Glucose Intravenous Infusion 5%

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Polyfusor D has the following composition:

Name

Specification

Reference

w/v

Glucose Monohydrate for Parenteral Use BP

5.5

(Equivalent to Anhydrous Glucose BP

5.0)

3 PHARMACEUTICAL FORM

Intravenous infusion

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

The produce is indicated in simple dehydration, carbohydrate depletion, and hypoglycaemic coma. It can also be used to provide a temporary increase in blood volume in haemorrhage and shock.

4.2 Posology and method of administration

Adults and Children

The rate of administration and volume infused will depend upon the requirements of the individual patient and judgement of the physician.

Elderly

Care should be taken to avoid circulatory overload, particularly in patients with cardiac and renal insufficiency.

For intravenous infusion

4.3 Contraindications

Diabetes, except as a treatment for hypoglycaemia. The intravenous infusion of glucose solutions may also be hazardous in, patients with impaired hepatic or renal function.

4.4 Special warnings and precautions for use

The infusion of these solutions should not be rapid or very prolonged large volumes of these solutions given too quickly may cause water intoxication; infusion over a long period can cause dehydration.

The label states: Do not use unless solution is clear and free from particles.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been assessed. But its use during these periods is not considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Thrombosis of the chosen vein is always a possibility with intravenous infusion.

4.9 Overdose

Overdosage may lead to fluid overload and hyperglycaemia. Fluid overload may need to be treated with a diuretic and hyperglycaemia with insulin.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glucose is a monosaccharide, which provides a source of energy.

5.2 Pharmacokinetic properties

Glucose is metabolised via pyruvic or lactic acid to carbon dioxide and water with the release of energy. All body cells are capable of oxidising glucose and it forms the principal source of energy in cellular metabolism.

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Name

Specification

Reference

%w/v

Water for Injections in bulk BP

To 100

Sodium Hydroxide BP

Hydrochloric Acid BP

6.2 Incompatibilities

Incompatible with blood, frusemide, hydralazine cyanocobalamin, kanamycin sulphate, novobiocin sodium or warfarin sodium

6.3 Shelf life

Semi-rigid, cylindrical neutral polythene container with a 'Twist-off seal: 36 months.

Polyethylene bottle with cap and administration/addition points: 36 months.

6.4 Special precautions for storage

Store at 2° to 25°C

6.5 Nature and contents of container

Sealed semi-rigid, cylindrical neutral polythene container with a 'Twist-off seal at one end and a ring tab at the opposite end Or

Polyethylene bottle with a cap with an administration point and an addition point (KabiPac)

The container holds 100, 250, 500 or 1000ml

6.6 Special precautions for disposal and other handling

Do not dilute before use

Use standard sterile peritoneal dialysis equipment

7 MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

8 MARKETING AUTHORISATION NUMBER

PL 08828/0056

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/06/1989 / 12/04/2005

10 DATE OF REVISION OF THE TEXT

23/09/2009