SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Component	Per 500 ml	Per 1000 ml
Potassium chloride	1.0 g K+ 13.5 mmol	2.0 g K+ 27 mmol
Sodium chloride	4.5 g Na+ 75 mmol	9.0 g Na+ 150 mmol
	Cl" 88.5 mmol	Cl" 177mmol

Osmolality approx. 332 mOsm/kg H₂O. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM

Solution for infusion (Intravenous Infusion)

Colourless to faintly straw-coloured solution without visible particles in bags, individually

overwrapped.

pH 3.5 - 6.5

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For prophylactic and replacement therapy requiring the use of sodium chloride and potassium.

4.2 Posology and method of administration

For intravenous infusion under medical supervision.

The volume of solution needed to replenish deficits varies with hydration state, age, body weight, complementary treatment and clinical and biochemical status.

Doses may be expressed in terms of mEq or mmol of potassium, mass of potassium or mass of potassium salt:

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+

Posology

-    Adults:

500ml to 3000ml/24h

-    Paediatric population:

0 - 10kg body weight: 100ml/kg/24h

10 - 20kg body weight: 1000ml + (50ml/kg over 10kg)/24h

> 20kg body weight: 1500ml + (20ml/kg over 20kg)/24h

Posology for prevention and treatment ofpotassium depletion Typical doses of potassium for the prevention of hypokalaemia and treatment of mild potassium deficiency may be up to 50mmoles per day. In severe hypokalaemia the recommended dosage is 20mmol potassium over 2 to 3 hours (i.e. 7-10 mmol/h) with ECG monitoring, but the dose and rate of administration are subject to clinical and laboratory assessment in each case.

The recommended maximal dose of potassium is 2-3mmol/kg/24h.

Patients with renal impairment should receive lower doses.

Method of Administration

Route of administration

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 a central vein, to avoid localized hyperkalaemia the catheter must not be in the atrium or ventricle.

Rate of administration

The rate of administration of potassium containing solutions should not exceed 15 to 20 mmoles/h to avoid dangerous hyperkalaemia. Rapid infusion may be harmful.

Monitoring

Adequate urine flow must be ensured and careful monitoring of plasma-potassium and other electrolyte concentrations is essential. Higher dosage or high speed infusion must be performed under ECG control.

4.3 Contraindications

Hyperkalaemia such as is associated with severe renal insufficiency or adrenocortical insufficiency.

Hyperchloraemia. Patients with fluid and sodium retention, congestive heart failure, or severely impaired renal function.

4.4 Special warnings and precautions for use

Potassium Chloride 0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion is a hypertonic solution, with an approximate osmolarity of 332mOsm/l.

Potassium replacement must be used with caution to patients with conditions associated with high potassium levels including cardiac disease, oedema, renal dysfunction, hepatic insufficiency or digitilisation, acute dehydration, acute acidosis, extensive tissue destruction as occurs with tissue trauma and severe burns, haemolysis, rhabdomyolysis or hepatic insufficiency.

Sodium salts should be administered with caution to patients with hypertension.

Fluid replacement therapy should be administered with caution to very young and elderly patients who have reduced capacity to compensate for fluctuations in fluid and electrolyte balance.

Administration should be carried out under regular and careful surveillance. Regular monitoring of clinical status, plasma potassium, serum and/or urinary electrolytes, plasma creatinine levels, BUN level, acid-base balance and ECG is essential in patients receiving potassium therapy, particularly those with cardiac or renal impairment. Plasma electrolyte concentrations should be carefully monitored especially in patients with pre-existing imbalances or conditions predisposing to hyperkalaemia, such as renal or adrenal insufficiency.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure.

Adequate urine flow must be ensured and fluid balance should be monitored.

During long-term treatment, a convenient nutritive treatment supply must be given to the patient.

4.5 Interaction with other medicinal products and other forms of interaction

Care should be taken in the concurrent use of drugs containing potassium, potassiumsparing diuretics such as spironolactone and triamterene, and drugs which have the potential for inducing hyperkalaemia, ACE (angiotensin converting enzyme) inhibitors, angiotensin II receptor antagonists, tacrolimus and cyclosporine, as well as drugs which promote sodium retention such as corticosteroids.

Check compatibility of medicinal products with the solution before use.

