Label: information for the user

Potassium B. Braun 0.04 mEq/ml Prediluted in 5% glucose solution for infusion

Potassium chloride and Glucose

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

This medicationcontains a potassium chloride and glucose solution. It is administered through a narrow-bore catheter into a vein (intravenous drip).

This medication is used to maintain or restore your potassium levels andmeet your basic energy needs.

Do not use Potassium B. Braun 0.04 mEq/mL Prediluted in 5% Glucose Solution for Infusion

• If you have abnormally high levels of potassium or chloride in your blood (hyperkalemia or hyperchloremia)
• If you have severe kidney disease
• If you have had head injuries (within the first 24 hours)

• If you have excessive water in your body (hyperhydration)
• If you have high levels of glucose in your blood (hyperglycemia)
• If you have recently had a stroke

Warnings and Precautions

Patients with acute diseases, pain, postoperative stress, infections, burns, neurological, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (hormone that regulates the amount of body fluids) have a certain risk of developing abnormally low levels of sodium in the blood (acute hyponatremia) that can lead to brain inflammation (encephalopathy).

Children, fertile women, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage have a certain risk of severe and potentially fatal brain inflammation caused by a sudden decrease in sodium levels in the blood.

Consult your doctor before starting to use Potassium B. Braun 0.04 mEq/mL Prediluted in 5% Glucose Solution.

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

• Kidney problems:

You will receive this medication as a slow intravenous infusion after your doctor has ensured that your kidneys are functioning properly. If you have kidney problems, your potassium levels, blood levels, and electrocardiogram will be monitored while you receive this medication. Your doctor will ensure that the infusion is stopped if it worsens.

• Heart disease:

If you have heart disease, this medication will be administered with caution.

• Swelling of the lower limbs (edematous states) or water in the lungs (pulmonary edema).

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

• High levels of salts in the blood
• Certain type of diabetes:

This medication will be administered with caution

• if you have diabetes
• in other conditions when your body does not process sugars normally (for example, if you are taking other medications, see the section “Use of Potassium B. Braun 0.04 mEq/mL Prediluted in 5% Glucose Solution with other medications”)

Your glucose levels will be controlled.

• Blood transfusion

This medication will not be administered simultaneously, or before or after blood administration, through the same route.

• Too much potassium in the blood

If you have a disease where potassium levels are too high in your blood, such as Addison's disease (a specific adrenal gland disease).

• Burns

If you have burns, this medication will be administered with caution

• Dehydration

If you are dehydrated, this medication will be administered with caution

Your electrocardiogram, fluid balance, blood electrolytes, and glucose levels will be checked regularly while you are receiving this medication.

Older patients, who are more prone to heart and kidney problems, will be continuously 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 rigorously monitor your child's electrolyte levels and fluid balance.

This medication will be administered to your child with caution, if their electrolyte levels, especially sodium, are too low. Your doctor will rigorously monitor your child's electrolyte levels and fluid balance.

Use of Potassium B. Braun 0.04 mEq/mL Prediluted in 5% Glucose Solution with other medications

Inform your doctor, nurse, or pharmacist if you are using or have recently used other medications,especially the following medications that increase the effect of vasopressin and the risk of having low sodium levels (hyponatremia):

• Carbamazepines and oxcarbazepine used for epilepsy treatment
• Vincristine and ifosfamide used for cancer treatment
• Cyclophosphamide for cancer and autoimmune disease treatment
• Selective serotonin reuptake inhibitors (SSRIs) for depression treatment
• Antipsychotics for mental disorders
• Opioid analgesics for severe pain relief
• Nonsteroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and for treating body inflammation.
• Desmopressin for treating diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine)
• Oxytocin used during childbirth
• Vasopressin and terlipressin used for treating bleeding esophageal varices (dilated veins in the esophagus caused by liver problems)
• Diuretics (medications that increase urine excretion)

.

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 0.04 mEq/mL Prediluted in 5% Glucose Solution may be adjusted, especially at the end of treatment.

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

• Potassium-sparing medications, for example, spironolactone or triamterene (medications that increase urine flow)
• Angiotensin-converting enzyme (ACE) inhibitors (medications for high blood pressure or heart failure)
• Angiotensin II receptor antagonists (medications for high blood pressure)
• Nonsteroidal anti-inflammatory drugs (for acute or chronic pain and for body 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).If you are taking certain medications called corticosteroids, adrenocorticotropic hormone, and diuretics, 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, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

Potassium B. Braun 0.04 mEq/mL Prediluted in 5% Glucose Solution does not affect your ability to drive or operate machines.

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 conditionespecially if your heart or kidneys do not function correctly. While receiving this medication, your blood glucose and electrolyte (salt) levels, fluid balance, and electrocardiogram will be monitored regularly. Your doctor will ensure that your urine flow is sufficient.

