SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

20% w/v Glucose Intravenous Infusion BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1000ml of solution contain

Dextrose monohydrate for parenteral use 220.0g (Equivalent to anhydrous dextrose    200.0g)

Caloric value Theoretical osmolarity Titration acidity (to pH 7.4) pH

3.    PHARMACEUTICAL FORM

Solution for infusion

Clear, colourless or slightly yellowish solution.

Caloric value    3350 kJ/l = 800    kcal/l

Theoretical osmolarity    1110 mOsm/l

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

pH    3.5 - 5.5

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Parenteral nutrition;

High-caloric carbohydrate therapy, especially when fluid intake is restricted, as for example in renal insufficiency;

Hypoglycaemia

4.2 Posology and method of administration

Dosage

The dosage of the solution depends on the patient’s individual glucose and fluid requirements.

Adults:

Maximum daily doses and infusion/drop rates: Maximum 30 ml per kg body weight (BW) dose

Infusion rate 1.25 ml per kg BW per h Drop rate    0.41 drops per kg BW per min

Values for a patient of 70 kg BW:

Infusion rate 87 ml per h = 17.5 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. The blood glucose level should not exceed 6.1 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

When determining the dose, the following limits of daily total parenteral fluid administration must be strictly observed:

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.

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 20 % 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/foetal 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.

4.8. 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 PHARMACOLOGICAL PROPERTIES

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.

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

Hydrochloric acid (for pH adjustment), 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

Special precautions for storage

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.

6.6    Special precautions for disposal

Single-dose container. Discard unused contents.

Only to be used if the solution is clear and the container or its closure do not show visible signs of damage.

7    MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen Germany

8    MARKETING AUTHORISATION NUMBER

PL 03551/0061

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1 August 2001 / 19/08/2009

10 DATE OF REVISION OF THE TEXT

07/07/2015