Summary of medicine characteristics - STERIFLEX NO.17 KCL 0.3% NACL 0.18% & GLUCOSE 4% IV INFUSSION
1. Trade 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
3. Pharmaceutical FormIntravenous fluid
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
4.8. 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
4.9. OverdoseSymptoms 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.
5.1. 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
5.3. Preclinical Safety DataNone.
6.1. 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
36 months
500 ml & 1000 ml Polyolefin bags:
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
6.6. Instruction for Use/HandlingOpening 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.