Multibic potassium-free solution for hemodialysis/for hemofiltration

Patient Information Leaflet

multiBic bezpotasowy roztwór do hemodializy/do hemofiltracji
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents:

1. What multiBic bezpotasowy is and what it is used for
2. Important information before using multiBic bezpotasowy
3. How to use multiBic bezpotasowy
4. Possible side effects
5. How to store multiBic bezpotasowy
6. Contents of the pack and other information

1. What multiBic bezpotasowy is and what it is used for

multiBic bezpotasowy is a solution for continuous renal replacement therapy, used to remove metabolic waste products from the body in patients with kidney disease. It is used in patients with kidney impairment, as well as in the treatment of poisoning. The type of solution administered to the patient depends on the blood potassium (salt) level. Your treating physician will regularly monitor the potassium concentration in your blood.

2. Important information before using multiBic bezpotasowy

When not to use multiBic bezpotasowy

• if there is hypersensitivity to any active substance or any of the other ingredients of the medicine (listed in section 6);
• if hypokalaemia is present (potassium blood concentration is very low);
• if metabolic alkalosis is present (a condition in which there is too much bicarbonate in the blood);
• if adequate blood flow through the haemofilter (filter used for blood filtration) cannot be achieved;
• if there is a high risk of bleeding associated with medications necessary to prevent clotting in the haemofiltration circuit.

Warnings and precautions
Before starting treatment with multiBic bezpotasowy, discuss this with your doctor.

• Do not use until the solutions in both chambers of the bag have been completely mixed.
• The solution must not be used if its temperature is below room temperature.
• The set of infusion lines used for administering the ready-to-use solution should be inspected every 30 minutes. If precipitate (solid deposit) is observed in the lines, the bag and infusion lines must be replaced immediately, and the patient must be closely monitored.
• The treating physician will monitor the patient's hydration status (amount of water in the body), and blood concentrations of potassium, sodium, other salts, certain metabolic products, and glucose. The physician may also provide dietary recommendations.

Children
There is no established experience regarding the use of multiBic bezpotasowy in children.

multiBic bezpotasowy and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future use.
The following interactions may occur:

• increased toxic effects of cardiac glycosides (used in heart disease);
• electrolyte supplementation, parenteral nutrition (intravenous feeding), and other infusion therapies. Consider their impact on serum concentrations and fluid status during treatment;
• this therapy may reduce blood concentrations of certain medicinal products. Dose adjustments may be required.

Pregnancy and breastfeeding:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
There are no data or only limited data available on the use of multiBic bezpotasowy during pregnancy and breastfeeding.
This medicine should be used during pregnancy only if clearly needed and as deemed necessary by the physician.
Breastfeeding is not recommended during treatment with multiBic bezpotasowy.

3. How to use multiBic bezpotasowy solution for hemodialysis/hemofiltration

multiBic bezpotasowy solution for hemodialysis/hemofiltration is administered in a hospital or other medical facility. The attending physician has the knowledge of how to use this medicinal product.
In case of doubts, please consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of multiBic bezpotasowy:

• nausea
• vomiting
• muscle cramps
• changes in blood pressure

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

• shortness of breath
• ankle and leg swelling
• dehydration (e.g. dizziness, muscle cramps, feeling thirsty)
• blood disorders (e.g. abnormal blood salt levels)

The exact frequency of these events is unknown (cannot be estimated from available data).
Reporting suspected adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the "national reporting system" listed in Annex V.*
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store multiBic bezpotasowy solution for hemodialysis/hemofiltration

Keep this medicine out of the sight and reach of children.
Do not store at temperatures below 4°C.
Storage conditions after mixing both compartments of the bag:
The ready-to-use solution must 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, following “Expiry date”. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What multiBic bezpotasowy contains

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

What multiBic bezpotasowy looks like and contents of the pack:
multiBic bezpotasowy is supplied in a dual-chamber bag (two chambers containing different solutions). After mixing the solutions from both chambers, 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 colourless.
Each bag is equipped with an HF connector, Luer lock connector and an injection port, and is covered with a protective foil.

Pack size:
2 bags of 5000 ml each

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Information intended only for medical personnel – see end of this leaflet.
The following information is intended only for medical personnel:
1000 ml of ready-to-use solution contains:

pH ≈ 7.4
Theoretical osmolarity (Osmolar. teoret.) 292 mOsm/L
Use only if the ready-to-use solution is clear and colourless, and the bag and bag connectors are undamaged.
The solution is intended for single use only. Any unused portion of the solution must be discarded.
Use exclusively via a pump integrated with a device for extracorporeal blood purification.

Instructions for use
The dialysis/filtration solution should be administered in three steps:

1. Removal of the protective film and careful inspection of the bag

The protective film should be removed immediately before use. Plastic packaging may occasionally become damaged during transport from the manufacturer to the clinic (dialysis unit) or within the clinic itself. This may lead to contamination and growth of bacteria and fungi in the solutions. For this reason, the bag should be carefully inspected before mixing. Particular attention should be paid even to the smallest damage to the closure, the seal separating the two chambers, and the corners of the bag, in search of possible contamination.

2. Mixing the contents of both chambers

Both solutions should be mixed immediately before administration, thus obtaining a ready-to-use solution.
A) B) C)

Unfold the small …..until the seal
chamber. Roll up the bag with the solution, between both chambers
starting from the corner opens along its entire length, and
opposite the small the solutions from both chambers mix
chamber… together.

After mixing the solutions from both chambers, check whether the seal line is completely open, the mixed solution is clear and colourless, and the bag is not leaking.

3. Administration of the ready-to-use solution

The ready-to-use solution should be administered immediately after mixing or within 48 hours after mixing.
Any additives to the ready-to-use solution may be introduced only after thorough mixing. After adding any additive, the ready-to-use solution should be carefully remixed before administration.
Sodium chloride solution (up to 30%) or alternatively Water for Injections are compatible with this medicinal product and may, if necessary, be administered to adjust the sodium concentration in order to limit the rate of sodium concentration changes in cases of severe hyper- or hyponatremia.
Detailed information is provided in the Product Characteristics.
Unless otherwise directed, the ready-to-use solution should be warmed immediately before use to a temperature of 36.5°C – 38.0°C. The exact temperature should be determined according to clinical requirements and the technical equipment used.