Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Glucose 10% is a hypertonic solution. In the body, however, glucose containing fluids can become physiologically hypotonic due to rapid glucose metabolization (see section 4.2).

Depending on the tonicity of the solution, and depending on a patient's underlying clinical condition and capability to metabolize 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, postoperative 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 was reported to worsen ischaemic brain damage and impair recovery.

This solution should be used with caution in patients with hypervolemia, renal insufficiency and impending or manifest cardiac decompensation.

The solution should also be administered with caution to patients with increased serum osmolarity.

Disorders of fluid and electrolyte balance like hypotonic dehydration or pathologically low levels of serum electrolytes, must be corrected prior to administration of Glucose 10 % w/v solution for infusion.

Special attention must be paid to hypokalaemia. Then supplementation of potassium is absolutely mandatory.

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 adequetely monitored and treated with insulin. The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.

Solutions containing glucose should be used with caution in patients with manifest or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

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 other disease states 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.
Refeeding or repletion of malnourished or depleted patients may in particular cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Clinical monitoring should include blood glucose, serum electrolytes, fluid and acid-base balance in general. Frequency and kind of laboratory testing depend on the overall condition of the patient, the prevailing metabolic situation and the administered dose. Also monitor total volume and amount of glucose administered.

Electrolytes and vitamins should 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 with, before, or after administration of blood, because of the possibility of pseudo-agglutination.

Effects on Driving

4.7     Effects on ability to drive and use machines

No effects to be expected.