Potassium B. Braun 0.04 mEq/ml prediluted in sodium chloride 9 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml solution for infusion

Potassium chloride and Sodium chloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml is and what it is used for
2. What you need to know before using Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml
3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml
4. Possible side effects
5. How to store Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml
6. Contents of the pack and other information

1. What Potassium B. Braun 0.04 mEq/ml Prefilled in Sodium Chloride 9 mg/ml is and what it is used for

This medicine contains a solution of potassium chloride and sodium chloride. It is administered through a narrow catheter into a vein (intravenous infusion).

This medicine is used to maintain or restore your levels of sodium, potassium, chloride, and also fluids when these levels are low.

2. What you need to know before using Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml

Do not use Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml

• if you have abnormally high levels of potassium (hyperkalemia) or chloride (hyperchloremia), or very high levels of sodium in your blood (severe hypernatremia)
• if you have severe kidney disease
• if you have excess water in your body tissues (hyperhydration)

Warnings and precautions

Talk to your doctor before starting to use Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml.

Your doctor will exercise special caution when using this medicine if you have:

• High levels of sodium in the blood (hypernatremia)

• Swelling of the lower limbs (edematous states) or fluid in the lungs (pulmonary edema):

If you have any of these conditions, large amounts of this medicine will be administered only with caution.

• Kidney and liver function:

You will receive this medicine as a slow intravenous infusion after your doctor has ensured that your kidneys and liver are functioning properly. If this is not the case, your blood potassium levels and heart function will be monitored while you receive this medicine. Your doctor will ensure that the infusion is stopped if your condition worsens.

• Heart disease:

If you have a heart condition, this medicine will be administered with caution.

If you have high levels of acidic substances in your blood, your doctor will take special care when administering this medicine.

Your doctor will take special care if you have Addison's disease (a specific disorder of the adrenal gland), as potassium levels could become too high.

Your heart rate, fluid balance, blood electrolytes, and sodium chloride levels will be monitored while you are receiving this medicine.

If you are elderly, you are more likely to have heart and kidney problems, so you will be closely monitored during treatment and the dose will be carefully adjusted.

Children

This medicine will be administered to your child with special caution. Your doctor will strictly monitor electrolyte levels and fluid balance.

Use of Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines.

If you are taking digoxin or similar medicines that help your heart function, inform your doctor, as their effectiveness may change. The amount of Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml may be adjusted, especially towards the end of treatment.

Inform your doctor if you are taking medicines containing potassium or that may lead to high potassium levels, such as:

• potassium-sparing agents, for example spironolactone or triamterene (medicines that increase urine flow)
• ACE inhibitors (medicines used to treat high blood pressure or heart failure)
• AT1 receptor antagonists (medicines for blood pressure)
• non-steroidal anti-inflammatory agents (for acute or chronic pain and inflammation)
• cyclosporine, tacrolimus (medicines used after organ transplantation)
• suxamethonium (a medicine used during anesthesia)

Your doctor will exercise special caution if you are receiving/taking medicines that retain potassium, as they may cause heart problems (cardiac arrhythmia).

Additionally, your doctor will monitor you if you are using medicines that may retain sodium, as these can cause swelling due to water retention (edema).

If you are taking medicines such as corticosteroids (used to treat a wide range of conditions such as asthma, hay fever, hives, eczema, painful joints or muscles, nerve-impingement pain, inflammatory bowel disease, lupus, multiple sclerosis), adrenocorticotropic hormone (used to treat a wide range of conditions such as infantile spasms, multiple sclerosis, arthritis, lupus, Stevens-Johnson syndrome), and diuretics (for high blood pressure), the amount of potassium lost through your kidneys may increase.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine may be used during pregnancy and breastfeeding if your doctor considers it necessary.

Driving and using machines

Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml has no effect on the ability to drive or operate machinery.

3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor again.

Dosage

Your doctor will determine the amount of medication you will receive, which will depend on your age, weight, and condition, especially if your heart or kidneys are not functioning properly. While receiving this medicine, blood levels of sodium chloride and electrolytes (salts), fluid balance, and your heart function will be routinely monitored. Your doctor will ensure that your urinary flow is adequate.

The maximum recommended dose for an adult is 40 ml/kg body weight per day. In cases where more potassium is required, your doctor will consider the use of other doses.

This medicine will be administered for as long as you need salts and fluids via infusion.

Elderly patients

In principle, the same dose as in adults may be used. However, the dose may be adjusted to avoid heart or kidney problems.

Use in children and adolescents

In children and adolescents, your doctor will decide the dose individually; therefore, your child may receive a lower dose.

Method of administration

This medicine will be administered through an intravenous infusion (intravenous drip).

If you receive more Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml than you should

This is unlikely to happen, as your doctor will determine your daily dose.

Signs of overdose

If you receive too much medication or have kidney problems, salt levels and water and acid-base balances may be affected. You may experience tissue fluid accumulation and potassium intoxication.

If sodium levels rise too rapidly, your brain may be damaged (osmotic demyelination syndrome).

Potassium levels in blood may rise excessively. Signs of this condition may include:

• Low blood pressure (hypotension)
• Irregular heartbeat or cardiac arrest
• General weakness and lethargy
• Muscle weakness, inability to move
• Numbness, weakness, and heaviness in legs
• Confusion

If you have received too much chloride, this may cause loss of bicarbonate and thus lead to high levels of acidic substances in the blood.

