20% W/V GLUCOSE INTRAVENOUS

Dosage 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). 5 g of glucose per h Drop rate 28 drops per min Note: If the oxidative metabolisation of glucose is impaired, which may be the case in the post-operative or post-traumatic phase or in the presence of hypoxia or organ failure, glucose intake should be limited to 2 – 4 g of glucose per kg body weight per day.

1 mmol/l (110 mg/100 ml).

Children:

The maximum daily dose, in g of glucose per kg body weight and in ml of solution per kg body weight, is for Pre-term neonates: 18 g glucose ≡ 90 ml solution Term neonates : 15 g glucose ≡ 75 ml solution 1st – 2nd year: 15 g glucose ≡ 75 ml solution 3rd – 5th year: 12 g glucose ≡60 ml solution 6th – 10th year: 10 g glucose ≡ 50 ml solution 11th – 14th year: 8 g glucose ≡ 40 ml solution For use of Glucose 200 mg/ml Solution for Infusion in neonates, due account should be taken of the high osmolarity of the solutions (see section 3).

When determining the dose, the following limits of daily total parenteral fluid administration must be strictly observed: 1st day of life: 50 – 70 ml per kg body weight 2nd day of life: 70 – 90 ml per kg body weight 3rd day of life: 80 – 100 ml per kg body weight 4th day of life: 100 – 120 ml per kg body weight from 5th day of life: 100 – 130 ml per kg body weight 1st year: 100 – 140 ml per kg body weight 2nd year: 80 – 120 ml per kg body weight 3rd – 5th year: 80 – 100 ml per kg body weight 6th – 10th year: 60 – 80 ml per kg body weight 11th – 14th year: 50 – 70 ml per kg body weight Method of administration Intravenous infusion via a central venous catheter.

It should be noted that these solutions constitute only one component of parenteral nutrition. In total parenteral nutrition, glucose infusions should always be accompanied by infusion of sufficient quantities of amino acid solutions, lipid emulsions, electrolytes, vitamins, and trace elements.

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.

Metabolism and nutrition disorders Not known:

Hospital Acquired Hyponatraemia 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

General 20% 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 metabolise 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.

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.

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.

: – Hyperhydration – Pulmonary oedema – Acute congestive heart failure