Bicavera

Package leaflet: Information for the user

bica Vera 1.5% Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What bica Vera is and what it is used for
2. What you need to know before using bica Vera
3. How to use bica Vera
4. Possible side effects
5. How to store bica Vera
6. Contents of the pack and other information

1. What bica Vera is and what it is used for

bica Vera is used for blood purification through the peritoneal membrane in patients with end-stage chronic renal failure. This type of blood purification is called peritoneal dialysis.

2. What you should know before using bica Vera

Do not use bica Vera 1.5% Glucose, 1.75 mmol/l Calcium:

• If your blood potassium level is very low;
• If your blood calcium level is very high.

Peritoneal dialysis must not be started if you have:

• Abdominal disorders such as:
• Wounds or recent surgery,
• Severe burns,
• Extensive skin inflammatory reactions,
• Peritonitis (inflammation of the peritoneum),
• Non-healing exudative skin lesions,
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestines,
• Intestinal inflammations,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning (sepsis) caused by bacteria,
• Very high levels of fats in the blood,
• Poisoning due to waste products of urine that cannot be eliminated by peritoneal dialysis,
• Severe malnutrition and weight loss, particularly if an adequate protein-rich diet cannot be maintained.

Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts) due to vomiting and/or diarrhea,

1 of 22

• In case of peritonitis, recognizable by cloudy dialysate, abdominal pain, fever, or feeling unwell, or in very rare cases, blood poisoning (sepsis). Please show the bag containing the drained dialysate to your doctor.
• In case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy which can be fatal.

Peritoneal dialysis may lead to loss of proteins and water-soluble vitamins.
An adequate diet or use of nutritional supplements is recommended to prevent nutritional deficiencies.
Your doctor will monitor your electrolyte balance (salts), total blood cell count, residual kidney function, body weight, and nutritional status.

Other medicines and bica Vera
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since peritoneal dialysis may affect the action of certain medicines, your doctor may need to adjust their dosage, especially for:

• Medicines used to treat heart conditions, such as digoxin; your doctor will periodically monitor your blood potassium levels and, if necessary, take appropriate corrective measures,
• Medicines affecting calcium levels, such as those containing calcium or vitamin D,
• Medicines increasing urinary excretion, such as diuretics,
• Oral medicines that lower blood sugar levels, or insulin. Your blood glucose level should be monitored regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
There are insufficient adequate data on the use of bica Vera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should use bica Vera only if your doctor considers it absolutely necessary.

Driving and operating machinery:
bica Vera does not affect or affects negligibly your ability to drive vehicles or operate machinery.

3. How to use bica Vera

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration, frequency of use, required volumes of solution, and dwell times of the fluid in the peritoneal cavity.
If abdominal distension occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: Normally 2,000–2,500 ml of solution four times daily, depending on body weight and residual renal function. After a dwell time of 2 to 10 hours, the solution is drained.
• Children: The physician will determine the required dialysis solution volume based on the child's tolerance, age, and body surface area. The recommended initial dose is 600–800 ml/m² (up to 1,000 ml/m² at night) of body surface area, administered four times daily. 2 of 22

3 of 22
Automated Peritoneal Dialysis (APD)
For this dialysis, the bica Vera sleep•safe system is used. Exchanges of dialysis solution are automatically controlled by the sleep•safe device during the night.

• Adults: The usual prescription is 2,000 ml (maximum 3,000 ml) per exchange, with 3–10 exchanges during the night and connection time to the device of 8–10 hours, plus one or two daytime exchanges.
• Children: The volume per exchange should be 800–1,000 ml/m² (up to 1,400 ml/m²) of body surface area, with 5–10 exchanges during the night. Infuse bica Vera only into the peritoneal cavity.

Use bica Vera only if the solution is clear and the bag is undamaged.
The bica Vera solution is supplied in a dual-chamber bag. The solutions from the two chambers must be mixed as described before use.
Instructions for use
stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)
Warm the solution bag to body temperature.
This must be done using a dedicated heating device. The heating time for a 2,000 ml bag starting at 22°C is approximately 120 minutes.
Further detailed information can be found in the bag warmer's instructions for use.
Do not use microwave ovens to warm the bags, due to the risk of overheating.
After warming, the solution may be used for dialysis exchanges.

