Potasio B. Braun 0,02 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 0.02 mEq/ml Pre-diluted in

4% glucose and 0.18% sodium chloride infusion solution

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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

Contents of this leaflet:

1. What Potassium B. Braun 0.02 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride infusion solution is and what it is used for
2. What you need to know before you use Potassium B. Braun 0.02 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride infusion solution
3. How to use Potassium B. Braun 0.02 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride infusion solution
4. Possible side effects
5. How to store Potassium B. Braun 0.02 mEq/ml Pre-diluted in 4% glucose and 0.18% sodium chloride infusion solution
6. Contents of the pack and other information

1. What Potassium B. Braun 0.02 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 an energy supplement is also required, when dietary measures or oral medication are inadequate.

2. What you need to know before starting to use Potassium B. Braun 0.02 mEq/mL Premixed in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion

Do not use Potassium B. Braun 0.02 mEq/mL Premixed 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 have hyperglycemic states (high blood glucose levels), such as hyperosmolar coma, decompensated diabetes, or other glucose intolerances as seen during metabolic stress,
• 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 (within the first 24 hours),
• if you have excess water in your body tissues (hyperhydration).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Potassium B. Braun 0.02 mEq/mL Premixed 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 (affecting both heart and lungs),
  • severe diabetes or any other condition associated with glucose intolerance,
  • low levels of sodium (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.

Since 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).

Caution should be exercised 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 (when treatment is interrupted) in these patients may lead to toxicity,
• are elderly, because kidney or heart function may be impaired.
  (See also section “Use of Potassium B. Braun 0.02 mEq/mL Premixed in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion with other medicines”).

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

Children

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

Use of Potassium B. Braun 0.02 mEq/mL Premixed in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion with other medicines

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

Specifically inform your doctor if you are taking any of the following medicines, so that the dose of Potassium B. Braun 0.02 mEq/mL Premixed in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion can be adjusted accordingly:

• Corticosteroids, such as hydrocortisone, prednisone, or corticotropin (a 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, e.g., those containing spironolactone or triamterene,
  • angiotensin II receptor antagonists,
  • other medicines used to treat high blood pressure (also called ACE inhibitors),
  • non-steroidal anti-inflammatory agents,
  • 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 effectiveness).

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.

The safety of this medicine 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.

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

If you are pregnant or breastfeeding, your doctor should continuously monitor your heart 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 0.02 mEq/ml Pre-diluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion

This medicine will always be administered by healthcare personnel.

Method of administration

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

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 determine 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 normal 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 set 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 potassium dose must 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 0.02 mEq/ml Pre-diluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion than you should

It is unlikely this will happen, as your doctor will ensure the correct dose is given.

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 impairment, dialysis may also be required.

If you have any further questions about the use of this medicine, please 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, adverse effects are not expected to occur.

After administration of this medicine, overhydration (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 in the extremities, muscle weakness, flaccid paralysis, 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, irregular heartbeats, cardiac block, and cardiac arrest. It is very important that your doctor monitor 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 (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 in the extremities, loss of voluntary muscle movement (paralysis), loss of reflexes, sensation of weakness and heaviness.
• Severe or complete weakness of the respiratory muscles.
• Intestinal obstruction due to lack of intestinal muscle movement.
• Irregular heartbeats, 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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es

5. Storage of Potassium B. Braun 0.02 mEq/mL Premixed 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.

This 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 appear transparent. 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 0.02 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 0.02 mEq/ml Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Perfusion and Pack Contents

Potassium B. Braun 0.02 mEq/ml Prediluted in 4% Glucose and 0.18% Sodium Chloride is a solution for perfusion; therefore, it must be administered via intravenous infusion.

It is a sterile, clear, and 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 Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent review of this summary: February 2024

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

The following information is intended for healthcare professionals only:

Dosage

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 administered over 2 to 3 hours, with ECG monitoring.

The maximum recommended dose of potassium is 2 to 3 mmol/kg/24h. The infusion rate must not exceed 10–40 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 individual per day).

Maximum infusion rate:

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

Pediatric population:

The recommended dose for the 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 rate for Potassium B. Braun 0.02 mEq/ml Prefilled in glucose 4% and sodium chloride 0.18% solution for infusion administered via peripheral routes is 10 mmol per hour.

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

Warnings and special precautions for use

• Solutions with low salt concentrations, especially sodium, should only be administered to children with special caution.
• Potassium-containing solutions should 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 reduced capacity to handle sodium and fluids, such as those with heart disease—especially with a history of congestive heart failure—patients with renal failure, hepatic cirrhosis, pulmonary or peripheral edema, preeclampsia, or other conditions associated with sodium retention, as well as patients receiving steroids or corticotropin.
• Potassium supplements should be administered with caution in patients with heart disease, particularly in digitalized patients.
• Care must be taken when administering large-volume infusions of hypotonic fluids to patients with states of congestion or pulmonary edema.
• Infusion should also be administered cautiously in patients with hypotonic dehydration and in cases of hyponatremia.
• Administration of glucose solutions after acute ischemic cerebrovascular accidents is not recommended.
• Caution should be exercised when administering the solution to patients with diabetes, especially those with insulin-resistant hyperglycemia and those with glucose intolerance for any other reason.
• Glucose-containing solutions should 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 administration sets be replaced at least once every 24 hours.
• Hypokalemia associated with magnesium deficiency is always refractory to potassium treatment. Elderly patients, who are more prone to heart and renal failure, 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 and regular checks of fluid balance and serum electrolytes.

Management of overdose

In case of hyperkalemia, potassium administration should 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 the shift of extracellular potassium into cells, and/or use of diuretics, cation-exchange resins, or dialysis to enhance potassium excretion.

• If cardiac manifestations are present: intravenous administration of calcium salts (10–20 ml of 10% calcium gluconate). A second dose may be necessary 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, especially 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 cardiac toxicity due to digitalis.

Incompatibilities

In the absence of compatibility studies, this medicinal product should not be mixed with other 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 between various glucose-saline solutions and the following: 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).

Moreover, incompatibility signs have 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 at the injection site while these infusion solutions are being administered.

Signs of incompatibility have also been reported 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 storage conditions and duration of 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 0.02 mEq/ml Prefilled in glucose 4% and sodium chloride 0.18% solution for infusion.