International Medication Systems (UK) Ltd

Glucose Injection BP Minijet 50% w/v, solution for injection.

Glucose anhydrous 500mg in 1ml as 5g/10ml or 25g/50ml.

For a full list of excipients, see section 6.1

Solution for injection.

The clear, colourless solution is contained in a type 1 glass vial with an elastomeric closure. The container is specially designed for use with the IMS Minijet injector supplied.

a) As a source of energy in parenteral nutrition.

b) In severe hypoglycaemia due to insulin excess or other causes.

c) For the treatment of delirium tremens or acute alcohol intoxication.

Glucose injection 50% w/v is strongly hypertonic and is used partly because of its dehydrating effects. In delerium tremens or acute alcohol intoxication the patient must be rehydrated

Hypertonic solutions of glucose should be administered via a central vein. The dose is variable and depends upon the indication, clinical condition and size of the individual.

The rate of utilisation of glucose varies considerably from patient to patient. In general, the maximal rate has been estimated at 500-800mg/kg body weight/hour. If the patient's capacity to utilise glucose is exceeded, glycosuria and diuresis will occur.

Adults, elderly, children over 6 years:

Hypoglycaemia: 20-50ml of a 50% w/v solution, repeated as necessary according to the patient's response, by slow intravenous injection, e.g. 3ml/minute. After 25g of glucose has been given, it is advisable to interrupt the injection and evaluate the effect. The exact dose required to relieve hypoglycaemia will vary. After the patient responds, supplemental oral feeding is indicated to avoid relapse, especially after insulin shock therapy.

Acute alcoholism: 50ml of glucose 50% w/v solution should be administered intravenously. Unmodified insulin (20 units) and thiamine hydrochloride (100mg) should be added to the infusion. Blood sugar should be measured frequently until stable.

The intravenous use of strongly hypertonic solutions of glucose is contraindicated in patients with anuria, intracranial or intraspinal haemorrhage, or delirium tremens if the patient is already dehydrated.

Known sensitivity to corn or corn products, hyperglycaemic coma, or ischaemic stroke.

Hypertonic solutions of glucose should be administered via a large central vein to minimise the damage at the site of injection.

Use with caution in patients with diabetes mellitus, severe undernutrition, carbohydrate intolerance, thiamine deficiency, hypophosphataemia, haemodilution, sepsis and trauma. Rapid infusion of hypertonic glucose solution may lead to hyperglycaemia. Patients should be observed for signs of mental confusion or loss of consciousness.

Prolonged use in parenteral nutrition may affect insulin production; blood and urine glucose should be monitored. Fluid and acid-base balance and electrolyte status should also be determined during therapy with dextrose.

None known.

Intravenous glucose may result in considerable foetal insulin production, with an associated risk of rebound hypoglycaemia in the new-born. Infusion should not exceed 5-10g/hour during labour or Caesarean section.

This preparation is intended for use only in emergencies.

Anaphylactoid reactions have been reported in patients with asthma and diabetes mellitus.

Local pain, inflammation, irritation, thrombophlebitis and fever may occur.

Hypokalaemia, hypomagnesaemia or hypophosphataemia may result from the use of hypertonic solutions via the intravenous route.

Prolonged or rapid administration of hyperosmotic >5%) solutions may lead to dehydration.

The administration of glucose without adequate levels of thiamine (which form the coenzyme systems in its metabolism), may precipitate overt deficiency states, e.g. Wernicke's encephalopathy.

Excess glucose infusion produces increased CO₂, which may be important in respiratory failure, and stimulates catecholamine secretion.

The patient becomes hyperglycaemic and glycosuria may occur. This can lead to dehydration, hyperosmolar coma and death.

Treatment: The infusion should be discontinued and the patient evaluated. Insulin may be administered and appropriate supportive measures taken.

Glucose, the natural sugar occurring in the blood, is the principle source of energy for the body. It is readily converted to fat and is also stored in the liver and muscles as glycogen. When a rapid rise in blood sugar is demanded by the body, glycogen is quickly liberated as d-glucose. When the supply of glucose is insufficient, the body mobilises fat stores which are converted to acetate with production of energy by the same oxidative pathways employed in the combustion of glucose.

It may decrease body protein and nitrogen losses. Glucose is also the probable source of glucuronic acid with which many foreign substances and their metabolites combine to form excretion products. It probably provides the basic substances required for the formation of hyalluronates and chondroitin sulphates, the supporting structures of the organism. It can be converted to a pentose essential for the formation of nucleic acids by the cells.

Glucose is metabolised to carbon dioxide and water with the release of energy.

Not applicable since glucose has been used in clinical practice for many years and its effects in man are well known.

Water for Injections

Glucose solutions which do not contain electrolytes should not be administered concomitantly with blood through the same infusion set as haemolysis and clumping may occur. This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

Unopened: 3 years

Once open: Use immediately. Discard any unused portion.

Store below 25°C.

The solution is contained in a type I glass vial with an elastomeric closure which meets all the relevant specifications. The product is available as 10 ml and 50ml.

The container is specially designed for use with the IMS Minijet injector. Do not use the injection if crystals have separated. For single use only. Discard any remaining contents after use.

International Medication Systems (UK) Ltd

208 Bath Road

Slough

Berkshire

SL1 3EW

UK

PA 255/8/3

Date of first authorization: 08 September 1977

Date of last renewal: 08 September 2007

September 2008