Leaflet: Information for the user

Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

Potassium Chloride, Glucose, Sodium Chloride

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

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

1.What is Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion and what it is used for

2.What you need to know before you start using Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

3.How to use Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

4.Possible side effects

5.Storage of Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

6.Contents of the pack and additional information

This medication contains the following active principles: potassium chloride, glucose (as monohydrate) and sodium chloride. This medication is an infusion solution and will be administered through a vein via a fine tube.

This medication belongs to the group of medications called intravenous solutions that affect electrolyte balance – electrolytes with carbohydrates (used to maintain bodily fluids in correct balance).

This medication is indicated for the prevention or treatment of potassium deficiency (an electrolyte) in your body, when you require a supply of water, electrolytes and carbohydrates because dietary measures or oral medication are inadequate.

No use Cloruro de potasio Kabi 0,04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3%.

-if you are allergic to potassium chloride, glucose, or sodium chloride or to any of the other components of this medication (listed in section 6)

-if your blood potassium levels are elevated (hyperkalemia)

-if you have a severe kidney disease with oliguria (reduced urine output), anuria (absence of urine production), or azotemia (presence of excess nitrogen waste in the blood due to kidney failure)

-if your blood chloride levels are elevated (hyperchloremia)

-if your blood sodium levels are elevated (hypernatremia)

-if you are experiencing excessive water in the body (hyperhydration)

-if you are experiencing high blood glucose levels, such 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 an acute ischemic stroke (sudden loss of brain function due to a blockage in blood flow)

-within the first 24 hours after a head trauma.

Warnings and Precautions

Consult your doctor or nurse before starting to use Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion.

The administration of potassium should be carried out under strict medical supervision. During the administration of this medication, and in order to detect early signs of excessive potassium levels (hyperkalemia), your doctor will monitor your heart with electrocardiograms and perform periodic blood tests to determine your blood potassium levels, especially:

- if you have any heart or kidney disease, or other conditions that may favor the development of hyperkalemia.

- if you are taking other medications that may increase your blood potassium levels (see subheading below).

Your doctor should exercise extreme caution if you are receiving digitalis, especially when suspending the administration of potassium, as a rapid decrease in potassium levels can cause digitalis toxicity. In these cases, the treatment with potassium should not be stopped abruptly.

The potassium solution should only be administered if you have a normal urine flow. If not, you may need to receive a solution that does not contain potassium.

Your doctor will perform frequent medical and laboratory tests to monitor changes in fluid balance and acid-base balance, as well as your blood electrolyte and glucose levels.

If you are in an emergency situation and your blood potassium levels are very low, or if you are taking digitalis medications, it is not recommended to administer glucose solutions, as the presence of glucose prevents potassium levels from increasing as quickly as they should.

If you experience episodes of intracranial hypertension, your doctor will closely monitor your blood glucose levels.

Since this medication contains glucose, it should be administered with caution if you have vitamin B1 deficiency or diabetes. Your doctor can give you this medication only if you have previously been started on an appropriate treatment.

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

This medication should be administered with special caution if you are elderly, as you may be taking other medications (see subheading below) or may have impaired kidney or heart function, or other conditions that may affect your blood potassium levels.

If administration is prolonged, extravasation (leakage of the solution from the vein into the surrounding tissue) or thrombophlebitis (inflammation of the vein associated with clot formation) may occur.

Be especially careful with Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion:

• if you are experiencing critical states, pain, postoperative stress, infections, burns, or central nervous system diseases.
• if you have any heart, liver, or kidney disease and are being treated with a medication that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it may increase the risk of developing low sodium levels in the blood (hyponatremia) while in the hospital. (see section Use of Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion with other medications).

All patients should be closely monitored. In cases where normal regulation of blood water content is altered due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This can cause headaches, nausea, seizures, lethargy, coma, cerebral edema, and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (see section 4. Possible side effects).

Children, fertile women, and patients with brain diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of suffering from severe and potentially fatal brain inflammation caused by acute hyponatremia.

Use of Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.It is particularly important to inform your doctor if you are taking:

•Medications that may cause potassium levels in the blood to be too high due to additive effects, particularly if the kidneys do not function correctly:

• Diuretics that spare potassium (amiloride, triamterene, spironolactone, eplerenone)
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as captopril, enalapril, lisinopril)
• Angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)
• Medications containing potassium, such as potassium penicillin salts
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (diclofenac, indomethacin, piroxicam, mefenamic acid, celecoxib)
• Heparin
• Pentamidine, trimethoprim
• Ciclosporin, tacrolimus
• β-Adrenergic blockers (propranolol, nadolol, atenolol)
• Succinylcholine (suxamethonium)

•Medications that may reduce potassium levels in the blood, so higher doses of potassium may be needed:

• 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

•Digitoxin (digoxin and methyldigoxin) (high potassium levels can reduce its effect, and a sudden decrease in these levels can cause digitalis toxicity)

•Antiarrhythmic medications (such as quinidine, hydroquinidine, procainamide) (high potassium levels increase their activity, and low potassium levels reduce their efficacy)

•Lithium carbonate (sodium can accelerate renal excretion of lithium, leading to a decrease in its therapeutic effect)

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

•Corticosteroids with glucocorticoid activity (such as hydrocortisone) (these medications can cause high blood glucose levels)

•Insulin and oral antidiabetic medications (biguanides, sulfonylureas) (glucose can reduce their effect).

