Multibic

Package leaflet: Information for the user

multiBic without potassium solution for haemodialysis/haemofiltration

Please read this leaflet carefully before using this medicine because 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 you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Contents of this leaflet:
  1. What multiBic without potassium is and what it is 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. Contents of the pack and other information

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

multiBic without potassium is a solution for continuous renal replacement therapy used to remove 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 you will be given depends on the amount of potassium (a salt) in your blood. Your doctor will regularly monitor your potassium levels.

2. What you should know before using multiBic without potassium

Do not use multiBic without potassium

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6)
• if you have hypokalemia (your potassium levels are very low)
• if you have metabolic alkalosis (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 you have a high risk of bleeding related to medications that prevent clotting in the hemofilter

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

• It must only be used after mixing the two solutions in the dual-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The administration sets (tubing) used for delivering the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid material) is observed within the tubing, the bag and tubing must be replaced immediately and the patient must be closely monitored.
• Your doctor will monitor your hydration status (amount of water in the body), potassium, sodium, and other electrolyte levels, certain waste products, and blood sugar levels. Your doctor may also give you dietary advice.

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 medicines.
The following interactions are possible:

• increased risk of digitalis toxicity (a medicine used to treat heart conditions)
• electrolyte supplements, parenteral nutrition (intravenous feeding), and other infusion therapies. The effect of these on blood concentrations and fluid status must be considered when using this therapy.
• this therapy may reduce blood concentrations of certain medicines. Dose adjustments may be necessary.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before starting treatment with this medicine.
Data on the use of multiBic without potassium during pregnancy and breastfeeding are limited or lacking.
This medicine should be used during pregnancy only if your doctor considers it necessary.
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 everyone experiences them.
Side effects of multiBic without 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 include:

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system at the following address:
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 temperatures below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored above +30°C and must be used within a maximum of 48 hours.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

6. Package contents and other information

What multiBic without potassium contains

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

Description of the appearance of multiBic without potassium and package contents
multiBic without potassium is supplied in a dual-chamber bag (two compartments containing different solutions). Mixing the solutions from both compartments produces 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 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 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
Local representative
Fresenius Medical Care Italia S.p.A.
Tel: + 39 0373 974 1
Information intended for healthcare professionals: see the end of this leaflet.
The following information is intended exclusively for physicians or healthcare professionals:
1000 ml of ready-to-use solution contain:

Sodium chloride	6.136 g
Sodium hydrogen carbonate	2.940 g
Calcium chloride dihydrate	0.2205 g
Magnesium chloride hexahydrate	0.1017 g
Glucose monohydrate	1.100 g
(Glucose)	(1.000 g)
K+
Na+2	140 mmol/l
Ca2+2	1.5 mmol/l
Mg2+	0.50 mmol/l
Cl-	109 mmol/l
HCO3-	35 mmol/l
Glucose	5.55 mmol/l

pH ≈ 7.4
Theoretical osmolarity (theor. osm.) 292 mOsm/L
Do not use the ready-to-use solution if it is not clear and colorless or if the bag and connectors are not intact.
For single use only. Unused solution must be discarded.
Use only with infusion pumps.
Instructions for use
The dialysis/hemofiltration solution must be administered in 3 steps:
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 microbial or fungal growth in the solutions. Therefore, careful visual inspection of the bag and container is required before mixing. Particular attention must be paid to even minor damage to the closure, the hermetic seal, and the corners of the container.
2 Mixing 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, check that the weld is completely open, that the solution is clear and colorless, and that the bag does not leak.
3 Administration 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 may be used to adjust the sodium concentration in order to limit the rate of change in sodium concentration in cases 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.

Package leaflet: information for the user

multiBic 2 mmol/l potassium solution for hemodialysis/hemofiltration

Please 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, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What multiBic 2 mmol/l potassium is and what it is 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
6. Contents of the pack and other information

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

multiBic 2 mmol/l potassium is a solution for continuous renal replacement therapy to remove 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 you will be administered depends on the amount of potassium (a salt) in your blood. Your doctor will regularly monitor your potassium levels.

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

Do not use multiBic 2 mmol/l potassium:

• if you are allergic to the active substances or to 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 adequate blood flow through the haemofilter (the filter used for blood filtration) cannot be achieved
• if you have a high risk of bleeding related to medications that prevent blood clotting 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 dual-chamber bag (2 compartments).
• It must never be used below room temperature under any circumstances.
• The cannulae used for administering the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid material) is observed within these cannulae, the bag and cannulae must be replaced immediately and the patient must be closely monitored.
• Your doctor will check your hydration status (amount of water in the body), potassium, sodium, other electrolyte levels, certain waste products, and blood sugar levels. Your doctor may also advise you on 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 medicines.
The following interactions are possible:

