MULTIBIC 5000 ML Solution for hemofiltration

Зміст інструкції

1. multiBic senza potassio solution for hemodialysis/hemofiltration
   1. What is multiBic without potassium and what is it used for
   2. What you need to know before using multiBic without potassium
   3. How to use multiBic without potassium
   4. Possible side effects
   5. How to store multiBic without potassium
   6. Content of the pack and other information
2. multiBic 2 mmol/l potassio soluzione per emodialisi/emofiltrazione
   1. What is multiBic 2 mmol/l potassium and what is it used for?
   2. What you need to know before using multiBic 2 mmol/l potassium
   3. How to use multiBic 2 mmol/l potassium
   4. Possible side effects
   5. How to store multiBic 2 mmol/l potassium
3. multiBic 3 mmol/l potassio soluzione per emodialisi/emofiltrazione
   1. What is multiBic 3 mmol/l potassium and what is it used for
   2. What you need to know before using multiBic 3 mmol/l potassium
   3. How to use multiBic 3 mmol/l potassium
   4. Possible side effects
   5. How to store multiBic 3 mmol/l potassium
4. multiBic 4 mmol/l potassio soluzione per emodialisi/emofiltrazione
   1. What is multiBic 4 mmol/l potassium and what is it used for
   2. What you need to know before using multiBic 4 mmol/l potassium
   3. How to use multiBic 4 mmol/l potassium
   4. Possible side effects
   5. How to store multiBic 4 mmol/l potassium
   6. Content of the pack and other information

multiBic senza potassio solution for hemodialysis/hemofiltration

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4. Contents of this leaflet:
• 1. What multiBic senza potassio is and what it is used for
• 2. What you need to know before using multiBic senza potassio
• 3. How to use multiBic senza potassio
• 4. Possible side effects
• 5. How to store multiBic senza potassio
• 6. Contents of the pack and other information

1. What is multiBic without potassium and what is it used for

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

2. What you need to know before using multiBic without potassium

Do not use multiBic without potassium

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• if you have hypokalaemia (your potassium levels are very low)
• if you have metabolic alkalosis (a condition in which there is too much bicarbonate in the blood)
• if you cannot achieve sufficient blood flow through the haemofilter (the filter used for blood filtration)
• if you have a high risk of bleeding related to medicines that prevent coagulation in the haemofilter

Warnings and precautions
Talk to your doctor before using multiBic without potassium.

• It must only be used after mixing the two solutions in the double-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The cannulae used for applying the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid matter) is observed inside these cannulae, the bag and cannulae must be replaced immediately and the patient must be carefully monitored.
• The doctor will check your hydration status (amount of water in the body), potassium, sodium, other salts, some waste products and blood sugar levels. The doctor may also advise you on your diet.

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

Other medicines and multiBic without potassium
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
The following interactions are plausible:

• toxic effects of digitalis (a medicine for the treatment of heart disease)
• electrolyte substitutes, parenteral nutrition (feeding via a vein) and other infusion therapies. Their effect on blood concentration and fluid status must be considered when using this therapy.
• this therapy may reduce the concentration of medicines in the blood. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before starting treatment with this medicine.
Data on the use of multiBic without potassium during pregnancy and breastfeeding are limited or absent.
This medicine should only be used during pregnancy if your doctor considers it a
necessary treatment.
Breastfeeding is not recommended during treatment with multiBic without potassium.

3. How to use multiBic without potassium

multiBic without potassium will be administered in a hospital or clinic. The doctor will know how
to use this medicine.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

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

The side effects of multiBic without potassium include:

• nausea (feeling unwell)
• vomiting (feeling unwell)
• muscle cramps
• changes in blood pressure Some side effects may be caused by too much or too little fluid. These are:
• shortness of breath
• swelling of the ankles and legs
• dehydration (e.g. dizziness, muscle cramps, feeling thirsty)
• blood disorders (e.g., abnormal salt concentrations in the blood)

The exact frequency of these events is not known (cannot be defined based on available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact
your doctor or nurse. You can also report side effects directly through the
national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store multiBic without potassium

Keep this medicine out of the sight and reach of children.
Do not store at a temperature below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at a temperature above +30°C and must be
used within a maximum of 48 hours.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month.

