Potasio B. Braun 0,04 meq/ml prediluted in glucose 4% and sodium chloride 0,18% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium B. Braun 0.04 mEq/ml Pre-diluted in

4% glucose and 0.18% sodium chloride solution for infusion

Potassium chloride, Glucose monohydrate, Sodium chloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Potassium B. Braun 0.04 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride solution for infusion is and what it is used for
2. What you need to know before you use Potassium B. Braun 0.04 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride solution for infusion
3. How to use Potassium B. Braun 0.04 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride solution for infusion
4. Possible side effects
5. How to store Potassium B. Braun 0.04 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride solution for infusion
6. Contents of the pack and other information

1. What Potassium B. Braun 0.04 mEq/ml Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion is and What It Is Used For

This medicine is an infusion solution (administered through an intravenous drip).

This medicine is used to maintain or restore your levels of potassium, sodium, chloride, and fluids in cases where energy supplementation is also required and dietary measures or oral medication are inadequate.

2. What you need to know before starting to use Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion

Do not use Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion

• if you are allergic to potassium or any of the other ingredients of this medicine (listed in section 6),
• if you have abnormally high levels of potassium (hyperkalemia) or chloride (hyperchloremia) in your blood,
• if you have severe kidney disease with oliguria (reduced urine output), anuria (absence of urine production), or azotemia (excess nitrogenous waste in the blood due to kidney failure),
• if your blood sodium levels are elevated (hypernatremia),
• if you suffer from hyperglycemic states (high blood glucose levels), such as hyperosmolar coma, decompensated diabetes, or other glucose intolerances, including metabolic stress situations,
• if you have renal tubular acidosis (a kidney function disorder),
• if you have a history of stroke (acute cerebrovascular accident),
• if you have sustained head injuries (during the first 24 hours),
• if you have excess body water (hyperhydration).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion if you have or have had any of the following conditions:

• heart disease,
• cirrhosis (end-stage chronic liver damage),
• cardiopulmonary disease (involving both heart and lungs),
• severe diabetes or any other condition associated with glucose intolerance,
• low sodium levels (hyponatremia),
• acute ischemic stroke (when a blood vessel supplying the brain is blocked by a blood clot), as hyperglycemia may worsen brain damage and impair recovery.

Because this medicine contains sodium, it should be administered with caution if you have hypertension, congestive heart failure, pulmonary or peripheral edema (fluid accumulation), renal insufficiency, preeclampsia (development of hypertension during pregnancy), or other conditions associated with sodium retention, as well as if you are taking corticosteroids or corticotropin (see next subsection).

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

Exercise caution before administering this medicine to patients who:

• are receiving steroid medications (e.g., cortisone), as these increase salt and water retention,
• are being treated with digitalis glycosides such as digoxin (used in heart failure). A sudden drop in potassium levels (upon discontinuation of treatment) in these patients may lead to toxicity,
• are elderly, since kidney or heart function may be impaired.

(See also section “Use of Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion with other medicines”)

Children

Special attention and strict monitoring of electrolyte and fluid levels are required when administering this medicine to children.

Use of Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines, so that the dose of Potassium B. Braun 0.04 mEq/mL Prefilled in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion can be adjusted accordingly:

• corticosteroids, such as hydrocortisone, prednisone, or corticotropin hormone (produced in the brain), as they may reduce glucose tolerance.

Corticosteroids are also associated with sodium and water retention.

• digoxin (a medicine used to treat heart failure),
• medicines that may lead to elevated potassium levels, such as:
  • potassium-sparing diuretics, for example, those containing spironolactone or triamterene,
  • angiotensin II receptor antagonists,
  • other medicines used to treat high blood pressure (also known as ACE inhibitors),
  • non-steroidal anti-inflammatory drugs (NSAIDs),
  • cyclosporine or tacrolimus (used in organ transplantation to prevent rejection),
  • suxamethonium (a muscle relaxant),
  • potassium-containing medicines such as potassium salts of penicillin,
  • heparin,
  • pentamidine, trimethoprim,
  • β-adrenergic blockers (propranolol, nadolol, atenolol).

Concomitant administration of these medicines with potassium may severely increase blood potassium levels, which could lead to cardiac arrhythmia.

