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POTASSIUM CHLORIDE 0.3% SODIUM CHLORIDE 0.9% IV INFUSION BP AS STERIFLEX NO. 15 OR FREEFLEX

Active substance(s): POTASSIUM CHLORIDE / SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3%, Sodium Chloride 0.9% IV Infusion BP, as Steriflex
No. 15 or freeflex

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 15 has the following composition:
Name
Specification Reference
Potassium Chloride
EP
Sodium Chloride for Injections
EP

3

%w/v
0.3
0.9

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
The 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
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 solution should be administered to ensure adequate renal function.
The label states:

Do not use unless solution is clear and free from particles.
Rapid infusion may be harmful.
Contains 10 mmol Potassium (500 ml)
Contains 20 mmol Potassium (1000 ml)

4.5

Interaction 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.

4.6

Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been
established, 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
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 provides essential ions to maintain the
intracellular/extracellular milieu.

5.2

Pharmacokinetic properties
Not applicable.

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 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 & 1000 ml PVC Bags :
500 & 1000 ml Polyolefin Bags :

24 months.
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 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
polypropylene

to

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 or 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.

7

MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

8

MARKETING AUTHORISATION NUMBER(S)
PL 08828/0079

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05th June 1989 / 10th November 1994

10

DATE OF REVISION OF THE TEXT
June 2000

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