Prospecto: information for the user

Potassium Kabi 0.02 mEq/ml in Glucose 5% solution for infusion EFG

potassium chloride, glucose (as monohydrate)

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

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

-If you have any doubts, consult your doctor or nurse.

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

1.What is Potassium Kabi 0.02 mEq/ml in Glucose 5% and for what it is used

2.What you need to know before starting to use Potassium Kabi 0.02 mEq/ml in Glucose 5%

3.How to use Potassium Kabi 0.02 mEq/ml in Glucose 5%

4.Possible adverse effects

5.Storage of Potassium Kabi 0.02 mEq/ml in Glucose 5%

6.Contents of the package and additional information

Potasio Kabi 0.02 mEq/ml in Glucosa 5% 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 energy sources. This solution provides 200 kilocalories per liter.

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

• potassium loss from the body (for example after treatment with certain diuretics)
• low potassium levels in the blood (hypokalemia) in situations where potassium chloride and water losses can occur, including:
• • when unable to eat or drink due to illness or after surgery
  • profuse sweating due to high fever

You should not be given Potasio Kabi 0.02 mEq/ml in Glucose 5%.

• if your blood potassium levels are higher than normal (hyperkalemia)
• if your blood chloride levels are higher than normal (hyperchloremia)
• if you have severe kidney problems (you may not be able to urinate or produce very little urine)
• if you have an untreated heart failure that causes symptoms such as:

-difficulty breathing

-swelling of the ankles

• if your adrenal gland does not function properly (Addison's disease)
• if your diabetes is not adequately treated, allowing your blood sugar levels to be higher than normal (uncompensated diabetes)
• in states of glucose intolerance, such as:

• metabolic stress (when the body's metabolism does not function correctly, for example due to a serious illness)
• hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medication.
• high blood sugar levels (hyperglycemia)
• high blood lactate levels (hyperlacticemia)

Warnings and precautions

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

Consult your doctor or nurse before being given Potasio Kabi 0.02 mEq/ml in Glucose 5% if:

• you have any type of heart disease, including heart failure
• you have respiratory failure (lung disease)
• you have reduced kidney function (you may need special monitoring in the above conditions)

• you have a condition affecting the amount of steroid hormones in the body (adrenocortical insufficiency)
• you are very dehydrated (loss of body water, for example, due to vomiting or diarrhea)
• you have a severe skin injury (such as burns)
• you have had a head injury in the past 24 hours
• you have increased pressure inside the skull (intracranial hypertension)
• you have had a recent stroke
• you are allergic to corn (Potasio Kabi 0.02 mEq/ml in Glucose 5% contains a sugar derived from corn)

• if you have a condition that could cause high levels of vasopresin, a hormone that regulates the fluid in your body. You may have too much vasopresin in your body if, for example:

• you have had a sudden or serious illness
• you are in pain
• you have had surgery
• you have infections, burns, or central nervous system diseases
• you have diseases related to your heart, liver, or kidneys
• you are taking certain medications

This may increase the risk of low sodium levels in the blood and can cause headache, nausea, convulsions, lethargy, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of brain inflammation are:

• Children
• Women (particularly if they are of childbearing age)

• people with problems with their cerebrospinal fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain injury.

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

Your doctor should take into account if you are receiving parenteral nutrition (intravenous nutrition). You may need to receive extra nutrition during long-term treatments with Potasio Kabi 0.02 mEq/ml in Glucose 5%.

Since the infusion of Potasio Kabi 0.02 mEq/ml in Glucose 5% contains sugar (glucose), this 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 altered due to increased secretion of antidiuretic hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (symptomatic hyponatremic encephalopathy) are considered a medical emergency.

Children

The infusion of Potasio Kabi 0.02 mEq/ml in Glucose 5% should be administered with special caution in children.

Newborns, especially premature and low-birth-weight babies, have a higher risk of developing:low or high blood sugar levels (hypoglycemia or hyperglycemia)due to the infusion of glucose solutions.

• Low blood sugarin newborns can cause convulsions, coma, and brain damage
• High blood sugarhas been associated with brain hemorrhage, late-onset fungal or bacterial infection, necrotizing enterocolitis, retinopathy of prematurity, respiratory problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Use ofPotasio Kabi 0.02 mEq/ml in Glucosa 5% withother medications

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

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

• cardiac glycosides used in the treatment of heart failure (such as digoxin)
• antiarrhythmics used to suppress abnormal heart rhythm (such as quinidine, hydroquinidine, procainamide)
• medications that increase potassium levels in the blood, such as:

• potassium-sparing diuretics (such as amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used mainly to treat high blood pressure)
• angiotensin II receptor antagonists (used to treat high blood pressure)
• ciclosporin (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and to treat some skin diseases)
• medications that contain potassium (such as potassium supplements, salt substitutes containing potassium)

• Some medications act on vasopressin. These may include:

• diabetic medications (chlorpropamide)
• cholesterol-lowering medications (clofibrate)
• antiepileptic medications (carbamazepine)
• products similar to amphetamine (such as MDMA)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or enhance the effects of vasopresin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)

-Other medications that increase the risk of hyponatremia also include diuretics (urine-promoting tablets) in general and antiepileptic medications such as oxcarbazepine.

Do not administer Potasio Kabi 0.02 mEq/ml in Glucose 5% through the same route as a blood transfusion. This may damage red blood cells or cause them to clump.

Use of Potasio Kabi 0.02 mEq/ml in Glucosa 5% with food and drinks

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

Pregnancy and breastfeeding

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

This medication can be administered during pregnancy and breastfeeding. Your doctor will closely monitor the amount of medication to be administered. Your doctor will also perform blood tests to check the levels of chemicals present in the blood, as changes in potassium levels in the blood can affect the functioning of your heart and your baby.