1. Preparation of the solution

• Place the bag on a solid surface. Open the outer wrapper of the bag and the disinfectant cap. Check the bag containing the solution before use (label, expiration date, clarity of the solution, integrity of the bag). Wash hands with an antiseptic product. Roll the bag from one of the upper ends until the middle seal opens. The solutions contained in the two compartments will mix automatically. Continue rolling the bag from the top edge until the lower triangular seal is completely open. The ready-to-use solution should be used immediately, or at the latest within 24 hours after mixing.

2. Preparing for the bag exchange

• Hang the bag containing the solution on the uppermost hook of the IV pole, unroll the infusion line of the solution bag, and place the DISC in the organizer. After unrolling the drainage bag line, hang the drainage bag on the lowermost hook of the IV pole, and place the disinfection cap in the organizer. Place the catheter adapter in the organizer. Disinfect hands and remove the protective cap from the DISC. Connect the catheter adapter to the DISC.

3. Drainage

Open the catheter clamp. Drainage begins.
Position ●

4. Washing

Fill the drainage bag with fresh solution (approximately 5 seconds).
Position ● ●

5. Infusion

Connect the solution bag to the catheter.
Position ○ ◑ ●

6. Safety Position

Close the catheter adapter by automatic insertion of the PIN.
Position ● ● ● ●

7. Disconnection

4 of 22
Remove the catheter adapter from the DISC and screw the new disinfection cap onto the
catheter adapter.

8. Closing the DISC

Close the DISC with the open end of the used disinfection cap protector,
placed in the right hole of the organizer.

9. Check the drained dialysate and proceed with its disposal.

**The sleep •safe system for automated peritoneal dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically warmed inside the machine
(cycler).

1. Preparation of the solution

Check the bag containing the solution (label, expiration date, solution clarity,
ensure that the bag and its outer pouch are undamaged, and that the central seal is intact). Place
the bag on a solid surface. Open the bag's outer pouch. Wash hands with an antibacterial product.
Press firmly along the central seal and the connector of the bag. Roll the bag, laid out
on its pouch, from the opposite diagonal end toward the bag's connector. This will open the central seal.
Continue rolling until the central seal of the smaller chamber also opens. Check that all seals
are completely open. Verify that the solution is clear and that the bag has no leaks.

2. Unroll the infusion line from the bag.

3. Remove the protective closure cap and insert the bag's connector into one of the free ports of the sleep•safe device.

4. The bag is now ready for use with the sleep•safe set.

Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, bica Vera can be used independently at home. Ensure
that all procedures learned during training are followed and maintain adequate hygienic
conditions when performing dialysis exchanges.
Always check the clarity of the drained dialysate. See section 2, “Warnings and precautions”.
If you use more bica Vera than you should
If an excess of solution is infused into the peritoneal cavity, it can be drained out. However,
if too many bags are used, consult your doctor, as fluid and/or electrolyte imbalances may occur.
If you forget to use bica Vera
Try to achieve the total volume of dialysate prescribed within 24 hours to avoid the risk of potentially life-threatening consequences. Consult your doctor if you are unsure.
If you have any doubts about the use of this medicine, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, bica Vera can cause side effects, although not everyone experiences them.
The following side effects may occur during peritoneal dialysis treatment in general:
Very common (may affect more than 1 in 10 people):

• Peritoneal inflammation with signs such as cloudiness of the drained dialysate, abdominal pain, fever, feeling unwell, or, very rarely, blood poisoning. Please show the drainage bag to your doctor;
• Skin inflammation at the catheter exit site or along the catheter tunnel, recognizable by redness, swelling, pain, exudation, or crusting;
• Abdominal wall hernia.

5 of 22
If you notice any of these side effects, inform your doctor immediately.
Other side effects related to the treatment include:
Common (may affect up to 1 in 10 people):

• Problems with dialysate infusion or drainage;
• Sensation of abdominal stretching or fullness;
• Shoulder pain;

Uncommon (may affect up to 1 in 100 people):

• Diarrhea;
• Constipation;

Not known (frequency cannot be estimated from the available data):

• Breathing difficulties due to elevation of the diaphragm;
• Encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

The following side effects may occur when using bica Vera:
Very common (may affect more than 1 in 10 people):

• Potassium deficiency;

Common (may affect up to 1 in 10 people):

• High blood sugar levels;
• High blood fat levels, weight gain;

Uncommon (may affect up to 1 in 100 people):

• Excess calcium if the diet is too rich in calcium;
• Too low body fluid levels, which may be indicated by rapid decrease in body weight;
• Low blood pressure;
• Rapid heartbeat;
• Too high body fluid levels, which may be indicated by rapid weight gain;
• Fluid retention in tissues and lungs;
• High blood pressure;
• Breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://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 bica Vera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and carton after EXP. The expiry date refers to the last day of that month.
Do not store at temperatures below 4°C.
6 of 22
The ready-to-use solution must be used immediately, within a maximum of 24 hours after mixing.
Do not use this medicine if you notice that the solution is cloudy or if the bag is damaged.