• medicines that may lead to decreased potassium levels, such as:

  • adrenocorticotropic hormone (ACTH),
  • corticosteroids,
  • diuretics (loop diuretics, thiazides and related agents, osmotic diuretics, carbonic anhydrase inhibitors),
  • high doses of penicillins,
  • aminoglycosides,
  • cisplatin,
  • foscarnet,
  • amphotericin B,
  • theophylline,
  • insulin,
  • folic acid and vitamin B12,
  • β2-adrenergic agonists.

• Digitalis glycosides (digoxin and methyldigoxin) (high potassium levels may reduce their effect, while a sudden drop in potassium levels may cause digitalis toxicity).

• Antiarrhythmic medicines (such as quinidine, hydroquinidine, procainamide) (high potassium levels increase their activity, while low potassium levels reduce their efficacy).

• Lithium carbonate (sodium may accelerate renal excretion of lithium, leading to reduced therapeutic effect).

• Corticosteroids with mineralocorticoid activity (such as fludrocortisone) or ACTH (corticotropin) (these medicines promote water and sodium retention).

• Corticosteroids with glucocorticoid activity (such as hydrocortisone) (these medicines may cause blood glucose levels to become too high).

• Insulin and oral antidiabetic agents (biguanides, sulfonylureas) (glucose may reduce their effect).

Pregnancy and breastfeeding

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

The safety of its use during pregnancy and breastfeeding has not been established. Therefore, it should only be used when the beneficial effects clearly outweigh the potential risks to the fetus or nursing infant.

Administration of large volumes of glucose-containing solutions to the mother during labor, especially in complicated deliveries, may cause hyperglycemia, hyperinsulinemia (high blood insulin levels), and acidosis in the fetus, and thus may be harmful to the newborn.

If you are pregnant or breastfeeding, your doctor should continuously monitor your cardiac function and blood potassium levels, as abnormalities could lead to serious cardiac disturbances in both mother and fetus or newborn.

3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Perfusion

This medicine will always be administered by healthcare personnel.

Method of administration

Your doctor or nurse will administer this medicine to you via an intravenous infusion (through a drip into a vein).

The container of this medicine contains a significant volume of air. Therefore, to avoid the risk of air entering your bloodstream, this product must not be administered under pressure.

Dosage

Your doctor will decide the most appropriate dose for you, which will depend on your age, weight, and clinical condition. While you are receiving this medicine, your blood glucose levels, electrolyte (salts) levels, and fluid balance will be routinely monitored.

The recommended maximum dose of potassium is 2–3 mEq/kg/day. The usual maximum dose for an adult is 40 ml per kg of body weight per day (maximum 2.8 L). This medicine must not be administered through the same infusion equipment as blood.

The amount of glucose administered with the solution should not exceed 4–5 mg/kg/min.

Use in children

Children will receive a reduced dose. The amount to be administered will be determined by the doctor and will depend on the child's body weight.

In children, the dose of potassium should not exceed 3 mEq/kg/day.

The recommended daily fluid dose for these patients is as follows:

• 0 – 10 kg body weight: 4 ml/kg/h
• 10 – 20 kg body weight: add 2 ml/kg/h for each kg above 10 kg

• 20 kg body weight: add 1 ml/kg/h for each kg above 20 kg

If you receive more Potassium B. Braun 0.04 mEq/ml Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Perfusion than you should

This is unlikely to happen, as your doctor will determine the appropriate dose for you.

However, if your doctor accidentally administers too much of the medicine or infuses it too rapidly, you may develop potassium intoxication. The symptoms that may occur are described in section 4, “Possible side effects.”

Your doctor will immediately stop the infusion and decide on the most appropriate treatment to normalize your condition. In patients with kidney failure, dialysis may also be required.

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 can cause adverse effects, although not everyone will experience them.

When the medicine is used as recommended in this leaflet, the occurrence of adverse effects is not expected.

After administration of this medicine, hyperhydration (fluid retention), hyperglycemia, hyperchloremic acidosis (high blood chloride levels), and hyperkalemia may occur, especially if the solution is administered too rapidly or in excess, or if your kidneys are not functioning properly. Symptoms of hyperkalemia mainly affect nerves, muscles, and the heart, and include itching or tingling of the extremities, muscle weakness, flaccid paralysis (muscles become limp), respiratory paralysis, intestinal paralysis, mental confusion, loss of reflexes, apathy, cold skin, pallor (grayish skin tone), weakness and heaviness in the legs, hypotension (low blood pressure), electrocardiogram abnormalities, abnormal heart rhythms, cardiac block, and cardiac arrest. It is very important that your doctor monitors your heart to assess the severity of possible hyperkalemia.

