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 they have the same symptoms 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

What equiVera is and what it is used for
What you need to know before using equiVera
How to use equiVera
Possible side effects
How to store equiVera
Contents of the pack and other information

1. What equiVera is and what it is used for

equiVera 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 equiVera

Do not use equiVera 1.5% Glucose, 1.25 mmol/l Calcium if:

Your blood potassium level is very low;
Your blood calcium level is very 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,
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,
Uremic intoxication due to waste products in the blood that cannot be removed by peritoneal dialysis,
Severe malnutrition and weight loss, especially if adequate protein-rich nutrition is not possible.

Warnings and precautions
Inform your doctor immediately:

If you experience severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
If you suffer from hyperparathyroidism or have low blood calcium levels. You may need to take phosphate binders containing calcium and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a high calcium concentration should be used.
If you develop peritonitis, recognizable by cloudy dialysate, abdominal pain, fever, or general malaise, or in very rare cases, blood poisoning. Please show the bag containing the drained dialysate to your doctor.
If you have polycystic kidneys.
If you experience severe abdominal pain, abdominal distension or vomiting. These may be signs of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy that can be fatal.

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

Other medicines and equiVera
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 in the case of:

Medicines for heart failure, such as digoxin. Your doctor will periodically monitor your blood potassium levels and take appropriate corrective measures if necessary.
Medicines affecting calcium levels, such as those containing calcium or vitamin D,
Medicines increasing urinary excretion, such as diuretics,
Orally taken medicines that lower blood sugar levels, or insulin. Your blood sugar level must be monitored regularly.

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

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

3. How to use equiVera

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 discomfort occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

Adults: The usual dose is 2000–2500 ml of solution administered four times daily, depending on body weight and renal function. After a dwell time of 2 to 10 hours, the solution is drained.
Children: The 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/m (up to 1000 ml/m at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD)
For this dialysis, the equiVera 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 2000 ml (maximum 3000 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 800–1000 ml/m (up to 1400 ml/m) of body surface area, with 5–10 exchanges during the night.

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

Instructions for use
For use of the stay•safe system in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Warm the solution bag to body temperature.
This must be done using a dedicated bag warmer. The warming time for a 2000 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 localized overheating. After warming, the solution may be used for dialysis exchanges.

1. Preparation of the solution

Check the heated bag containing the solution (label, expiration date, clarity of the solution, absence of damage to the bag and outer packaging, integrity of the seal).
Place the bag on a rigid surface. Open the outer packaging of the bag and the disinfection cap package. Wash hands with an antibacterial lotion. Roll the bag, placed on the protective wrapper sheet, from one of the upper edges until the central seam opens. The solutions contained in the two compartments will automatically mix. Now roll the bag from the upper edge until the seal on the lower side of the triangle is completely opened. Check that all seals are fully open. Check that the solution is clear and that the bag shows no leaks.

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 insert the DISC into the organizer. After unrolling the line of the drainage bag, hang the drainage bag on the lowermost hook of the IV pole.
Place the catheter adapter into one of the two slots of the organizer. Place the new disinfection cap into the other free slot. Disinfect hands and remove the protective cap from the DISC.
Connect the catheter adapter to the DISC.

3. Drainage

Open the clamp on the extension line. Drainage begins. Position ●

4. Flushing

At the end of the drainage, allow fresh solution to flow into the drainage bag (approximately 5 seconds).
Position ●●

5. Infusion

Start the infusion by turning the control switch to Position ○ ◑ ●

6. Safety position

Close the catheter extension by inserting the PIN into the catheter adapter. Position

●●● Close the clamp on the catheter extension.

7. Disconnection

Remove the protective cap from the new disinfection cap and screw it onto the old one.
Unscrew the catheter from the DISC and screw the catheter adapter onto the new disinfection cap.

8. Closing the DISC:

Close the DISC using the open end of the used disinfection cap, which remains in the right hole
of the organizer.

Check the clarity and weight of the drained dialysate and proceed with disposal if it appears clear.

For use of the sleep•safe system in automated peritoneal dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically warmed inside
the machine (cycler).
sleep•safe system 3000 ml:
1. Prepare the solution: see the stay•safe system
2. Unroll the infusion line of the bag.
3. Remove the protective cap.
4. Insert the bag's connector into the free port of the sleep•safe device.
5. The bag is now ready for use with the sleep•safe set.
sleep•safe system 5000 ml:

1. Preparation of the solution:

Check the bag containing the solution (label, expiration date, clarity of the solution, integrity of the bag and outer wrapper, and ensure the seals are intact). Place the bag on a firm, flat working surface. Open the outer wrapper of the bag. Wash hands with an antiseptic hand lotion. Unroll the middle seal and the connector of the bag. Roll up the bag laid flat on the outer wrapper, starting from the diagonal end towards the bag connector. The middle seal will open. Continue rolling until the seal of the small chamber also opens. Check that all seals are completely open. Verify that the solution is clear and that there are no leaks from the bag.
2-5. see the sleep•safe 3000 ml system
Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, equiVera may be used independently at home. Ensure that all procedures learned during training are followed 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 equiVera 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 equiVera
Try to achieve the total volume of dialysate prescribed within 24 hours to avoid the risk of potentially life-threatening consequences. You must consult your doctor if you are unsure.
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Peritoneal inflammation with signs of cloudy dialysate drainage, 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, discharge 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
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 equiVera:
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 levels of fats in the blood
Increase in body weight

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

Calcium deficiency
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

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

Overactive parathyroid gland with potential disturbances in bone metabolism

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 equiVera

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, following the word "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 should 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. Pack contents and other information

What equiVera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.786 g
Sodium bicarbonate 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:
1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 103.5 mmol/l chloride, 34 mmol/l
bicarbonate and 83.25 mmol/l glucose.
The other components of equiVera are water for injections, hydrochloric acid, sodium hydroxide,
carbon dioxide.

