Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Potassium chloride, Sodium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Potassium chloride, Sodium chloride

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for This medicine contains a solution of potassium chloride and sodium chloride. It is administered given to you through a tube placed into a vein (intravenous drip). You will receive it to maintain or restore your potassium, sodium, chloride and fluid levels when the levels are low.

What you need to know before you take it

e this medicine Do not use Potassium Chloride 0.15%w/v and Sodium Chloride 0.9% w/v

if you have high levels of potassium (hyperkalaemia) or chloride (hyperchloraemia) or too high levels of sodium (severe hypernatraemia) in your blood.
if you have serious kidney disease
if you have too much water in your body (hyperhydration) Warnings and precautions

Talk to your doctor before you are given Potassium Chloride 0.15 % w/v and Sodium Chloride 0.9% w/v. Before or when giving you this medicine, your doctor will pay special attention to the following: • • •

•

High levels of sodium in your blood (hypernatraemia) Swelling of the lower limbs (oedematous states) or water on your lungs (pulmonary oedema): If you have one of these conditions, you will be given large amounts of this medicine only carefully. Kidney and liver function You will receive this medicine as a slow intravenous drip after your doctor has made sure that your kidneys and liver are working properly. If they don't do so, your potassium blood levels and your heart will be monitored while you receive this medicine. Your doctor will make sure to stop the infusion in case your condition worsens. Heart disease: If you suffer from a heart disease, this medicine will be given to you with caution.

If you have high levels of acidic substances in your blood your doctor will take special care when giving you this solution. Your doctor will take special care if you have Addison's disease (a specific disease of the adrenal gland) as your potassium levels might become too high. The rhythm of your heart, your fluid balance, the salts in your blood and your level of sodium chloride will be monitored while you are receiving this medicine. If you are elderly, you are more likely to suffer from heart and kidney problems, will be closely monitored during treatment and the dosage will be carefully adjusted.. Children This medicine will be given to your child only with special caution. Their doctor will closely monitor their salt and fluid balance. Other medicines and Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are taking digoxin or similar medicines that help your heart to work better, tell your doctor as it may change how they work. The amount of Potassium Chloride 0.15 % w/v and Sodium Chloride 0.9 % w/v may have to be adjusted, especially at the end of therapy. Also tell your doctor if you are taking medicines that contain potassium or may lead to high potassium levels, such as

potassium-sparing medicines e.g. spironolactone or triamterene (medicines that increase urine flow)
ACE inhibitors (medicines to treat high blood pressure or heart failure)
Angiotensin II receptor antagonists (a type of blood pressure medicine)

• • •

non-steroidal anti-inflammatory agents (for sudden or long lasting pain and inflammation) ciclosporin, tacrolimus (medicines that are used after an organ transplant) suxamethonium (a medicine that is used during operations to put you to sleep).

They will take special care of you if you receive/take medicines that make you hold on to potassium as these may lead to heart problems (cardiac arrhythmia). Also, you doctor will take care if you use medicines that make you hold on to sodium because these may lead to swelling due to a build up of water (oedema). If you are taking certain medicines, namely corticosteroids, (used to treat a wide range of diseases such as asthma, hayfever, hives, eczema, painful joints or muscles, pain caused by a trapped nerve, inflammatory bowel disease, lupus, multiple sclerosis), ACTH (used to treat a wide variety of diseases such as spasms in infants and children, multiple sclerosis, arthritis, lupus, Stevens-Johnson syndrome) and loop diuretics (for high blood pressure), the amount of potassium lost through your kidneys can be increased. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking/using this medicine. This medicine can be given while you are pregnant or breast-feeding if your doctor thinks it is necessary.

Driving and using machines Potassium Chloride 0.15 % w/v and Sodium Chloride 0.9 % w/v has no influence on the ability to drive or use machines.

