Kalii hloridum 0,3% + Natrii hloridum 0,9% Kabi

Leaflet attached to the packaging: information for the user

Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi, (3 mg + 9 mg)/ml, solution for infusion
Potassium Chloride + Sodium Chloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi and what is it used for
• 2. Important information before using Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi
• 3. How to use Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi
• 4. Possible side effects
• 5. How to store Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi
• 6. Contents of the packaging and other information

1. What is Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi and what is it used for

Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi is an aqueous solution of sodium chloride and potassium chloride.
Sodium chloride and potassium chloride are chemical compounds (often referred to as "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 0.3% + Sodium Chloride 0.9% Kabi

Kabi

When not to use Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi:

• shortness of breath;
• swelling of the ankles;

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 0.3% + Sodium Chloride 0.9% Kabi, the patient should inform their 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 0.3% + Sodium Chloride 0.9% Kabi and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor, in particular, 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);
• medicines containing potassium;
• corticosteroids (anti-inflammatory medicines).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, 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 in the blood 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 0.3% + Sodium Chloride 0.9% Kabi

The medicine is administered by a doctor or nurse.
The doctor will determine the dose and method of administration of this medicine 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 0.3% + Sodium Chloride 0.9% Kabi should be administered slowly, in the form of 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 0.3% + 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 the amount of urine produced (production of adequate amounts of urine).

Using a higher dose of Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi than recommended

In case of using too much of the medicine, the following 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 a feeling of weakness), feeling of disorientation, coma, and increased breathing rate.
The patient should immediately inform their doctor if they experience any of these symptoms. The infusion will be discontinued, and the patient will receive treatment depending on the symptoms that occur.
If the patient has any further doubts about using this medicine, they should consult their 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 the use of the medicine after it was approved for use. The frequency cannot be determined based on the available data. Side effects may occur due to the method of administration.

The patient should immediately inform their doctor if they experience any of the following side effects:

• infection at the injection site;
• increased blood volume (hypervolemia);
• infusion of the solution into the surrounding tissues (extravasation). This can cause tissue damage and lead to scarring.
• excessive sensitivity to touch or pain at the injection site;
• vein inflammation, where the solution was administered (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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
The medicine should not be used after the expiry date stated on the bottle. The expiry date refers to the last day of the stated month.
Only a clear solution, free from visible solid particles, from an undamaged packaging should be used.
From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage time and conditions of the prepared solution.
Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi contains

• The active substances of the medicine are potassium chloride and sodium chloride. 1 ml of the solution contains 3 mg of potassium chloride and 9 mg of sodium chloride. Each 500 ml bottle contains 1.50 g of potassium chloride and 4.5 g of sodium chloride. Each 1000 ml bottle contains 3.00 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 0.3% + Sodium Chloride 0.9% Kabi looks like and what the packaging contains

Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi is a clear, colorless solution, free from visible solid particles.
It is available in 500 ml or 1000 ml LDPE (KabiPac) bottles with a polyisoprene stopper and a 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 0.3% 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 0.3% w/v & NaCl 0.9% w/v Fresenius Kabi, solution for infusion
Ireland
Potassium Chloride 0.3% w/v & Sodium chloride 0.9% w/v Solution for Infusion
Lithuania
Potassium Chloride/ Sodium Chloride Fresenius 3 mg/9 mg/ml infusion solution
Latvia
Potassium Chloride/ Sodium Chloride Fresenius 3 mg/9 mg/ml solution for infusions
Poland
Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi
Portugal
Cloreto de Potássio 0,3% p/v e Cloreto de Sódio 0,9% p/v Kabi
Slovenia
Kalijev klorid/natrijev klorid Kabi 0.3 mg/9 mg in 1 ml solution for infusion
United Kingdom
Italy
Potassium Chloride 0.3% w/v & Sodium chloride 0.9% w/v Solution for Infusion
Sodio Cloruro e Potassio Cloruro Kabi
Date of last revision of the leaflet:26.02.2016
------------------------------------------------------------------------------------------------------------------------------
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 solid particles, from an 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 reduce the risk of vein hardening. When administering into a central vein, it should be ensured that the catheter is not located in the atrium or ventricle of the heart to avoid local hyperkalemia.
Potassium-containing solutions should be administered slowly.
Rate of administration
During intravenous administration of potassium, to avoid the risk of hyperkalemia, the infusion rate should not exceed 15 to 20 mmol/hour.
In no case should the recommendations in the "Dosage" section be exceeded.
Dosage schedule
Recommended dosage for 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 appropriate 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 dosage 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 kidney function impairment Patients with kidney function impairment should receive lower doses.

Potassium Chloride 0.3% + Sodium Chloride 0.9% Kabi is a hypertonic solution with an osmolality of approximately 388 mOsm/l.
The medicine should be administered under regular and careful 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 serum, 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 predisposing to hyperkalemia, such as kidney failure or adrenal insufficiency, acute dehydration, or extensive tissue damage, which occurs, for example, in severe burns. In patients undergoing digitalis therapy, regular monitoring of potassium levels in the serum is necessary.
Caution should be exercised when using sodium salts in patients with hypertension, heart failure, peripheral or pulmonary edema, kidney function impairment, 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 0.3% + 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 0.3% + 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 contained in the Summary of Product Characteristics of the added medicine.
The doctor should familiarize themselves with the instructions for use of the added medicine. Before adding the medicine, the solubility and/or stability in water at the pH of Potassium Chloride 0.3% + 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 time and conditions of the prepared solution.