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POTASSIUM CHLORIDE 0.3% & SODIUM CHLORIDE 0.9% SOLN FOR INFU

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% w/v & Sodium Chloride 0.9% w/v Solution for
Infusion - BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride
Sodium Chloride
mmol/l:

3.00 g/l
9.00 g/l
K+: 40

Na+:

154

Cl-: 194

For excipients: see 6.1.

3.

PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Potassium Chloride 0.3% & Sodium Chloride 0.9% Solution for Infusion is
indicated for the prevention and treatment of potassium depletion and/or
hypokalaemia, in sodium chloride and water-losing conditions.

4.2.

Posology and Method of Administration
Adults, the Elderly and Children
Doses may be expressed in terms of mEq or mmol of each cation, mass of
each cation, or mass of each cation salt:
- for sodium
1 g NaCl = 394 mg of Na+ or 17.1 mEq or 17.1 mmol of Na+ and Cl1 mmol Na+ = 23mg Na+
- for potassium
1 g KCl = 525 mg of K+ or 13.4 mEq or 13.4 mmol of K+ and Cl1 mmol K+ = 39.1 mg K+

The dosage of this solution depends on the age, weight, clinical and biological
(acid-base balance) conditions of the patient, concomitant therapy and in
particular the patient's hydration state.
General posology
The recommended dosage for treatment of isotonic fluid depletion
(extracellular dehydration) by means of any intravenous solution is:
- for adults: 500 ml to 3 litres/24h
- for babies and children: 20 to 100 ml per 24 h and per kg of body weight,
depending of the age and the total body mass.
Posology for prevention and treatment of potassium depletion
A typical dose of potassium for the prevention of hypokalaemia may be up to
50 mmoles daily and similar doses may be adequate in mild potassium
deficiency.
The maximal recommended dose of potassium is 2 to 3 mmol/kg/24h.
When used for the treatment of hypokalaemia, the recommended dosage is 20
mmoles of potassium over 2 to 3 hours (i.e. 7-10 mmol/h) under ECG control.
The maximum recommended administration rate should not exceed 15-20
mmol/h.
Patients with renal impairment should receive lower doses.
In any case, the dosage given under “General Posology” should not be
exceeded.
Administration
Route of administration
The administration is performed by intravenous route using sterile and nonpyrogenic equipment.
Intravenous potassium should be administered via a large peripheral or central
vein to diminish the risk of causing sclerosis. If infused through a central vein,
to avoid localised hyperkalaemia, ensure that the catheter is not in the atrium
or ventricle.
Solutions containing potassium should be administered slowly.
Rate of administration
As administered intravenously, to avoid dangerous hyperkalaemia, potassium
should not be given faster than 15 to 20 mmoles/h.

Monitoring
Adequate urine flow must be ensured and careful monitoring of plasmapotassium and other electrolyte concentrations is essential. High dosage or
high speed infusion must be performed under ECG control.

4.3.

Contraindications
The solution is contraindicated in patients with:
-

4.4.

documented hyperkalaemia, hyperchloremia or hypernatremia
severe renal insufficiency (with oliguria/anuria)
uncompensated cardiac failure
Addison’s disease.

Special Warning and Precautions for Use
Potassium chloride 0.3% & Sodium chloride 0.9% solution is an hypertonic
solution, with an approximate osmolarity of 388 mOsm/l.
Administration should be carried out under regular and careful surveillance.
Regular monitoring of clinical status, plasma electrolyte concentrations,
plasma creatinine levels, BUN level, acid-base balance and ECG is essential in
patients receiving potassium therapy, particularly those with cardiac or renal
impairment.
Adequate urine flow should be ensured and fluid balance should be monitored.
Potassium salts should be administered with considerable care to patients with
cardiac disease or conditions predisposing to hyperkalaemia such as renal or
adrenocortical insufficiency, acute dehydration, or extensive tissue destruction
as occurs with severe burns. In patients under digitalis therapy, regular
monitoring of the plasma potassium level is mandatory.
Sodium salts should be administered with caution to patients with
hypertension, heart failure, peripheral or pulmonary oedema, impaired renal
function, pre-eclampsia, or other conditions associated with sodium retention
(see also Section 4.5 – Interactions with other medicaments and other forms of
interaction).

4.5.

