Label:Information for the User

Potassium B. Braun 0.04 mEq/ml Predilutedin

glucose 4% and sodium chloride 0.18% solution for infusion

Potassium chloride, Glucose monohydrate, Sodium chloride

Read this label carefully before starting to use this medication, because 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, pharmacist, or nurse.

-This medication has been prescribed to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.See section 4.

1.What is Potassium B. Braun 0.04 mEq/ml Prediluted in glucose 4%, and sodium chloride 0.18% solution for infusion and how it is used

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

3.How to use Potassium B. Braun 0.04 mEq/ml Prediluted in glucose 4%, and sodium chloride 0.18% solution for infusion

4.Possible adverse effects

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

6.Contents of the package and additional information

This medication is an infusion solution (administered through a vein using an IV drip).

This medication is used to maintain or restore your potassium, sodium, chloride, and fluid levels in cases where you also need an energy supplement when dietary measures or oral medication are inadequate.

No usePotasio B. Braun0,04 mEq/ml Prediluido en glucosa 4%,y cloruro de sodio0,18% solución para perfusión

• if you are allergic to potassium or any of the other components of this medication (including those 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 excretion), anuria (absence of urine production), or azotemia (presence of excess nitrogen waste in the blood due to kidney failure),
• if your blood sodium levels are elevated (hypernatremia),
• if you have hyperglycemia (high blood glucose levels) as in cases of hyperosmolar coma, uncontrolled diabetes, or other glucose intolerance such as in situations of metabolic stress,
• if you have tubular renal acidosis (alteration of kidney function),
• if you have had a previous stroke (acute cerebrovascular accident),
• if you have had head injuries (within the first 24 hours) if you have excessive water in your body tissues (hyperhydration).

Contraindications and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Potasio B. Braun 0,04 mEq/ml Prediluido en glucosa 4%, and cloruro de sodio 0,18% solución para perfusión if you have or have had any of the following conditions:

• heart disease,
• cirrhosis (result of chronic liver damage) 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 supplying blood to the brain is blocked by a blood clot), as hyperglycemia can worsen brain damage and affect recovery.

Since this medication contains sodium, it should be administered with caution if you have hypertension, congestive heart failure, pulmonary edema, peripheral edema, 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 subheading below).

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

Caution should be exercised before administering the medication in patients who:

• are receiving steroid medications (e.g., cortisone) as these increase sodium and water retention,
• are being treated with digitalis such as digoxin (used for heart failure). A sudden drop in potassium levels (when treatment is discontinued) in these patients can lead to toxicity,
• are elderly, as their kidneys or heart may not function correctly,
• (See also section on "Use of Potasio B. Braun 0,04 mEq/ml Prediluido en glucosa 4%, and cloruro de sodio 0,18% solución para perfusión with other medications")

Children

Special attention should be paid and the levels of salts and liquids should be strictly controlled when administering this medication to children.

Use of Potasio B. Braun 0,04 mEq/ml Prediluido en glucosa 4%, and cloruro de sodio 0,18% solución para perfusión with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Inform your doctor especially if you are taking any of the following medications, so that the amount of Potasio B. Braun 0,04 mEq/ml Prediluido en glucosa 4%, and cloruro de sodio 0,18% solución para perfusión can be adjusted accordingly:

• corticosteroids, such as hydrocortisone, prednisone, or corticotropin (produced in the brain) as this may lead to a reduction in glucose tolerance.

Corticosteroids are also associated with sodium and water retention.

• digoxin (a medication used to treat heart failure)
• medications that can lead tohigh levels of potassiumsuch as:
• • potassium-sparing diuretics, such as those containing spironolactone or triamterene,
  • angiotensin II receptor antagonists,
  • other medications used to treat high blood pressure (also called ACE inhibitors),
  • anti-inflammatory non-steroidal medications,
  • ciclosporin or tacrolimus (used in organ transplants to prevent rejection),
  • suxamethonium (muscle relaxant),
  • medications containing potassium such as potassium penicillin salts
  • heparin,
  • pentamidine, trimethoprim,
  • β-blockers (propranolol, nadolol, atenolol).

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

• medications that can lead to adecrease 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,
  • folate and vitamin B12,
  • β2-adrenergic agonists.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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 for the fetus and the infant.

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

If you are pregnant or breastfeeding, your doctor should continuously monitor your heart and potassium levels, as incorrect levels can cause severe cardiac alterations in both the mother and the fetus or newborn.

This medication will always be administered by a healthcare professional.

Administration Form

Your doctor or nurse will administer this medication to you through an IV line (intravenous route).

The container of this medication contains a significant volume of air. To avoid the risk of air entering your bloodstream, this product should not be administered through a pressure infusion.

Dosage

Your doctor will decide on the most suitable dose for you, which will depend on your age, weight, and clinical condition. While receiving this medication, your blood glucose levels and electrolyte (salt) levels, as well as your fluid balance, will be monitored regularly.

The maximum recommended dose of potassium is 2-3 mEq/kg/day. The maximum normal dose for an adult is 40 mL/kg of body weight per day (maximum 2.8 L). Do not receive this medication 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 your doctor and will depend on the child's weight.

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

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

• 0 - 10 kg of body weight: 4 mL/kg/h
• 10 - 20 kg of body weight: add 2 mL/kg/h for each kg above 10 kg
• > 20 kg of body weight: add 1 mL/kg/h for each kg above 20 kg

If you receive more Potasio B. Braun 0.04 mEq/mL Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion than you should

It is unlikely that this will happen, as your doctor will ensure that the most suitable dose is defined for you.

