SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

10% w/v Glucose Intravenous Infusion BP

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1000ml of solution contain

Dextrose monohydrate for parenteral use 110.0g (Equivalent to anhydrous dextrose    100.0g)

Caloric value    1675 kJ/l ^ 400 kcal/l

Theoretical Osmolarity    555 mOsm/l

Titration acidity (to pH 7.4)    < 1 mmol/l

pH    3.5 - 5.5

3    PHARMACEUTICAL FORM

Solution for infusion.

Clear, colourless or almost colourless aqueous solution.

Total energy:    1675 kJ/l = 400 kcal/l

Theoretical osmolarity:    555 mOsm/l

Titration acidity (to pH 7.4)    < 1 mmol/l

pH    3.5 - 5.5

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

-    Energy supply;

-    Vehicle solution for supplementary medication.

4.2    Posology and method of administration

Dosage

The dose is to be adjusted according to the individual glucose and fluid requirements Dosage for adults, the elderly and adolescents from 15^th year of age

The maximum daily dose is 40 ml per kg body weight (BW), corresponding to 4 g of glucose per kg BW.

Note

In the presence of metabolic disorders (e.g. postoperatively or after injuries, hypoxia, organ insufficiencies), the oxidative metabolism of glucose may be impaired. In such situations the glucose intake should be limited to 2 - 4 g/kg BW/day. The blood glucose level should not exceed 6.1 mmol/l (110 mg/100 ml).

The maximum infusion rate is 2.5 ml per kg BW per hour, corresponding to 0.25 g of glucose per kg BW per hour. The maximum drop rate is 0.8 drops per kg BW per minute.

Thus for a patient weighing 70 kg the maximum infusion rate is approx. 175 ml/hour (corresponding maximum drop rate 58 drops/min), resulting in a glucose intake of 17.5 g/hour.

Dosage for paediatric patients

The daily dose is limited by the maximum fluid intake:

1st	day of life :	50 -	70	ml	per	kg	BW
2nd	day of life :	70 -	- 90	ml	per	kg	BW
3rd	day of life :	80 -	- 100	ml	per	kg	BW
4th	day of life :	100 -	- 120	ml	per	kg	BW
from 5th day of life		: 100 -	130	ml	per	kg	BW
	1st year :	100 -	- 140	ml	per	kg	BW
3rd	2nd year :	80 -	- 120	ml	per	kg	BW
	- 5th year :	80 -	- 100	ml	per	kg	BW
6th	- 10th year :	60 -	80	ml	per	kg	BW
1 1 th	- 14th year :	50 -	70	ml	per	kg	BW

The corresponding glucose amounts are below the maximum recommended glucose doses for the respective age groups.

If the solution is used as vehicle solution, a volume should be chosen that yields the desired concentration of the medicament to be dissolved or diluted.

Method of administration

Intravenous infusion. The solution can be administered peripherally.

If 10 % w/v Glucose Intravenous Infusion is used as vehicle solution the possibility of peripheral infusion depends on the characteristics of the mixture prepared.

4.3 Contraindications

-    Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour

-    Decompensated diabetes mellitus, diabetic coma

-    Untreated diabetes insipidus

-    Acute states of shock or collapse

-    Intracranial or spinal haemorrhage

-    Metabolic acidosis

-    Renal failure (oligo- or anuria) in absence of renal replacement therapy

-    Hyperhydration

-    Pulmonary oedema

-    Acute cardiac failure

4.4 Special warnings and precautions for use

Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia was reported to worsen ischaemic brain damage and impair recovery.

This solution should be used with caution in patients with hypervolemia, renal insufficiency and impending or manifest cardiac decompensation.

The solution should also be administered with caution to patients with increased serum osmolarity.

Disorders of fluid and electrolyte balance like hypotonic dehydration or pathologically low levels of serum electrolytes, must be corrected prior to administration of Glucose 10 % w/v solution for infusion.

Special attention must be paid to hypokalaemia. Then supplementation of potassium is absolutely mandatory.

Unstable metabolism (e.g. postoperatively or after injuries, hypoxia, organ insufficiencies) impairs oxidative metabolism of glucose and may lead to metabolic acidosis.

States of hyperglycaemia should be adequetely monitored and treated with insulin. The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.

Solutions containing glucose should be used with caution in patients with manifest or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

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 other disease states 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.

Refeeding or repletion of malnourished or depleted patients may in particular cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Clinical monitoring should include blood glucose, serum electrolytes, fluid and acid-base balance in general. Frequency and kind of laboratory testing depend on the overall condition of the patient, the prevailing metabolic situation and the administered dose. Also monitor total volume and amount of glucose administered.

