Glucosio 33% ACME

Glucosio 33% ACME 20% is hypertonic (in vitro tonicity, in a container) and provides a source of calories in a minimal volume of water. Glucosio 33% ACME 20% is frequently used in both adults and children to restore blood Glucosio 33% ACME concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes.

Glucosio 33% ACME 20% may be used to provide temporary relief from the symptoms of cerebral oedema and from hypoglycaemic coma. Hyperosmotic Glucosio 33% ACME with or without insulin may also correct hyperkalaemia in renal failure.

Dosage of Glucosio 33% ACME depends on the age, weight, clinical condition of the patient.

Fluid and acid base balance, serum Glucosio 33% ACME, serum sodium, and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonists due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids (in vivo tonicity). Glucosio 33% ACME 20 % may become extremely hypotonic after administration due to Glucosio 33% ACME metabolism in the body.

Posology

Adults and the elderly

For the reversal of hypoglycaemic coma. Up to 125ml of a 20% w/v solution.

As an energy source and in carbohydrate depletion. Up to 3 Litres per day dependent on the needs of the patient.

Paediatric population

Only to be used under the supervision of a paediatrician

Method of administration

Glucosio 33% ACME 20% must be administered by the intravenous route; it must not be administered by subcutaneous or intramuscular route. Except in the emergency treatment of severe hypoglycaemia, Glucosio 33% ACME 20% should be administered via a central vein.

Glucosio 33% ACME 20% is provided in a concentration that is ready for administration.

Glucosio 33% ACME 20% is contraindicated in patients with:

-

- the Glucosio 33% ACME - galactose malabsorption syndrome

- anuria or intraspinal or intracranial haemorrhage, or ischaemic stroke and in patients with delirium tremens if such patients are already dehydrated

- with hyperglycaemic coma.

Rapid administration of hypertonic Glucosio 33% ACME solutions may produce substantial hyperglycaemia and hyperosmolar syndrome; patients should be observed for signs of mental confusion and loss of consciousness, especially those patients with chronic uraemia or carbohydrate intolerance.

Prolonged use in parenteral nutrition may affect insulin production; blood and urine Glucosio 33% ACME should be monitored.

Glucosio 33% ACME 20 % intravenous infusion is a hypertonic solution (in vitro, in a container). In the body, however, Glucosio 33% ACME containing fluids can become extremely physiologically hypotonic due to rapid Glucosio 33% ACME metabolism.

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 metabolize Glucosio 33% ACME, intravenous administration of Glucosio 33% ACME 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 disease), patients with heart, liver and kidney diseases and patients exposed to vasopressin agonists are at 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.

Intravenous administration of Glucosio 33% ACME 20% may result in other electrolyte disturbances such as: hypokalaemia, hypophosphataemia and hypomagnesaemia.

Special care should be taken during injection to avoid leakage into the surrounding tissue.

None known.

* Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy.

** Hyperglycaemia (possibly indicated by mental confusion or loss of consciousness) and glycosuria may occur as a result of the rate of administration or metabolic insufficiency. If undetected and untreated hyperglycaemia can lead to dehydration, hyperosmolar coma and death.

The administration of Glucosio 33% ACME without adequate levels of thiamine may precipitate overt deficiency states e.g. Wernicke's encephalopathy. Sodium retention, oedema, pulmonary oedema and congestive heart failure may be induced in patients with severe under-nutrition.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose of Glucosio 33% ACME 20% may lead to hyperglycaemia and glycosuria leading to dehydration, hyperosmolar coma and death.

The blood levels of Glucosio 33% ACME can be reduced by slow infusion of insulin. Careful monitoring of blood Glucosio 33% ACME levels would be necessary.

Pharmacotherapeutic group: Solutions for parenteral nutrition, Carbohydrates

ATC code: B05BA03

The metabolism of Glucosio 33% ACME is an energy source for the body.

Glucosio 33% ACME is rapidly metabolised into carbon dioxide and water

Glucosio 33% ACME solutions which do not contain electrolytes, should not be administered concomitantly with blood through the same infusion set, because of the possibilities of agglomeration.

Use as directed by the physician.

Glucosio 33% ACME 20% is provided in a concentration that is ready for administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.