POTASSIUM B. BRAUN 0.04 mEq/mL PREDILUTED IN 4% GLUCOSE AND 0.18% SODIUM CHLORIDE SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Potassium B. Braun 0.04 mEq/ml Prediluted 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 the pack:

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
2. What you need to know before you use Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion
3. How to use Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion
4. Possible side effects
5. Storage of Potassium B. Braun 0.04 mEq/ml Prediluted 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 a solution for infusion (it is given to you through a drip in a vein).

This medicine is used to maintain or restore your levels of potassium, sodium, chloride, and fluids when you also need an energy supplement and when dietary measures or oral medication are not suitable.

2. What you need to know before you use Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion

Do not usePotassium B. Braun 0.04 mEq/ml Prediluted 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 production), anuria (absence of urine production), or azotemia (excess nitrogen waste in the blood due to kidney failure),
• if your blood sodium levels are high (hypernatremia),
• if you have hyperglycemic states (high blood glucose levels) such as in cases of hyperosmolar coma, uncontrolled diabetes, or other glucose intolerances as in metabolic stress situations,
• if you have renal tubular acidosis (kidney function disorder),
• if you have had a stroke (acute cerebrovascular accident),
• if you have had head injuries (within the first 24 hours)
• if you have excess water in your body tissues (hyperhydration).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting to use Potassium B. Braun 0.04 mEq/ml Prediluted 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 (final result of chronic liver damage) or any cardiopulmonary disease (involving heart and lungs),
• severe diabetes or any other condition associated with glucose intolerance,
• low sodium levels (hyponatremia),
• acute ischemic stroke (when a blood vessel that supplies blood to the brain is blocked by a blood clot), as hyperglycemia can worsen brain damage and affect recovery.

Since this medicine contains sodium, it should be administered with caution if you have hypertension, congestive heart failure, fluid accumulation (edema) in the lungs or peripherally, 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).

Adequate vitamin intake (particularly vitamin B1) should be ensured.

Caution should be exercised before administering the medicine to patients who:

• receive steroid medications (e.g., cortisone) as these increase salt and water retention,
• are treated with digitalis such as digoxin (used in heart failure). A sudden drop in potassium levels (when treatment is interrupted) in these patients can lead to toxicity,
• are elderly, as their kidneys or heart may not function properly,
• (See also section on "Use of Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion with other medicines")

Children

Special attention and rigorous control of electrolyte and fluid levels should be exercised when administering this medicine to children.

Use of Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion with other medicines

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

Especially tell your doctor if you are taking any of the following medicines, so that the amount of Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion can be adjusted accordingly:

• corticosteroids, such as hydrocortisone, prednisone, or corticotropin (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 high potassium levelssuch 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 transplants to prevent rejection),
  • suxamethonium (muscle relaxant),
  • medicines containing potassium, such as potassium salts of penicillin
  • heparin,
  • pentamidine, trimethoprim,
  • β-adrenergic blockers (propranolol, nadolol, atenolol).

The concomitant administration of these medicines with potassium can severely increase potassium levels in the blood, which can lead to cardiac arrhythmia.

• medicines that may lead to a decrease in potassium levelssuch as:
• • adrenocorticotropic hormone,
  • corticosteroids,
  • diuretics (loop diuretics, thiazides, and related diuretics, 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 can reduce their effect, and a sudden drop in potassium levels can cause digitalis toxicity).
• Antiarrhythmic medicines (such as quinidine, hydroquinidine, procainamide) (high potassium levels increase their activity, and low potassium levels reduce their effectiveness).
• Lithium carbonate (sodium can accelerate the renal excretion of lithium, leading to a decrease in its 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 can cause high blood glucose levels).
• Insulin and oral antidiabetics (biguanides, sulfonylureas) (glucose can reduce their effect).

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 its use during pregnancy and breastfeeding has not been established. Therefore, it should only be used when the benefits clearly outweigh the potential risks to the fetus and the infant.

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

If you are pregnant or breastfeeding, your doctor should continuously monitor your heart and blood potassium levels, as incorrect levels can lead to severe cardiac disorders in both the mother and the 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 infusion

This medicine will always be administered by healthcare personnel.

Method of administration

Your doctor or nurse will administer this medicine to you through a drip in a vein (intravenously).

The container of this medicine contains a significant amount of air. Therefore, to avoid the risk of air entering your bloodstream, this product should not be administered by pressure infusion.

