Potassium Kabi 0.04 meq/ml in glucose 5% solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium Kabi 0.04 mEq/ml in Glucose 5% solution for infusion EFG

potassium chloride, glucose (as monohydrate)

Read the entire leaflet carefully before you start using 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, ask your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Potassium Kabi 0.04 mEq/ml in Glucose 5% is and what it is used for
2. What you need to know before using Potassium Kabi 0.04 mEq/ml in Glucose 5%
3. How to use Potassium Kabi 0.04 mEq/ml in Glucose 5%
4. Possible side effects
5. How to store Potassium Kabi 0.04 mEq/ml in Glucose 5%
6. Contents of the pack and other information

1. What Potassium Kabi 0.04 mEq/ml in 5% Glucose is and what it is used for

Potassium Kabi 0.04 mEq/ml in 5% Glucose is a solution of potassium chloride and glucose in water. Potassium chloride is a chemical substance (often referred to as "salt") found in the blood. Glucose is one of the body's sources of energy. This solution provides 200 kilocalories per liter.

This medicine is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• loss of potassium from the body (e.g., following treatment with certain diuretics)
• low blood potassium levels (hypokalemia) in situations where losses of potassium chloride and water may occur, including:
  • when a person is unable to eat or drink due to illness or after surgery
  • marked sweating due to high fever

2. What you need to know before using Potassium Kabi 0.04 mEq/mL in 5% Glucose

Do not administer Potassium Kabi 0.04 mEq/mL in 5% Glucose if:

• your blood potassium levels are higher than normal (hyperkalemia)

• your blood chloride levels are higher than normal (hyperchloremia)

• you have serious problems with kidney function (you may not urinate or produce little urine)

• you have untreated or inadequately treated heart failure (decompensated heart failure) causing symptoms such as:

  • difficulty breathing
  • swelling of the ankles

• you have inadequate adrenal gland function (Addison's disease)

• your diabetes is not adequately treated, resulting in blood sugar levels above normal (uncompensated diabetes)

• you have conditions of glucose intolerance, such as:

  • metabolic stress (when the body's metabolism is not functioning properly, for example due to a serious illness)
  • hyperosmolar coma (loss of consciousness). This is a type of coma that may occur if you have diabetes and do not receive enough medication.
  • elevated blood sugar levels (hyperglycemia)
  • elevated blood lactate levels (hyperlactatemia)

Warnings and precautions

This medicine has a higher concentration than blood (hypertonic solution). Your doctor will take this into account when calculating the dose to be administered.

Consult your doctor or nurse before receiving Potassium Kabi 0.04 mEq/mL in 5% Glucose if:

• you have any type of heart disease, including heart failure

• you have respiratory insufficiency (lung disease)

• you have reduced kidney function (you may require special monitoring under the above conditions)

• you have an adrenal gland disorder affecting the amount of steroid hormones in your body (adrenocortical insufficiency)

• you are severely dehydrated (loss of body water, for example due to vomiting or diarrhea)

• you have extensive skin injury (such as in burns)

• you have had a head injury within the past 24 hours

• there is increased pressure within the skull (intracranial hypertension)

• you have recently had a stroke

• you are allergic to corn (Potassium Kabi 0.04 mEq/mL in 5% Glucose contains a sugar derived from corn)

• you have a condition that could cause high levels of vasopressin, a hormone regulating your body's fluid balance. You may have excessive vasopressin if, for example:

  • you have had an acute or serious illness
  • you are experiencing pain
  • you have undergone surgery
  • you have infections, burns, or central nervous system disorders
  • you have heart, liver, or kidney diseases
  • you are taking certain medications

This may increase the risk of low blood sodium levels (hyponatremia) and may cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death. Brain swelling increases the risk of death and brain damage. Individuals at higher risk of cerebral edema include:

• Children
• Women (particularly those of childbearing age)
• Individuals with conditions affecting cerebrospinal fluid levels, such as meningitis, intracranial hemorrhage, or brain injury.

You will be monitored frequently while receiving this medicine. Your doctor will take blood and urine samples to monitor your condition. Special attention will be given if you have heart or kidney problems.

Your doctor should consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion). You may require additional nutritional support during long-term treatment with Potassium Kabi 0.04 mEq/mL in 5% Glucose.

Since the infusion of Potassium Kabi 0.04 mEq/mL in 5% Glucose contains sugar (glucose), it may cause an increase in blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• adjust the infusion rate
• administer insulin to reduce blood sugar levels

This is especially important if you are diabetic.

All patients must be closely monitored. In cases where the normal regulation of blood water content is disrupted due to increased secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low blood sodium levels (hyponatremia). This may cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency.

Children

Infusion of Potassium Kabi 0.04 mEq/mL in 5% Glucose must be administered with special caution in children.

Newborns, especially premature infants and those with low birth weight, are at increased risk of developing blood sugar levels that are too low or too high (hypoglycemia or hyperglycemia) due to glucose-containing infusions.

