SODIUM CHLORIDE 0.45% AND GLUCOSE 5% INTRAVENOUS INFUSION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Sodium Chloride 0.45% and Glucose 5% Intravenous Infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 45 has the following composition:

Name                     ­Specification Reference %w/v

Potassium Chloride                EP

Sodium Chloride for Injections        EP

(Equivalent to Anhydrous Glucose

3 PHARMACEUTICAL FORM

Intravenous fluid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

An isotonic solution for maintenance treatment of dehydration with carbohydrate loss.

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

A reduced volume and rate of infusion may be necessary to avoid circulatory overload, particularly in patients with cardiac or renal insufficiency.

For intravenous infusion.

4.3 Contraindications

Patients with impaired renal or cardiac function. The intravenous infusion of glucose containing solutions may be hazardous in patients with impaired liver function. Steriflex No. 45 is not suitable for the treatment of insulin coma.

4.4 Special warnings and precautions for use

Glucose-Saline solutions should not be administered rapidly for prolonged periods particularly in infants and the elderly. In potassium deficient patients administration of saline will increase potassium loss, so that if it is given, potassium supplements should also be given.

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 Fertility, pregnancy and lactation

The safety of this solution 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. If Infusion is protracted then another vein should be selected after 12–24 hours.

4.9 Overdose

Overdose may lead to fluid overload and electrolyte imbalance and possibly hyperglycaemia.

Hyperglycaemia may need to be treated with insulin and fluid overload with a diuretic.

Electrolyte disturbances may need to be treated with either sodium-free or sodium containing fluids.

5.1 Pharmacodynamic properties

Sodium chloride provides essential sodium and chloride ions to maintain the osmotic tension of the extracellular fluid and tissues.

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.

6.1 List of excipients

Water for Injections in bulk

Hydrochloric Acid

Sodium Hydroxide

6.2 Incompatibilities

Incompatibilities Amiodarone, Amphotericin B, Amascrine and sodium nitroprusside.

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 ml & 1000 ml PVC bags:          24 months

500 ml & 1000 ml Polyolefin bags:      36 months

6.4 Special precautions for storage

Store at 2° to 25°C

6.5 Nature and contents of container

The container is a flexible 500 ml & 1000 ml 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 ml & 1000 ml polyolefin bag sealed in a polyolefin overwrap.