6. Pack contents and other information

What bica Vera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.786 g
Sodium hydrogen carbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 16.5 g
(equivalent to 15.0 g of glucose)
These amounts of active substances are equivalent to:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 104.5 mmol/l chloride, 34 mmol/l
bicarbonate and 83.25 mmol/l glucose.
The other components of bica Vera are water for injections, hydrochloric acid, sodium hydroxide,
carbon dioxide.

Description of the appearance of bica Vera and pack contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 358 mOsm/l, the pH is approximately 7.40.
bica Vera is available in a dual-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other the acidic electrolyte solution with glucose, in a 1:1 ratio.
bica Vera is available in the following delivery systems and pack sizes:
stay•safe : sleep•safe :
4 bags containing 2,000 ml 4 bags of 2,000 ml
4 bags containing 2,500 ml 4 bags of 2,500 ml
4 bags containing 3,000 ml 4 bags containing 3,000 ml
2 bags containing 5,000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Fresenius Medical Care Italia S.p.a., Via Crema 8, 26020 Palazzo Pignano (CR) - Italy

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

This medicinal product is authorised in the European Economic Area Member States under the following names:
see the end of this multilingual summary of product characteristics.
7 of 22

Last page of the multilingual summary of product characteristics:
This medicinal product is authorised in the European Economic Area Member States under the following names:
B & NL: bicaVera 1.5 % glucose, 1.75 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 1.5 % Glucose, 1.75 mmol/l Calcium, Peritonealdialyselösung
DK: bicaVera 1.5% glucose, 1.75 mmol/l calcium, Peritonealdialysevæske
E: bicaVera Glucosa 1.5% Calcio 1.75 mmol/l solución para diálisis peritoneal
F, B & L: bicaVera 1.5 % glucose, 1.75 mmol/l calcium, solution pour dialyse péritonéale
FIN: bicaVera 1.5 % glukoosi, 1.75 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 1.5 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis
GR & CY: bicaVera 1.5% γλυκόζη, 1,75 mmol/l ασβέστιο, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
I: bicaVera 1.5 % Glucosio, 1.75 mmol/l Calcio, Soluzione per dialisi peritoneale
IS: bicaVera 1.5% Glucose, 1.75 mmol/l Calcium, kviðskilunarlausn
N: bicaVera 1.5 % glukose, 1.75 mmol/l kalsium, peritonealdialysevæske
P: bicaVera 1.5% Glucose 1.75 mmol/l Cálcio, Solução para diálise peritoneal
S: bicaVera 1.5% Glucose, 1.75 mmol/l Calcium, peritonealdialysvätska
8 of 22

Package leaflet: Information for the user

bica Vera 2.3% Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What bica Vera is and what it is used for

2. What you need to know before using bica Vera

3. How to use bica Vera

4. Possible side effects

5. How to store bica Vera

6. Contents of the pack and other information

7. What bica Vera is and what it is used for
   bica Vera is used for blood purification through the peritoneal membrane in patients with end-stage chronic renal failure. This type of blood purification is called: peritoneal dialysis

2. What you need to know before using bica Vera

Do not use bica Vera 2.3% Glucose, 1.75 mmol/l Calcium if:

• Your blood potassium level is very low;
• Your blood calcium level is very high;
• The volume of your body fluids is too low;
• Your blood pressure is low.

Peritoneal dialysis must not be started if you have:

• Abdominal disorders, such as:
  • Wounds or surgery,
  • Severe burns,
  • Extensive inflammatory skin reactions,
  • Peritonitis,
  • Non-healing exudative skin lesions.
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestines,
• Intestinal inflammations,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning caused by bacteria,
• Very high levels of fats in the blood,
• Poisoning due to waste products of urine that cannot be removed by peritoneal dialysis,
• Severe malnutrition and weight loss, particularly if an adequate diet containing proteins cannot be provided.

Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
• In case of peritonitis, recognizable by cloudy dialysate, abdominal pain, fever, feeling unwell, or, in very rare cases, blood poisoning. Please show the bag containing the drained dialysate to your doctor.
• In case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy that may be fatal.

Peritoneal dialysis may cause loss of proteins and water-soluble vitamins. An adequate diet or the use of dietary supplements is recommended to prevent nutritional deficiencies.
Your doctor will monitor your electrolyte balance (salts), total blood cell count, residual kidney function, body weight, and nutritional status.

Other medicines and bica Vera
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since peritoneal dialysis may affect the action of certain medicines, your doctor may need to adjust their dosage, especially in the case of:

• Medicines used to treat heart conditions, such as digoxin; your doctor will periodically check your blood potassium level and, if necessary, take appropriate corrective measures,
• Medicines affecting calcium levels, such as those containing calcium or vitamin D,
• Medicines increasing urinary excretion, such as diuretics,
• Oral medicines lowering blood sugar levels, or insulin. Your blood sugar level must be monitored regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There are insufficient data on the use of bica Vera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should use bica Vera only if your doctor considers it absolutely necessary.

Driving and using machines:
bica Vera does not affect or affects negligibly your ability to drive vehicles or operate machinery.

3. How to use bica Vera

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration, frequency of use, required volumes of solution, and dwell times of the fluid in the peritoneal cavity.
If abdominal distension occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: normally 2,000–2,500 ml of solution four times daily, depending on body weight and residual renal function. After a dwell time of 2 to 10 hours, the solution is drained.
• Children: your doctor will determine the required dialysis solution volume based on tolerance, age, and body surface area. The recommended initial dose is 600–800 ml/m² (up to 1,000 ml/m² at night) of body surface area, administered four times daily. 10 of 22

Automated Peritoneal Dialysis (APD)
For this dialysis, the bica Vera sleep•safe system is used. The exchanges of dialysis solution are automatically controlled by the sleep•safe device during the night.

• Adults: the usual prescription is 2,000 ml (maximum 3,000 ml) per exchange, with 3–10 exchanges during the night and a connection time to the device of 8–10 hours, plus one or two daytime exchanges.
• Children: the volume per exchange should be 800–1,000 ml/m² (up to 1,400 ml/m²) of body surface area, with 5–10 exchanges during the night.

Infuse bica Vera only into the peritoneal cavity.
Use bica Vera only if the solution is clear and the bag is undamaged.
The bica Vera solution is supplied in a dual-chamber bag. The solutions from the two chambers must be mixed as described before use.

Instructions for Use
stay•safe System for Continuous Ambulatory Peritoneal Dialysis (CAPD)

Warm the solution bag to body temperature.
This must be done using a dedicated heating device. The warming time for a 2,000 ml bag starting at 22°C is approximately 120 minutes.
Further detailed information can be found in the instructions for use of the solution bag heater.
Do not use microwave ovens to warm the bags, due to the risk of overheating.
After warming, the solution may be used for dialysis exchanges.

1. Preparation of the solution

Place the bag on a solid surface. Open the outer wrapper of the bag and the disinfection cap. Check the bag containing the solution before use (label, expiration date, clarity of the solution, integrity of the bag). Wash hands with an antibacterial product. Roll the bag from one of the upper ends until the central seal opens. The solutions contained in the two compartments will automatically mix. Continue rolling the bag from the top edge until the lower triangular seal is completely open. The ready-to-use solution should be used immediately, and at most within 24 hours after mixing.

2. Preparation for bag exchange

Hang the bag containing the solution on the uppermost hook of the IV pole. Unroll the infusion line from the solution bag and place the DISC in the organizer. After unrolling the line of the drain bag, hang the drain bag on the lowermost hook of the IV pole and place the disinfection cap in the organizer. Place the catheter adapter in the organizer. Disinfect your hands and remove the protective disinfection cap from the DISC. Connect the catheter adapter to the DISC.

3. Drainage

Open the catheter clamp. Drainage begins.
Position ●

4. Washing

Fill the drainage bag with fresh solution (approximately 5 seconds).
Position ● ●

5. Infusion

Connect the solution bag to the catheter.
Position ○ ◑ ●

6. Safety position

Close the catheter adapter by automatic insertion of the PIN.
Position ● ● ● ●
11 of 22

7. Disconnection

Remove the catheter adapter from the DISC and screw the new disinfection cap onto the
catheter adapter.

8. Closing the DISC

Close the DISC using the open end of the used disinfection cap's protective cap,
placed in the right hole of the organizer.