• increased risk of digitalis toxicity (a medicine used to treat heart conditions)
• electrolyte replacements, parenteral nutrition (intravenous feeding), and other infusion therapies. Their effects on blood concentrations and fluid status must be considered when using this therapy.
• This therapy may reduce blood concentrations of certain medicines. Dose adjustments may therefore be necessary.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before starting treatment with this medicine.
Data on the use of multiBic 2 mmol/l potassium during pregnancy and breastfeeding are limited or unavailable. This medicine should be used during pregnancy only if your doctor considers it necessary.
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. Your 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 2 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 include:

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

The exact frequency of these events is unknown (cannot be estimated from the available data).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or nurse.
You may also report side effects directly via the national reporting system at the following address:
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 temperatures below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at temperatures above +30°C and must be used within a maximum of 48 hours.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What multiBic 2 mmol/l potassium contains

• The active substances are potassium chloride, sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other components 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 supplied in a dual-chamber bag (two compartments containing different solutions). Mixing the solutions from both compartments produces 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 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
Information intended for healthcare professionals: see the end of this leaflet.
The following information is intended exclusively for physicians or healthcare professionals:
1000 ml of ready-to-use solution contains:

Potassium chloride	0.1491 g
Sodium chloride	6.136 g
Sodium hydrogen carbonate	2.940 g
Calcium chloride dihydrate	0.2205 g
Magnesium chloride hexahydrate	0.1017 g
Glucose monohydrate	1.100 g
(Glucose)	(1.000 g)
K+	2.0 mmol/l
Na+	140 mmol/l
Ca2+	1.5 mmol/l
Mg2+	0.50 mmol/l
Cl-	111 mmol/l
HCO3-	35 mmol/l
Glucose	5.55 mmol/l

pH ≈ 7.4
Theoretical osmolarity (theor. osm.) 296 mOsm/L
Do not use the ready-to-use solution if it is not clear and colorless or if the bag and connectors are not intact.
For single use only. Unused solution must be discarded.
Use with infusion 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 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 microbial or fungal growth in the solutions. Therefore, careful visual inspection of the bag and container is required before mixing. Particular attention must be paid to even the slightest damage to the closure, the hermetic seal, and the corners of the container.
2 Mixing 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, check that the seal is fully open, that the solution is clear and colorless, and that the bag does not leak.
3 Administration 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 may be used to adjust the sodium concentration in order to limit the rate of change in sodium concentration in cases 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.

Package leaflet: Information for the user

multiBic 3 mmol/l potassium solution for haemodialysis/haemofiltration

Please 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
  1. What multiBic 3 mmol/l potassium is and what it is 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.
  6. Package contents and other information.

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

multiBic 3 mmol/l potassium is a solution for continuous renal replacement therapy used to remove 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 you will be administered depends on the amount of potassium (a salt) in your blood. Your doctor will regularly monitor 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 substances or to 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 medications that prevent clotting in the haemofilter

Warnings and precautions
Talk to your doctor before using multiBic 3 mmol/l potassium.

• It must only be used after mixing the two solutions in the dual-chamber bag (2 compartments).
• It must not be used below room temperature under any circumstances.
• The cannula used for administering the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid material) is observed inside the cannula, the bag and cannula must be replaced immediately and the patient must be closely monitored.
• Your doctor will monitor your hydration status (amount of water in the body), potassium levels, sodium levels, other electrolytes, certain waste products, and blood sugar levels. Your 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
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
The following interactions are possible:

• increased risk of digitalis toxicity (a medicine used to treat heart conditions)
• electrolyte replacements, parenteral nutrition (intravenous feeding), and other infusion therapies. Their effect on blood concentrations and fluid status should be considered when using this therapy.
• This therapy may reduce blood concentrations of certain medicines. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor 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 be used during pregnancy only if your doctor considers it necessary.
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 gets 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 include:

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

The exact frequency of these events is unknown (cannot be estimated from the available data).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via 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 medicinal product out of the sight and reach of children.
Do not store at temperatures below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored at temperatures above +30°C and must be used within a maximum of 48 hours.
Do not use this medicinal product after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What multiBic 3 mmol/l potassium contains

• The active substances are potassium chloride, sodium chloride, sodium hydrogen carbonate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate.
• The other components 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 supplied in a dual-chamber bag (two compartments containing different solutions). Mixing the solutions from both compartments yields 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 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
Information intended for healthcare professionals only: see the end of this leaflet.
The following information is intended exclusively for physicians or healthcare professionals:
1000 ml of ready-to-use solution contains:

