Kalii chloridum 0.3% + natrii chloridum 0.9% kabi

Package leaflet: Information for the user

Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi, (3 mg + 9 mg)/ml, solution for infusion
Potassium chloride + Sodium chloride
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

1. What Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi is and what it is used for
2. Important information before administration of Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi
3. How to use Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi
4. Possible side effects
5. How to store Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi
6. Contents of the pack and other information

1. What Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi is and what it is used for

Kalii chloridum 0.3% + Natrii chloridum 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 naturally occur in the blood.
This medicine is used for the prevention and treatment of:

• loss of potassium from the body (e.g. after treatment with certain diuretics (medicines that increase urine production));
• low blood potassium levels (hypokalaemia) in situations that may cause loss of potassium chloride 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 administration of Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi

When not to use Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi:

• if the patient has increased potassium levels in the blood (hyperkalaemia);
• if the patient has increased chloride levels in the blood (hyperchloraemia);
• if the patient has increased sodium levels in the blood (hypernatraemia);
• if the patient has severe kidney disease (reduced or no urine output);
• if the patient has heart failure that is not properly treated (uncompensated heart failure) and causes symptoms such as:
• shortness of breath;
• ankle swelling;
• if the patient has adrenal gland disorders (Addison's disease).

Warnings and precautions
This medicine has a higher concentration of certain ions than blood (a hypertonic solution). Your doctor will take this into account when determining the dose for the patient.
Before starting treatment with Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi, inform your doctor or nurse if the patient has:

• any heart disease or heart failure;
• impaired kidney function;
• adrenal gland disorder affecting steroid hormone levels in the body (adrenocortical insufficiency);
• dehydration (excessive loss of water, e.g. due to vomiting or diarrhoea);
• severe wounds with extensive skin damage, e.g. after burns;
• high blood pressure;
• subcutaneous oedema, particularly around the ankles (peripheral oedema), or in the lungs (pulmonary oedema);
• high blood pressure during pregnancy (pre-eclampsia);
• any other diseases causing excessive sodium retention in the body.

The patient's condition should be closely monitored during treatment with this medicine. Your doctor will take blood and urine samples to assess the patient's condition. Special care is required for patients with heart or kidney disease.

Kalii chloridum 0.3% + Natrii chloridum 0.9% Kabi and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Inform your doctor, in particular, if the patient is taking:

• cardiac glycosides used in heart disease (such as digoxin);
• antiarrhythmic medicines used to treat irregular heartbeat (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 (ACE) 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, thinks she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
This medicine may be used in pregnant women and during breastfeeding. The doctor will carefully monitor the amount of medicine administered. The doctor will also perform blood tests to monitor levels of chemical substances in the blood, as changes in blood potassium levels may affect the heart function of both mother and foetus.
The doctor will also closely monitor the patient's blood pressure, as sodium chloride may cause an increase in blood pressure (risk of pre-eclampsia).

Driving and using machines
This medicine has no effect on the ability to drive or operate machinery.

3. How to use Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi

The medicine is administered by a doctor or nurse.
The doctor will determine the dose and method of administration depending on the patient's age, body weight, clinical and biological condition, and hydration status (amount of water in the body). The dose may also depend on other medicines the patient is taking.
Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi should be administered slowly as an intravenous infusion.
The doctor will determine the infusion rate. If the patient requires a large volume or rapid infusion, the doctor will monitor the ECG (heart activity recording).
During treatment with Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi, the doctor will order blood tests to monitor blood levels of potassium and other electrolytes (such as sodium or chlorides). The doctor will also monitor urine output (adequate urine production).
Use of a higher than recommended dose of Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi
If too much of the medicine is administered, the following may occur: tingling and burning of hands and feet (paresthesia), muscle weakness, difficulty moving (paralysis), irregular heartbeat (arrhythmia), heart block (very slow heartbeat), cardiac arrest (heart stops beating), confusion, fluid accumulation in the lungs causing breathing difficulties (pulmonary edema), fluid accumulation under the skin, especially around the ankles (peripheral edema), blood acidification (acidosis) leading to feelings of weakness, disorientation, coma, and increased breathing rate.
If any of these symptoms occur, the doctor should be informed immediately. The infusion will be stopped and the patient will receive appropriate treatment depending on the symptoms present.
If there are any further doubts regarding the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported during use of the medicine after marketing authorization. The frequency cannot be determined from the available data. Adverse reactions may occur due to the route of administration.
If any of the following adverse reactions occur in the patient, a doctor should be informed immediately:

• infection at the site of administration;
• increased blood volume (hypervolemia);
• leakage of solution into surrounding tissues (extravasation). This may cause tissue damage and lead to scarring;
• excessive sensitivity to touch or pain at the site of administration;
• inflammation of the vein into which the solution was administered (phlebitis). This may cause redness, swelling and pain or burning along the vein used for administration;
• blood clot at the site of administration, causing pain, swelling or redness in the affected area;
• fever.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continued monitoring of the medicine’s safety and helps provide more information on its safe use.