How to take it

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Dose The recommended dose that you will be given will be determined by your doctor . It will depend on your age, weight and condition, especially if your heart or kidneys do not work properly. While you receive this medicine your blood sodium chloride and electrolyte (salt) levels, water balance and heart will be checked regularly. Your doctor will make sure that your urine flow is sufficient. The recommended maximum dose for an adult is 40 ml/kg body weight/day.

In cases where more potassium is needed, your doctor will think about using other strengths as well. This medicine may be given to you as long as you need salts and fluid via a drip into your vein. Elderly In principle, the same dose as for adults can be used. However, if you are elderly it might be necessary to adjust the dose stated to avoid heart or kidney problems. Use in children and adolescents In children and adolescents the dose will depend upon the individual needs. Therefore, your child may receive a reduced dose. Method of administration The medicine will be administered to you through a tube placed into a vein (intravenous drip). If you receive more Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v than you should It is unlikely that this occurs because your doctor will determine your daily doses. Signs of an overdose If you have received too much of this medicine or you have kidney problems your salt levels and water and acid-base balance may be affected. You may also experience tissue fluid accumulation and potassium intoxication. If your sodium level increases too rapidly your brain may become damaged (osmotic demyelination syndrome). Potassium blood levels may especially be excessively increased. Signs of such disorder may be:

Low blood pressure (hypotension)
Irregular heart beats or your heart stops beating
General weakness and listlessness
Muscle weakness, inability to move
Very marked numbness, weakness or heaviness of your legs
Confusion. If you have received too much chloride this may cause a loss of bicarbonate and consequently high levels of acidic substances in your blood. Actions to be taken in case of an overdose

In such a case the infusion rate will be stopped immediately. You may also be given medicines that increase your urine flow. Your heart rate will be monitored continuously. Your doctor will decide on further medication such as insulin or other measures to bring your salt levels, water balance and acidbase balance back to normal. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: ww.mhra.gov.uk/yellowcard 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.

How to store it

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Keep this medicine out of the sight and reach of children. Do not use Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v after the expiry date which is stated on the labels of the bottles and the carton. The expiry date refers to the last day of that month. Do not use the product if the solution appears cloudy or discoloured, if you find particles in the solution or if the bottle and its closure are damaged. This container is for single use only. After use discard container and any remaining contents. Do not reconnect partially used containers. The equipment to be primed with the solution in order to prevent air entering the system. In case of an adverse reaction, infusion must be stopped immediately. The product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Do not store above 25°C.

Contents of the pack and other information

What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion contains

The active substances are potassium chloride and sodium chloride. 1 ml of solution for infusion contains: Potassium chloride Sodium chloride

1.5 mg 9.0 mg

1 litre of solution for infusion contains 20 mmol potassium, 154 mmol sodium and 174 mmol chloride.

The other ingredient is water for injections. •

Theoretical osmolarity pH approximately

340 mOsmol/l 4.5- 7.0

What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion looks like and contents of the pack Solution for infusion Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, is a clear, colourless solution of potassium chloride and sodium chloride in water. It comes in plastic (polyethylene) bottles containing 500 ml or 1000 ml supplied in packs of 10 x 500 ml and 10 x 1000 ml.. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany Postal address 34209 Melsungen Phone: +49/5661/71-0 Fax: +49/5661/714567 Manufacturers B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany B. Braun Medical S.A.

Carretera de Terrassa 121 08191 Rubi, Barcelona, Spain This leaflet was last revised in 07/2024

The following information is intended for healthcare professionals only: Posology Adults: The following recommendations are general guidelines on potassium, however prescribing should follow local guidelines. Potassium The amount required for correction of moderate potassium deficiency and in maintenance may be calculated according to the following formula: mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** – serum-K+actual [mmol/l]) *Term represents the extracellular fluid volume ** should be 4.5 mmol/l The maximum recommended dose of potassium is 2 – 3 mmol/kg body weight (b.w.)/24 h. Paediatric population Generally a substitution rate of 0.5 mmol/kg potassium BW per hour should not be exceeded. Continuous ECG monitoring should be applied during infusion. Maximum daily dose The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours. In any case the limits for daily fluid intake must not be exceeded. Infusion rate The infusion rate will depend on the conditions of the individual patient (see section 4.4). In patients with chronic hyponatraemia the rate of infusion should be slow, so that the resulting increase of the serum sodium level is limited to a maximum of 0.35 mmol/l/h.

