Potassium Chloride 0.3% and Sodium Chloride 0.9% Solution for Infusion – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Potassium Chloride 0.3% and Sodium Chloride 0.9% Solution for Infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Potassium Chloride 0.3% and Sodium Chloride 0.9% Solution for Infusion has the following composition:

3 PHARMACEUTICAL FORM

Solution for Infusion

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

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.

Method of administration

For Solution for 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 the solution is clear and free from particles. Rapid infusion may be harmful.

Contains 20 mmol Potassium (500 ml) Contains 40 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 Fertility, pregnancy and lactation

The use of potassium containing solutions during pregnancy and lactation has not been assessed, but their 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.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellow card or search for MHRA Yellow card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

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

Pharmacotherapeutic group: Blood substitutes and perfusion solutions;

Electrolytes

ATC code: B05BB01

Potassium chloride and sodium chloride provide essential ions to maintain the intracellular/extracellular milieu.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

6.2 Incompatibilities

Incompatibilities have been demonstrated in potassium containing solution for 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 : 24 months.

500 & 1000 ml Polyolefin Bags : 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.

1. a) A hermetically sealed polythene bag
2. b) A rectangular pouch consisting of polyamide/polythene composite
3. c)

   Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene

   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

05^th June 1989 / 10^th November 1994

10 DATE OF REVISION OF THE TEXT

27/12/2024