However, if your doctor accidentally administers too much medication or injects it too quickly, you may experience potassium intoxication. The symptoms that may appear are described in section 4 "Possible adverse effects."

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

After administration of this medicine, hyperhydration (fluid retention), hyperglycemia, hyperchloremic acidosis (high chloride content in blood) and hyperkalemia may occur, especially if the solution is administered too quickly or in excess, or if your kidneys do not function properly. Hyperkalemia symptoms 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, cardiac arrhythmias, cardiac block, and cardiac arrest. It is very important that your doctor monitor your heart to assess the severity of possible hyperkalemia.

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

The following side effects may appear in some people:

- Elevated potassium and/or glucose levels 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 total weakness of the respiratory muscles.

- Intestinal obstruction due to lack of intestinal muscle movement.

- Cardiac arrhythmias, cardiac block, cardiac arrest.

- Injection site infection.

- Fever.

- Inflammation, hardening, or contraction 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 abnormalitiesInform your doctor if you experience pain or sensitivity at the injection site.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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 store at a temperature above 25°C.

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

This medication is for single use only.

This medication must have a transparent appearance. Do not use this medication if the solution is not clear, or if the container shows visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

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

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

• The other components are:

Water for injection preparations

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

Potassium B. Braun 0.04 mEq/mL Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion is a solution for infusion, i.e., it must be administered through a venous catheter.

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 Responsible for Manufacturing

Marketing Authorization Holder

B. Braun Medical S.A.
Carreterade Terrassa 121
08191Rubí, Barcelona

Spain

Responsible for Manufacturing
B. Braun Melsungen AG
Carl-Braun-Straße 134212 Melsungen

Germany
Tel: +49-5661710
Fax: +49-56614567

B. Braun Medical S.A.
Carreterade Terrassa 121
08191Rubí, Barcelona

Spain
Tel: +34-935866200
Fax: +34-935881096

Last review date of this leaflet: February 2024

For more detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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The following information is intended only 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 acute severe 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:

The fluid needs in adults are generally maintained with volumes of 30 to 40 ml of liquid 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 above 10 Kg

- > 20 Kg of body weight: add 1 ml/Kg/h for each Kg above 20 Kg

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

Administration form

The maximum infusion 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 veins is 10 mmol per hour.

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

Warnings and precautions for special 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 has been shown to be adequate.
• Solutions containing sodium chloride should be used with caution in patients who have a reduced ability to control sodium and fluids, such as heart disease, especially with a history of congestive heart failure, patients with renal insufficiency, 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 patients who are digitalized.
• Care should be taken when administering large-volume infusions of hypotonic liquids to patients with congestive or pulmonary edema states.
• Infusion should also be administered with caution in patients with hypotonic dehydration and in cases of hyponatremia.
• Administration of glucose solutions after acute ischemic stroke is not recommended.
• Care should be taken when administering the solution to patients with diabetes, especially those with refractory hyperglycemia to insulin and patients with glucose intolerance for any other reason.

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

-It is recommended that all intravenous equipment be replaced at least once every 24 hours.

- The hypokalemia associated with magnesium deficiency is always refractory to potassium treatment.

-Older patients, who are more prone to heart failure and renal insufficiency, should be closely monitored during treatment and doses should be carefully adjusted to avoid cardiovascular and renal complications due to fluid overload.

• In emergency situations where there is severe hypokalemia (<2.5 mEq/l) or when the patient is digitalized, it is not recommended to use glucose solutions.
• Clinical monitoring should include electrocardiograms, regular checks of fluid and electrolyte balance.

Treatment of overdose

In the case of hyperkalemia, administration of potassium should be suspended and appropriate measures should be taken to reduce plasma potassium levels.

The treatment of hyperkalemia depends on its severity. 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 bicarbonate to promote the passage of extracellular potassium into the cell, and the use of diuretics, cation exchange resins, or dialysis to increase its excretion.

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

It should be noted that a rapid decrease in plasma potassium levels in digitalized patients can cause digitalis toxicity.

Incompatibilities

Unless compatibility has been proven, this medication should not be mixed with others.

Potassium chloride in intravenous mixtures has been shown to be incompatible with amoxicillin sodium, amphotericin B, dobutamine hydrochloride, and penicillin G sodium. Additionally, it is not recommended to administer the following medications in "Y" when potassium mixtures are being administered: azithromycin, promethazine hydrochloride, diazepam, phenytoin sodium, succinylcholine sodium, or ergotamine tartrate.

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

On the other hand, signs of incompatibility have been reported when some medications are diluted in solutions containing glucose, including: amoxicillin sodium/clavulanate, ampicillin sodium, interferon alfa-2b, and procainamide hydrochloride. However, it should be noted that some of these medications, such as amoxicillin sodium/clavulanate, may be injected directly into the injection site while these infusion solutions are being administered.

Additionally, signs of incompatibility have been reported when some medications are diluted in solutions containing chloride, including amsacrine and trimetrexate glucuronate.

Valid period after opening

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

For more information on this medication, please consult the technical data sheet of Potassium B. Braun 0.04 mEq/mL Prediluted in 4% Glucose and 0.18% Sodium Chloride Solution for Infusion.