Method of administration The maximum rate of Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion administration via peripheral lines is 10 mmol potassium per hour. For greater infusion rates, the solutions should be infused via a central line. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy. Contraindications − Hyperkalaemia, − Severe renal impairment with oliguria, anuria or azotaemia − Hyperchloraemia and severe hypernatraemia, − Hyperhydration. Special warnings and precautions Disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalized oedema, pulmonary oedema, hypertension, pre-eclampsia, severe renal insufficiency. liver cirrhosis. Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects. Paediatric population: Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level. Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Shelf life after first opening the container From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Official document: view the original leaflet →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine.

Medicines with the same active substance: Potassium chloride, Sodium chloride (5 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Correction or maintenance of potassium, sodium, chloride and fluid balance, depending upon the clinical condition of the patient. The solution is particularly indicated in the treatment of hypokalaemia, hypotonic and isotonic dehydration, and hypochloraemic alkalosis.

4.2. Posology and method of administration

The dosage is dependent on age, weight and clinical condition of the patient, especially those with renal or cardiac insufficiency. Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring.

Adequate urine flow must be ensured.

Adults:

The following recommendations are general guidelines on potassium, however prescribing should follow local guidelines.

Potassium

The amount required for correction of moderate potassium deficiency and in maintenance may be calculated according to the following formula:

mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** – serum- K+actual [mmol/l])

*Term represents the extracellular fluid volume

** should be 4.5 mmol/l

The maximum recommended dose of potassium is 2 – 3 mmol/kg b.w./24 h.

Fluids

Generally, not more than 40 ml fluid/kg b.w./day should be supplied. In cases where more potassium is needed, other strengths should be considered as well.

Paediatric population:

The volume and rate of infusion will depend upon the requirements of the individual patient. Reduced volumes and rates of infusion may be required. Generally a substitution rate of 0.5 mmol/kg bw per hour should not be exceeded. Continuous ECG monitoring should be applied during infusion.

Maximum daily dose

The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours. In any case the limits for daily fluid intake must not be exceeded.

Elderly

Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age. See section 4.

Infusion rate

The infusion rate will depend on the conditions of the individual patient (see section 4.4).

In patients with chronic hyponatraemia the rate of infusion should be slow so that the resulting increase of the serum sodium level is limited to a maximum of 0.35 mmol/l/h.

Duration of use

This medicinal product may be administered as long as there is an indication for electrolyte and fluid administration.

Method and route of administration

Intravenous use.

The maximum rate of Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion administration via peripheral lines is 10 mmol potassium per hour. For greater infusion rates, the solutions should be infused via a central line.

As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

4.3. Contraindications

- Hyperkalaemia,

- Severe renal impairment with oliguria, anuria, or azotaemia,

- Hyperchloraemia and severe hypernatraemia,

- Hyperhydration.

4.4. Special warnings and precautions for use

Special warnings

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion should only be administrated with caution in cases of:

• Hypernatraemia

• patients with oedematous states

• pulmonary oedema

• disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalised oedema, pulmonary oedema, hypertension, pre-eclampsia, severe renal insufficiency or liver cirrhosis.

Solutions containing potassium should be administered slowly and only after renal function has been established and proved adequate. In patients with renal impairment, its use must be carefully controlled by frequent determinations of plasma potassium concentrations and periodic ECGs. The infusion must be discontinued if signs of renal insufficiency develop during infusion.

Potassium supplements should be administered with caution in patients with cardiac disease particularly in digitalised patients (see section 4.5).

Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects.

As a slightly hypertonic solution the infusion should also be administered with care in patients with hypertonic dehydration.

