multibic bezpotasovi roztvur do hemodializi/do hemofiltracii

Leaflet attached to the packaging: information for the user

multiBic potassium-free solution for hemodialysis/hemofiltration

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is multiBic potassium-free and what is it used for
• 2. Important information before using multiBic potassium-free
• 3. How to use multiBic potassium-free
• 4. Possible side effects
• 5. How to store multiBic potassium-free
• 6. Package contents and other information

1. What is multiBic potassium-free and what is it used for

multiBic potassium-free is a solution for continuous renal replacement therapy, used to remove metabolic products from the patient's body. It is used in patients with kidney damage and also in the treatment of poisoning. The type of solution the patient receives depends on the amount of potassium (salt) in the blood. The attending physician will regularly check the patient's blood potassium levels.

2. Important information before using multiBic potassium-free

When not to use multiBic potassium-free

• if there is hypersensitivity to any active substance or any other component of the medicine (listed in section 6);
• if there is hypokalemia (very low potassium levels in the blood);
• if there is metabolic alkalosis (a condition where there is too much bicarbonate in the blood);
• if it is not possible to achieve sufficient blood flow through the hemofilter (a filter used to filter blood);
• if there is a high risk of bleeding associated with medications necessary to prevent clotting in the hemofilter.

Warnings and precautions

Before starting to use multiBic potassium-free, discuss it with your doctor.

• Do not use until the solutions in both compartments of the bag are fully mixed.
• Do not use the solution at a temperature lower than room temperature.
• The drainage set used to administer the ready-to-use solution should be checked every 30 minutes. If precipitate (solid sediment) is found in the drains, the bag and drains should be replaced immediately and the patient should be closely monitored.
• The attending physician will check the patient's hydration status (amount of water in the body), blood potassium, sodium, and other electrolyte levels, as well as some metabolic products and sugar levels. The doctor may also provide dietary advice.

Children

There is no information on the use of multiBic potassium-free in children.
multiBic potassium-free 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 take.
The following interactions may occur:

• toxic effects of digitalis glycosides (used in heart disease);
• electrolyte supplementation, parenteral nutrition (intravenous nutrition), and other infusion treatments. Their impact on serum levels and fluid status during this treatment should be considered;
• this therapy may decrease the levels of medicinal products in the blood. Dose modification may be required.

Pregnancy and breastfeeding:

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
There are no data or only limited data on the use of multiBic potassium-free in pregnancy and breastfeeding.
This medicine should only be used in pregnancy if the doctor considers it necessary.
Breastfeeding is not recommended during treatment with multiBic potassium-free.

3. How to use multiBic potassium-free

multiBic potassium-free is administered in a hospital or other medical facility. The attending physician has the knowledge to use this medicine.
In case of doubts, consult a doctor.

4. Possible side effects

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

Side effects of multiBic potassium-free:

• nausea
• vomiting
• muscle cramps
• blood pressure changes

Some side effects may be caused by too much or too little fluid in the body. These include:

• shortness of breath
• swelling of the ankles and feet
• dehydration (e.g., dizziness, muscle cramps, thirst)
• blood disorders (e.g., abnormal electrolyte levels in the blood)

The exact frequency of these events is not known (cannot be estimated from available data).

Reporting suspected side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the doctor or nurse. Side effects can be reported directly to the "national reporting system" listed in Annex V.*
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 multiBic potassium-free

Store the medicine out of sight and reach of children.
Do not store below 4°C.
Storage conditions after mixing the contents of both compartments of the bag:
The ready-to-use solution should not be stored above 30°C and should be used within 48 hours.
Do not use this medicine after the expiry date stated on the label, after the "Expiry Date". The expiry date is the last day of the given month.

6. Package contents and other information

What multiBic potassium-free contains

• The active substances are: sodium chloride, sodium bicarbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, and glucose monohydrate.
• Other components of the medicine are: water for injections, hydrochloric acid (25%), carbon dioxide, and sodium dihydrogen phosphate dihydrate.

What multiBic potassium-free looks like and what the package contains:

multiBic potassium-free is supplied in a two-compartment bag (two compartments containing different solutions). After mixing the solutions from both compartments, a ready-to-use solution is obtained.
Each bag contains a total of 5000 ml of solution. The ready-to-use solution is clear and colorless.
Each bag is equipped with an HF connector, a Luer lock connector, and an injection port, and is covered with a protective foil.
Package size:
2 bags of 5000 ml

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1,
61352 Bad Homburg v.d.H., Germany

Manufacturer

Fresenius Medical Care Deutschland GmbH, Frankfurter Strasse 6-8, 66606 St. Wendel, Germany

Distributor:

Fresenius Medical Care Polska S.A.
tel.: +48 61 83 92 600
Date of last revision of the leaflet:02/2025
Information intended for healthcare professionals only, see the end of this leaflet.
The following information is intended for healthcare professionals only:

1000 ml of the ready-to-use solution contains:

pH ≈ 7.4
Theoretical osmolality (Osmolar. teoret.) 292 mOsm/l
Use only if the ready-to-use solution is clear and colorless, and the bag and connectors are undamaged.
The solution is for single use only. Any unused portion of the solution should be discarded.
Use only with a pump integrated with the extracorporeal blood treatment device.

Instructions for use

The hemodialysis/hemofiltration solution should be administered in three stages:

• 1. Remove the protective foil and carefully inspect the bag

Remove the protective foil immediately before use. Plastic packaging may occasionally be damaged during transport from the manufacturer to the clinic (dialysis station) or within the clinic itself. This can cause contamination and growth of bacteria and fungi in the solutions.
Therefore, the bag should be carefully inspected before mixing. Particular attention should be paid to even the smallest damage to the closure, the weld separating the two compartments, and the corners of the bag, looking for possible contamination.

• 2. Mixing the contents of both compartments

Both solutions should be mixed immediately before use, resulting in a ready-to-use solution.
A)
B) C)

Unfold the small
compartment.
Roll up the bag with the solution,
starting from the corner
opposite the small
compartment…
…..until the weld between the two compartments
opens along its entire length, and
the solutions from both compartments mix.
After mixing the solutions from both compartments, check that the weld line is completely open, the mixed solution is clear and colorless, and the bag does not leak.

• 3. Using the ready-to-use solution

The ready-to-use solution should be used immediately after mixing or within 48 hours of mixing.
Any additives to the ready-to-use solution can only be introduced after it has been thoroughly mixed. After adding an additive, the ready-to-use solution should be thoroughly mixed again before use.
Additions of sodium chloride solution (up to 30%) or alternatively water for injections are compatible with this medicinal product and may be administered, if necessary, to adjust the sodium concentration to limit the rate of change of sodium concentration in cases of severe hyper- or hyponatremia.
Detailed information is contained in the Summary of Product Characteristics.
Unless otherwise instructed, the ready-to-use solution should be warmed to a temperature of 36.5°C - 38.0°C before use. The exact temperature is determined based on clinical requirements and the equipment used.