Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion – BP – Summary of Product Characteristics (SmPC) – (emc)

Posology

Adults, the Elderly, Adolescents and Children

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Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly important for hypotonic fluids.

Potassium Chloride 0.3% & Sodium Chloride 0.9% Solution for Infusion has a tonicity of 388 mOsm/l (approx.)

The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury, infections), and concomitant therapy should be determined by the consulting physician experienced in paediatric intravenous fluid therapy (see sections 4.4. and 4.8).

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+

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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 3Liters /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

Typical dose of potassium for the prevention of hypokalemia 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 treatment of hypokalemia, 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.

Patient with renal impairment should receive lower doses.

In any case, the dosage given under “ general posology” should not be exceeded.

Method of Administration

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The administration is performed by intravenous route using sterile and non-pyrogenic equipment.

Intravenous potassium should be administered in a large peripheral or central vein to diminish the risk of causing sclerosis. If infused through central vein, to avoid localized hyperkalemia, ensure that the catheter is not in the atrium or ventricle.

The osmolarity of a final admixed infusion solution must be taken into account when peripheral administration is considered.

Hyperosmolar solutions may cause venous irritation and phlebitis. Thus, clinically significant hyperosmolar solutions are recommended to be administered through a large central vein, for rapid dilution of the hyperosmolar solution.

Additional electrolyte supplementation may be indicated according to the clinical needs of the patient. When introducing additives to Potassium chloride 0.3% w/v & Sodium Chloride 0.9% w/v solution for infusion, the instructions for use of the medication to be added and other relevant literature must be consulted (see also Special precautions for disposal and other handling, section 6.6).

Risk of air embolism

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Rate of administration

Solutions containing potassium should be administered slowly. As administered intravenously, to avoid a dangerous hyperkalemia potassium should not be given faster than 15 to 20 mmoles/h. Rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious neurologic complications) (see also Special Warnings and precautions for Use; section 4.4).

Monitoring

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.

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