6. Content of the pack and other information

What multiBic without potassium contains

• The active ingredients are sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other ingredients are: water for injections, hydrochloric acid 25%, carbon dioxide and disodium hydrogen phosphate dihydrate.

Description of the appearance of multiBic without potassium and contents of the pack
multiBic without potassium is distributed in a double-chamber bag (two compartments containing
different solutions). By mixing the solutions from both compartments, the ready-to-use solution is obtained.
Each bag contains 5000 ml of total solution. The ready-to-use solution is clear and colourless.
Each bag is equipped with an HF connector, a Luer-Lock connector and an injection port
and is wrapped in a protective film.
Pack:
2 bags of 5000 ml

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
Local Representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
The following information is intended exclusively for doctors or healthcare professionals:

1000 ml of ready-to-use solution contains:
pH  7.4
Theoretical osmolarity (theor. osmolar.) 292 mOsm/l
Do not use the ready-to-use solution if it is not clear and colourless and if the bag and connectors are not
intact.
For single use only. Unused solution must be disposed of.
Use with metering pumps.

Instructions for use
The hemodialysis/hemofiltration solution must be administered in 3 phases:
1 Removal of the protective film and careful inspection of the bag
The protective film must be removed only immediately before
administration.
Plastic containers may occasionally be damaged during
transport from the manufacturer to the dialysis clinic or within the clinic itself. This
may lead to contamination and microbiological or fungal growth in the solutions. A
thorough visual inspection of the bag and container is therefore necessary before
mixing. Particular attention should also be paid to any damage to the
closure, the hermetic seal and the corners of the container.
2 Mix the two compartments
The two solutions must be mixed immediately before use to obtain
the ready-to-use solution.

A)B) C)

After mixing both compartments, it must be checked that the weld is
completely open, that the solution is clear and colourless and that the bag is not leaking.
3 Application of the ready-to-use solution
The ready-to-use solution must be used immediately, or within a maximum of
48 hours after mixing.
Any addition to the ready-to-use solution must be made only after the
ready-to-use solution has been completely mixed. After each addition, the
ready-to-use solution must be thoroughly mixed again before use.
Additions of sodium chloride solution (up to 30%) and alternatively water for
injections are compatible with this medicinal product and can be used
to adjust the sodium concentration in order to limit the rate of change
of the sodium concentration in case of hyper- or hyponatremia. For further details refer to
the Summary of Product Characteristics.
Unless otherwise prescribed, the ready-to-use solution must be heated to
36.5°C – 38°C immediately before infusion. The exact temperature will be
selected based on clinical requirements and the technical equipment used.

multiBic 2 mmol/l potassio soluzione per emodialisi/emofiltrazione

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What multiBic 2 mmol/l potassio is and what it is used for
• 2. What you need to know before using multiBic 2 mmol/l potassio
• 3. How to use multiBic 2 mmol/l potassio
• 4. Possible side effects
• 7. How to store multiBic 2 mmol/l potassio
• 8. Contents of the pack and other information

1. What is multiBic 2 mmol/l potassium and what is it used for?

MultiBic 2 mmol/l potassium is a solution for continuous renal replacement therapy for
the elimination of waste products from the body in people with kidney disease. It is used in
patients with renal failure and also for the treatment of intoxications. The type of solution that
will be administered to you depends on the amount of potassium (a salt) in your blood. The doctor
will regularly check your potassium levels.

2. What you need to know before using multiBic 2 mmol/l potassium

Do not use multiBic 2 mmol/l potassium:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• if you have hypokalaemia (your potassium levels are very low)
• if you have metabolic alkalosis (a condition in which there is too much bicarbonate in the blood)
• if you are unable to achieve sufficient blood flow through the haemofilter (the filter used for blood filtration)
• if you have a high risk of bleeding related to medicines that prevent coagulation in the haemofilter

Warnings and precautions
Talk to your doctor before using multiBic 2 mmol/l potassium.

