KALII 1.5 mg/9 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. Table of Contents of the Leaflet
2. What is Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi and what is it used for
3. Important information before using Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
   1. Kabi
   2. When not to use Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi:
   3. Warnings and precautions
   4. Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
4. How to use Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
   1. Using a higher dose of Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi than recommended
5. Possible side effects
   1. Tell your doctor immediately if you experience any of the following side effects:
   2. Reporting side effects
6. How to store Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
7. Contents of the pack and other information
   1. What Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi contains
   2. What Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi looks like and contents of the pack
   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. Administration and preparation

Package Leaflet: Information for the User

Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi, (1.5 mg + 9 mg)/ml, Solution for Infusion
Potassium Chloride + Sodium Chloride

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

• Keep this 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, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi and what is it used for
• 2. Important information before using Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
• 3. How to use Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
• 4. Possible side effects
• 5. How to store Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi
• 6. Contents of the pack and other information

1. What is Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi and what is it used for

Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi is a solution of sodium chloride and potassium chloride. Sodium chloride and potassium chloride are chemical compounds (often called "salts") that occur naturally in the blood.
This medicine is used to prevent and treat:

• loss of potassium 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 loss of potassium and water:
• when the patient cannot eat or drink due to illness or after surgery;
• when the patient has excessive sweating due to high fever;
• loss of sodium chloride and dehydration.

2. Important information before using Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi

Kabi

When not to use Potassium Chloride 0.15% + Sodium Chloride 0.9% 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 high sodium levels in the blood (hypernatremia);
• if the patient has severe kidney disease (reduced or absent urine production);
• if the patient has heart failure that is not properly treated (uncompensated heart failure) and causes symptoms such as:
• shortness of breath;
• swelling of the ankles;
• if the patient has adrenal gland disorders (Addison's disease).

Warnings and precautions

This medicine has a higher concentration of certain ions 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% + Sodium Chloride 0.9% Kabi, the patient should inform the doctor or nurse if they have:

• any heart disease or heart failure;
• kidney function impairment;
• adrenal gland disease that affects steroid hormone levels in the body (adrenal insufficiency);
• dehydration (excessive water loss, e.g. due to vomiting or diarrhea);
• severe wounds with extensive skin damage, e.g. after burns;
• high blood pressure;
• swelling under the skin, especially around the ankles (peripheral edema) or in the lungs (pulmonary edema);
• high blood pressure during pregnancy (pre-eclampsia);
• any other diseases that cause the body to retain too much sodium (sodium retention).

The patient's condition should be closely monitored 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.

Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi and other medicines

The patient should tell the doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform the doctor about the use of:

• cardiac glycosides used in heart disease (such as digoxin);
• anti-arrhythmic drugs used to treat irregular heart rhythm (such as quinidine, hydroquinidine, procainamide);
• medicines that increase potassium levels in the blood, such as:
• potassium-sparing diuretics, i.e. medicines that increase urine production (such as 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;
• corticosteroids (anti-inflammatory medicines).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
This medicine may be used in pregnant and breastfeeding women. The doctor will closely monitor the amount of medicine used by the patient. The doctor will also perform blood tests to monitor the levels of chemical substances in the blood, as changes in potassium levels can affect the mother's and fetus's heart function.
The doctor will also closely monitor the patient's blood pressure, as sodium chloride can cause blood pressure to rise (risk of pre-eclampsia).

Driving and using machines

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

3. How to use Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi

The 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, and hydration status. The dose of the medicine also depends on other medicines used by the patient.
Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi should be administered slowly, as an intravenous infusion.
The doctor will determine the infusion rate. If the patient needs a large volume or rapid infusion, the doctor will monitor the ECG recording.
During treatment with Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi, the doctor will order blood tests to monitor potassium and other electrolyte levels (such as sodium or chlorides) in the blood. The doctor will also monitor urine production.

Using a higher dose of Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi than recommended

If too much medicine is used, the following symptoms may occur: tingling and burning of hands and feet (paresthesia), muscle weakness, difficulty moving (paralysis), irregular heart rhythm (arrhythmia), heart block (very slow heart rate), cardiac arrest (heart stops working), confusion, fluid accumulation in the lungs causing breathing difficulties (pulmonary edema), fluid accumulation under the skin, especially around the ankles (peripheral edema), acidosis of the blood (leading to feelings of weakness), disorientation, coma, and increased breathing rate.
The doctor should be informed immediately if the patient experiences 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 following side effects have been reported during use of the medicine after it was marketed. The frequency cannot be determined from the available data. Side effects may occur due to the method of administration.

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

• infection at the injection site;
• increased blood volume (hypervolemia);
• infusion of the solution into surrounding tissues (extravasation). This can cause tissue damage and scarring.
• excessive sensitivity to touch or pain at the injection site;
• vein inflammation (phlebitis). This can cause redness, swelling, and pain or burning along the vein where the solution was administered.
• blood clot at the injection site, causing pain, swelling, or redness in the area where the clot occurred;
• fever.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi

Store the medicine out of sight and reach of children.
There are no special precautions for storing the 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.
Use only a clear solution, free from visible particles, with undamaged packaging.
From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage conditions and time of the prepared solution.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi contains

• The active substances of the medicine are potassium chloride and sodium chloride. 1 ml of solution contains 1.5 mg of potassium chloride and 9 mg of sodium chloride. Each 500 ml bottle contains 0.75 g of potassium chloride and 4.5 g of sodium chloride. Each 1000 ml bottle contains 1.50 g of potassium chloride and 9.00 g of sodium chloride.
• The other ingredients are: water for injections, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH).

What Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi looks like and contents of the pack

Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi is a clear, colorless solution, free from visible particles.
It is available in 500 ml or 1000 ml LDPE (KabiPac) bottles with a polyisoprene stopper and polyolefin cap.
Pack size: 10 bottles in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Fresenius Kabi Deutschland GmbH
Freseniusstrasse 1, D-61169 Friedberg
Germany
Labesfal – Laboratórios 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:

Belgium
KCl 0.15% w/v & NaCl 0.9% w/v Fresenius Kabi, solution for infusion
Estonia
Potassium Chloride/Sodium Chloride Fresenius
France
Chlorure de potassium 0,9% et chlorure de sodium 0,9% Kabi, solution for perfusion
Spain
Cloruro de potasio Kabi 0,04 mEq/ml/ en Cloruro de sodio 0,9% solution for perfusion EFG
Netherlands
KCl 0.15% w/v & NaCl 0.9% w/v Fresenius Kabi, solution for infusion
Ireland
Potassium Chloride 0.15% w/v & Sodium chloride 0.9% w/v Solution for Infusion
Lithuania
Potassium Chloride/ Sodium Chloride Fresenius 1,5 mg/9 mg/ml infusion solution
Latvia
Potassium Chloride/ Sodium Chloride Fresenius 1,5 mg/9 mg/ml solution for infusions
Poland
Kalii chloridum 0,15% + Natrii chloridum 0,9% Kabi
Portugal
Cloreto de Potássio 0,15% p/v e Cloreto de Sódio 0,9% p/v Kabi
Slovenia
Kalijev klorid/natrijev klorid Kabi 0.15 mg/9 mg v 1 ml raztopina za infundiranje
United Kingdom
Potassium Chloride 0.15% w/v & Sodium chloride 0.9% w/v Solution for Infusion
Date of last revision of the leaflet:26.02.2016
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Information intended for healthcare professionals only:

Administration and preparation

This medicine is intended for single use only. Any unused solution should be discarded.
Only a clear solution, free from visible particles, with undamaged packaging, should be used.
Route of administration
Intravenous administration using sterile equipment free from pyrogens.
Intravenous administration of potassium should be performed in a large peripheral vein or central vein to minimize the risk of vein hardening. When administering through 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.
Rate of administration
When administering potassium intravenously, to avoid the risk of hyperkalemia, the infusion rate should not exceed 15 to 20 mmol/hour.
Do not exceed the recommended dose in the "Posology" section.
Dosing schedule
Recommended dosing in the treatment of isotonic dehydration (extracellular dehydration) using any intravenous solution:

• adult patients: 500 ml to 3 liters per day,
• infants and children: 20 to 100 ml per day per kilogram of body weight, depending on age and total body weight.

Dosage

• Adult patients, elderly patients, and adolescents The usual dose of potassium for the prevention of hypokalemia is up to 50 mmol per day, and similar doses may be suitable for the treatment of mild potassium deficiency. In the treatment of hypokalemia, the recommended dose is 20 mmol of potassium over 2 to 3 hours (e.g. 7-10 mmol/hour) while monitoring the ECG recording.
• Children The recommended dose for the treatment of hypokalemia is 0.3-0.5 mmol/kg body weight/hour. The dose should be determined based on frequent laboratory tests. The maximum recommended dose of potassium is 2-3 mmol/kg body weight/day.
• Patients with renal impairment Patients with renal impairment should receive lower doses.

Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi is a hypertonic solution with an osmolality of approximately 348 mOsm/l.
The medicine should be administered under regular and close supervision. In patients treated with potassium, and especially in patients with heart or kidney disease, it is necessary to regularly monitor their clinical condition, electrolyte levels, and creatinine levels in the blood, blood urea nitrogen levels, acid-base balance, and ECG recording.
Adequate urine output should be ensured, and fluid balance should be monitored.
Caution should be exercised when using potassium salts in patients with heart disease or conditions that predispose to hyperkalemia, such as kidney failure or adrenal insufficiency, acute dehydration, or extensive tissue damage, which can occur in severe burns. In patients undergoing dialysis, regular monitoring of potassium levels in the blood is necessary.
Caution should be exercised when using sodium salts in patients with hypertension, heart failure, peripheral or pulmonary edema, kidney disease, pre-eclampsia, or other conditions associated with sodium retention.
Shelf life of the medicine for use (added medicines)
The chemical and physical stability of each added medicine in the pH of Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi should be established.
In the absence of compatibility studies, this medicine should not be mixed with other medicines.
The doctor is responsible for assessing the incompatibility of the added medicine with Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi by checking for changes in color and/or precipitation, formation of insoluble compounds or crystals. The doctor should also check the information in the Summary of Product Characteristics of the added medicine.
The instructions for use of the added medicine should be consulted. Before adding the medicine, its solubility and/or stability in water at the pH of Potassium Chloride 0.15% + Sodium Chloride 0.9% Kabi (pH: 4.5-7.0) should be confirmed.
Medicines with proven incompatibility should not be added.
From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage conditions and time of the prepared solution.