Dosage

Your doctor will decide the most suitable dose for you, depending on your age, weight, and clinical situation. While you are receiving this medicine, your blood glucose and electrolyte levels and fluid balance will be routinely monitored.

The maximum recommended dose of potassium is 2-3 mEq/kg/day. The maximum normal dose for an adult is 40 ml per kg of body weight per day (maximum 2.8 liters). You should not receive this medicine 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 decided by the doctor and will depend on the child's weight.

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

The recommended daily fluid dose in 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 infusion than you should

This is unlikely to happen since your doctor will decide the most suitable dose for you.

However, if your doctor accidentally administers more medicine than necessary or injects it too quickly, you may experience potassium intoxication. The symptoms that may appear are described in section 4 "Possible side effects".

Your doctor will immediately stop the administration and decide on the most suitable treatment to normalize your situation. In patients with kidney failure, dialysis may also be necessary.

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 the medicine is used as recommended in this leaflet, side effects are not expected to occur.

After administration of this medicine, hyperhydration (fluid retention), hyperglycemia, hyperchloremic acidosis, and hyperkalemia may occur, especially if the solution is administered too quickly or in excess, or if your kidneys do not function properly. The symptoms of hyperkalemia mainly affect the nerves, muscles, and heart, and include tingling or numbness of the limbs, muscle weakness, flaccid paralysis, respiratory paralysis, intestinal paralysis, mental confusion, loss of reflexes, apathy, cool skin, pale skin (grayish skin tone), weakness, and heaviness of the legs, hypotension (low blood pressure), electrocardiogram abnormalities, cardiac arrhythmias, cardiac block, and cardiac arrest. It is very important that your doctor monitors your heart to assess the severity of possible hyperkalemia.

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

The following side effects may occur in some people:

• High potassium and/or glucose levels in the blood, fluid retention, hyperchloremic acidosis.
• Mental confusion, apathy.
• Muscle weakness, tingling or numbness of the limbs, loss of voluntary muscle movement (paralysis), loss of reflexes, feeling of weakness and heaviness.
• Severe or total weakness of the respiratory muscles.
• Intestinal obstruction due to lack of movement of the intestinal muscles.
• Cardiac arrhythmias, cardiac block, cardiac arrest.
• Infection at the injection site.
• Fever.
• Inflammation, hardening, or contraction of the vein where the medicine is administered, venous thrombosis, cool skin, pale skin (grayish skin tone), hypotension.
• Pain, irritation, extravasation, and necrosis at the injection site.
• Electrocardiogram abnormalities

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: 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 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 which is stated on the label and on the outer packaging after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

This medicine is for single use only.

This medicine should have a clear appearance. Do not use this medicine if the solution is not clear or if the container shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

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

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

• The other components are:

Water for injectable preparations

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

Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose, and 0.18% sodium chloride is an infusion solution, i.e., it should be administered through a venous drip.

It is a sterile, transparent, and colorless solution of the aforementioned substances in water.

It is presented in 500 ml or 1,000 ml colorless polyethylene bottles, 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

ManufacturerB. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen

Germany Tel: +49-5661 710 Fax: +49-5661 4567

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

Spain Tel: +34-935 866 200 Fax: +34-935 881 096

Date of the last revision of this prospectus: February 2024

Detailed and updated 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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The information that appears below is intended solely for healthcare professionals:

Dosage

The normal dose of potassium for the prevention of hypokalemia may be up to 50 mmoles per day.

In the case of severe acute hypokalemia, the dose is up to 20 mmoles of potassium in 500 ml over 2 or 3 hours, with ECG monitoring.

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

Adults:

Hydration needs 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 person with 70 Kg and per day).

Maximum infusion rate:

Up to 5 ml/Kg of 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 of body weight: 4 ml/Kg/h
• 10-20 Kg of body weight: add 2 ml/Kg/h for each Kg from 10 Kg
• > 20 Kg of body weight: add 1 ml/Kg/h for each Kg from 20 Kg

In children, potassium infusion should not exceed 2-3 mmol/Kg of body weight or 40 mmol/m2/day.