• It must only be used after mixing the two solutions in the double-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The cannulae used for applying the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid matter) is observed inside these cannulae, the bag and cannulae must be replaced immediately and the patient must be carefully monitored.
• The doctor will check your hydration status (amount of water in the body), potassium, sodium, other salts, some waste products and blood sugar levels. The doctor may also advise you on your diet.

Children
The use of multiBic 2 mmol/l potassium has not been established in children.

Other medicines and multiBic 2 mmol/l potassium
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
The following interactions are plausible:

• toxic effects of digitalis (a medicine for the treatment of heart disease)
• electrolyte substitutes, parenteral nutrition (intravenous feeding) and other infusion therapies. Their effect on blood concentration and fluid status must be considered when using this therapy.
• This therapy may reduce the blood concentration of medicines. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before starting treatment with this medicine.
Data on the use of multiBic 2 mmol/l potassium during pregnancy and breastfeeding are limited or
absent. This medicine should only be used during pregnancy if the doctor considers it
necessary treatment.
Breastfeeding is not recommended during treatment with multiBic 2 mmol/l potassium.

3. How to use multiBic 2 mmol/l potassium

multiBic 2 mmol/l potassium will be administered in a hospital or clinic. The doctor will know how
to use this medicine.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

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

Side effectsof multiBic 2 mmol/lpotassium include:

• nausea (feeling unwell)
• vomiting (feeling unwell)
• muscle cramps
• changes in blood pressure

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

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

The exact frequency of these events is not known (cannot be defined based on available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform
your doctor or nurse. You can also report side effects directly through the
national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store multiBic 2 mmol/l potassium

Keep this medicine out of the sight and reach of children.
Do not store at a temperature below +4°C
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at a temperature above +30°C and must be
used within a maximum of 48 hours.
Do not use this medicine after the expiry date which is stated on the label after EXP. The date
of expiry refers to the last day of that month.

• 6. Package contents and other information

What multiBic 2 mmol/l potassium contains

• The active ingredients are potassium chloride, sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other ingredients are: water for injections, hydrochloric acid 25%, carbon dioxide and disodium hydrogen phosphate dihydrate.

Description of the appearance of multiBic 2 mmol/l potassium and contents of the pack
multiBic 2 mmol/l potassium is distributed in a double-chamber bag (two compartments
containing different solutions). Mixing the solutions of the two compartments results in the
ready-to-use solution.
Each bag contains 5000 ml of total solution. The ready-to-use solution is clear and colourless.
Each bag is provided with an HF connector, a Luer-Lock connector and an injection port
and is wrapped in a protective film.
Pack:
2 bags of 5000 ml

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
Local representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
The following information is intended exclusively for doctors or healthcare professionals:

1000 ml of ready-to-use solution contains:
pH  7.4
Theoretical osmolarity (theoretical osmolar.) 296 mOsm/l
Do not use the ready-to-use solution if it is not clear and colourless and if the bag and connectors are not
intact.
For single use only. Unused solution must be disposed of.
Use with metering pumps.

Instructions for use
The solution for haemodialysis/haemofiltration must be administered in 3 stages:
1 Removal of the protective film and careful inspection of the bag
The protective film must only be removed immediately before administration.
Plastic containers may occasionally be damaged during transport from the
manufacturer to the dialysis clinic or within the clinic itself. This can lead to
contamination and microbiological or fungal growth in the solutions. Therefore, a
careful visual inspection of the bag and container is necessary before mixing. Particular
attention should also be paid to any damage to the closure, the hermetic seal and the
corners of the container.
2 Mix the two compartments
The two solutions must be mixed immediately before use to obtain the
ready-to-use solution.

