Sodium Chloride 0.45% And Glucose 5% Intravenous Infusion
SUMMARY OF PRODUCT 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
Sodium Chloride for Injections EP 5.5
(Equivalent to Anhydrous Glucose 5.0)
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 PHARMACOLOGICAL PROPERTIES
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 PHARMACEUTICAL PARTICULARS
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.
6.6 Special precautions for 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.
MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
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MARKETING AUTHORISATION NUMBER(S)
PL 08828/0028
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/06/1989 / 27/01/2001
DATE OF REVISION OF THE TEXT
11/09/2009
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