40% W/V GLUCOSE INTRAVENOUS

Posology The dosage of the solution depends on the patient’s individual glucose and fluid requirements. Fluid balance, serum glucose, 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. 4. 8). Therapy of hypoglycaemia For the treatment of hypoglycaemia, the dose and the administration rate have to be adjusted according to the actual blood glucose concentration and the general condition of the patient.

25 g of glucose per kg bodyweight per hour (4 mg glucose/kg/min) should not be exceeded in order to avoid exceeding the glucose oxidation capacity of the patient. 3) Acute phase = resuscitation phase when the patient requires vital organ support (sedation, mechanical ventilation, vasopressors, fluid resuscitation).

Stable phase = patient is stable on, or can be weaned, from this vital support. Recovery phase = patient who is mobilizing Elderly patients Basically, the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

g. in the early post- operative or post-traumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values. Close monitoring of blood glucose levels is recommended in order to prevent hyperglycaemia.

Method of administration Intravenous use. For central venous infusion only.

General Undesirable effects are listed according to their frequencies as follows:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) General disorders and administration site conditions: Not known: Local reactions at the site of administration, including local pain, vein irritation, thrombophlebitis or tissue necrosis in case of extravasation.

4).

Neurological disorders:

Not known: Hyponatraemic encephalopathy 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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Special warnings 40% w/v Glucose Intravenous Infusion BP is a hypertonic solution. 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.

Due to the risk of developing a severe lactic acidosis and/or a Wernicke encephalopathy a preexisting thiamine (Vitamin B1) deficiency must be corrected before infusion of glucose containing solutions. 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. 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.

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.

Sudden discontinuation of high glucose infusion rates can lead to profound hypoglycaemia due to 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 hypoglycaemia 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, characterized 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. 8). 3). The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

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.

Newborns, especially preterm neonates with low birth weight, are especially at risk of hyperglycaemia or hypoglycaemia. Close monitoring of the blood glucose level is mandatory to avoid long term adverse events or fatal overdosage.

– Hypersensitivity to the active substance. : – Hyperhydration – Pulmonary oedema – Acute congestive heart failure