Potassium chloride	0.2237 g
Sodium chloride	6.136 g
Sodium hydrogen carbonate	2.940 g
Calcium chloride dihydrate	0.2205 g
Magnesium chloride hexahydrate	0.1017 g
Glucose monohydrate	1.100 g
(Glucose)	(1.000 g)
K+	3.0 mmol/l
Na+	140 mmol/l
Ca2+	1.5 mmol/l
Mg2+	0.50 mmol/l
Cl-	112 mmol/l
HCO3-	35 mmol/l
Glucose	5.55 mmol/l

pH ≈ 7.4
Theoretical osmolarity (theor. osm.) 298 mOsm/l
Do not use the ready-to-use solution if it is not clear and colourless or if the bag and connectors are not intact.
For single use only. Unused solution must be discarded.
Use with infusion pumps.
Instructions for use
The haemodialysis/hemofiltration solution must be administered in 3 steps:
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 microbial or fungal growth in the solutions. Therefore, careful visual inspection of the bag and container is necessary before mixing. Particular attention should be paid to any minor damage to the closure, the hermetic seal, and the corners of the container.
2 Mixing 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, check that the weld is completely open, that the solution is clear and colourless, and that the bag does not leak.
3 Administration 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 additions 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.
Sodium chloride solution (up to 30%) and alternatively water for injections are compatible with this medicinal product and may be used to adjust the sodium concentration in order to limit the rate of change in sodium concentration in cases 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.

Patient Information Leaflet: Information for the User

multiBic 4 mmol/l potassium solution for haemodialysis/haemofiltration

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
  1. What multiBic 4 mmol/l potassium is and what it is 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. Package contents and other information

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

multiBic 4 mmol/l potassium is a solution for continuous renal replacement therapy used to remove 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 you will be given depends on the amount of potassium (a salt) in your blood. Your doctor will regularly monitor your potassium levels.

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 substances or to any of the other ingredients of this medicine (listed in section 6)
• if you have hyperkalaemia (your potassium levels are too high)
• if you have metabolic alkalosis (a condition in which there is too much bicarbonate in the blood)
• if adequate blood flow cannot be achieved through the haemofilter (the filter used for blood filtration)
• if you are at high risk of bleeding related to medications that prevent clotting in the haemofilter

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

• Must be used only after mixing the two solutions in the dual-chamber bag (2 compartments).
• Must not be used below room temperature under any circumstances.
• The tubing sets used for administering the ready-to-use solution must be inspected every 30 minutes. If precipitate (solid material) is observed within the tubing, the bag and tubing must be replaced immediately and the patient must be closely monitored.
• Your doctor will monitor your hydration status (amount of water in the body), potassium, sodium, and other electrolyte levels, certain waste products, and blood sugar levels. Your doctor may also advise you on 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 possible:

• increased risk of digitalis toxicity (a medicine used to treat heart conditions)
• electrolyte replacements, parenteral nutrition (intravenous feeding), and other infusion therapies. Their effects on blood concentrations and fluid status must be taken into account when using this therapy.
• This therapy may reduce blood concentrations of certain medicines. A dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor before starting treatment with this medicine.
Data on the use of multiBic 4 mmol/l potassium during pregnancy and breastfeeding are limited or
unavailable. This medicine should be used during pregnancy only if your doctor considers it
necessary.
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, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of multiBic 4 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 include:

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

The exact frequency of these events is unknown (cannot be estimated from the 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 may also report side effects directly via the national reporting system at the following website:
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 temperatures below +4°C.
Storage conditions after mixing the two compartments:
The ready-to-use solution must not be stored above +30°C and must be used within a maximum of 48 hours.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

6. Package contents and other information

What multiBic 4 mmol/l potassium contains

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

Description of the appearance of multiBic 4 mmol/l potassium and package contents
multiBic 4 mmol/l potassium is supplied in a dual-chamber bag (two compartments containing different solutions). Mixing the solutions from both compartments produces 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 equipped 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
Information intended for healthcare professionals: see the end of this leaflet.
The following information is intended exclusively for physicians or healthcare professionals:
1000 ml of ready-to-use solution contains:

Potassium chloride	0.2982 g
Sodium chloride	6.136 g
Sodium hydrogen carbonate	2.940 g
Calcium chloride dihydrate	0.2205 g
Magnesium chloride hexahydrate	0.1017 g
Glucose monohydrate	1.100 g
(Glucose)	(1.000 g)
K+	4.0 mmol/l
Na+2+	140 mmol/l
Ca2+2	1.5 mmol/l
Mg2+	0.50 mmol/l
Cl-	113 mmol/l
HCO3-	35 mmol/l
Glucose	5.55 mmol/l

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 or if the bag and connectors are not intact.
For single use only. Unused solution must be discarded.
Use with infusion pumps.
Instructions for use
The dialysis/hemofiltration solution must be administered in 3 steps:
1 Removal of 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 microbial or fungal growth in the solutions. Therefore, careful visual inspection of the bag and container is necessary before mixing. Particular attention must be paid to even minor damage to the closure, the hermetic seal, and the corners of the container.
2 Mixing 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, check that the weld is fully open, that the solution is clear and colourless, and that the bag does not leak.
3 Administration 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 may be used to adjust the sodium concentration in order to limit the rate of change in sodium concentration in cases 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 technical equipment used.