A)B) C)

After mixing both compartments, it must be checked that the seal is
completely open, that the solution is clear and colourless and that the bag is not leaking.
3 Application of the ready-to-use solution
The ready-to-use solution must be used immediately, or within a maximum of
48 hours after mixing.
Any addition to the ready-to-use solution must only be made after the
ready-to-use solution has been completely mixed. After each addition, the
ready-to-use solution must be completely mixed again before use.
Additions of sodium chloride solution (up to 30%) and alternatively water for
injections are compatible with this medicine and can be used
to adjust the sodium concentration in order to limit the rate of change
of the sodium concentration in case of hyper- or hyponatraemia. For further details refer to the
Summary of Product Characteristics.
Unless otherwise prescribed, the ready-to-use solution must be warmed to
36.5°C – 38°C immediately before infusion. The exact temperature will
be selected according to clinical requirements and the technical equipment used.

multiBic 3 mmol/l potassio soluzione per emodialisi/emofiltrazione

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4. Contents of this leaflet:
• 1. What multiBic 3 mmol/l potassio is and what it is used for.
• 2. What you need to know before using multiBic 3 mmol/l potassio.
• 3. How to use multiBic 3 mmol/l potassio.
• 4. Possible side effects.
• 9. How to store multiBic 3 mmol/l potassio.
• 10. Contents of the pack and other information

1. What is multiBic 3 mmol/l potassium and what is it used for

MultiBic 3 mmol/l potassium is a solution for continuous renal replacement therapy for
the elimination of waste products from the body in people with kidney disease. It is used in
patients with renal failure and also for the treatment of intoxications. The type of solution that
will be administered to you depends on the amount of potassium (a salt) in your blood. The doctor
will regularly check your potassium levels.

2. What you need to know before using multiBic 3 mmol/l potassium

Do not use multiBic 3 mmol/l potassium:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• if you have hypokalaemia (your potassium levels are very low)
• if you have metabolic alkalosis (a condition in which there is too much bicarbonate in the blood)
• if you cannot achieve sufficient blood flow through the haemofilter (the filter used for blood filtration)
• if you have a high risk of bleeding related to medicines that prevent coagulation in the haemofilter
• Warnings and precautionsTalk to your doctor before using multiBic 3 mmol/l potassium.
• It must only be used after mixing the two solutions in the double-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The cannulae used for applying the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid matter) is observed inside these cannulae, the bag and cannulae must be replaced immediately and the patient must be carefully monitored.
• The doctor will check your hydration status (amount of water in the body), potassium, sodium, other salts, some waste products and blood sugar levels. The doctor may also advise you on your diet.

Children
The use of multiBic 3 mmol/l potassium has not been established in children.

Other medicines and multiBic 3 mmol/l potassium
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
The following interactions are plausible:

• toxic effects of digitalis (a medicine for the treatment of heart disease)
• electrolyte substitutes, parenteral nutrition (intravenous feeding) and other infusion therapies. Their effect on blood concentration and fluid status must be considered when using this therapy.
• This therapy may reduce the concentration of medicines in the blood. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before starting treatment with this medicine.
Data on the use of multiBic 3 mmol/l potassium during pregnancy and breastfeeding are limited or
absent. This medicine should only be used during pregnancy if the doctor considers it
a necessary treatment.
Breastfeeding is not recommended during treatment with multiBic 3 mmol/l potassium.

3. How to use multiBic 3 mmol/l potassium

multiBic 3 mmol/l potassium will be administered in a hospital or clinic. The doctor will know how to
use this medicine.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

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

The side effects of multiBic 3 mmol/l potassium include:

• nausea (feeling unwell)
• vomiting (feeling sick)
• muscle cramps
• changes in blood pressure

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

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

The exact frequency of these events is not known (cannot be defined based on available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the
national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store multiBic 3 mmol/l potassium

Keep this medicine out of the sight and reach of children.
Do not store at a temperature below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at a temperature above +30°C and must be
used within a maximum of 48 hours.
Do not use this medicine after the expiry date which is reported on the label after EXP. The date
of expiry refers to the last day of that month.

• 6. Package contents and other information

What multiBic 3 mmol/l potassium contains

• The active ingredients are potassium chloride, sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other ingredients are: water for injections, hydrochloric acid 25%, carbon dioxide and disodium hydrogen phosphate dihydrate.