Method of administration

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

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

Special warnings and precautions for use

• Solutions with low salt concentrations, especially sodium, should only be administered to children with special caution.
• Solutions containing potassium should be administered slowly and only after renal function has been established and proven to be adequate.
• Solutions containing sodium chloride should be used with caution in patients with reduced ability to control sodium and fluids, such as heart disease, especially with a history of congestive heart failure, patients with renal failure, liver 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.
• Caution should be exercised when administering large-volume infusions of hypotonic fluids to patients with congestive or pulmonary edema.
• The infusion should also be administered with caution in patients with hypotonic dehydration and in cases of hyponatremia.
• Administration of glucose solutions is not recommended after acute ischemic cerebrovascular accidents.
• Attention should be paid when administering the solution to patients with diabetes, especially those with insulin-resistant hyperglycemia and patients with glucose intolerance for any other reason.

Solutions containing glucose should not be administered simultaneously, before, or after blood administration through the same infusion equipment due to the possibility of pseudoagglutination.

• Hypokalemia associated with magnesium deficiency is always refractory to potassium treatment.
• Elderly patients, who are more prone to heart failure and renal failure, should be closely monitored during treatment, and the dose should be carefully adjusted to avoid cardiocirculatory and renal complications derived from fluid overload.
• In emergency situations where there is severe hypokalemia (<2.5 mEq/l) or when the patient is digitalized, the use of glucose solutions is discouraged.
• Clinical monitoring should include electrocardiograms, regular checks of fluid and electrolyte balance.

Treatment of overdose

In case of hyperkalemia, potassium administration should be discontinued, and corrective measures should be taken to reduce plasma potassium.

Treatment of hyperkalemia depends on the severity of the condition. Different regimens have been established, consisting of the administration of calcium to counteract the negative effects of hyperkalemia on the heart, the use of insulin and glucose or sodium bicarbonate to promote the passage of potassium from the extracellular space to the interior of the cell, and/or the use of diuretics, cation exchange resins, or dialysis to increase its excretion.

• If there are cardiac manifestations: administration of calcium salts intravenously (10-20 ml of 10% calcium gluconate). In some cases, a second administration may be necessary.
• To rapidly decrease plasma potassium: intravenous administration of insulin and glucose (e.g., 5-15 units of insulin along with 50 ml of 50% glucose). Alternatively or additionally, in acidotic patients, sodium bicarbonate can be administered intravenously (40-160 mEq administered in 5 minutes).
• To eliminate excess potassium from the body: use of diuretics, especially loop diuretics (furosemide), cation exchange resins (sodium or calcium polystyrene sulfonate) rectally or orally, or hemodialysis or peritoneal dialysis in severe cases of renal failure and hypercatabolism.

It should be taken into account that a rapid decrease in plasma potassium levels in digitalized patients can cause cardiac toxicity due to digitalis.

Incompatibilities

In the absence of compatibility studies, this medicinal product should not be mixed with others unless compatibility has been previously proven.

Potassium chloride in intravenous mixtures has been shown to be incompatible with sodium amoxicillin, amphotericin B, dobutamine hydrochloride, and sodium penicillin G. Similarly, it is not recommended to administer the following drugs in a "Y" connection when administering potassium mixtures: azithromycin, promethazine hydrochloride, diazepam, sodium phenytoin, sodium methylprednisolone succinate, or ergotamine tartrate.

It has been described that the glucose-saline solution with a 4% glucose content and 0.18% sodium chloride is incompatible with mitomycin due to the low pH of this solution. Similarly, incompatibility samples have been observed for different glucose-saline solutions with: sodium phenytoin, sodium heparin, haloperidol lactate, imipenem-cilastatin sodium, and meropenem. However, some of these drugs may be compatible with glucose-saline solutions depending on different factors such as the concentration of the drug in the solution (sodium heparin) or the time elapsed between the dissolution and administration of the solution (imipenem-cilastatin sodium and meropenem).

On the other hand, signs of incompatibility have been described when some medications are diluted in solutions containing glucose, 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, can be injected directly into the injection point while these infusion solutions are being administered.

Signs of incompatibility have also been described when some medications are diluted in solutions containing chloride, including amsacrine and trimetrexate glucuronate.

Shelf life after opening

2 years. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours and 2 - 8°C, unless the dilution is made under controlled and validated aseptic conditions.

For more information on this medicinal product, the Potassium B. Braun 0.04 mEq/ml Prediluted in 4% glucose and 0.18% sodium chloride solution for infusion technical data sheet should be consulted.