Special caution must be exercised if the solution is administered to acidotic patients.

Caution should be exercised when the solution is administered to patients with Addison's disease as these patients are predisposed to hyperkalaemia.

Paediatric population:

Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level.

Elderly patients:

Elderly patients, who are more likely to suffer from cardiac insufficiency and renal impairment, should be closely monitored during treatment, and the dosage should be carefully adjusted, in order to avoid cardio circulatory and renal complications resulting from fluid overload.

Precautions for use

Clinical supervision should include ECGs, regular checks of fluid balance and serum electrolytes.

It is recommended that intravenous equipment is replaced at least once every 24 hours.

4.5. Interaction with other medicinal products and other forms of interaction

● Digoxin, cardiac glycosides

In patients under treatment with cardiac glycosides, care should be taken to keep the potassium concentration constant.

In case of hyperkalaemia - the effect of cardiac glycosides may be weakened, and in case of hypokalaemia it may result in cardiac glycoside toxicity. Interactions might occur in the concurrent administration of other antiarrhythmics. Potassium administration must be very carefully discontinued in these patients.

● Drugs with the potential to induce hyperkalaemia

Care should be taken in the concurrent use of drugs containing potassium, potassium-sparing diuretics and drugs with a potential to induce hyperkalaemia, such as:

- spironolactone

- triamterene

- ACE inhibitors,

- Angiotensin II receptor antagonists,

- non-steroidal anti-inflammatory agents

- ciclosporin

- tacrolimus

- suxamethonium

The concomitant administration of potassium-containing solutions and these drugs may lead to severe hyperkalaemia, which may in turn lead to cardiac arrhythmia.

The concomitant use of sodium-retaining drugs (e.g. corticosteroids, non-steroidal anti- inflammatory agents) may lead to oedema.

● Drugs leading to a decrease of the serum potassium level

ACTH, corticosteroids and loop diuretics can increase the renal elimination of potassium.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). However, as all components of Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to pregnancy are to be expected.

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion can be used during pregnancy if clinically needed.

Nevertheless, caution should be exercised in the presence of pre-eclampsia (see section 4.4).

Breast-feeding

There are no or limited amount of data from the use of potassium chloride and sodium chloride in lactating women.

However, as all components of this medicinal product are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to lactation are to be expected.

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion can be used during breastfeeding if clinically needed.

Fertility

No data available.

4.7. Effects on ability to drive and use machines

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

When used accordingly no adverse drug reactions are to be expected.

Undesirable effects are listed according to their frequencies as follows:

Very Common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to < 1/100)

Rare (≥ 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (frequency cannot be estimated from the available data)

General disorders and administration site conditions

Not known: Local reactions at the infusion site, including local pain, venous irritation and occasionally thrombophlebitis may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Symptoms

In case of overdose hyperkalaemia, hyperhydration, acid-base imbalances, oedema, particularly hypernatraemia, hyperchloraemia or potassium intoxication and electrolyte disorders can result.

The symptoms of hyperkalaemia are primarily cardiovascular disorders and include hypotension, cardiac arrhythmia, heart block, ECG abnormalities with development of biphasic curves and cardiac arrest. Other symptoms include paresthesias of extremities, muscle or respiratory paralysis, areflexia, weakness and mental confusion.

Rapid increase of the serum sodium level in patients with chronic hyponatraemia may lead to the osmotic demyelination syndrome (see section 4.4).

Treatment

Immediate interruption of the infusion, ECG monitoring, if necessary enhancement of urine flow and thus fluid and electrolyte excretion, administration of sodium bicarbonate and insulin. If insulin is given to increase cellular uptake of potassium, glucose should be given to avoid hypoglycaemia. In patients with persistent ECG abnormalities e.g. calcium gluconate may be administered to antagonise the cardiotoxic effects of potassium. Haemodialysis or peritoneal dialysis may be required in patients with renal insufficiency.

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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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