SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Glucose 20% IV Infusion BP, as Steriflex No. 31 and freeflex

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex 31 has the following composition:

Name	Specification Reference	%w/v
Glucose Monohydrate for Parenteral Use	EP	22.0
(Equivalent to Anhydrous Glucose		20.0

3    PHARMACEUTICAL FORM

Solution for infusion.

4.    CLINICAL PARTICULARS

4.1. Therapeutic Indications

The product is used 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. It may be combined with amino acid solutions in parenteral nutrition.

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 via a central vein.

4.3. Contra-Indications

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

4.4. Special Warnings and Special 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.

Rebound hypoglycaemia may occur following the use of concentrated solutions of glucose.

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

4.5. Interactions 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 has not been assessed but its use in this period 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.    Pre-clinical Safety Data

None stated

6.

6.1.

List of Excipients

Name	Specification Reference	%w/v
Water for Injection in Bulk	EP	To 100
Hydrochloric Acid	EP	QS
Sodium Hydroxide	BP	QS

6.2. Incompatibilities

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

Because of the nature of the plastic material of the Steriflex bag (PVC) this solution should not be used as a vehicle for the administration of drugs, which may be sorbed to the surface of the bag to varying and significant degrees.

6.3. Shelf Life

500 & 1000ml PVC Bags - 24 months.

500 & l000ml Polyolefin Bags - 36 months

6.4. Special Precautions for Storage

Store at 2° to 25°C

6.5. Nature and Content of Container

The container is a flexible 500 or 1000ml bag made of medical grade PVC.

a)    A hermetically sealed polythene bag.

b)    A rectangular pouch consisting of polyamide/polythene composite

c)    Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene ethylene propylene composite, plugged with a polycarbonate plug with either a bromobutyl (West 4481/45) or gum (West 7006/45) stopper.

Or

A flexible 500 or 1000ml polyolefine bag sealed in a polyolefine overwrap.

6.6. Instructions for Use, Handling and Disposal

Opening the overwrap:

Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves

of the overwrap apart, releasing the bag onto a clean surface.

Setting up the solution:

Position the roller clamp of the giving-set to just below the drip chamber and close.

Hold the base of the giving set port firmly and grip the wings of the twist of tab. Twist to remove the protective cover. Still holding the base of the giving-set port push the set spike fully into the port to ensure a leak proof connection. Prime the set in accordance with the manufacturer’s instructions.

7 MARKETING AUTHORISATION HOLDER

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

8    MARKETING AUTHORISATION NUMBER(S)

PL 08828/0029

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/02/2009

10 DATE OF REVISION OF THE TEXT

11/02/2009