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	3.00 g/l
Sodium Chloride	9.00 g/l
mmol/l:	+ o	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 Cl^-1 mmol Na+ = 23mg Na+

-    for potassium

1 g KCl = 525 mg of K+ or 13.4 mEq or 13.4 mmol of K+ and Cl^-1 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 ofpotassium 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.

Adequate urine flow must be ensured and careful monitoring of plasma-potassium 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:

-    documented hyperkalaemia, hyperchloremia or hypernatremia

-    severe renal insufficiency (with oliguria/anuria)

-    uncompensated cardiac failure

-    Addison’s disease.

4.4. 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.

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.

All packs may not be marketed.

6.6.    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.    Opening

a.    Remove the Viaflo container from the overpouch just before use.

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.

2.    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.

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.

3.    Techniques for injection of additive medications Warning: Additives may be incompatible.

To add medication before administration

a. Disinfect medication site.

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

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.

7. 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