9. Check the drained dialysate and proceed with its disposal.

sleep•safe system for automated peritoneal dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically warmed in the machine (cycler).

1. Preparation of the solution

Check the bag containing the solution (label, expiration date, solution clarity,
ensure the bag and its overwrap are undamaged, and the middle seal is intact). Place
the bag on a solid surface. Open the overwrap of the bag. Wash hands with an
antibacterial product. Flatten the middle seal and the connector of the bag. Roll the bag,
laid out on the overwrap, from the diagonal end towards the bag connector. The middle seal will open.
Continue until the middle seal of the smaller chamber also opens. Check that all
seals are completely open. Verify that the solution is clear and that the bag shows no
leaks.

2. Unroll the infusion line of the bag.

3. Remove the protective closure cap and insert the bag's connector into one of the free ports of the sleep•safe device.

4. The bag is now ready for use with the sleep•safe set.

Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, bica Vera can be used independently at home. Always
follow all procedures learned during training and maintain adequate hygienic conditions
when performing dialysis exchanges.
Always check the clarity of the drained dialysate. See section 2. “Warnings and precautions”.
If you use more bica Vera than you should
If an excess of solution has been infused into the peritoneal cavity, it may be drained out. However,
if too many bags have been used, consult your doctor, as fluid and/or electrolyte imbalances may occur.
If you forget to use bica Vera
Try to achieve the total prescribed volume of dialysate within 24 hours to avoid the risk of potentially life-threatening consequences.
You should consult your doctor if you are unsure.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, bicaVera can cause side effects, although not everyone experiences them.
The following side effects may occur during peritoneal dialysis treatment in general:
Very common (may affect more than 1 in 10 people):

• Peritonitis (inflammation of the peritoneum) with signs such as cloudiness of the drained dialysate, abdominal pain, fever, feeling unwell, or, in very rare cases, blood poisoning. Please show the drainage bag to your doctor;
• Skin inflammation at the catheter exit site or along the catheter tract, recognizable by redness, swelling, pain, exudation, or crusting; 12 out of 22
• Abdominal wall hernia. If you notice any of these side effects, inform your doctor immediately.

Other side effects related to the treatment are:
Common (may affect up to 1 in 10 people):

• Problems with infusion or drainage of the dialysate;
• Sensation of abdominal stretching or fullness;
• Shoulder pain;

Uncommon (may affect up to 1 in 100 people):

• Diarrhoea;
• Constipation;

Not known (frequency cannot be estimated from the available data):

• Breathing difficulties due to elevation of the diaphragm;
• Encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

The following side effects may occur when using bicaVera:
Very common (may affect more than 1 in 10 people):

• Potassium deficiency;

Common (may affect up to 1 in 10 people):

• High blood sugar levels;
• High blood fat levels, weight gain;

Uncommon (may affect up to 1 in 100 people):

• Excess calcium if the diet is too rich in calcium;
• Too low body fluid levels, which may be indicated by rapid weight loss;
• Low blood pressure;
• Rapid heartbeat;
• Too high body fluid levels, which may be indicated by rapid weight gain;
• Fluid retention in tissues and lungs;
• High blood pressure;
• Breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: https://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 bica Vera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and carton after EXP. The expiry date refers to the last day of that month.
Do not store at temperatures below 4°C.
The ready-to-use solution must be used immediately, within a maximum of 24 hours after mixing.
Do not use this medicine if you notice that the solution is cloudy or if the bag is damaged.

6. Package contents and other information

What bica Vera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.786 g
Sodium hydrogen carbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 25 g
(equivalent to 22.73 g of glucose)
These amounts of active substances are equivalent to:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 104.5 mmol/l chloride, 34 mmol/l
bicarbonate, and 126.1 mmol/l glucose.
The other components of bica Vera are water for injections, hydrochloric acid, sodium hydroxide,
carbon dioxide.