Adverse effects related to intravenous administration may also occur. These include fever, infection at the injection site, local pain, venous irritation, venous thrombosis (blood clot formation), inflammation, hardening or constriction of the vein, extravasation, and necrosis (tissue death).

The following adverse effects may occur in some people:

• Elevated levels of potassium and/or glucose in the blood, fluid retention, hyperchloremic acidosis.
• Mental confusion, apathy.
• Muscle weakness, itching or tingling of the extremities, loss of voluntary muscle movement (paralysis), loss of reflexes, sensation of weakness and heaviness.
• Severe or complete weakness of respiratory muscles.
• Intestinal obstruction due to lack of intestinal muscle movement.
• Abnormal heart rhythms, cardiac block, cardiac arrest.
• Infection at the injection site.
• Fever.
• Inflammation, hardening or constriction of the vein where the medicine is administered, venous thrombosis, cold skin, pallor (grayish skin tone), hypotension.
• Pain, irritation, extravasation, and necrosis at the injection site.
• Electrocardiogram abnormalities. Inform your doctor if you experience pain or tenderness at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines. Website: 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 4% Glucose and 0.18% Sodium Chloride Solution for Infusion

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 store above 25°C.

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

This medicine is for single use only.

This medicine should be clear and transparent in appearance. Do not use this medicine if the solution is not clear, or if the container shows any visible signs of damage.

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

6. Contents of the container and other information

Composition of Potassium B. Braun 0.04 mEq/mL Prediluted in Glucose 4% and Sodium Chloride 0.18% Solution for Infusion

• The active substances are potassium chloride, sodium chloride and glucose.

• The other components are:

Water for injections

Appearance of Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion and container contents

Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride is a solution for infusion, i.e. it must be administered via an intravenous infusion set.

It is a sterile, clear, colourless solution of the above-mentioned substances in water.

It is supplied in colourless polyethylene bottles of 500 ml or 1,000 ml, available in packs of 10 bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

• Braun Medical S.A.
  Carretera de Terrassa 121
  08191 Rubí, Barcelona
  Spain

Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Tel: +49-5661710
Fax: +49-56614567

• Braun Medical S.A.
  Carretera de Terrassa 121
  08191 Rubí, Barcelona
  Spain
  Tel: +34-935866200
  Fax: +34-935881096

Date of latest revision of this package leaflet: February 2024

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

The following information is intended for healthcare professionals only:

Posology

The usual dose of potassium for the prevention of hypokalaemia may be up to 50 mmol per day.

In cases of severe acute hypokalaemia, the dose is up to 20 mmol of potassium in 500 ml over 2 to 3 hours, with ECG monitoring.

The maximum recommended dose of potassium is 2 to 3 mmol/kg/24h. The infusion rate should not exceed 10 to 40 mmol/h to avoid hyperkalaemia. In the case of peripheral infusions, the potassium concentration should be less than 40 mmol/l to avoid pain.

Adults:

Daily fluid requirements in adults are generally maintained with volumes of 30 to 40 ml of fluid per kg of body weight per day (maximum 2800 ml for a 70 kg person per day).

Maximum infusion rate:

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

Paediatric population:

The recommended dose for treatment of carbohydrate and fluid depletion in children is:

• 0–10 kg body weight: 4 ml/kg/h
• 10–20 kg body weight: add 2 ml/kg/h for each kg above 10 kg

• 20 kg body weight: add 1 ml/kg/h for each kg above 20 kg

In children, potassium infusion should not exceed 2–3 mmol/kg body weight or 40 mmol/m²/day.

Method of administration

The maximum infusion rate of Potassium B. Braun 0.04 mEq/ml Premixed in 4% glucose and 0.18% sodium chloride solution for infusion via peripheral lines is 10 mmol per hour.

As a general rule, infusion pumps should be used for potassium infusion, particularly when adjusting correction therapy.