4.6    Fertility, pregnancy and lactation

Administration of intravenous fluids to pregnant and lactating women requires consideration of the consequences of possible unwanted effects in relation to the desired therapeutic objective.

Sodium salts should be administered with caution to patients with pre-eclampsia.

Hyperkalaemic and hypokalaemic serum levels lead to impaired cardiac function of the maternal and foetal hearts. Therefore, maternal electrolyte levels must be controlled regularly. As long as the maternal electrolyte serum levels are kept within the physiological range, there are no potential concerns regarding administration of Potassium Chloride

0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion during pregnancy and lactation.

4.7    Effects on ability to drive and use machines

Not applicable

Undesirable effects

Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:

For United Kingdom Yellow Card Scheme Website: www.mhra.gov .uk/yellowcard

For Ireland

HPRA Pharmacovigilance

Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafetv@,hpra.ie

4.9 Overdose

Excessive or rapid administration of potassium-containing solutions may cause hyperkalaemia with hypotension, cardiac arrhythmias, heart block, ECG abnormalities and cardiac arrest, mental confusion, and neuromuscular dysfunction such as muscle weakness, paraesthesia and paralysis. Excessive or rapid administration of sodium chloride solution may lead to fluid and electrolyte imbalances such as hypokalaemia, hypervolaemic haemodilution, sodium accumulation and hypernatraemia with resultant dehydration of organs particularly the brain, and oedema, also hypertension, tachycardia, oedema, anorexia and nausea. Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.

Treatment depends on the individual clinical situation but involves administration of calcium to counteract the effects of hyperkalaemia on cardiac excitability, the use of agents such as insulin or sodium bicarbonate to promote cellular uptake of potassium, and enhanced potassium excretion with exchange resins or dialysis. Discontinue infusion if adverse reaction occurs.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group (ATC code): “electrolytes” (B05BB01).

Potassium Chloride 0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion is a hypertonic solution, with an approximate osmolarity of 332 mOsmol/l.

The pharmacodynamic properties of this solution are those of its components (potassium, sodium and chloride). Potassium is predominantly an intracellular cation, primarily found in muscle; only about 2% is present in the extracellular fluid. It is essential for numerous metabolic and physiological processes including nerve conduction, muscle contraction, and acid-base regulation.

Sodium is mainly an extracellular cation. Chloride is mainly an extracellular anion. Intracellular chloride is in high concentration in red blood cells and gastric mucosa

5.2 Pharmacokinetic properties

The pharmacokinetic properties of this solution are those of its components (potassium, sodium 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.

5.3    Preclinical safety data

Preclinical safety data of Potassium Chloride 0.2%w/v Sodium Chloride 0.9%w/v Solution for Infusion in animals are not relevant since potassium chloride and sodium chloride are physiological components of the body. Toxic effects are not to be expected if serum electrolytes are kept within physiological range.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Water for Injections in bulk

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

2 years

Use immediately on removal from overwrap.

6.4    Special precautions for storage

Do not store above 25^oC. Do not freeze. Store in the original outer container (overwrap) to prevent moisture loss to the air.

6.5    Nature and contents of container

Flexible Macoflex PVC bags containing 500ml or 1000ml solution, individually overwrapped in transparent polypropylene laminate.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Do not use unless the solution is clear and the container undamaged.

Discard any unused solution. For single use only.

The space between the bag and the overwrap is not guaranteed sterile.

Before use, remove the bag from the plastic overwrapping.

Remove the twist-off protector of the infusion site and connect by clamping to the administration set.

Addition of medicinal products :

Confirm additive compatibility before addition through the injection port.

Clean the injection site using antiseptic solution.

Carefully introduce the sterile needle into the sterile chamber in the injection site, attach the needle to the container with the medicinal product, introduce the needle through the second membrane into the bag and inject the medicine.

Carefully withdraw the needle.

Mix thoroughly with the solution.

Use immediately.

7 MARKETING AUTHORISATION HOLDER

MACO PHARMA (UK) LTD

8^th Floor - Regal House

70 London Road

Twickenham

Middlesex

TW1 3QS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 12580/0017

PA 931/7/2

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07 May 2004/02 December 2005 Date of last renewal: 07 May 2009

10    DATE OF REVISION OF THE TEXT

25/01/2016