Multibic with potassium 4 mmol/l solution for hemodialysis/for hemofiltration

Package leaflet: Information for the user

multiBic with potassium 4 mmol/l solution for haemodialysis/for haemofiltration
Please read all of this leaflet carefully before use, as it contains information important for the patient.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet:

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

1. What multiBic with potassium 4 mmol/l is and what it is used for

multiBic with potassium 4 mmol/l solution for haemodialysis/for haemofiltration is a solution used in continuous renal replacement therapy to remove metabolic waste products from the body of patients with kidney disease. It is used in patients with kidney impairment, as well as in the treatment of poisonings. The type of solution administered to the patient depends on the blood potassium (salt) level. Your treating physician will regularly monitor the patient's blood potassium concentration.

2. Important information before using multiBic with potassium 4 mmol/l

When not to use multiBic with potassium 4 mmol/l

• if there is hypersensitivity to any active substance or any of the other components of the medicine (listed in section 6);
• if hyperkalemia is present (potassium concentration in blood is very high);
• if metabolic alkalosis is present (a condition in which there is too much bicarbonate in the blood);
• if adequate blood flow through the hemofilter (the 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 hemofilter.

Warnings and precautions
Before starting treatment with multiBic with potassium 4 mmol/l, discuss this with your doctor.

• Do not use until complete mixing of the solutions from both chambers of the bag has occurred.
• The solution must not be used if its temperature is lower than room temperature.
• The set of administration lines used for delivering the ready-to-use solution should be inspected every 30 minutes. If precipitate (solid deposit) is observed in the lines, the bag and administration lines must be replaced immediately and the patient should be closely monitored.
• Your treating physician will monitor your hydration status (amount of water in the patient's body), and blood levels of potassium, sodium, other salts, certain metabolic products, and glucose. The doctor may also provide dietary recommendations.

Children
There is no established experience regarding the use of multiBic with potassium 4 mmol/l in children.
Interaction of multiBic with potassium 4 mmol/l with other medicines:
Inform your doctor about all medicines currently used or recently taken, as well as any medicines you plan to take.
The following interactions may occur:

• toxic effects of digitalis 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 adjustment may be required.

Pregnancy and breastfeeding:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 with potassium 4 mmol/l during pregnancy and breastfeeding.
This medicine should be used during pregnancy only if the doctor considers such treatment necessary.
Breastfeeding is not recommended during treatment with multiBic with potassium 4 mmol/l.

3. How to use multiBic with potassium 4 mmol/l

multiBic with potassium 4 mmol/l solution for haemodialysis/haemofiltration is administered in a hospital or other medical facility. The attending physician has the knowledge on how to use this medicine.
In case of doubts, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions of multiBic with potassium 4 mmol/l:

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

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

• shortness of breath
• swelling of ankles and legs
• dehydration (e.g. dizziness, muscle cramps, feeling thirsty)
• blood disorders (e.g. abnormal salt levels in the blood)

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

5. How to store multiBic with potassium 4 mmol/l

Keep this medicine out of sight and reach of children.
Do not store at temperatures below 4°C.
Storage conditions after mixing both chambers of the bag:
The ready-to-use solution should not be stored above 30°C and must be used within 48 hours.
Do not use this medicine after the expiry date stated on the label after "Expiry date". The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What multiBic with potassium 4 mmol/l contains

• The active substances are: potassium chloride, 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 with potassium 4 mmol/l looks like and contents of the pack:
multiBic with potassium 4 mmol/l 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
This information is intended for medical personnel only, see end of this leaflet.
The following information is intended for medical personnel only:
1000 ml of ready-to-use solution contains:

pH ≈ 7.4
Theoretical osmolarity (Osmolar. teoret.) 300 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 haemodialysis/hemofiltration solution should be administered in three steps:

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

The protective film must 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 must be carefully inspected before mixing. Particular attention should be paid to even the smallest damage to the closure, the seal separating the two chambers, and the corners of the bag when checking for possible contamination.

2. Mixing the contents of both chambers

Both solutions must be mixed immediately before use to obtain the ready-to-use solution.
A) B) C)

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

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

3. Administration of the ready-to-use solution

The ready-to-use solution must be used immediately after mixing or within 48 hours of mixing.
Any additives to the ready-to-use solution may only be introduced after thorough mixing. After adding any additive, the ready-to-use solution should be carefully mixed again before administration.
Addition of sodium chloride solution (up to 30%) or alternatively water for injections is compatible with this medicinal product and may, if necessary, be administered to adjust the sodium concentration in order to limit the rate of changes in sodium concentration in cases of severe hyper- or hyponatraemia.
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.