Electrolytes and vitamins should 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 with, before, or after administration of blood, because of the possibility of pseudo-agglutination.

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Pregnancy and Lactation

For 10 % w/v glucose solutions for infusion no controlled clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foeta1 development, parturition or postnatal development.

Yet caution should be exercised when prescribing to pregnant or nursing women and careful monitoring of blood glucose is necessary.

4.7 Effects on ability to drive and use machines

No effects to be expected.

Undesirable Effects

Provided the product is used in accordance with the directions given, undesirable effects are not to be expected.

The following side effects, which are not directly related to the product but to the conditions of administration, underlying disorders or accompanying treatment, may occur:

Metabolism and nutrition disorders

-    Hypokalemia may be related to insulin therapy. In addition, hypokalaemia, hypomagnesaemia and hypophosphataemia may be caused by refeeding with glucose especially in malnourished patients.

-    Abrupt discontinuation and/or insulin application may cause rebound hypoglycemia, especially in patients with glucose tolerance disorders.

Vascular disorders

Thrombophlebitis may be caused by osmolarities above 800 mmol/l. The osmolarity of the added medication should be kept in mind.

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.

4.9 Overdose

Symptoms

Overdose may cause hyperglycaemia, glucosuria, serum hyperosmolarity, possibly leading to hyperosmotic and hyperglycaemic coma, further hyperhydration and electrolyte disorders.

Emergency treatment, antidotes

The disorders mentioned above can be corrected by reduction of the glucose intake, administration of insulin and/or appropriate supplementation of electrolytes.

5.1 Pharmacodynamic properties

Pharmaco-therapeutic group:

Solutions for parenteral nutrition, carbohydrates, ATC code: B05B A03

Glucose is metabolised ubiquitously as the natural substrate of the cells of the body. Under physiological conditions glucose is the most important energy-supplying carbohydrate with a caloric value of approx. 17 kJ or 4 kcal/g. Nervous tissue, erythrocytes and medulla of the kidneys are amongst the tissues with an obligate requirement for glucose. In adults, the normal concentration of glucose in blood is 60 - 100 mg/100 ml, or 3.3 - 5.6 mmol/l (fasting).

Glucose serves to maintain the blood glucose level and for the synthesis of important body components. It serves for the synthesis of glycogen, the storage form of glucose. Primarily insulin, glucagon, glucocorticosteroids and catecholamines are involved in the regulation of the blood glucose concentration.

A normal electrolyte and acid-base status is a prerequisite for the optimal utilization of administered glucose. So acidosis, in particular, can indicate impairment of oxidative glucose metabolism.

Metabolism of glucose and electrolytes are closely related to each other. Potassium, magnesium and phosphate requirements may increase and may therefore have to be monitored and supplemented according to individual needs. Especially cardiac and neurological functions may be impaired without supplementation.

Glucose intolerance may occur under pathological conditions, e.g. diabetes mellitus and metabolic stress (e.g. intra-, and postoperatively, severe disease, injury, sepsis). Severity of hyperglycaemia and glucosuria are related to the severity of the pathological state.

Infusion of higher concentrated glucose solutions can aggravate brain damage and cerebral oedema in cases of head injury, cerebrovascular accidents and ischemia.

5.2. Pharmacokinetic Properties

On infusion glucose is first distributed in the intravascular space and then is taken up into the intracellular space.

In glycolysis, glucose is metabolised to pyruvate or to lactate. Lactate can be partially re-introduced into the glucose metabolism (Cori cycle). Under aerobic conditions pyruvate is completely oxidized to carbon dioxide and water. The final products of the complete oxidation of glucose are eliminated via the lungs (carbon dioxide) and the kidneys (water).

Practically no glucose is excreted renally by healthy persons. In pathological metabolic conditions (e.g. diabetes mellitus, postaggression metabolism) associated with hyperglycaemia, glucose is also excreted via the kidneys (glucosuria) when the maximum tubular resorption capacity (at blood glucose levels higher than 180 mg/100 ml or 10 mmol/l) is exceeded.

5.3    Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to the safety instructions already stated in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for injections

6.2. Incompatibilities

Because of its acid pH, the solution may be incompatible with other medicaments.

6.3    Shelf life

In the unopened container the product has a shelf life of 3 years

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container

Polyethylene containers; contents: 500, 1000 ml. available in packs of 10 x 500 ml 10 x 1000 ml.