KALII 1.5 mg/50 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
2. What Potassium Chloride 0.15% + Glucose 5% Kabi is and what it is used for
3. Important information before using Potassium Chloride 0.15% + Glucose 5% Kabi
   1. When not to use Potassium Chloride 0.15% + Glucose 5% Kabi:
   2. Warnings and precautions
   3. Children and adolescents
   4. Potassium Chloride 0.15% + Glucose 5% Kabi and other medicines
   5. Potassium Chloride 0.15% + Glucose 5% Kabi with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
4. How to use Potassium Chloride 0.15% + Glucose 5% Kabi
   1. Overdose of Potassium Chloride 0.15% + Glucose 5% Kabi
5. Possible side effects
   1. Tell your doctor or nurse immediately if you experience any of the following side effects:
   2. Side effects related to the method of administration:
   3. Reporting side effects
6. How to store Potassium Chloride 0.15% + Glucose 5% Kabi
7. Package contents and other information
   1. What Potassium Chloride 0.15% + Glucose 5% Kabi contains
   2. What Potassium Chloride 0.15% + Glucose 5% Kabi looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Handling and preparation of the solution

Package Leaflet: Information for the User

Potassium Chloride 0.15% + Glucose 5% Kabi, (1.5 mg + 50 mg)/ml, Solution for Infusion
Potassium Chloride + Glucose

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse. See section 4.

Package Leaflet Contents

• 1. What Potassium Chloride 0.15% + Glucose 5% Kabi is and what it is used for
• 2. Important information before using Potassium Chloride 0.15% + Glucose 5% Kabi
• 3. How to use Potassium Chloride 0.15% + Glucose 5% Kabi
• 4. Possible side effects
• 5. How to store Potassium Chloride 0.15% + Glucose 5% Kabi
• 6. Package contents and other information

1. What Potassium Chloride 0.15% + Glucose 5% Kabi is and what it is used for

Potassium Chloride 0.15% + Glucose 5% Kabi is a solution for infusion containing potassium chloride and glucose.
Potassium chloride is a chemical compound (a type of salt) that occurs naturally in the blood. Glucose is
one of the sources of energy for the body. This solution for infusion provides 200 kilocalories per liter.
This medicine is used as a source of carbohydrates (sugars) in the prevention and treatment of:

• potassium loss from the body (e.g. after treatment with certain diuretics (tablets that increase urine production));
• low potassium levels in the blood (hypokalemia) in situations that may cause potassium and water loss:
• when the patient cannot eat or drink due to illness or after surgery;
• when the patient has excessive sweating due to high fever.

2. Important information before using Potassium Chloride 0.15% + Glucose 5% Kabi

When not to use Potassium Chloride 0.15% + Glucose 5% Kabi:

• if the patient has high potassium levels in the blood (hyperkalemia);
• if the patient has high chloride levels in the blood (hyperchloremia);
• if the patient has severe kidney disease (reduced or absent urine production);
• if the patient has heart failure that is not properly treated (uncontrolled heart failure) and causes symptoms such as:
• shortness of breath;
• swelling of the ankles;
• if the patient has adrenal gland disorders (Addison's disease);
• if the patient has diabetes that is not properly treated and causes high blood sugar levels (uncontrolled diabetes);
• if the patient has other types of glucose intolerance, such as:
• metabolic stress (a condition in which the patient's metabolism does not work properly, e.g. due to severe illness);
• hyperosmolar coma (loss of consciousness); this is a type of coma that can occur in diabetic patients who do not receive enough medication;
• high blood sugar levels (hyperglycemia);
• high lactate levels in the blood (hyperlactatemia).

Warnings and precautions

This medicine has a higher concentration than blood (hypertonic solution). The doctor will take this into account when determining the dose for the patient.
Before starting treatment with Potassium Chloride 0.15% + Glucose 5% Kabi, you should tell your doctor or nurse:

• if you have any heart disease or heart failure;
• if you have respiratory failure (lung disease);
• if you have kidney impairment (the patient may require special monitoring if they have any of the above diseases);
• if you have adrenal gland disease (a gland located on top of the kidney) that affects the level of steroid hormones in the body (adrenal insufficiency);
• if you are dehydrated (excessive water loss, e.g. due to vomiting or diarrhea);
• if you have severe burns with extensive skin damage, e.g. after a burn;
• if you have had a head injury in the last 24 hours;
• if you have high blood pressure in the skull (intracranial hypertension);
• if you have had a stroke recently;
• if you are allergic to corn (Potassium Chloride 0.15% + Glucose 5% Kabi contains sugar derived from corn);
• if you have a condition that may cause increased levels of vasopressin (a hormone that regulates water content in the body). Increased vasopressin levels in the body may occur: if the patient has had a sudden or severe illness; if the patient is in pain; if the patient has had surgery; if the patient has an infection, burn, or central nervous system disease; if the patient has heart, liver, or kidney disease; if the patient is taking certain medications. This may increase the risk of low sodium levels in the blood, which can lead to headache, nausea, seizures, lethargy, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. The risk of brain swelling is higher in:
• children;
• women (especially of childbearing age);
• patients with disorders of cerebrospinal fluid, which may be caused by meningitis, intracranial hemorrhage, or brain damage.

