POTASSIUM B.BRAUN 0.04 mEq/ml Prediluted in 0.9% Sodium Chloride Solution for Infusion

2. What you need to know before you use Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml

Do not use Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 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 the tissues of your body (hyperhydration)

Warnings and precautions

Consult your doctor before starting to use Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml.

Your doctor will be particularly careful with this medicine if you have:

• High levels of sodium in the blood (hypernatremia)

• Swelling of the lower limbs (edematous conditions) or water in the lungs (pulmonary edema):

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

• Renal and hepatic 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 this is not the case, your blood levels of potassium and heart will be monitored while you receive this medicine. Your doctor will make sure to stop the infusion if it worsens.

• Heart disease:

If you suffer from heart disease, this medicine will be administered with caution.

If you have high levels of acidic substances in your blood, your doctor will be particularly careful when giving you this medicine.

Your doctor will be particularly careful if you have Addison's disease (a specific disease of the adrenal gland) since potassium levels could become too high.

Your heart rate, water balance, blood salts, and sodium chloride level will be monitored while you are receiving this medicine.

If you are elderly, you are more likely to suffer from 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 the levels of salts and water balance.

Using Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml with other medicines

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

If you are taking digoxin or similar medicines that help your heart work, tell your doctor as it may change its function. The amount of Potassium B. Braun 0.04 mEq/ml Prediluted in Physiological 9 mg/ml may be adjusted, especially at the end of treatment.

Tell your doctor if you are taking medicines that contain potassium or may lead to high levels of potassium such as:

• potassium-sparing medicines, e.g. spironolactone or triamterene (medicines that increase urine flow).
• ACE inhibitors (medicines for 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).
• cyclosporin, tacrolimus (medicines used after organ transplantation).
• suxamethonium (a medicine used during anesthesia).

Your doctor will be particularly careful if you receive/take medicines that capture potassium, as they may cause heart problems (cardiac arrhythmia).

Additionally, your doctor will take care if you use medicines that may capture sodium, as they may cause swelling due to water accumulation (edema).

If you are taking medicines such as corticosteroids (used to treat a wide range of diseases such as asthma, hay fever, urticaria, eczema, painful joints or muscles, nerve pain, inflammatory bowel disease, lupus, multiple sclerosis), adrenocorticotropic hormone (used to treat a wide variety of diseases such as spasms in children, 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 Physiological 9 mg/ml has no effects on the ability to drive or use machines.

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

Follow exactly the administration instructions indicated by your doctor. In case of doubt, consult your doctor again.

Dose

Your doctor will determine the amount of medicine that will be administered to you, and it will depend on your age, weight, and situation, especially if your heart or kidneys are not working properly. While you receive this medicine, the levels of sodium chloride and electrolytes (salts) in your blood, water balance, and your heart will be routinely monitored. Your doctor will ensure that your urine flow is sufficient.

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

This medicine will be administered to you for as long as you need salts and fluid through infusion.

Elderly

In principle, the same dose as for adults can be used. However, it is possible to adjust the dose in order to avoid heart and kidney problems.

Use in children and adolescents

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

Method of administration

This medicine will be administered to you through a drip in a vein (intravenous drip).

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

It is unlikely that this will happen, as your doctor will determine your daily dose.

Signs of overdose

If you receive more medicine or have kidney problems, the levels of salt and water and acid-base balance may be affected. You may experience accumulation of fluid in the tissues and potassium intoxication.

If the level of sodium increases too quickly, your brain may be damaged (osmotic demyelination syndrome).

The levels of potassium in your blood may increase excessively. The signs of this disorder may be:

• Low blood pressure (hypotension)
• Irregular heartbeats or the heart stops beating
• General weakness and languor
• Muscle weakness, inability to move
• Numbness, weakness, and heaviness of legs
• Confusion

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

Actions to be taken in case of overdose

In this case, the infusion will be stopped immediately. It is possible that you will receive medicines to increase urine flow. Your heart rate will be continuously monitored. Your doctor will decide on additional medication such as insulin or other measures to normalize your levels of salt, water balance, and acid-base balance.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Tell your doctor if you notice pain or sensitivity or inflammation of blood clots at the injection site.

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting side 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 Physiological 9 mg/ml

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

Do not use this medicine after the expiry date which is stated on the label and on the outer packaging after EXP. The expiry date is the last day of the month stated.

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

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

The equipment 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 must be used immediately. Otherwise, the times and conditions of use are the responsibility of the user.

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

Do not store above 25°C.

6. Contents of the pack 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 solution for infusion contains 3 mg of potassium chloride and 9 mg of sodium chloride.

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

The other component is water for injectable preparations

Appearance and pack contents

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

It is presented in plastic bottles (polyethylene) containing 500 ml or 1000 ml each, available in packs of 10 x 500 ml and 10 x 1000 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

• Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

ManufacturerB. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Phone: +49-5661-71-0

Fax: +49-5661-4567

• Braun Medical S.A.

Carretera de Terrassa 121

08191 Rubí, Barcelona

Spain

Phone: +34-93-5866200

Fax: +34-93-5881096

This medicine is authorized in the Member States of the EEA 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 solution for infusion

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 last revision of this leaflet:August 2018

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

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This information is intended only for healthcare professionals:

Dosage

Adults:

The following recommendations are general guidelines for potassium, however, it should be prescribed according to local guidelines.

Potassium

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

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

*The term represents the extracellular fluid volume

**should be 4.5 mmol/l

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

Pediatric population:

Generally, the substitution rate should not exceed 0.5 mmol of potassium/kg of body weight per hour. During infusion, electrocardiographic monitoring should be performed

Maximum daily dose

The maximum recommended dose of potassium is 3 mmol per kg of body weight in 24 hours. In no case should the maximum daily dose be exceeded.

Infusion rate:

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

In patients with chronic hyponatremia, the infusion rate should be slow, so that the resulting increase in serum sodium levels is limited to a maximum of 0.35 mmol/l per hour.

Method of administration

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

As a basic rule, infusion pumps should be used for potassium infusion in the adjustment of correct therapy.

Contraindications

Hyperkalemia

Severe renal failure with oliguria and anuria or azotemia

Hyperchloremia and severe hypernatremia

Hyperhydration.

Special warnings and precautions

Disorders where sodium intake has been restricted, such as heart failure, generalized edema, pulmonary edema, hypertension, pre-eclampsia, severe renal failure, or liver cirrhosis.

The supplement of sodium chloride should be carried out slowly in patients with chronic hyponatremia, as the excessively rapid correction of serum sodium levels can lead to osmotic side effects in rare cases.

Pediatric population:

Premature or full-term babies may retain excess sodium due to immature renal function. In premature or full-term infants, repeated infusion of sodium chloride should only be administered after determining the serum sodium level.

Incompatibilities In the absence of compatibility studies, this medicine should not be mixed with other medicines.

Shelf life after first opening of the container

From a microbiological point of view, unless the opening method prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, the times and conditions of use are the responsibility of the user.