Description of the appearance of bica Vera and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 401 mOsm/l; the pH is approximately 7.40.
bica Vera is available in a dual-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other contains the acidic electrolyte glucose solution in a 1:1 ratio.
bica Vera is available in the following delivery systems and pack sizes:
stay•safe: sleep•safe:
4 bags containing 2,000 ml 4 bags of 2,000 ml
4 bags containing 2,500 ml 4 bags of 2,500 ml
4 bags containing 3,000 ml 4 bags containing 3,000 ml
2 bags containing 5,000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Fresenius Medical Care Italia S.p.a., Via Crema 8, 26020 Palazzo Pignano (CR) - Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
see the end of this multilingual summary of product characteristics.
14 of 22

Last page of the multilingual summary of product characteristics:
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
B & NL: bicaVera 2,3 % glucose, 1,75 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 2,3 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung
DK: bicaVera 2,3% glucose, 1,75 mmol/l calcium, Peritonealdialysevæske
E: bicaVera Glucosa 2,3% Calcio 1,75 mmol/l solución para diálisis peritoneal
F, B & L: bicaVera 2,3 % glucose, 1,75 mmol/l calcium, solution pour dialyse péritonéale
FIN: bicaVera 2,3 % glukoosi, 1,75 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 2.3 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis
GR & CY: bicaVera 2,3% γλυκόζη, 1,75 mmol/l ασβέστιο, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
I: bicaVera 2,3 % Glucosio, 1,75 mmol/l Calcio, Soluzione per dialisi peritoneale
IS: bicaVera 2,3% Glucose, 1,75 mmol/l Calcium, kviðskilunarlausn
N: bicaVera 2,3 % glukose, 1,75 mmol/l kalsium, peritonealdialysevæske
P: bicaVera 2,3% Glucose 1,75 mmol/l Cálcio, Solução para diálise peritoneal
S: bicaVera 2,3% Glucose, 1,75 mmol/l Calcium, peritonealdialysvätska
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Package leaflet: Information for the user

bica Vera 4.25% Glucose, 1.75 mmol/l Calcium, Peritoneal Dialysis Solution
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What bica Vera is and what it is used for
2. What you need to know before using bica Vera
3. How to use bica Vera
4. Possible side effects
5. How to store bica Vera
6. Contents of the pack and other information

1. What bica Vera is and what it is used for

bica Vera is used for blood purification through the peritoneal membrane in patients with end-stage chronic renal failure. This type of blood purification is called: peritoneal dialysis.

2. What you need to know before using bica Vera

Do not use bica Vera 4.25% Glucose, 1.75 mmol/l Calcium if:

• Your blood potassium level is very low;
• Your blood calcium level is very high;
• The volume of your body fluids is too low;
• Your blood pressure is low.

Peritoneal dialysis must not be started if you have:

• Abdominal disorders such as:
• Wounds or recent surgery,
• Severe burns,
• Extensive inflammatory skin reactions,
• Peritonitis (inflammation of the peritoneum),
• Non-healing exudative lesions,
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestines,
• Intestinal inflammation,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning (sepsis) caused by bacteria,
• Very high levels of fats in the blood,
• Intoxication due to waste products of urine that cannot be eliminated by peritoneal dialysis,
• Severe malnutrition and weight loss, especially if an adequate protein-rich diet is not possible.

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Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts) due to vomiting and/or diarrhea;
• In case of peritonitis, recognizable by cloudy dialysate, abdominal pain, fever, or general malaise, and in very rare cases, blood poisoning (sepsis). Please show the bag containing the drained dialysate to your doctor.
• In case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy which can be fatal. Peritoneal dialysis may lead to loss of proteins and water-soluble vitamins. An adequate diet or use of nutritional supplements is recommended to prevent nutritional deficiencies. Your doctor will monitor your electrolyte balance (salts), total blood cell count, residual kidney function, body weight, and nutritional status. Other medicines and bica Vera Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Since peritoneal dialysis can affect the action of certain medicines, your doctor may need to adjust their dosage, especially in the case of:
• Medicines used to treat heart conditions, such as digoxin; your doctor will periodically check your blood potassium levels and, if necessary, take appropriate corrective measures;
• Medicines affecting calcium levels, such as those containing calcium or vitamin D;
• Medicines increasing urinary excretion, such as diuretics;
• Oral medicines that lower blood sugar levels, or insulin. Your blood glucose level should be monitored regularly.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
There are insufficient data on the use of bica Vera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should use bica Vera only if your doctor considers it absolutely necessary.

Driving and use of machines:
bica Vera does not affect or affects negligibly your ability to drive or operate machinery.

3. How to use bica Vera

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration, frequency of use, volume of solution required, and dwell time of the fluid in the peritoneal cavity.
If abdominal distension occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: normally 2,000–2,500 mL of solution four times daily, depending on body weight and residual renal function. After a dwell time of 2 to 10 hours, the solution is drained.