The doctor will closely monitor the patient's condition during treatment with this medicine. The doctor will take blood and urine samples to determine the patient's condition. Patients with heart or kidney disease should be monitored closely.
The doctor will consider whether the patient is receiving intravenous nutrition (nutrition administered through a drip into a vein).
In the case of prolonged administration of Potassium Chloride 0.15% + Glucose 5% Kabi, the patient may require additional nutrition.
Potassium Chloride 0.15% + Glucose 5% Kabi contains sugar (glucose), which may cause high blood sugar levels (hyperglycemia). In this case, the doctor may:

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

This is especially important in patients with diabetes.
Patients should be closely monitored. In cases where proper regulation of water content in the blood is disrupted due to increased secretion of antidiuretic hormone (ADH), infusion of fluids with low salt concentration (hypotonic solutions) may lead to low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling, and death, so the occurrence of these symptoms (severe symptomatic encephalopathy with hyponatremia) is considered a life-threatening condition.

Children and adolescents

Potassium Chloride 0.15% + Glucose 5% Kabi should be administered with caution in children.
Newborns, especially premature and low-birth-weight infants, are more susceptible to low or high blood sugar levels(hypo- or hyperglycemia) during intravenous administration of glucose solutions.

• Low blood sugar levelsin newborns can cause prolonged seizures, coma, and brain damage.
• High blood sugar levelsare associated with bleeding into the brain, delayed bacterial and fungal infections, gastrointestinal infection (necrotizing enterocolitis), vision damage (retinopathy of prematurity), lung disease (bronchopulmonary dysplasia), prolonged hospital stay, and death.

Potassium Chloride 0.15% + Glucose 5% Kabi and other medicines

Tell your doctor or nurse about all medicines you are taking, or have recently taken, and any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• cardiac glycosides used in heart disease (e.g. digoxin);
• anti-arrhythmic medicines used to treat irregular heartbeat (e.g. quinidine, hydroquinidine, procainamide);
• medicines that increase potassium levels in the blood, such as:
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene);
• angiotensin-converting enzyme inhibitors (mainly used to treat high blood pressure);
• angiotensin II receptor antagonists (used to treat high blood pressure);
• cyclosporine (used to prevent transplant rejection);
• tacrolimus (used to prevent transplant rejection and treat certain skin diseases);
• potassium-containing medicines (e.g. potassium supplements, salt substitutes containing potassium).
• certain medicines that affect the action of vasopressin, including:
• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• antiepileptic medicines (carbamazepine);
• amfetamine-like medicines (including MDMA);
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotic medicines;
• opioids used to treat severe pain;
• pain-relieving and/or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs, NSAIDs);
• medicines that mimic or enhance the action of vasopressin, 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 medicines that increase the risk of hyponatremia, including all diuretics and antiepileptic medicines such as oxcarbazepine.

Do not administer Potassium Chloride 0.15% + Glucose 5% Kabi through the same needle as a blood transfusion. This may cause red blood cells to break down or clump together.

Potassium Chloride 0.15% + Glucose 5% Kabi with food and drink

Ask your doctor about using Potassium Chloride 0.15% + Glucose 5% Kabi with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or nurse for advice before using this medicine.
This medicine may be used in pregnant and breastfeeding women. The doctor will closely monitor the dose given to the patient. The doctor will order blood tests to monitor the levels of substances in the blood, as changes in potassium levels can affect the mother's and fetus's heart function.
Special caution is required when administering this medicine to pregnant women during labor, especially in combination with oxytocin (a hormone used to induce labor and prevent bleeding), due to the risk of hyponatremia.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

3. How to use Potassium Chloride 0.15% + Glucose 5% Kabi

This medicine is administered by a doctor or nurse.
The doctor will determine the dose and method of administration based on the patient's age, weight, clinical and biological condition, hydration status, and reason for treatment. The dose of the medicine also depends on other medicines the patient is taking.
The doctor will monitor the patient's fluid balance, blood acidity, urine flow, and electrolyte levels (especially sodium) in the blood (mainly in patients with high levels of vasopressin or patients taking other medicines that enhance the action of vasopressin), at the start of infusion and during its administration.
The doctor will determine the infusion rate.
If the patient requires a large volume or rapid infusion, the doctor will check the ECG (heart function test).
During treatment with Potassium Chloride 0.15% + Glucose 5% Kabi, the doctor will order blood tests to monitor the levels of:

• potassium;
• other electrolytes (such as sodium or chlorides) and other substances in the blood, such as creatinine (a product of muscle breakdown). If the patient has kidney impairment, the doctor may reduce the dose of the medicine.