• Low blood sugar in newborns may cause seizures, coma, and brain damage
• High blood sugar has been associated with brain hemorrhage, late-onset fungal or bacterial infections, intestinal tract infection (necrotizing enterocolitis), eye damage (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Use of Potassium Kabi 0.04 mEq/mL in 5% Glucose with other medicines

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

It is particularly important to inform your doctor if you are taking:

• cardiac glycosides used to treat heart failure (such as digoxin)

• antiarrhythmics used to suppress abnormal heart rhythms (such as quinidine, hydroquinidine, procainamide)

• medicines that increase blood potassium levels, such as:

  • potassium-sparing diuretics (such as amiloride, spironolactone, triamterene)
  • angiotensin-converting enzyme (ACE) inhibitors (used mainly for high blood pressure)
  • angiotensin II receptor antagonists (used for high blood pressure)
  • cyclosporine (used to prevent transplant rejection)
  • tacrolimus (used to prevent transplant rejection and to treat certain skin conditions)

• potassium-containing medicines (such as potassium supplements, potassium-containing salt substitutes)

• Some medicines affect the hormone vasopressin. These may include:

  • antidiabetic medicines (chlorpropamide)
  • cholesterol-lowering medicines (clofibrate)
  • antiepileptic medicines (carbamazepine)
  • amphetamine-like substances (including MDMA)
  • some cancer medicines (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used to treat depression)
  • antipsychotics
  • opioids for severe pain relief
  • pain and/or anti-inflammatory medicines (also known as NSAIDs)
  • medicines that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)

• Other medicines that increase the risk of hyponatremia include diuretics ("water pills") in general and antiepileptics such as oxcarbazepine.

Potassium Kabi 0.04 mEq/mL in 5% Glucose must not be administered through the same line as a blood transfusion. This may damage red blood cells or cause them to clump together.

Use of Potassium Kabi 0.04 mEq/mL in 5% Glucose with food and drinks

You should ask your doctor what you may eat or drink.

Pregnancy and breastfeeding

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

This medicine may be administered during pregnancy and breastfeeding. Your doctor will carefully monitor the amount of medicine to be administered. Your doctor will also perform blood tests to monitor chemical levels in your blood, as changes in blood potassium levels may affect the function of your heart and your baby's heart.

This medicine should be administered with special caution to pregnant women during labor, especially if combined with oxytocin (a hormone that may be given to induce labor and control bleeding), due to the risk of hyponatremia.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

3. How to use Potassium Kabi 0.04 mEq/ml in 5% Glucose

This medicine must be administered by a doctor or nurse.

Your doctor will decide how much you need and when it will be administered, depending on your age, weight, clinical and biological condition, your hydration status (amount of water in the body), and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

Before and during the infusion, your doctor will monitor the fluid levels in your body, blood acidity, urine output, and the levels of electrolytes (particularly sodium) in your blood (especially in patients with high levels of vasopressin hormone, or those taking other medications that enhance the effects of vasopressin).

The infusion rate will be determined by your doctor.

If you require a large volume or rapid infusion of this medicine, your doctor will monitor your ECG (heart activity).

During treatment with Potassium Kabi 0.04 mEq/ml in 5% Glucose, your doctor will take blood samples to monitor your levels of:

• potassium
• other electrolytes (such as sodium and chloride), and other substances normally present in the blood, such as creatinine (a byproduct of muscle breakdown)

If you have renal insufficiency, you will receive a lower dose.

If you are given more Potassium Kabi 0.04 mEq/ml in 5% Glucose than you should

If you are administered an excessive amount of this medicine (overdose), you may experience:

• tingling and burning sensations in arms and legs (paresthesia)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (arrhythmia)
• heart block (very slow heart rhythm)
• cardiac arrest (heart stops beating, which may be fatal)
• mental confusion
• blood acidification (acidosis), causing fatigue, confusion, lethargy, and increased respiratory rate

If you notice any of these symptoms, you must inform your doctor immediately. The administration of the medicine will be stopped, and you will be treated according to your symptoms.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of adverse effects is unknown.

Inform your doctor or nurse if any of the following adverse effects occur:

• abnormal increase in blood volume (hypervolemia)
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential occurrence in patients with corn allergy)
• fever
• cold

Side effects that may occur due to the administration technique include:

• infection at the injection site
• irritation or pain at the infusion site (redness or swelling)
• irritation and inflammation of the vein through which the infusion is administered (phlebitis). This may cause redness, pain or burning, and swelling in the vein where the solution is being administered.
• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.
• low levels of sodium in the blood (hyponatremia). Low sodium levels may lead to brain damage and death due to swelling (cerebral edema) (see section “Warnings and precautions”)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Kabi 0.04 mEq/ml in Glucose 5%

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the solution is not clear or contains visible particles. Do not use this medicine if the container is damaged.