Actions to take in case of overdose

In this case, the infusion will be stopped immediately. You may receive medications to increase urine flow. Your heart rhythm will be continuously monitored. Your doctor will decide on additional treatment, such as insulin or other measures, to normalize your salt levels, water balance, and acid-base balance.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

When this medicine is used according to the instructions, side effects are very unlikely to occur.

Inform your doctor if you notice pain, tenderness, or swelling due to blood clots at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Potassium B. Braun 0.04 mEq/ml Prediluted in Sodium Chloride 9 mg/ml

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the solution is cloudy or discolored, if you observe particles in the solution, or if the container or closure is damaged.

This medicine is for single use only. After use, dispose of the container and any remaining contents. Do not reconnect partially used containers.

The administration set must be primed with the solution to prevent air from entering the system.

In case of an adverse reaction, the infusion must be stopped immediately.

The medicine should be used immediately. Otherwise, the storage times and conditions during use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

Do not store above 25°C.

6. Contents of the container and other information

Composition of Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml

The active substances are potassium chloride and sodium chloride.

1 ml of infusion solution contains 3 mg of potassium chloride and 9 mg of sodium chloride.

1 litre of infusion solution contains 40 mmol of potassium, 154 mmol of sodium and 194 mmol of chloride.

The other component is water for injections.

Appearance of the product and contents of the container

Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml is a clear, colourless solution of potassium chloride and sodium chloride in water.

It is supplied in plastic (polyethylene) bottles containing 500 ml or 1,000 ml each, available in packs of 10 x 500 ml and 10 x 1,000 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

• Braun Melsungen AG
  Carl-Braun Strasse 1
  34212 Melsungen
  Germany

Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Tel: +49-5661-71-0
Fax: +49-5661-4567

• Braun Medical S.A.
  Carretera de Terrassa 121
  08191 Rubí, Barcelona
  Spain
  Tel: +34-93-5866200
  Fax: +34-93-5881096

This medicinal product is authorised in the EEA Member States under the following names:

Czech Republic: Kaliumchlorid/natriumchlorid 0,3% + 0,9% B. Braun
Estonia: Kalii chloridum/Natrii chloridum B. Braun 3 mg/ml + 9 mg/ml, infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Spain: Cloruro Potásico 0,04 mEq/ml en Fisiológico 9 mg/ml Prediluido B. Braun solución para perfusión
Finland: Kalii chloridum/Natrii chloridum B. Braun 3 mg/ml + 9 mg/ml infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Ireland: Potassium Chloride 0.3 % w/v and Sodium Chloride 0.9 % w/v solution for infusion
The Netherlands: Kaliumchloride 0,3% - Natriumchloride 0,9%, oplossing voor intraveneuze infusie
Poland: Potassium Chloride 0.3% + Sodium Chloride 0.9% B. Braun
Portugal: Cloreto de Potássio 0.3%+ Cloreto de Sódio 0.9% B.Braun
Slovakia: Kaliumchlorid/natriumchlorid 0,3% + 0,9% B. Braun
United Kingdom: Potassium Chloride 0.3% w/v and Sodium Chloride 0.9 % w/v solution for infusion

Date of the most recent review of this summary: August 2018

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Dosage

Adults:

The following recommendations are general guidelines for potassium; however, local guidelines should be followed.

Potassium

The amount required to correct moderate potassium deficiency and for maintenance can be calculated using the following formula:

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

*The term represents the volume of extracellular fluid
** target should be 4.5 mmol/l

The recommended maximum dose of potassium is 2 to 3 mmol per kg of body weight per 24 hours.

Paediatric population

Potassium replacement rate should generally not exceed 0.5 mmol/kg body weight per hour. Electrocardiographic monitoring is required during infusion.

Maximum daily dose

The recommended maximum dose of potassium is 3 mmol per kg of body weight in 24 hours. The maximum daily dose must never be exceeded.

Infusion rate:

The infusion rate will depend on the patient's clinical condition (see section 4.4).

In patients with chronic hyponatraemia, the infusion rate must be slow so that the resulting increase in serum sodium levels does not exceed 0.35 mmol/l per hour.

Method of administration

The maximum rate of administration of Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml via peripheral lines is 10 mmol of potassium per hour. For higher infusion rates, administration must be via a central line.

As a general rule, infusion pumps should be used for potassium infusion to ensure accurate and safe therapy delivery.

Contraindications

Hyperkalaemia

Severe renal failure with oliguria and anuria or azotaemia

Severe hyperchloraemia and hypernatraemia

Hyperhydration.

Warnings and special precautions

Conditions where sodium intake restriction is indicated, such as cardiac failure, generalized oedema, pulmonary oedema, hypertension, pre-eclampsia, severe renal failure or hepatic cirrhosis.

Sodium chloride supplementation should be administered slowly in patients with chronic hyponatraemia, as excessively rapid correction of serum sodium levels may rarely lead to osmotic side effects.

Paediatric population:

Premature or full-term infants may retain excess sodium due to immature renal function. Repeated infusion of sodium chloride should only be administered after determination of serum sodium levels in premature or full-term infants.

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

Shelf-life after first opening of the container

From a microbiological standpoint, unless the method of opening ensures no risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of storage in use are the responsibility of the user.