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

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

Older adults

Initially, the same dose as in adults can be used. However, it is possible to adjust the dose 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.

Administration form

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

If you receive morePotassium B. Braun 0.04mEq/ml Prediluted in Glucose 5% solution for infusionthan you should

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

Your doctor will monitor your chemical and fluid balance, blood glucose and electrolyte (including sodium) levels before and during treatment, especially in patients with altered vasopressin release (hormone that regulates fluid balance) and patients taking medications that increase vasopressin action due to a risk of abnormally low sodium levels in the blood (hyponatremia).

Signs of overdose

If you receive more medication or have kidney problems, your salt, sugar, and fluid and acid-base balance levels may be affected. You may also experience tissue fluid accumulation and potassium intoxication.

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.
• Abnormal electrocardiogram until the heart stops beating
• General weakness and lethargy
• Muscle weakness, inability to move
• Numbness, weakness, and heaviness in legs
• Confusion

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.

Whenthis medication is used as instructed, it is very unlikely that side effects will occur.

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

You may develop an imbalance in the levels of fluids and certain minerals in your body. You may develop low levels of sodium (hyponatremia), potassium, phosphate, and magnesium in your blood.

Abnormally low levels of sodium in the blood may cause a serious condition called hyponatremia. It may cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy. Symptoms of encephalopathy include: headache, nausea, vomiting, seizures, fatigue, and lack of energy.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is an adverse effect that does not appear 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.

Before opening: Do not store above 25°C.

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 closure are damaged.

This container is for single use. After use, discard the container and any remaining contents.

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

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofPotassiumB.Braun0.04mEq/mlPredilutedinGlucose5%

• The active principles are potassium chloride and glucose.

1 ml of infusion solution contains 3 mg of potassium chloride and 50 mg of glucose.

1,000 ml of infusion solution contains 40 mmol of potassium and 40 mmol of chloride.

The other component is water for injection.

Caloric value (approx.)835 kJ/l?200 kcal/l

Theoretical osmolality (approx)358 mOsm/l

Approximate pH3.5 – 6.5

Appearance of the product and contents of the container

Potassium B.Braun 0.04 mEq/ml Prediluted in Glucose 5%solution for infusion is a sterile, transparent and colorlessuntil slightly yellowish color of potassium chloride and glucose in water.

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

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 RepublicKaliumchlorid/glucose0.3%+ 5% B. Braun

EstoniaKalii chloridum/Glucosum B. Braun3 mg/ml+ 50 mg/ml, infusioneste, liuos / infusionsvätska, lösning / infusioonilahus

SpainPotasio B.Braun 0.04 mEq/ml Prediluted in Glucose 5%solution for infusion

FinlandKalii chloridum/Glucosum B. Braun(3 mg/ml)+ 50 mg/ml infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus

IrelandPotassium Chloride0.3%w/v and Glucose 5% w/v solution for infusion

The NetherlandsKaliumchloride0,3%- Glucose 5%, oplossing voor intraveneuze infusie

PolandPotassium Chloride0,3%+ Glucose 5% B. Braun

PortugalCloreto de Potássio0.3%+ Glucose 5% B.Braun

SlovakiaKaliumchlorid/glucose0,3%+ 5% B. Braun

United KingdomPotassium Chloride0.3%w/v and Glucose 5% w/v solution for infusion

Date of the last review of this leaflet: August 2018

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

--------------------------------------------------------------------------------------------------------------------

Thisinformation 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 in maintenance can becalculated according to the following formula:

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

Maximum infusion rate

Up to 5 ml/kg of body weight per hour, corresponding to 0.25 g glucose/kg of body weight per hour

Pediatric population:

Generally, the rate of substitution should not exceed 0.5 mmol of potassium/kg of body weight per hour.

Maximum daily dose

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

Administration form

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

Warnings and special precautions

Solutions with low electrolyte content, especially sodium, should be administered with caution in patients with hyponatremia.

Care should be taken to avoid a marked decrease in plasma sodium levels, as it could be associated with the risk of osmotic central nervous system injury.

Pediatric population

The infusion of hypotonic fluids, along with the non-osmotic secretion of antidiuretic hormone (in pain, post-operative state, nausea and vomiting) could trigger hyponatremia.

Treatment of overdose

Immediate discontinuation of infusion, electrocardiogram monitoring, if necessary, increase in urine flow and therefore, excretion of fluids and electrolytes, administration of sodium bicarbonate and insulin. If insulin is administered to increase cellular uptake of potassium, glucose should be administered to prevent hypoglycemia. In patients with persistent electrocardiogram abnormalities, calcium gluconate may be administered to counteract the cardiotoxic effects of potassium. Hemodialysis or peritoneal dialysis may be necessary in patients with renal insufficiency.

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 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 storage in use are the responsibility of the user.

For complete information on this medicinal product, see the technical data sheet.