Overdose of Potassium Chloride 0.15% + Glucose 5% Kabi

If too much of the medicine is administered (in the infusion), the following may occur:

• tingling and burning sensation in the hands and feet (paresthesia);
• muscle weakness;
• difficulty moving (paralysis);
• irregular heartbeat (arrhythmia);
• heart block (very slow heartbeat);
• cardiac arrest (the heart stops working, a life-threatening situation);
• confusion;
• acidosis of the blood (leading to feelings of weakness, disorientation, coma, and increased breathing rate). You should immediately inform your doctor if you experience any of these symptoms. The infusion will be stopped and the patient will receive treatment depending on the symptoms that occur.

If you have any further questions about using 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 not known.

Tell your doctor or nurse immediately if you experience any of the following side effects:

• increased blood volume (hypervolemia);
• allergic reactions, including a severe allergic reaction known as anaphylactic reaction (a possible clinical sign of corn allergy);
• fever;
• chills.

Side effects related to the method of administration:

• infection at the injection site;
• irritation or pain at the injection site (redness or swelling);
• irritation and inflammation of the vein into which the solution was administered (phlebitis). This can cause redness, pain, or burning sensation and swelling along the vein into which the solution was administered;
• blood clot at the injection site (thrombophlebitis), causing pain, swelling, or redness in the area where the clot occurred;
• low sodium levels in the blood (hyponatremia). Low sodium levels can lead to brain damage and death caused by brain swelling (see section "Warnings and precautions").

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
email: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Potassium Chloride 0.15% + Glucose 5% Kabi

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month.
Do not use this medicine if the solution is not clear or if particles are visible. Do not use this medicine if the bottle is damaged.

6. Package contents and other information

What Potassium Chloride 0.15% + Glucose 5% Kabi contains

• The active substances are potassium chloride and glucose (in the form of glucose monohydrate). 1 ml of solution contains 1.50 mg of potassium chloride and 50 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 ingredients are water for injection, sodium hydroxide (to adjust pH), and concentrated hydrochloric acid (to adjust pH).

What Potassium Chloride 0.15% + Glucose 5% Kabi looks like and what the package contains

Potassium Chloride 0.15% + Glucose 5% Kabi is a clear solution, free from visible particles.
It is available in 500 ml or 1000 ml LDPE (KabiPac) bottles with a polyisoprene stopper and a polyolefin cap.
Package size: 10 bottles in a cardboard box.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo

• 3465 – 157 Santiago de Besteiros Portugal

For more information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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

Belgium
Potassium Chloride 0.15% + Glucose 5% Fresenius Kabi
Bulgaria
Калиев хлорид + Глюкоза Каби 1,5 mg/ml + 50 mg/ml инфузионен разтвор
Estonia
Potassium Chloride/Glucose Fresenius 1,5 mg/50 mg/ml
France
Chlorure de potassium 0,15% et glucose 5% Kabi, solution pour perfusion
Spain
Cloruro de potasio Kabi 20 mEq/l en Glucosa 5% solución para perfusion EFG
Netherlands
Kaliichloride 0.15% + Glucose 5% Fresenius Kabi
Ireland
Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion
Lithuania
Potassium Chloride/ Glucose Fresenius 1,5 mg/50 mg/ml infuzinis tirpalas
Latvia
Potassium Chloride/Glucose Fresenius 1,5 mg/50 mg/ml šķīdums infūzijām
Poland
Kalii chloridum 0,15% + Glucosum 5% Kabi
Portugal
Cloreto de Potássio 0,15% p/v e Glucose 5% p/v Kabi
Slovenia
Kalijev klorid/Glukoza Kabi 1,5 mg/50 mg v 1 ml raztopina za infundiranje
United Kingdom
Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion
Date of last revision of the package leaflet:29.06.2018
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Information intended for healthcare professionals only:

Handling and preparation of the solution

This medicine is for single use only. Any unused solution should be discarded.
Only use a clear solution, free from visible particles and with an intact package.
Route of administration
Intravenous administration using sterile equipment free from pyrogens.
Intravenous administration of potassium should be done into a large peripheral vein or central vein, to reduce the risk of vein hardening. When administering into a central vein, ensure that the catheter is not in the atrium or ventricle of the heart, to avoid local hyperkalemia.
Solutions containing potassium should be administered slowly.
Infusion rate
To avoid the risk of dangerous hyperkalemia, the infusion rate during potassium administration should not exceed 15 to 20 mmol/hour.
Do not exceed the recommended dose (see section "Dosage").

• amphotericin B;
• dobutamine.

Do not add medicines with known incompatibility.
From a microbiological point of view, this medicine mixed with other medicines should be used immediately, unless mixing is performed in controlled and validated aseptic conditions. If the medicine is not used immediately, the user is responsible for the storage time and conditions of the prepared solution.