Potassium B. Braun 0.02 mEq/ml Prediluted inFisiológico 9 mg/ml

infusion solution

Potassium chloride and Sodium chloride

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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

This medication is used to maintain or restore your sodium, potassium, chloride, and fluid levels when they are low.

No usePotassium B. Braun 0.02 mEq/mL Diluted in Physiological 9 mg/mL

• If you have abnormally high levels of potassium (hyperkalemia), chloride (hyperchloremia), or very high levels of sodium in your blood (severe hypernatremia)
• If you have a 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 0.02 mEq/mL Diluted in Physiological 9 mg/mL.

Your doctor will take special care with this medication if you have:

• High levels of sodium in your blood (hypernatremia)
• Swelling of the lower limbs (edematous states) or water in the lungs (pulmonary edema)

If you have one of these conditions, you will receive large amounts of this medication only with caution.

• Renal and hepatic function:

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

• Heart disease:

If you suffer from heart disease, this medication 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 medication.

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

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

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 medication will be administered to your child with special caution. Your doctor will strictly monitor your child's salt levels and fluid balance.

Use ofPotassium B. Braun 0.02 mEq/mL Diluted in Physiological 9 mg/mLwith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications.

If you are taking digoxin or similar medications that help your heart function, inform your doctor as it may change its functioning. The amount of Potassium B. Braun 0.02 mEq/mL Diluted in Physiological 9 mg/mL may be adjusted, especially at the end of treatment.

Inform your doctor if you are taking medications that contain potassium or may lead to high potassium levels such as:

• Potassium-saving medications, for example, spironolactone or triamterene (medications that increase urine flow)
• ACE inhibitors (medications to treat high blood pressure or heart failure)
• AT1 receptor antagonists (medications for high blood pressure)
• Non-steroidal anti-inflammatory agents (for acute or chronic pain and inflammation).
• Ciclosporin, tacrolimus (medications used after organ transplantation).
• Suxamethonium (medication used during anesthesia).

Your doctor will take special care of you if you receive/take medications that capture potassium, as they may cause heart problems (cardiac arrhythmia).

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

If you are taking medications such as corticosteroids (used to treat a wide range of diseases such as asthma, hay fever, urticaria, eczema, joint pain or muscles, nerve compression 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 lactation

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

This medication may be used during pregnancy and lactation if your doctor considers it necessary.

Driving and operating machines

Potassium B. Braun 0.02 mEq/mL Diluted in Physiological 9 mg/mL has no effect on your ability to drive or operate machines.

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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 medication to be administered, and it will depend on your age, weight, and condition, especially if your heart or kidneys do not function correctly. While receiving this medication, your blood levels of sodium chloride and electrolytes (salts), fluid balance, and heart will be monitored regularly. 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 potassium is necessary, your doctor will study the use of other doses.

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

Older adults

Initially, the same dose as in adults can be used. However, it may be necessary to adjust the dose to avoid heart and kidney problems.

Use in children and adolescents

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

Administration form

This medication will be administered through a drip in a vein (intravenous infusion).

If you receive more Potasio B. Braun 0.02 mEq/ml Prediluido in Fisiológico 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 medication or have kidney problems, your salt levels and fluid and acid-base balances may be affected. You may experience tissue fluid accumulation and potassium intoxication.

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

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

• Low blood pressure (hypotension)
• Irregular heartbeats or the heart stops beating
• 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 a loss of bicarbonate and therefore 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 medication to increase urine flow. Your heart rate will be monitored continuously. Your doctor will decide on additional medication, such as insulin or other measures, to normalize your salt levels, fluid balance, and acid-base balance.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

When this medication is used as directed, it is very unlikely that side effects will occur.

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

Reporting 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 prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

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

This medication 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 medication must be used immediately. Otherwise, the times and conditions of storage in use are the responsibility of the user.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Do not store above 25°C.

Composition ofPotassium B. Braun 0.02mEq/ml Prediluted in Physiological 9 mg/ml

The active principles are potassium chloride and sodium chloride.

1 ml of infusion solution contains 1.5 mg of potassium chloride and 9 mg of sodium chloride.

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

The other component is water for injection.

Theoretical osmolality340 mOsmol/L

Approximate pH 4.5 – 7.0

Appearance of theproduct and contents of the packaging

Potassium B. Braun 0.02 mEq/ml Prediluted in Physiological 9 mg/mlis a transparent and colorless solution of potassium chloride and sodium chloride in water.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Melsungen AG

Carl-Braun Strasse 1

34212 Melsungen

Germany

Responsible for manufacturing

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany
Tel: +49-5661-71-0

Fax: +49-5661-4567

B. Braun Medical S.A.

Carretera de Terrassa 121

08191 Rubí, Barcelona

Spain
Tel: +34-93-5866200

Fax: +34-93-5881096

This medicinal product is authorized in the Member States of the EEA with the following names:

Czech RepublicPotassium chloride/sodium chloride 0.15%+ 0.9% B. Braun

EstoniaPotassium chloride/sodium chloride B. Braun 1.5 mg/ml+ 9 mg/ml, infusion solution / infusion solution, solution / infusioonilahus

SpainPotassium B. Braun 0.02mEq/ml Prediluted in Physiological 9 mg/ml

FinlandPotassium chloride/sodium chloride B. Braun 1.5 mg/ml + 9 mg/ml infusion solution / infusion solution, solution / infusioonilahus

IrelandPotassium Chloride 0.15 % w/v and Sodium Chloride 0.9 % w/v solution for infusion

The NetherlandsPotassium chloride 0.15% - Sodium chloride 0.9%, solution for intravenous infusion

PolandPotassium Chloride 0.15% + Sodium Chloride 0.9% B. Braun

PortugalSodium chloride 0.15% + Sodium chloride 0.9% B.Braun

SlovakiaPotassium chloride/sodium chloride 0.15% + 0.9% B. Braun

United KingdomPotassium Chloride 0.15% w/v and Sodium Chloride 0.9 % w/v solution for infusion

Date of the last review of this leaflet: April 2017

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http.//www.aemps/gob.es/

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This information is intended solely 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 maintenance can be calculated according to the following formula:

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

*The term represents the volume of extracellular fluid

** 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.

Paediatric population

Generally, the rate of substitution 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 per 24 hours. In no case should the maximum daily dose be exceeded.

Infusion rate

The infusion rate will depend on the state of each patient (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.

Administration form

The maximum rate of administration of Potassium B. Braun 0.02 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 to adjust a correct therapy.

Contraindications

Hyperkalemia

Severe renal insufficiency with oliguria and anuria or azotemia

Severe hyperchloremia and hypernatremia

Overhydration.

Warnings and special precautions

Conditions where sodium restriction has been indicated, such as heart failure, generalized edema, pulmonary edema, hypertension, preeclampsia, severe renal insufficiency, or liver cirrhosis.

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

Paediatric population:

Preterm or term infants may retain an excess of sodium due to immature renal function. In preterm or term infants, repeated infusion of sodium chloride should only be administered after determining serum sodium levels.

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

Period of validity after the first opening of the packaging

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 storage in use are the responsibility of the user.