Description of the appearance of multiBic 3 mmol/l potassium and contents of the pack
multiBic 3 mmol/l potassium is distributed in a double-chamber bag (two compartments
containing different solutions). Mixing the solutions of the two compartments results in the
ready-to-use solution.
Each bag contains 5000 ml of total solution. The ready-to-use solution is clear and colourless.
Each bag is provided with an HF connector, a Luer-Lock connector and an injection port
and is wrapped in a protective film.
Packaging:
2 bags of 5000 ml

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
Local Representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
The following information is intended exclusively for doctors or healthcare professionals:
1000 ml of ready-to-use solution contains:
pH  7.4
Theoretical osmolarity (theor. osmolar.) 298 mOsm/l
Do not use the ready-to-use solution if it is not clear and colourless and if the bag and connectors are not
intact.
For single use only. Unused solution must be discarded.
Use with metering pumps.

Instructions for use
The hemodialysis/hemofiltration solution must be administered in 3 steps:
1 Removal of the protective film and careful inspection of the bag
The protective film must only be removed immediately before
administration.
Plastic containers may occasionally be damaged during
transport from the manufacturer to the dialysis clinic or within the clinic itself. This
may lead to contamination and microbiological or fungal growth in the solutions. Therefore, a
careful visual inspection of the bag and container is necessary before
mixing. Particular attention should also be paid to any damage to the
closure, the hermetic seal and the corners of the container.
2 Mix the two compartments
The two solutions must be mixed immediately before use to obtain
the ready-to-use solution.

A)B) C)

After mixing both compartments, it must be checked that the seal is
completely open, that the solution is clear and colourless and that the bag is not leaking.
3 Application of the ready-to-use solution
The ready-to-use solution must be used immediately, or within a
maximum of 48 hours after mixing.
Any addition to the ready-to-use solution must only be made after the
ready-to-use solution has been completely mixed. After each addition, the
ready-to-use solution must be completely mixed again before use.
Additions of sodium chloride solution (up to 30%) and alternatively water for
injections are compatible with this medicine and can be used
to adjust the sodium concentration in order to limit the rate of change
of the sodium concentration in case of hyper- or hyponatremia. For further details refer to the
Summary of Product Characteristics.
Unless otherwise prescribed, the ready-to-use solution must be warmed to
36.5°C – 38°C immediately before infusion. The exact temperature will
be selected according to clinical requirements and the technical equipment used.

multiBic 4 mmol/l potassio soluzione per emodialisi/emofiltrazione

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
• 1. What multiBic 4 mmol/l potassio is and what it is used for
• 2. What you need to know before using multiBic 4 mmol/l potassio
• 3. How to use multiBic 4 mmol/l potassio
• 4. Possible side effects
• 11. How to store multiBic 4 mmol/l potassio
• 12. Contents of the pack and other information

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

multiBic 4 mmol/l potassium is a solution for continuous renal replacement therapy for the elimination
of waste products from the body in people with kidney disease. It is used in patients with
renal failure and also for the treatment of intoxications. The type of solution that will be
administered to you depends on the amount of potassium (a salt) in your blood. The doctor will check
your potassium levels regularly.

2. What you need to know before using multiBic 4 mmol/l potassium

Do not use multiBic 4 mmol/l potassium:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• if you have hyperkalemia (your potassium levels are very high)
• if you have metabolic alkalosis (a condition in which there is too much bicarbonate in the blood)
• if you are unable to achieve sufficient blood flow through the hemfilter (the filter used for blood filtration)
• if you have a high risk of bleeding related to medicines that prevent coagulation in the hemfilter

Warnings and precautions
Talk to your doctor before using multiBic 4 mmol/l potassium.

• It must only be used after mixing the two solutions in the double-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The cannulae used for applying the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid matter) is observed inside these cannulae, the bag and cannulae must be replaced immediately and the patient must be carefully monitored.
• The doctor will check your hydration status (amount of water in the body), potassium levels, sodium, other salts, some waste products and blood sugar levels. The doctor may also advise you on your diet.

Children
The use of multiBic 4 mmol/l potassium has not been established in children.