5. How to store Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi

Keep the medicine out of the sight and reach of children.
There are no special requirements for storage of 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 indicated.
Only use the solution if it is clear, free from visible solid particles, and the container is undamaged.
From a microbiological point of view, the solution should be used immediately. Otherwise, the user is responsible for the storage conditions and duration of the prepared solution.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi contains

• The active substances are potassium chloride and sodium chloride. 1 ml of 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.
• Other ingredients: water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi looks like and contents of the pack
Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi is a clear, colourless solution free from visible particles.
It is available in 500 ml or 1000 ml LDPE bottles (KabiPac) with a polyisoprene stopper and a polyolefin cap.
Pack size: 10 bottles in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

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 authorised in the European Economic Area countries 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 pour perfusion
Spain Cloruro de potasio Kabi 0,04 mEq/ml/ en Cloruro de sodio 0,9% solución para perfusion EFG
Netherlands KCl 0.3% w/v & NaCl 0.9% w/v Fresenius Kabi, oplossing voor infusie
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 infuzinis tirpalas
Latvia Potassium Chloride/ Sodium Chloride Fresenius 3 mg/9 mg/ml šķīdums infūzijām
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 v 1 ml raztopina za infundiranje
United Kingdom Potassium Chloride 0.3% w/v & Sodium chloride 0.9% w/v Solution for Infusion
Italy Sodio Cloruro e Potassio Cloruro Kabi

Information intended exclusively for medical professionals:

Administration and preparation
This medicinal product is intended for single use only. Any unused portions of the solution
must be discarded.
Only use a clear solution, free from visible particles, in undamaged packaging.
Route of administration
Intravenous administration using sterile, pyrogen-free equipment.
Potassium should be administered intravenously into a large peripheral vein or central vein to
reduce the risk of phlebitis. When administered via a central vein, ensure that the catheter tip is not
located in the atrium or ventricle of the heart to avoid the risk of local hyperkalemia.
Potassium-containing solutions must be administered slowly.
Rate of administration
To avoid the risk of hyperkalemia during intravenous potassium administration, the infusion rate
should not exceed 15 to 20 mmol/hour.
Under no circumstances should recommendations from the section “Dosage regimen” be exceeded.

Dosage regimen
Recommended dosing for 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.

Dosing

• Adult patients, elderly patients, and adolescents: The usual daily dose of potassium for prevention of hypokalemia is up to 50 mmol. Similar doses may be appropriate in mild potassium deficiency. For treatment of hypokalemia, the recommended dose is 20 mmol of potassium administered over 2 to 3 hours (e.g., 7–10 mmol/hour), with continuous ECG monitoring.
• Children: In the treatment of hypokalemia, the recommended dose is 0.3–0.5 mmol/kg body weight/hour. The dose should be adjusted based on frequent laboratory monitoring. The maximum recommended dose of potassium is 2–3 mmol/kg body weight/day.
• Patients with impaired renal function: Patients with impaired renal function should receive reduced doses.

Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi is a hypertonic solution with an osmolarity of approximately 388 mOsm/l.
The medicinal product must be administered under regular and careful supervision. In patients receiving potassium therapy, and particularly in patients with cardiac or renal disorders, regular monitoring of clinical status, serum electrolyte and creatinine concentrations, blood urea nitrogen, acid-base balance, and ECG is essential.
Adequate urine output must be ensured, and fluid balance should be closely monitored.
Caution is required when administering potassium salts to patients with heart disease or conditions predisposing to hyperkalemia, such as renal insufficiency, adrenal insufficiency, acute dehydration, or extensive tissue damage, as seen in severe burns. In patients receiving digitalis therapy, regular monitoring of serum potassium concentration is essential.
Caution is also required when administering sodium salts to patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre-eclampsia, or other conditions associated with sodium retention.

Shelf-life after addition (added medicinal products)
The chemical and physical compatibility of each added medicinal product at the pH of Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi must be established.
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
The physician is responsible for assessing incompatibility of any medicinal product added to Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi by checking for color change and/or precipitation, formation of insoluble complexes, or crystals. Information provided in the Summary of Product Characteristics of the added medicinal product should also be reviewed.
The instructions for use of the added medicinal product should be consulted. Prior to addition, solubility and/or stability in water at the pH of Kalii chloridum 0,3% + Natrii chloridum 0,9% Kabi (pH: 4.5–7.0) should be confirmed.
Medicinal products with known incompatibility should not be added.
From a microbiological standpoint, the product should be used immediately. Otherwise, the responsibility for storage duration and conditions of the prepared solution lies with the user.