• Medications that lead to an increase in the effect of vasopressin (see section Warnings and Precautions), such as:

- Medications that stimulate the release of vasopressin (e.g., antipsychotics, narcotics)

- Medications that potentiate the action of vasopressin (e.g., nonsteroidal anti-inflammatory drugs)

- Medications that act like vasopressin, called vasopressin analogs

Other medications that increase the risk of hyponatremia, including diuretics in general and antiepileptic medications.

Pregnancy, lactation, and fertility

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

The safety of its use during pregnancy and lactation has not been established. Therefore, it should only be used when the benefits clearly outweigh the potential risks for the fetus or infant.

This medication should be administered with special caution in pregnant women during delivery, especially if it is administered in combination with oxytocin (a hormone that can be administered to induce labor and control bleeding) due to the risk of hyponatremia.

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 may be harmful to the newborn.

Since this medication contains sodium, caution should be exercised in situations of preeclampsia during pregnancy.

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

Driving and operating machinery

Not relevant.

This medication will be administered to you by a doctor or other healthcare professional through an infusion (perfusion) into a vein.

Your doctor will decide on the dose you should receive, taking into account the severity of hypokalemia, your age, weight, and clinical condition (especially if you have any heart or kidney disease), and how long you need to receive it.

The maximum recommended dose of potassium is 2-3 mEq/kg/day. In adults, the potassium dose should not exceed 200 mEq per day. The recommended dose to meet maintenance requirements is 40-80 mEq per day.

Your doctor will decide on the amount of fluid you should receive. However, in general, you should not be administered more than 40 ml/kg/day (maximum 3000 ml per day).

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

If your kidneys do not function correctly, you should receive a lower dose.

As a general rule, the infusion rate should never exceed 20 mEq of potassium per hour when administered through a peripheral vein.

Use in children and adolescents

In children, the potassium dose should not exceed 3 mEq/kg/day, and daily maintenance needs are 2-2.5 mEq/kg.

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

- less than 10 kg of weight: 100 ml/kg

- between 10 and 20 kg of weight: 1000 ml + 50 ml/kg that exceeds 10 kg

- more than 20 kg of weight: 1500 ml + 20 ml/kg that exceeds 20 kg

Oral administration of potassium supplements or ingestion of foods rich in potassium should replace intravenous administration of this medication as soon as possible.

If you take more Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion than you should

Excessive administration of potassium solutions can cause hyperkalemia, which can be potentially fatal, especially if your kidneys do not function correctly. In case of overdose, alterations in fluid and electrolyte balance, edema, and circulatory and cardiac alterations (see symptoms in section 4. Possible adverse effects) may also occur.

In case of hyperkalemia, your doctor should suspend administration and take the necessary measures to reduce blood potassium levels.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20.

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

After administration of this medicine, hiperhidratación (fluid retention), hypoglycemia, 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 primarily affect nerves, muscles, and the heart, and include tingling or numbness 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 occur due to intravenous administration. These side effects include fever, injection site infection, local pain, venous irritation, venous thrombosis (blood 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, tingling or numbness in the extremities, loss of voluntary muscle movement (paralysis), loss of reflexes, sensation of weakness and heaviness
• Severe or total weakness of respiratory muscles
• Intestinal obstruction due to lack of intestinal muscle movement
• Cardiac arrhythmias, cardiac block, cardiac arrest
• Injection site infection
• Fever
• Venous inflammation, hardening, or contraction 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

Headache, nausea, convulsions, lethargy. This may be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters the brain cells and causes inflammation. This can cause increased intracranial pressure and hyponatremic encephalopathy.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Once the packaging is opened, the solution must be used immediately.

This medication is for single use only. Dispose of unused solution.

Do not use this medication if you observe that the solution is not transparent or contains particles, or if the packaging is damaged.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty packaging and unused medications. This will help protect the environment.

Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion

• The active ingredients are potassium chloride, glucose, and sodium chloride. Each 100 mL of this medication contains 0.3 g of potassium chloride, 3.3 g of glucose (as monohydrate) and 0.33 g of sodium chloride.
• The other components (excipients) are hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injection preparations

Aspect of the product and content of the package

Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusionis a transparent and colorless solution.

This medication is available in polyethylene flasks (Kabipac). Boxes containing 10 flasks of 500 mL or 10 flasks of 1000 mL.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

Fresenius Kabi España, S.A.U.

