Package Insert: Information for the User

multiBic potassium-free solution for hemodialysis and hemofiltration

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects,consult your doctor or nurse,eveniftheyare not listed in this package insert. See section 4.

Contents of the package and additional information

multiBic without potassium is a continuous renal replacement therapy solution for the elimination of waste products from the body in individuals with kidney disease.It is used in patients with renal insufficiency and also for the treatment of intoxications. The type of solution administered depends on the amount of potassium (a salt) in the blood. Your doctor will regularly monitor your potassium levels.

Do not use multiBic without potassium if

Warnings and precautions

Consult your doctor before starting to usemultiBic without potassium

• Do not use before mixing the two solutions in a double-chamber bag (two compartments).
• Under no circumstances should it be used below room temperature.
• The used tubing lines must be inspected every 30 minutes for the solution ready for use.

If a precipitate (solid matter) is observed inside these tubing lines, the bags and tubing lines must be replaced immediately and the patient must be closely monitored.

• Your doctor will monitor your hydration status (amount of water in your body), potassium, sodium, other salts, certain waste products, and blood sugar levels). Your doctor may also advise you on your diet.

Children

The use of multiBic without potassium in children has not been established.

Use of multiBic without potassium with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

The following interactions may occur:

• Digitalis toxicity (heart disease medications)
• Electrolyte substitutions, parenteral nutrition (intravenous feeding) and other treatments with infusions. When using this therapy, its effect on serum blood concentration and fluid status must be taken into account.
• This therapy may reduce the concentration of medications in the blood. It may be necessary to adjust the dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor before using this medication.

There are no data or these are limited regarding the use of multiBic without potassium in pregnant women and breastfeeding women.

This medication should only be used during pregnancy if your doctor considers it necessary.

It is not recommended to breastfeed during treatment with multiBic without potassium.

multiBic without potassium will be administered in a hospital or clinic. Your doctor knows how to use this medication.

If you have any other questions about using this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects of multiBic without potassium include:

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

Some adverse effects may be caused by having too much or too little fluid. These are:

• difficulty breathing
• swelling of the ankles and legs
• dehydration (for example, dizziness, muscle cramps, sensation of thirst)
• blood disorders (for example, abnormal concentrations of salt in the blood)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store below 4°C.

Storage conditions after mixing the two compartments:

The ready-to-use solution should not be stored at a temperature above 30°C and should be used within a maximum period of 48 hours.

Do not use this medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated.

MultiBic without Potassium Composition

• The active ingredients are sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride hexahydrate, and glucose monohydrate.

• The other components are water for injection, hydrochloric acid 25%, carbon dioxide, and sodium dihydrogen phosphate dihydrate.

Appearance of the product and contents of the package

MultiBic without potassium is available in a double-chamber bag (two compartments containing different solutions). Mixing the solutions from the two compartments results in the ready-to-use solution.

Each bag contains 5,000 ml of solution in total. The ready-to-use solution is transparent and colorless.

Each bag is equipped with an HF connector, a Luer-lock connector, and an injection port and is covered with a protective film.

Package size:

2 bags of 5,000 ml

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

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

Manufacturer responsible

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

Local representative

Fresenius Medical Care España S.A.

C/ Ronda de Poniente, 8, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid)

Spain

Last review date of this leaflet: July 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Information intended only for healthcare professionals, see at the end of this leaflet.

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The following information is intended only for healthcare professionals:

1,000 ml of the ready-to-use solution contains:

pH ≈ 7.4

Theoretical osmolality: 292 mOsm/l

Do not use if the solution is not transparent and colorless and if the bag or connectors are damaged.

For single use only. Any remaining solution not used must be discarded.

Must be used with dialysis pumps.

Instructions for use

The dialysis and hemofiltration solution must be administered in three stages:

1.Removal of the outer bag and detailed inspection of the bag

The outer bag should only be removed immediately before administration.

Plastic containers may occasionally be damaged during transport from the manufacturing site to the clinic or within the clinic. In the solution, this may lead to contamination and microbial or fungal growth. Therefore, a careful visual inspection of the bag and solutions should be performed before use. Special attention should be paid to even minor defects of the stopper, welds, and edges of the bag.

2.Mixing of the two compartments

The two solutions must be mixed immediately before use to obtain the ready-to-use solution.

After both compartments have been mixed, it must be verified that the weld is completely open, that the solution is transparent and colorless, and that the container does not leak.

3.Administration of the ready-to-use solution

The ready-to-use solution must be used immediately, within 48 hours after mixing.

Any addition to the ready-to-use solution should only be made after the ready-to-use solution has been mixed completely. After adding a solution, the ready-to-use solution should be mixed again thoroughly before use.

Adding a sodium chloride solution (up to 30%) or alternatively water for injection is compatible with this medication and can be used to adjust the sodium concentration if necessary to limit the rate of sodium concentration changes in case of severe hypernatremia or hyponatremia. For more details, see the technical data sheet.

Unless otherwise prescribed, the ready-to-use solution should be heated immediately before infusion to 36.5°C – 38.0°C. The exact temperature should be selected depending on clinical requirements and the equipment used.