Freeflex
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.2% and Glucose 5% IV Infusion BP, as Steriflex No. 29 and freeflex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 29 has the following composition:
Name Specification Reference %w/v
Glucose Monohydrate for Parenteral Use EP 5.5
(Equivalent to Anhydrous Glucose 5.0)
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Intravenous infusion
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Potassium replacement therapy.
4.2. Posology and Method of Administration
Adults
The volume and rate of infusion will depend upon the requirements of the individual patient and 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 of 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 nonpotassium 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 hyperkalamia, 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 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 safety of this product has not been assessed but its use in this period 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
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 provides essential ions to maintain the intracellular/extracellular milieu.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
None stated.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
- Hydrochloric acid, concentrated
- Water for Injections.
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 at 2° to 25 °C
6.5. Nature and Contents of Container
The container is a flexible 500 ml or 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 or 1000 ml polyolefin bag sealed in a polyolefin overwrap.
6.6. Instruction for Use/Handling
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 UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 08828/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 14/08/2001
10 DATE OF REVISION OF THE TEXT
31/05/2005