SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 0.3%, Sodium Chloride 0.18% and Glucose 4% Intravenous Infusion BP, as Steriflex No. 17 or freeflex

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Steriflex No. 17 has the following composition:

Name	Specification Reference	%w/v
Potassium Chloride	EP	0.3
Glucose Monohydrate for Parenteral Use	EP	4.4
(Equivalent to Anhydrous Glucose		4.0)
Sodium Chloride BP for Injections	EP	0.18

3 PHARMACEUTICAL FORM

Intravenous fluid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Potassium Replacement Therapy

4.2. Posology and Method of Administration

Adults and Children

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

The rate of infusion should not exceed 10-20 mmols of potassium per hour. The total daily dosage of potassium should not exceed 200 mmols of potassium.

Children

The volume and rate of infusion will depend upon the requirements of the individual

patient and the judgement of the physician.

Correspondingly reduced volumes and rates of infusion may be required.

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. Contra-indications

Addison’s disease, adrenal insufficiency, acute or chronic renal disease, oliguria, anuria and patients with hyperkalaemia. The intravenous infusion of glucose solutions may also be hazardous in patients with impaired hepatic function.

4.4 Special warnings and precautions for use

Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may compromise cardiac function. Before administering potassium by the intravenous route a non-potassium containing hydrating solutions should be administered to ensure adequate renal function.

The label states: Rapid infusion may be harmful. Do not use unless the solution is clear and free from particles. Contains 20 mmol Potassium (500 ml) Contains 40 mmol Potassium (1000 ml)

4.5. Interactions with other Medicaments and other forms of Interaction

Care should be exercised in the concurrent administration of potassium containing intravenous solutions and potassium sparing diuretics.

4.6. Pregnancy and Lactation

The use 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

Undesirable Effects

Adverse effects are usually due to hyperkalaemia and include listlessness, mental confusion, parasthesiae, weakness, hypertension, arrhythmias and sometimes cardiac arrest. Thrombosis of the selected vein may occasionally occur.

4.9. Overdose

Symptoms of overdo sage include hypertension, cardiac, arrhythmias, heart block and cardiac arrest. Treatment is to stop infusion immediately and if there is persistent acidosis, administer an intravenous infusion of sodium lactate or sodium bicarbonate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection 10% with EGG monitoring.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Potassium chloride and sodium chloride provide essential ions to maintain the intracellular/extracellular milieu.

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.

List of excipients

Water for Injections in bulk Hydrochloric Acid Sodium Hydroxide

6.2. Incompatibilities

Incompatibilities have been demonstrated in potassium containing intravenous infusions with for example; amikacin, amphotericin, benzyl-penicillin and dobutamine.

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 between 2 and 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 448 1/45) or gum (West 7006/45) stopper.

Or

A flexible 500 ml & 1000 ml polyolefin bag sealed in a polyolefin overwrap.

6.6. Instruction for Use/Handling Opening the overwrap: