POTASSIUM KABI 0.04 mEq/mL in 5% GLUCOSE SOLUTION FOR INFUSION

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

You should not be given Potassium Kabi 0.04 mEq/ml in Glucose 5%:

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

• breathing difficulties
• swelling of the ankles
  • if your adrenal gland does not function properly (Addison's disease)
  • if your diabetes is not properly controlled, allowing your blood sugar levels to be higher than normal (uncontrolled diabetes)
  • in states of glucose intolerance, such as:

• metabolic stress (when the body's metabolism does not work properly, e.g. due to severe 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
• high lactate levels in the blood

Warnings and precautions

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

Tell your doctor or nurse before you are given Potassium Kabi 0.04 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 an adrenal gland disease that affects the amount of steroid hormones in the body (adrenocortical insufficiency).
• you are severely dehydrated (loss of body water, e.g. due to vomiting or diarrhea)
• you have a severe skin injury (such as burns)
• you have had a head injury in the last 24 hours.
• there is an increase in pressure inside the skull (intracranial hypertension)
• you have recently had a stroke
• if you are allergic to corn (Potassium Kabi 0.04 mEq/ml in Glucose 5% contains a corn-derived sugar)

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

• you have had a sudden or severe illness
• you are in pain
• you have had surgery
• you have infections, burns, or central nervous system diseases
• you have heart, liver, or kidney diseases
• you are taking certain medications

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

• Children
• women (especially if they are of childbearing age)
• people who have problems with their brain fluid levels, e.g. due to meningitis, brain hemorrhage, or brain injury.

Your doctor will closely monitor you while you are being given this medicine. 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 (nutrition administered by infusion into a vein). You may need to be given extra nutrition during long-term treatment with Potassium Kabi 0.04 mEq/ml in Glucose 5%.

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

• adjust the infusion rate
• give you insulin to reduce blood sugar levels

This is especially important if you are diabetic.

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

Children

The infusion of Potassium Kabi 0.04 mEq/ml in Glucose 5% should be administered with special caution in children.

Newborns, especially premature and low-birth-weight infants, are at higher risk of developing low or high blood sugar levels(hypoglycemia or hyperglycemia) due to glucose solution infusion.

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

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

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

It is especially important to tell your doctor if you are taking:

• cardiac glycosides used to treat heart failure (such as digoxin)
• anti-arrhythmics used to suppress abnormal heart rhythm (such as quinidine, hydroquinidine, procainamide)
• medicines that increase potassium levels in the blood, such as:

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

• Some medicines act on the vasopressin hormone. These may include:

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

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

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

Use of Potassium Kabi 0.04 mEq/ml in Glucose 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, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

This medicine can be used during pregnancy and breastfeeding. Your doctor will closely monitor the amount of medicine to be administered. Your doctor will also take blood samples to check the levels of chemical substances in the blood, as changes in potassium levels in the blood can affect 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 can be administered 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 use machines.

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

This medicine should be administered by a doctor or nurse.

Your doctor will decide what dose you need and when it will be administered, depending on your age, weight, clinical and biological condition, hydration status, and reason for treatment. The dose to be administered may also be affected by other treatments you are receiving.

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

The infusion rate will be determined by your doctor.

If you need a high 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 Glucose 5%, your doctor will take blood samples to check your levels of:

• potassium
• other electrolytes (such as sodium and chloride) and other chemical substances normally found in the blood, such as creatinine (a muscle breakdown product)

If you have kidney failure, you will receive a lower dose.

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

If you are given too much of this medicine (overdose), you may experience:

• tingling and burning in arms and legs (paresthesia)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (arrhythmia)
• heart block (very slow heart rate)
• heart stop (heart stops beating, which can cause death)
• mental confusion
• blood acidification (acidosis), which causes fatigue, confusion, lethargy, and increased respiratory rate.

If you notice any of these symptoms, you should tell your doctor immediately. The medicine will be stopped and you will be treated depending on the symptoms.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects is unknown.

Tell your doctor or nurse if you get any of the following side effects.

• abnormal increase in blood volume (hypervolemia)
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential occurrence in patients with corn allergy)
• fever
• common 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 inflammation)
• irritation and inflammation of the vein through which the infusion is given (phlebitis). This can cause redness, pain, or itching and swelling in the vein where the solution is being administered.
• blood clot formation (venous thrombosis) at the infusion site, which causes pain, inflammation, or redness in the area of the clot.
• low sodium levels in the blood (hyponatremia). Low sodium levels can cause brain damage and death due to swelling (cerebral edema) (see section "Warnings and precautions")

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side 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 special storage conditions.

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

Do not use this medicine if the solution is not clear or has visible particles. Do not use this medicine if the packaging is damaged.

6. Container Content and Additional Information

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

• The active ingredients 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 vial contains 1.5 g of potassium chloride and 25 g of glucose.
• Each 1000 ml vial contains 3.0 g of potassium chloride and 50 g of glucose.
• The other components are water for injectable preparations, sodium hydroxide, and hydrochloric acid for pH adjustment.

Appearance of the Product and Container Content

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

Only some 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 Member States of the European Economic Area Under the Following Names:

Date of Last Revision of this Leaflet: June 2018

This information is intended only for healthcare professionals:

Handling and Preparation

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

Use only if the solution is clear, particle-free, and the container is not damaged.

Route of Administration

Administration is by intravenous route using sterile and apyrogenic equipment.

Potassium should be administered intravenously through a large peripheral vein or central vein to reduce the risk of sclerosis. If perfused through a central vein, ensure that the catheter is not in the atrium 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 mmol per hour to avoid dangerous hyperkalemia.

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

Posology

General Advice

It may be necessary to monitor water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased release of non-osmotic vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in 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 0.04 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 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 above 10 kg)/24 hours

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

Posology for the Prevention and Treatment of Potassium Depletion

• Adults, elderly, and adolescents:

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

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

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

Patients with renal insufficiency should receive lower doses.

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

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 laboratory values obtained routinely.

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

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

Validity 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.

Validity Period in Use (with Additives):

Before use, the physical and chemical stability of any added medication should be established at the pH of Potassium Kabi 0.04 mEq/ml in Glucose 5% solution for infusion.

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

It is the responsibility of the physician to assess the incompatibility of the added medication with the Potassium Kabi 0.04 mEq/ml in Glucose 5% solution, controlling for possible changes in color and/or the formation of precipitates, insoluble complexes, or crystal appearance. The summary of product characteristics of the medications to be added should also be consulted.

Before adding a medication, it should be verified that it is soluble and/or stable in water at the pH of Potassium Kabi 0.04 mEq/ml in Glucose 5% solution for infusion (pH: 3.5 to 6.0).

As a guide, the following medications are incompatible with the Potassium Kabi 0.04 mEq/ml in Glucose 5% solution, although this list is not exhaustive:

• Amphotericin B
• Dobutamine

Additives 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 during use are the responsibility of the user.