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• Children: your doctor will determine the required dialysis solution volume based on the child's tolerance, age, and body surface area. The recommended initial dose is 600–800 mL/m² (up to 1,000 mL/m² at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD)
For this dialysis, the bica Vera sleep•safe system is used. Exchanges of dialysis solution are automatically controlled by the sleep•safe device during the night.

• Adults: the usual prescription is 2,000 mL (maximum 3,000 mL) per exchange, with 3–10 exchanges during the night and connection time to the device of 8–10 hours, plus one or two daytime exchanges.
• Children: the volume per exchange should be 800–1,000 mL/m² (up to 1,400 mL/m²) of body surface area, with 5–10 exchanges during the night.

Infuse bica Vera only into the peritoneal cavity.
Use bica Vera only if the solution is clear and the bag is intact.
The bica Vera solution is supplied in a dual-chamber bag. The solutions from the two chambers must be mixed as described before use.

Instructions for Use
stay•safe System for Continuous Ambulatory Peritoneal Dialysis (CAPD)

Warm the solution bag to body temperature.
This must be done using a dedicated heating device. The warming time for a 2,000 mL bag starting at 22°C is approximately 120 minutes.
Further detailed information can be found in the instructions for use of the bag warmer.
Do not use microwave ovens to warm the bags due to the risk of overheating.
After warming, the solution can be used for dialysis exchanges.

1. Preparation of the solution

Place the bag on a solid surface. Open the outer bag wrapper and the disinfection cap. Check the bag containing the solution before use (label, expiration date, clarity of the solution, integrity of the bag). Wash hands with an antiseptic product. Roll the bag from one of the upper ends until the central seal opens. The solutions contained in the two compartments will automatically mix. Continue rolling the bag from the top edge until the lower triangular weld is completely open. The ready-to-use solution should be used immediately, or at most within 24 hours from mixing.

2. Preparing the bag exchange

Hang the bag containing the solution on the upper hook of the IV pole, unroll the infusion line from the solution bag and place the DISC in the organizer. After unrolling the drainage bag line, hang the drainage bag on the lower hook of the IV pole and place the disinfection closure cap in the organizer. Place the catheter adapter in the organizer. Disinfect your hands and remove the protective closure cap from the DISC.
Connect the catheter adapter to the DISC.

3. Drainage

Open the catheter clamp. Drainage begins.
Position ●

4. Washing

Fill the drainage bag with fresh solution (approximately 5 seconds).
Position ● ●

5. Infusion

Connect the solution bag to the catheter.
Position ○ ◑ ●
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6. Safety position

Close the catheter adapter by automatically inserting the PIN.
Position ● ● ● ●

7. Disconnection

Remove the catheter adapter from the DISC and screw the new disinfection cap onto the
catheter adapter.

8. Closing the DISC

Close the DISC using the open end of the used disinfection cap's protective cap,
placed in the right hole of the organizer.

9. Check the drained dialysate and proceed with its disposal.

sleep•safe system for automated peritoneal dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically warmed inside the machine (cycler).

1. Preparation of the solution

Check the bag containing the solution (label, expiration date, solution clarity,
ensure that the bag and its outer pouch are undamaged and that the middle seal is intact).
Place the bag on a solid surface. Open the outer pouch of the bag. Wash hands with an
antibacterial product. Flatten the middle seal and the connector of the bag. Roll the bag,
flattened on its pouch, from the diagonal end towards the bag connector. The middle seal will
open. Continue until the middle seal of the smaller chamber also opens. Check
that all seals are completely open. Check that the solution is clear and that the bag
has no leaks.

2. Unroll the infusion line from the bag.

3. Remove the protective closure cap and insert the bag's connector into one of the free ports of the sleep•safe device.

4. The bag is now ready for use with the sleep•safe set.

Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, bica Vera can be used independently at home. Make sure
to follow all procedures learned during training and maintain adequate hygiene conditions
when performing dialysis exchanges.
Always check the clarity of the drained dialysate. See section 2, "Warnings and precautions".
If you use more bica Vera than you should
If an excess of solution is infused into the peritoneal cavity, it can be drained. However,
if too many bags are used, consult your doctor, as fluid and/or electrolyte imbalances may occur.
If you forget to use bica Vera
Try to achieve the total prescribed dialysate volume within 24 hours to avoid the risk of potentially life-threatening consequences.
You should consult your doctor if you are unsure.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, bica Vera can cause side effects, although not everyone experiences them.
The following side effects may occur during peritoneal dialysis treatment in general:
Very common (may affect more than 1 in 10 people):

• Peritonitis, with signs such as cloudiness of the drained dialysate, abdominal pain, fever, feeling unwell, or, in very rare cases, blood poisoning. Please show the drainage bag to your doctor;
• Skin inflammation at the catheter exit site or along the catheter tract, recognizable by redness, swelling, pain, exudation, or crusting;
• Abdominal wall hernia. If you notice any of these side effects, inform your doctor immediately.