Special warnings and precautions for use

• Solutions with low electrolyte concentrations, especially sodium, should be administered to children only with special caution.
• Potassium-containing solutions must be administered slowly and only after renal function has been established and proven adequate.
• Sodium chloride-containing solutions should be used with caution in patients with impaired ability to regulate sodium and fluid balance, such as those with cardiac disease—especially with a history of congestive heart failure—renal insufficiency, hepatic cirrhosis, pulmonary or peripheral edema, preeclampsia, or other conditions associated with sodium retention, as well as in patients receiving steroids or corticotropin.
• Potassium supplements should be administered with caution in patients with cardiac disease, particularly in digitalized patients.
• Caution is required when administering large volumes of hypotonic fluid infusions to patients with conditions involving congestion or pulmonary edema.
• Infusion should also be administered carefully in patients with hypotonic dehydration and in cases of hyponatremia.
• Administration of glucose solutions is not recommended following acute ischemic cerebrovascular accidents.
• Care should be taken when administering the solution to diabetic patients, especially those with insulin-resistant hyperglycemia or glucose intolerance for any other reason.

Glucose-containing solutions must not be administered simultaneously, before, or after blood transfusion through the same infusion set due to the risk of pseudoagglutination.

• It is recommended that all intravenous equipment be replaced at least once every 24 hours.
• Hypokalemia associated with magnesium deficiency is always refractory to potassium treatment.
• Elderly patients, who are more likely to suffer from cardiac and renal insufficiency, should be closely monitored during treatment, and doses should be carefully adjusted to avoid cardiocirculatory and renal complications due to fluid overload.
  • In emergency situations with severe hypokalemia (<2.5 mEq/l) or in digitalized patients, glucose solutions are not recommended.
  • Clinical monitoring should include electrocardiograms, regular assessment of fluid balance, and serum electrolyte levels.

Management of overdose

In case of hyperkalemia, potassium administration must be discontinued and appropriate corrective measures initiated to reduce plasma potassium levels.

Treatment of hyperkalemia depends on its severity. Established regimens include administration of calcium to counteract the adverse cardiac effects of hyperkalemia, use of insulin and glucose or sodium bicarbonate to promote intracellular shift of potassium, and/or use of diuretics, cation-exchange resins, or dialysis to enhance potassium excretion.

• In presence of cardiac manifestations: intravenous administration of calcium salts (10–20 ml of 10% calcium gluconate). A second dose may be required in some cases.
• To rapidly reduce plasma potassium: intravenous administration of insulin and glucose (e.g., 5–15 units of insulin with 50 ml of 50% glucose). Alternatively or additionally, in acidotic patients, intravenous sodium bicarbonate (40–160 mEq administered over 5 minutes) may be given.
• To eliminate excess potassium from the body: use of diuretics, particularly loop diuretics (furosemide), cation-exchange resins (sodium or calcium polystyrene sulfonate) administered orally or rectally, or hemodialysis or peritoneal dialysis in severe cases of renal failure and hypercatabolism.

It should be noted that a rapid decrease in plasma potassium levels in digitalized patients may precipitate digitalis-related cardiac toxicity.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products unless compatibility has been previously demonstrated.

Potassium chloride in intravenous mixtures has been shown to be incompatible with sodium amoxicillin, amphotericin B, dobutamine hydrochloride, and sodium penicillin G. Furthermore, "Y"-site administration of the following drugs is not recommended during potassium-containing infusions: azithromycin, promethazine hydrochloride, diazepam, sodium phenytoin, sodium methylprednisolone succinate, or ergotamine tartrate.

The glucose-saline solution containing 4% glucose and 0.18% sodium chloride has been reported to be incompatible with mitomycin due to the low pH of this solution. In addition, incompatibility has been observed with various glucose-saline solutions for the following drugs: sodium phenytoin, sodium heparin, haloperidol lactate, sodium imipenem-cilastatin, and meropenem. However, some of these drugs may be compatible with glucose-saline solutions depending on various factors such as drug concentration in the solution (e.g., sodium heparin) or the time interval between reconstitution and administration (e.g., sodium imipenem-cilastatin and meropenem).

Signs of incompatibility have also been reported when certain drugs are diluted in glucose-containing solutions, including sodium amoxicillin/clavulanic acid, sodium ampicillin, interferon alfa-2b, and procainamide hydrochloride. However, it should be noted that some of these drugs, such as sodium amoxicillin/clavulanic acid, may be injected directly into the infusion port while these perfusion solutions are being administered.

Incompatibility signs have also been described when certain drugs are diluted in chloride-containing solutions, including amsacrine and trimetrexate glucuronate.

Shelf-life after opening

2 years. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user and should not exceed 24 hours at 2–8°C, unless dilution occurs under controlled and validated aseptic conditions.

For further information on this medicinal product, please refer to the Summary of Product Characteristics for Potassium B. Braun 0.04 mEq/ml Premixed in 4% glucose and 0.18% sodium chloride solution for infusion.