Interaction with Other Medicinal Products and Other Forms of Interaction
Solutions containing potassium should be used with caution in patients
receiving drugs that increase plasma potassium concentrations (e.g. potassiumsparing diuretics, ACE inhibitors, Angiotensin II receptors antagonists,
ciclosporin, tacrolimus and drugs that contain potassium).

Corticosteroids are associated with the retention of sodium and water, with
oedema and hypertension.

4.6.

Pregnancy and Lactation
Hyperkalaemic and hypokalaemic serum levels lead to impaired cardiac
function of the maternal and foetal hearts. Therefore, maternal electrolyte
levels must be controlled regularly.
If taken for the corresponding indications and at the therapeutic dosage,
administration of Potassium chloride 0.3% & Sodium chloride 0.9% solution
would be possible during pregnancy and lactation.

4.7.

Effects on Ability to Drive and Use Machines
Not applicable.

4.8.

Undesirable Effects
Adverse reactions may be associated with the technique of administration,
including febrile response, infection at the site of injection, local pain or
reaction, vein irritation, venous thrombosis or phlebitis extending from the site
of injection, extravasation and hypervolemia.
In the case of undesirable effect(s), the infusion must be discontinued.

4.9.

Overdose
Excessive administration of potassium may lead to the development of
hyperkalaemia, especially in patients with renal impairment. Symptoms
include paraesthesia of the extremities, muscle weakness, paralysis, cardiac
arrhythmias, heart block, cardiac arrest, and mental confusion. Treatment of
hyperkalaemia involves the administration of calcium, insulin or sodium
bicarbonate, and exchange resins or dialysis.
Retention of excess sodium when there is a defective renal sodium excretion
may result in pulmonary and peripheral oedema.
Excessive administration of chloride salts may cause a loss of bicarbonate with
an acidifying effect.
In the event of accidental over infusion, treatment should be discontinued and
the patient should be observed for the appropriate signs and symptoms related
to the drug administered. The relevant symptomatic and supportive measures
should be provided as necessary.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Pharmacotherapeutic group (ATC code): electrolytes “B05BB01”.
Potassium Chloride 0.3% & Sodium Chloride 0.9% solution is an hypertonic
solution of electrolytes, with an approximate osmolarity of 388 mOsm/l.
The pharmacodynamic properties of the solution are those of the sodium,
potassium and chloride ions in maintaining the fluid and electrolyte balance.
Potassium is essential for numerous metabolic and physiological processes
including nerve conduction, muscle contraction, and acid-base regulation. A
normal concentration of potassium in plasma is about 3.5 to 5.0 mmoles per
litre. Potassium is predominantly an intracellular cation. The passage of
potassium into the cells and retention against the concentration gradient
requires active transport via the Na+/K+ ATPase enzyme.
Ions, such as sodium, circulate through the cell membrane, using various
mechanisms of transport, among which is the sodium pump (Na-K-ATPase).
Sodium plays an important role in neurotransmission and cardiac
electrophysiology, and also in its renal metabolism.
Chloride is mainly an extracellular anion. Intracellular chloride is in high
concentration in red blood cells and gastric mucosa. Reabsorption of chloride
follows reabsorption of sodium.

5.2.

Pharmacokinetic Properties
The pharmacokinetic properties of Potassium Chloride 0.3% & Sodium
Chloride 0.9% are those of the ions that its composition includes (sodium,
potassium and chloride).
Intravenous administration of the solution provides an immediate supply of
electrolytes to blood.
Factors influencing potassium transfer between intracellular and extracellular
fluid such as acid-base disturbances can distort the relationship between
plasma concentrations and total body stores. Potassium is excreted mainly by
the kidneys; it is secreted in the distal tubules in exchange for sodium or
hydrogen ions. The capacity of the kidneys to conserve potassium is poor and
some urinary excretion of potassium continues even when there is severe
depletion. Some potassium is excreted in the faeces and small amounts may
also be excreted in sweat.
After injection of radiosodium (24Na), the half-life is 11 to 13 days for 99% of
the injected Na and 1 year for the remaining 1%. The distribution varies

according to tissues: it is fast in muscles, liver, kidney, cartilage and skin; it is
slow in erythrocytes and neurons; it is very slow in the bone. Sodium is
predominantly excreted by the kidney, but there is extensive renal
reabsorption. Small amounts of sodium are lost in the faeces and sweat.