6. Contents of the pack and other information

Composition of Potassium Kabi 0.04 mEq/ml in Glucose 5%

• The active substances are potassium chloride and glucose (as monohydrate). Each ml of solution contains 3.0 mg of potassium chloride and 50.0 mg of glucose.

• Each 500 ml bottle contains 1.5 g of potassium chloride and 25 g of glucose.

• Each 1000 ml bottle contains 3.0 g of potassium chloride and 50 g of glucose.

• The other components are water for injections and sodium hydroxide and hydrochloric acid for pH adjustment.

Appearance of the product and contents of the pack

Potassium Kabi 0.04 mEq/ml in Glucose 5% is a clear solution, free from visible particles. It is available in 500 ml and 1000 ml low-density polyethylene bottles, closed with a polyolefin cap containing a polyisoprene rubber stopper. It is supplied in packs of 10 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.
C/ Marina, 16-18
08005 Barcelona

Manufacturer

Labesfal – Laboratorios Almiro, S.A
Zona Industrial do Lagedo, Santiago de Besteiros, 3465 – 157
Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of last revision of this summary: June 2018

This information is intended for healthcare professionals only:

Handling and Preparation

This product is for single use only. Any unused solution remaining must be discarded.

Use only if the solution is clear, free from visible particles, and the container is undamaged.

Route of Administration

Administration is performed intravenously using sterile, pyrogen-free equipment.

Intravenous potassium must be administered through a large peripheral vein or central vein to reduce the risk of phlebitis. If infused via a central vein, ensure the catheter tip is not positioned in the atrium or ventricle to avoid localized hyperkalemia.

Solutions containing potassium must be administered slowly.

Rate of Administration

Potassium must not be administered intravenously at a rate exceeding 15 to 20 mmol per hour to prevent dangerous hyperkalemia.

Under no circumstances should the dose exceed that specified in the section “General Dosage.”

Dosage

General Advice

It may be necessary to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists due to the risk of hyponatremia. Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Potassium 0.04 mEq/mL in 5% Glucose Solution for Infusion may become extremely hypotonic after administration due to glucose metabolism in the body.

General Dosage

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

• For adults: 500 mL to 3 liters every 24 hours

• For infants and children:

  • From 0 to 10 kg body weight: 100 mL/kg/24 hours
  • From 10 to 20 kg body weight: 1000 mL + (50 mL/kg for each kg above 10 kg)/24 hours

  • 20 kg body weight: 1500 mL + (20 mL/kg for each kg above 20 kg)/24 hours

Dosage for Prevention and Treatment of Potassium Depletion

• Adults, elderly patients, and adolescents:

Typical potassium doses for prevention of hypokalemia may be up to 50 mmol daily, and similar doses may be appropriate in mild to moderate potassium deficiency. The maximum recommended potassium dose is 2 to 3 mmol/kg every 24 hours.

When used for the treatment of hypokalemia, the recommended dose is 20 mmol of potassium over 2 or 3 hours (e.g., 7–10 mmol per hour) under electrocardiographic (ECG) monitoring.

The maximum recommended rate of administration must not exceed 15 to 20 mmol per hour.

Patients with renal impairment should receive lower doses.

Under no circumstances should the dose exceed that specified in “General Dosage.”

Use in the Pediatric Population

When used for the treatment of hypokalemia, the recommended dose is 0.3–0.5 mmol/kg body weight/hour. The dose should be adjusted according to routinely obtained laboratory values.

The maximum recommended daily potassium dose is 2 to 3 mmol/kg body weight/day.

The rate and volume of infusion depend on the patient's age, weight, clinical and metabolic condition, and concomitant therapy, and must be determined by a physician experienced in intravenous fluid therapy for pediatric patients.

Validity after first opening:

The stability of the product after first opening has not been evaluated; therefore, the product must be used immediately after first opening.

In-use shelf life (with additives):

Prior to use, the physical and chemical stability of any added medication must be established with respect to the pH of Potassium Kabi 0.04 mEq/mL in 5% Glucose Solution for Infusion.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

It is the physician’s responsibility to assess incompatibility of added medications with Potassium Kabi 0.04 mEq/mL in 5% Glucose Solution, monitoring for possible changes in color and/or formation of precipitates, insoluble complexes, or crystals. The summary of product characteristics of the added medicinal products should also be consulted.

Before adding a medicinal product, it must be verified that it is soluble and/or stable in water at the pH of Potassium Kabi 0.04 mEq/mL in 5% Glucose Solution for Infusion (pH: 3.5 to 6.0).

As a guide, the following medicinal products are incompatible with Potassium Kabi 0.04 mEq/mL in 5% Glucose Solution, although this list is not exhaustive:

• Amphotericin B
• Dobutamine

Additives known to be incompatible must not be used.

From a microbiological standpoint, mixtures of this medicinal product with other medicinal products should be used immediately unless mixing has been carried out under validated aseptic conditions. If not used immediately, the conditions and duration of storage during use are the responsibility of the user.