Freeflex
Potassium Chloride 0.2% Sodium Chloride 0.9% IV Infusion BP, as Sterifiex No. 28 and freeflex.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 28 has the following composition:
Name Specification Reference
%w/v
Potassium Chloride EP
0.2
Sodium Chloride for Injections EP
0.9
Posology and Method of Administration
The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.
Adults
The rate of infusion should not exceed 10-20 mmol of potassium per hour. The total daily dosage of potassium should not exceed 200 mmol of potassium.
Children
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 real 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
Intravenous infusion must be carried out slowly. Caution should be used with administration to patients receiving digitalistherapy, patients with renal or adrenal insufficiency, cardiac disease acute dehydration or heat cramp, those recieving potassium sparing diurectics and patients with sickle cell haemoglobinopathy.
Caution should be exercised in the volume and rate of infusion since fluid overload and hyperkalaemia may comprise cardiac function. Before administering potassium by the intravenous route a non potassium containing hydrating solution should be administered to ensure adequate renal function.
Repeated measurements of plasma potassium are necessary to determine whether further infusions are necessary and to avoid the development of hyperkalaemia this is especially liable to occur in renal failure. Continuous ECG monitoring is desirable.
The label states: Rapid infusion may be harmful.
Do not use unless the solution is clear and free from particles.
Contains 13.5 mmol potassium (500ml)
Contains 27 mmol potassium (1000ml)
4.5. Interactions with other Medicinal Products and other Forms of Interaction
Care should be exercised in the concurrent administration of potassium containing intravenous solutions and potassium sparing diuretics.
ACE-inhibitors; cyclosporin: care should be taken when administering to patients with digitalis therapy.
4.6. Pregnancy and Lactation
The use of potassium containing solutions during pregnancy and lactation has not been assessed but its use during these periods is not considered 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
Symptoms of overdosage 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 bicarbonate. Hyperkalaemia may be reversed by the administration of calcium gluconate injection
10% with ECG monitoring.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Potassium chloride and sodium chloride provide essential ions to maintain the intracellular/extracellular milieu.
5.2.
Pharmacokinetic Properties
Not applicable.
5.3. Pre-clinical Safety Data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
|
Name |
Specification Reference |
%w/v |
|
Water for Injections in bulk |
EP |
TO 100 |
|
Hydrochloric Acid |
EP |
QS |
|
Sodium Hydroxide |
BP |
QS |
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 sterifiex 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
500ml & 1000ml PVC bags - 24 months. 500ml & 1000ml 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 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 500ml or 1000ml polyolefine bag sealed in a polyolefine overwrap.
6.6. Instruction 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
PL 08828/0037
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20/04/1989 / 23/02/2009
10
DATE OF REVISION OF THE TEXT
23/02/2009