Marina 16-18,

08005 Barcelona

Spain

Responsible for manufacturing

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Last review date of thisleaflet: March 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion is a ready-to-use solution that must be administered by slow infusion.

The theoretical osmolarity of the solution is 376 mOsm/l.

Given the concentration of potassium in the solution (40 mEq/l), this medication is suitable for administration via peripheral vein. If a central vein is used, it is recommended to use the femoral vein and avoid the jugular and subclavian veins.

It is generally recommended not to exceed 40 mEq/l via peripheral vein

Dosage:

The dose and duration of treatment should be individualized for each patient, depending on the severity of hypokalemia, age, weight, and clinical status, especially in cases of heart or renal insufficiency.

The dose and administration rate should be determined by electrocardiographic monitoring and plasma potassium determinations.

In adults, the maximum recommended dose of potassium is 2-3 mEq/kg/day, without exceeding 200 mEq/day, with a recommended dose of 40-80 mEq/day for maintenance therapy.

The administration of fluid should be calculated for each patient based on the requirements for replacement or maintenance. However, in general, no more than 40 mL/kg/day (max. 3000 mL/day) should be administered.

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

In children, the dose of potassium should not exceed 3 mEq/kg/day, and the daily maintenance requirements are 2-2.5 mEq/kg.

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

- <10 kg

- between 10 and 20 kg of weight: 1000 mL + 50 mL/kg that exceeds 10 kg

- > 20 kg of weight: 1500 mL + 20 mL/kg that exceeds 20 kg

Patients with renal insufficiency should receive lower doses due to the risk of hyperkalemia.

The intravenous administration of potassium at a rate of 10 mEq/h is considered safe. When the administration rate exceeds 10 mEq/h, the patient should be closely monitored by ECGs and periodic plasma potassium determinations. In general, the infusion rate via peripheral vein should not exceed 20 mEq/h. Via central vein, higher administration rates may be achieved.

General recommendationsfor the administration of intravenous potassium solutions:

Precautions for preparation and handling:

Each container is for single use only. Discard unused contents.

The solution should be transparent and free of particles. Do not administer otherwise.

Use an aseptic technique to administer the solution, as well as to add medications to the solution, if necessary.

As with all parenteral solutions, before adding medications to the solution or administering simultaneously with other medications, check for incompatibilities of the added medications with the solution or the container. Also, consult the technical data sheet of the added medication.

It is the user's responsibility to evaluate the incompatibility of the added medication with Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion, monitoring for possible changes in color and/or the formation of precipitates, insoluble complexes, or crystals.

Before administering the mixture, verify the stability and osmolarity of the final solution.

When compatible medication is added to this formulation, the solution should be administered immediately, unless the dilution has been carried out in controlled and validated aseptic conditions.

Incompatibilities:

No incompatibilities have been found related to this medication, but there are with the active ingredients of the solution.

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 in "Y" the following drugs when administering potassium mixtures: azithromycin, promethazine hydrochloride, diazepam, phenytoin sodium, methylprednisolone sodium succinate, or ergotamine tartrate.

It has been described that the glucose-saline solution with a glucose content of 3.3% and sodium chloride content of 0.3% is incompatible with mitomycin due to the low pH of this solution. Additionally, incompatibilities have been observed for different glucose-saline solutions with: phenytoin sodium, heparin sodium, haloperidol lactate, imipenem-cilastatin sodium, and meropenem. However, some of these drugs may be compatible with glucose-saline solutions depending on various factors such as the concentration of the drug 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 described when some medications are diluted in solutions containing glucose, including: amoxicillin sodium/clavulanic acid, ampicillin sodium, interferon alfa-2b, and procainamide hydrochloride. However, we should note that some of these drugs, such as amoxicillin sodium/clavulanic acid, may be injected directly into the injection site 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.

Emergency treatment for hyperkalemia:

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 sodium to promote the passage of extracellular potassium into the cell, and/or the use of diuretics, cation exchange resins, or dialysis to increase its excretion:

• If cardiac manifestations exist: administration of calcium salts intravenously (10-20 mL of calcium gluconate 10%). 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 with 50 mL of glucose 50%). Alternatively or additionally, in acidotic patients, bicarbonate sodium may 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) via rectal or oral route, or hemodialysis or peritoneal dialysis in severe cases of renal insufficiency and hypercatabolism.

A rapid decrease in plasma potassium levels in digitalized patients may cause digitalis toxicity.

Preventive measures to avoid thrombophlebitis:

If administration is prolonged, extravasation or thrombophlebitis may occur. To avoid thrombophlebitis, it is recommended to change the catheter insertion site every 24-48 hours.

General advice

May need to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (SIADH syndrome) and patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important in products with a lower sodium concentration compared to serum sodium. After infusion ofPotassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion, a rapid and active transport of glucose to the body's cells occurs. This condition promotes an effect that can be considered as free water supply and may lead to severe hyponatremia.