Other side effects related to the treatment are:
Common (may affect up to 1 in 10 people):

• Problems with infusion or drainage of the dialysate;
• Feeling of abdominal stretching or fullness;
• Shoulder pain;

Uncommon (may affect up to 1 in 100 people):

• Diarrhoea;
• Constipation;

Not known (frequency cannot be estimated from the available data):

• Breathing difficulties due to elevation of the diaphragm;
• Encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

The following side effects may occur when using bica Vera:
Very common (may affect more than 1 in 10 people):

• Potassium deficiency;

Common (may affect up to 1 in 10 people):

• High blood sugar levels;
• High blood lipid levels, weight gain;

Uncommon (may affect up to 1 in 100 people):

• Excess calcium if the diet is too rich in calcium;
• Too low levels of body fluids, which may be indicated by a rapid decrease in body weight;
• Low blood pressure;
• Rapid heartbeat;
• Too high levels of body fluids, which may be indicated by a rapid weight gain;
• Fluid retention in tissues and lungs;
• High blood pressure;
• Breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://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 bica Vera

Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date stated on the bag and carton after EXP. The
expiry date refers to the last day of that month.
Do not store at temperatures below 4°C.
The ready-to-use solution must be used immediately and within a maximum of 24 hours after mixing.
Do not use this medicine if you notice that the solution is cloudy or if the bag is damaged.

6. Package contents and other information

What bica Vera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.786 g
Sodium hydrogen carbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 46.75 g
(equivalent to 42.5 g of glucose)
These amounts of active substances are equivalent to:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 104.5 mmol/l chloride, 34 mm/
l bicarbonate and 235.9 mmol/l glucose.
The other components of bica Vera are water for injections, hydrochloric acid, sodium hydroxide,
carbon dioxide.

Description of the appearance of bica Vera and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 511 mOsm/l; the pH is approximately 7.40.
bica Vera is supplied in a dual-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other contains the acidic electrolyte solution with glucose, in a 1:1 ratio.
bica Vera is available in the following delivery systems and pack sizes:
stay•safe: sleep•safe:
4 bags containing 2,000 ml 4 bags of 2,000 ml
4 bags containing 2,500 ml 4 bags of 2,500 ml
4 bags containing 3,000 ml 4 bags containing 3,000 ml
2 bags containing 5,000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Fresenius Medical Care Italia S.p.a., Via Crema 8, 26020 Palazzo Pignano (CR) - Italy

Manufacturer:
Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel - Germany
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This medicinal product is authorised in the European Economic Area countries with the following names:
see the end of this multilingual summary of product characteristics.

Last page of the multilingual summary of product characteristics:
This medicinal product is authorised in the European Economic Area countries with the following names:
B & NL: bicaVera 4,25 % glucose, 1,75 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 4,25 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung
DK: bicaVera 4,25% glucose, 1,75 mmol/l calcium, Peritonealdialysevæske
E: bicaVera Glucosa 4,25% Calcio 1,75 mmol/l solución para diálisis peritoneal
F, B & L: bicaVera 4,25 % glucose, 1,75 mmol/l calcium, solution pour dialyse péritonéale
FIN: bicaVera 4,25 % glukoosi, 1,75 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 4.25 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis
GR & CY: bicaVera 4,25% γλυκόζη, 1,75 mmol/l ασβέστιο, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
I: bicaVera 4,25 % Glucosio, 1,75 mmol/l Calcio, Soluzione per dialisi peritoneale
IS: bicaVera 4,25% Glucose, 1,75 mmol/l Calcium, kviðskilunarlausn
N: bicaVera 4,25 % glukose, 1,75 mmol/l kalsium, peritonealdialysevæske
P: bicaVera 4,25% Glucose 1,75 mmol/l Cálcio, Solução para diálise peritoneal
S: bicaVera 4,25% Glucose, 1,75 mmol/l Calcium, peritonealdialysvätska
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