.

States of hyperglycaemia should be adequately monitored and treated with insulin.
The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.

Profound hypoglycemia may follow sudden discontinuation of high glucose infusion rates because of the accompanying high serum insulin concentrations. This applies especially to children less than 2 years of age, patients with diabetes mellitus and patients with other disease states associated with impaired glucose homeostasis. In obvious cases, the glucose infusion should be tapered off within the last 30 – 60 minutes of the infusion. As a precaution it is recommended that each individual patient be monitored for 30 minutes for hypoglycemia on the first day of abrupt discontinuation of parenteral nutrition.

Clinical monitoring should include blood glucose, serum electrolytes, fluid and acid- base balance in general. A focus should be put on the sodium level as glucose solutions provide free water to the body and may therefore cause or worsen hyponatraemia. Frequency and kind of laboratory testing depend on the overall condition of the patient, the prevailing metabolic situation, the administered dose and the duration of treatment. Also monitor total volume and amount of glucose administered.

Parenteral nutrition in malnourished or depleted patients with full doses and full infusion rates from the very beginning and without adequate supplementation of potassium, magnesium and phosphate may lead to the refeeding syndrome, characterised by hypokalaemia, hypophosphataemia and hypomagnesaemia. Clinical manifestations may develop within a few days of starting parenteral nutrition. In such patients, infusion regimens should be built up gradually. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Special attention should be paid to hypokalaemia. Then, supplementation of potassium is mandatory.

Electrolytes and vitamins must be supplied as necessary. Vitamin B, especially thiamine, is needed for glucose metabolism.

Glucose infusions should not be administered through the same infusion equipment, simultaneously before, or after administration of blood, because of the possibility of pseudo-agglutination.

It should be noted that this solution constitutes only one component of parenteral nutrition. In total parenteral nutrition, glucose infusions should always be combined with an adequate supply of amino acids, lipids, electrolytes, vitamins and trace elements.

Paediatric population
For treatment of hypoglycaemia in children, use of 10% glucose solution is recommended.
Children in the 1st and 2nd year of life are especially at risk for rebound hypoglycaemia after abrupt discontinuation of high infusion rates, see above.

Effects on Driving

4.7   Effects on ability to drive and use machines

The solution has no or negligible influence on the ability to drive and use machines.