Other medicines and multiBic 4 mmol/l potassium
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
The following interactions are plausible:

• toxic effects of digitalis (a medicine for the treatment of heart disease)
• electrolyte substitutes, parenteral nutrition (intravenous feeding) and other infusion therapies. Their effect on blood concentration and fluid status must be considered when using this therapy.
• This therapy may reduce the blood concentration of medicines. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before starting treatment with this medicine.
Data on the use of multiBic 4 mmol/l potassium during pregnancy and breastfeeding are limited or
absent. This medicine should only be used during pregnancy if the doctor considers it
a necessary treatment.
Breastfeeding is not recommended during treatment with multiBic 4 mmol/l potassium.

3. How to use multiBic 4 mmol/l potassium

multiBic 4 mmol/l potassium will be administered in a hospital or clinic. The doctor will know how
to use this medicine.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

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

The side effectsof multiBic 4 mmol/lpotassium include:

• nausea (feeling unwell)
• vomiting (feeling sick)
• muscle cramps
• changes in blood pressure

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

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

The exact frequency of these events is not known (cannot be defined based on available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult
your doctor or nurse. You can also report side effects directly through the
national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store multiBic 4 mmol/l potassium

Keep this medicine out of the sight and reach of children.
Do not store at a temperature below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at a temperature above +30°C and must be
used within a maximum of 48 hours.
Do not use this medicine after the expiry date which is stated on the label after SCAD. The expiry
date refers to the last day of that month.

6. Content of the pack and other information

What multiBic 4 mmol/lpotassiumcontains

• The active ingredients are potassium chloride, sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other components are: water for injections, 25% hydrochloric acid, carbon dioxide and disodium hydrogen phosphate dihydrate.

Description of the appearance of multiBic 4 mmol/lpotassium and content of the pack
multiBic 4 mmol/l potassium is distributed in a double-chamber bag (two compartments
containing different solutions). By mixing the solutions of the two compartments, the ready-to-use
solution is obtained.
Each bag contains 5000 ml of total solution. The ready-to-use solution is clear and colourless.
Each bag is equipped with an HF connector, a Luer-Lock connector and an injection port
and is wrapped in a protective film.
Pack:
2 bags of 5000 ml

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
Local Representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
The following information is intended exclusively for doctors or healthcare professionals:
1000 ml of ready-to-use solution contains:
pH  7.4
Theoretical osmolarity (theor. osmolar.) 300 mOsm/l
Do not use the ready-to-use solution if it is not clear and colourless and if the bag and connectors are not
intact.
For single use only. Unused solution must be disposed of.
Use with metering pumps.

Instructions for use
The hemodialysis/hemofiltration solution must be administered in 3 phases:
1 Removal of the protective film and careful inspection of the bag
The protective film must be removed only immediately before
administration.
Plastic containers may occasionally be damaged during
transport from the manufacturer to the dialysis clinic or within the clinic itself. This
can lead to contamination and microbiological or fungal growth in the solutions. A
careful visual inspection of the bag and container is therefore necessary before
mixing. Particular attention should also be paid to any damage to the
closure, the hermetic seal and the corners of the container.
2 Mix the two compartments
The two solutions must be mixed immediately before use to obtain
the ready-to-use solution.

A)B) C)

After mixing both compartments, it must be checked that the seal is
completely open, that the solution is clear and colourless and that the bag does not leak.
3 Application of the ready-to-use solution
The ready-to-use solution must be used immediately, or within a
maximum of 48 hours after mixing.
Any addition to the ready-to-use solution must be made only after the
ready-to-use solution has been completely mixed. After each addition, the
ready-to-use solution must be thoroughly mixed again before use.
Additions of sodium chloride solution (up to 30%) and alternatively water for
injections are compatible with this medicinal product and can be used
to adjust the sodium concentration in order to limit the rate of change
in sodium concentration in case of hyper- or hyponatremia. For further details refer to the
Summary of Product Characteristics.
Unless otherwise prescribed, the ready-to-use solution must be warmed to
36.5°C – 38°C immediately before infusion. The exact temperature will be
selected according to clinical requirements and the technical equipment used.