POTASSIUM B. BRAUN 0.04 mEq/ml PREDILUTED IN 5% GLUCOSE SOLUTION FOR INFUSION

Introduction

Leaflet: information for the user

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

Potassium chloride and Glucose

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet:

1. What Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% is and what it is used for
2. What you need to know before starting to use Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5%
3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5%
4. Possible side effects
5. Storage of Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5%
6. Package contents and additional information

1. What Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion is and what it is used for

This medicine contains a solution of potassium chloride and glucose. It is administered through a narrow catheter in a vein (intravenous drip).

This medicine is used to maintain or restore your potassium levels and cover your basic energy needs.

2. What you need to know before starting to use Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion

Do not use Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% 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 (in the first 24 hours)

• if you have excess water in your body (hyperhydration)
• if you have high blood glucose levels (hyperglycemia)
• if you have recently had a stroke

Warnings and precautions

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

Children, women of childbearing age, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage are at 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 Glucose 5%.

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

• Kidney problems:

You will receive this medicine as a slow intravenous drip 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 medicine. Your doctor will ensure that the infusion is stopped in case of worsening.

• Heart disease:

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

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

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

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

This medicine will be administered with caution

• if you have diabetes
• in other conditions when your body does not process sugars normally (e.g., if you are taking other medications, see the section "Using Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% with other medications")

Your glucose levels will be monitored.

• Blood transfusion

This medicine will not be administered simultaneously, 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 disease of the adrenal gland).

• Burns

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

• Dehydration

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

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

Elderly 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 medicine will be administered to your child with special caution. Your doctor will strictly monitor the levels of salts and fluid balance.

This medicine will be administered to your child with caution if the levels of salts, especially sodium, are too low. Your doctor will strictly monitor the levels of salts and fluids.

Using Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion with other medications

Tell 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 low sodium levels (hyponatremia):

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

If you are taking digoxin or similar medications that help your heart function, inform your doctor, as it may change its function. The amount of Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% may be adjusted, especially at the end of treatment.

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

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

Your doctor will be particularly careful with 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 loop diuretics, 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 Glucose 5% has no effects on the ability to drive or use machines.

3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion

Follow your doctor's instructions for administration exactly. If in doubt, consult your doctor again.

Dose

Your doctor will determine the amount of medicine to be administered, depending on your age, weight, and situation, especially if your heart or kidneys are not functioning correctly. While you receive this medicine, your glucose and electrolyte (salt) levels in the blood, fluid balance, and electrocardiogram will be routinely monitored. 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 necessary, your doctor will study the use of other doses.

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

Elderly patients

In principle, the same dose as for 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.

Method of administration

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

If you receive more Potassium B. Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion than you should

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

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

Signs of overdose

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

Potassium levels in the blood 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 languor
• Muscle weakness, inability to move
• Numbness, weakness, and heaviness of legs
• Confusion

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, sensitivity, or inflammation of blood clots at the injection site.

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

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

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Glucose 5%

Before opening: Do not store above 25°C.

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 on the outer packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine 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 medicine should be used immediately. Otherwise, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the container and any remaining medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofPotassiumB.Braun0.04mEq/mlPredilutedinGlucose5%

• The active ingredients are potassium chloride and glucose.

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

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

The other component is water for injectable preparations

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

Theoretical osmolality (approx) 358 mOsm/l

pH approximately 3.5 – 6.5

Appearance of the Product and Container Content

Potassium B.Braun 0.04 mEq/ml Prediluted in Glucose 5% solution for infusion is a sterile, transparent, and colorless to slightly straw-colored solution 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen

Germany

Manufacturer

• 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 Medicinal Product is Authorized in the EEA Member States with the Following Names:

Czech Republic Kaliumchlorid/glucose 0.3% + 5% B. Braun

Estonia Kalii chloridum/Glucosum B. Braun 3 mg/ml + 50 mg/ml, infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus

Spain Potasio B.Braun 0.04 mEq/ml Prediluido en Glucosa 5% solución para perfusión

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

Ireland Potassium Chloride 0.3% w/v and Glucose 5% w/v solution for infusion

The Netherlands Kaliumchloride 0.3%- Glucose 5%, oplossing voor intraveneuze infusie

Poland Potassium Chloride 0.3% + Glucose 5% B. Braun

Portugal Cloreto de Potássio 0.3% + Glucose 5% B.Braun

Slovakia Kaliumchlorid/glucose 0.3%+ 5% B. Braun

United Kingdom Potassium Chloride 0.3% w/v and Glucose 5% w/v solution for infusion

Date of the Last Revision of this Leaflet: August 2018

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://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 necessary for the correction of moderate potassium deficiency and 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.

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, a substitution rate of 0.5 mmol of potassium/kg of body weight per hour should not be exceeded.

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.

Method of Administration

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

Special Warnings and Precautions

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

Caution should be exercised to avoid a marked decrease in plasma sodium levels, as this could be associated with the risk of central nervous system osmotic 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 interruption of the infusion, electrocardiographic 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 avoid hypoglycemia. In patients with persistent electrocardiogram abnormalities, gluconate calcium can be administered, for example, to counteract the cardiotoxic effects of potassium. Hemodialysis or peritoneal dialysis may be necessary in patients with renal failure.

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 point of view, unless the opening method precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

For complete information on this medicinal product, see the summary of product characteristics.