5.3.

Preclinical Safety Data
Preclinical safety data of Potassium Chloride 0.3% & Sodium Chloride 0.9%
in animals are not relevant since electrolytes are physiological components of
the body.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Water for Injections.

6.2.

Incompatibilities
As with all parenteral solutions, incompatibility of the additive medications
with the solution must be assessed before addition.
In the absence of compatibility studies, this solution must not be mixed with
other medicinal products.
It is the responsibility of the physician to judge the incompatibility of an
additive medication with the Potassium Chloride 0.3% & Sodium Chloride
0.9% solution, by checking for eventual colour change and/or eventual
precipitate, insoluble complexes or the appearance of crystals. The Instructions
for Use of the medication to be added must be consulted.
Before adding a drug, verify that it is soluble and/or stable in water at the pH
of the Potassium Chloride 0.3% & Sodium Chloride 0.9% solution (pH: 4.5 to
7.0).
Those additives known to be incompatible should not be used.

6.3.

Shelf Life
Shelf life as packaged: 3 years.
In-use shelf life (Additives)
The chemical and physical stability of any additive medication at the pH of the
Potassium Chloride 0.3% and Sodium Chloride 0.9% solution in the Viaflo

container should be established prior to use. From a microbiological point of
view, the diluted product must be used immediately unless dilution has taken
place in controlled and validated aseptic conditions.
If not used immediately, in-use storage times and conditions are the
responsibility of the user.

6.4.

Special Precautions for Storage
No special precautions for storage.

6.5.

Nature and Contents of Container
The bags known as Viaflo are composed of polyolefin/polyamide co-extruded
plastic (PL 2442). The bags are overwrapped with a protective plastic
overpouch composed of polyamide/polypropylene.
The bag size is either 500 or 1000ml.
Outer carton contents: - 20 bags of 500 ml
or - 10 bags of 1000ml.

6.6.

All packs may not be marketed.
Instructions for Use and Handling
Use only if the solution is clear, without visible particles and if the container is
undamaged. Administer immediately following the insertion of infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary container before
the administration of the fluid from the secondary container is completed.
The solution should be administered with sterile equipment using an aseptic
technique. The equipment should be primed with the solution in order to
prevent air entering the system.
Additives may be introduced before infusion or during infusion through the
injection site. When additive is used, verify isotonicity prior to parenteral
administration. Thorough and careful aseptic mixing of any additive is
mandatory. Solutions containing additives should be used immediately and not
stored.

Adding medication or using an incorrect administration technique may cause
the appearance of fever reactions due to the possible introduction of pyrogens.
In the case of adverse reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
1.

2.

Opening
a.
use.

Remove the Viaflo container from the overpouch just before

b.

Check for minute leaks by squeezing inner bag firmly. If leaks
are found, discard solution, as sterility may be impaired.

c.

Check the solution for limpidity and absence of foreign matters.
If solution is not clear or contains foreign matters, discard the
solution.

Preparation for administration
Use sterile material for preparation and administration.
a.

Suspend container from eyelet support.

b.
Remove plastic protector from outlet port at bottom of
container:
- grip the small wing on the neck of the port with one hand,
- grip the large wing on the cap with the other hand and twist,
- the cap will pop off.

3.

c.

Use an aseptic method to set up infusion.

d.

Attach administration set. Refer to complete directions
accompanying set for connection, priming of the set and
administration of the solution.

Techniques for injection of additive medications
Warning: Additives may be incompatible.
To add medication before administration
a.

Disinfect medication site.

b.

Using a syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.

c.

Mix solution and medication thoroughly. For high-density
medication such as potassium chloride, tap the ports gently
while ports are upright and mix.

Caution: Do not store bags containing added medications.
To add medication during administration

7.

a.

Close clamp on the set.

b.

Disinfect medication site.

c.

Using a syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.

d.

Remove container from IV pole and/or turn to an upright
position.

e.

Evacuate both ports by tapping gently while the container is in
an upright position.

f.

Mix solution and medication thoroughly.

g.

Return container to in use position, re-open the clamp and
continue administration.

MARKETING AUTHORISATION HOLDER
Baxter Healthcare Ltd.
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00116/0337

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
10th September 2001

10.

DATE OF REVISION OF THE TEXT
24 April 2003

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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