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

Driving and operating machines

This medication does not affect your ability to drive or operate machines.

This medication should be administered by a doctor or a nurse.

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

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

The rate of administration of the infusion will be determined by your doctor.

If you need a high volume or rapid infusion of this medication, your doctor will monitor your ECG (heart activity).

During treatment with Potasio Kabi 0.02 mEq/ml in Glucosa 5%, your doctor will take blood samples to monitor your levels of:

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

If you are administered more Potasio Kabi 0.02 mEq/ml in Glucosa 5% than you should

If you receive an excessive amount of this medication (overdose), you may experience:

If you observe any of these symptoms, you should inform your doctor immediately. You will stop receiving the medication, and treatment will be provided based on the symptoms.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of adverse effects is unknown.

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

Adverse effects that may occur due to administration technique include:

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the container. The expiration date is the last day of the month indicated.

Do not use this medication if the solution is not transparent or has visible particles. Do not use this medication if the container is damaged.

Potassium Kabi 0.02 mEq/ml in Glucose 5%

• The active ingredients are potassium chloride and glucose (as monohydrate). Each milliliter of solution contains 1.5 mg of potassium chloride and 50.0 mg of glucose.

• Each 500 ml bottle contains 0.75 g of potassium chloride and 25 g of glucose.
• Each 1000 ml bottle contains 1.50 g of potassium chloride and 50 g of glucose.
• The other components are water for injection and sodium hydroxide and hydrochloric acid for pH adjustment.

Appearance of the product and contents of the container

Potassium Kabi 0.02 mEq/ml in Glucose 5% is a transparent solution, free of visible particles. It is available in low-density polyethylene bottles of 500 and 1000 ml, closed with a polyolefin cap containing a polyisoprene rubber stopper. It is supplied in packs of 10 bottles

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18

08005 Barcelona

Responsible for manufacturing

Labesfal – Laboratorios Almiro, S.A.

Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157

Portugal

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: June 2018

This information is intended solely for healthcare professionals:

Handling and preparation

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

Use only if the solution is transparent, free of visible particles, and the container is not damaged.

Route of administration

The administration is carried out by intravenous route using a sterile and apyrogenic equipment.

Potassium administered intravenously should be administered through a large peripheral vein or central vein to reduce the risk of sclerosis. If administered through a central vein, ensure that the catheter is not in the auricle or ventricle to avoid localized hyperkalemia.

Solutions containing potassium should be administered slowly.

Administration rate

Potassium should not be administered intravenously at a rate greater than 15 to 20 mmoles per hour to avoid a dangerous hyperkalemia.

In no case should the dose indicated in the "General Posology" section be exceeded.

Posology

General advice

It may be necessary to control fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased vasopressin release (SIADH syndrome) and patients co-medicated with vasopressin agonist medications due to the risk of hyponatremia. Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Potassium 0.02 mEq/ml in Glucose 5% solution for infusion may become extremely hypotonic after administration due to glucose metabolism in the body.

General posology

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

• for adults: 500 ml to 3 liters per 24 hours

• for infants and children:

0 to 10 kg body weight: 100 ml/kg/24 hours

10 to 20 kg body weight: 1000 ml + (50 ml/kg above 10 kg)/24 hours

> 20 kg body weight: 1500 ml + (20 ml/kg above 20 kg)/24 hours

Posology for prevention and treatment of potassium depletion

• Adults, elderly, and adolescents:

The typical potassium doses for prevention of hypokalemia can be up to 50 mmoles per day and similar doses may be suitable for moderate potassium deficiency. The maximum recommended dose of potassium is 2 to 3 mmoles/kg per 24 hours.

When used for treatment of hypokalemia, the recommended dose is 20 mmoles of potassium in 2 or 3 hours (e.g. 7-10 mmoles per hour) under electrocardiographic (ECG) control.

The maximum recommended administration rate should not exceed 15 to 20 mmoles per hour.

Patients with renal insufficiency should receive lower doses.

In no case should the dose indicated in "General Posology" be exceeded.

Use in pediatric population

When used for treatment of hypokalemia, the recommended dose is 0.3 - 0.5 mmol/kg/body weight/h. The dose should be adjusted to laboratory values obtained habitually.

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

The administration rate and volume depend on age, weight, clinical and metabolic conditions of the patient, concomitant treatment, and should be determined by an experienced physician in intravenous fluid therapy for pediatric patients.

Valid period 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.

Valid period in use (with additives):

Before use, the physical and chemical stability of any added medication must be established at the pH of Potassium Kabi 0.02 mEq/ml in Glucose 5% solution for infusion.

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

It is the responsibility of the physician to evaluate the incompatibility of the added medication with the Potassium Kabi 0.02 mEq/ml in Glucose 5% solution, controlling possible changes in color and/or the formation of precipitates, insoluble complexes, or appearance of crystals. The technical data sheet of the medicinal products to be added 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 0.02 mEq/ml in Glucose 5% solution for infusion (pH: 3.5 to 6.0).

As a guide, the following medicinal products are incompatible with the solution of Potassium Kabi 0.02 mEq/ml in Glucose 5%, although this list is not exhaustive:

• Anfotericina B
• Dobutamina

Medicinal products that are known to be incompatible should not be used.

From a microbiological point of view, mixtures of this medicinal product with other medicinal products should be used immediately, unless the mixture has been prepared in controlled and validated aseptic conditions. If not used immediately, the conditions and storage times used during use are the responsibility of the user.