STERIFLEX NO.6 OR FREEFLEX, GLUCOSE INTRAVENOUS

Posology Adults and Children The rate of administration and volume infused will depend upon the requirements of the individual patient and judgement of the physician. Elderly Care should be taken to avoid circulatory overload, particularly in, patients with cardiac and renal insufficiency.

Use as a Diluent When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information or data sheet of the drug to be used. Method of administration For intravenous infusion. Fluid balance, serum glucose, 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 agonist drugs due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Glucose Infusion BP 5% as Steriflex No. 8).

Thrombosis of the chosen vein is always a possibility with intravenous infusion. 4). 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.

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The infusion of these solutions should not be rapid or very prolonged large volumes of these solutions given too quickly may cause water intoxication; infusion over a long period can cause dehydration. The physician should also be altered to the possibility of adverse reactions to drug additives diluted and administered in this container.

Prescribing information for additives to be administered in this manner should be consulted.

The label states:

Do not use unless solution is clear and free from particles. Glucose intravenous infusions are usually isotonic solutions. 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 metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.

g. 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. g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Diabetes, except as a treatment for hypoglycaemia. The intravenous infusion of glucose solutions may also be hazardous in, patients with impaired hepatic or renal function.