Description of the appearance of equiVera and pack contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 357 mOsm/l; the pH is approximately 7.4.
equiVera 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.
equiVera is a peritoneal dialysis solution available in the following application systems and pack sizes:
stay•safe : sleep•safe :
4 bags containing 2000 ml 4 bags containing 3000 ml
4 bags containing 2500 ml 2 bags containing 5000 ml
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the European Economic Area Member States under the following names:
B & NL: bicaVera 1,5 % glucose, 1,25 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 1,5 % Glucose, 1,25 mmol/l Calcium Peritonealdialyselösung
CZ: bicaVera 1,5 % glucose, 1,25 mmol/l calcium roztok pro peritoneální dialýzu
DK: bicaVera 1,5 % Glucose, 1,25 mmol/l calcium, peritonealdialysevæske
E: bicaVera Glucosa 1,5%, Calcio 1,25 mmol/l solución para diálisis peritoneal
F, B & L: BICAVERA 1,5 % GLUCOSE, 1,25 mmol/L calcium, solution pour dialyse péritonéale
FIN: bicaVera 1,5 % glukoosi, 1,25 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 1.5 % Glucose, 1.25 mmol/l Calcium Solution for peritoneal dialysis
GR & CY: bicaVera 1,25 mmol/l ασβέστιο, 1,5% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης
(κάθαρσης)
I: equiVera 1,5 % Glucosio, 1,25 mmol/l Calcio Soluzione per dialisi peritoneale
IS: bicaVera 1,5% Glucose, 1,25 mmol/l Calcium Kviðskilunarlausn
LV: Bicavera 1,5 % glikoze, 1,25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
N: bicaVera 1,5 % glukose, 1,25 mmol/l kalsium peritonealdialysevæske
P: Bicavera 1,5% Glucose 1,25 mmol/l Cálcio, Solução para diálise peritoneal
PL: bicaVera z 1,5% glukozą i wapniem 1,25 mmol/l
S: bicaVera 1,5% Glucose, 1,25 mmol/l Calcium, peritonealdialysvätska

Package leaflet: information for the user

equiVera 2.3% Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution

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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What equiVera is and what it is used for
What you need to know before using equiVera
How to use equiVera
Possible side effects
How to store equiVera
Package contents and other information

1. What equiVera is and what it is used for

equiVera 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 equiVera

Do not use equiVera 2.3% Glucose, 1.25 mmol/l Calcium if:

Your blood potassium level is very low;
Your blood calcium level is very low;
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,
Non-healing exudative skin lesions,
Umbilical, inguinal or diaphragmatic hernias,
Abdominal or intestinal tumors,
Intestinal inflammations,
Intestinal obstruction,
Lung diseases, especially pneumonia,
Blood poisoning caused by bacteria (sepsis),
Very high levels of fats in the blood,
Uremic intoxication due to waste products in the blood that cannot be removed by peritoneal dialysis,
Severe malnutrition and weight loss, particularly if adequate protein-rich nutrition is not possible.

Warnings and precautions
Inform your doctor immediately:

If you experience severe loss of electrolytes (salts) due to vomiting and/or diarrhea;
If you suffer from hyperparathyroidism or have low blood calcium levels. You may need to take phosphate binders containing calcium and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a high calcium concentration should be used;
If you develop peritonitis, which may present as cloudy dialysate, abdominal pain, fever, or general malaise, or in very rare cases, blood poisoning (sepsis). Please show the bag containing the drained dialysate to your doctor;
If you have polycystic kidneys;
If you experience severe abdominal pain, abdominal distension, or vomiting. These symptoms may indicate encapsulating peritoneal sclerosis, a potentially fatal complication of peritoneal dialysis therapy.

Peritoneal dialysis may lead to 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, kidney function, body weight, and nutritional status.

Other medicines and equiVera
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 in the case of:

Medicines for heart failure, such as digoxin; your doctor will periodically monitor your blood potassium levels and take appropriate corrective measures if necessary;
Medicines affecting calcium levels, such as those containing calcium or vitamin D;
Medicines that increase 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 a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There are insufficient data on the use of equiVera in pregnant or breastfeeding women. You should use equiVera during pregnancy or breastfeeding only if your doctor considers it absolutely necessary.

Driving and using machines
equiVera does not affect or affects negligibly your ability to drive or operate machinery.

3. How to use equiVera

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 discomfort occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

Adults: The usual dose is 2000 - 2500 ml of solution administered 4 times daily, depending on body weight and renal function. After a dwell time of 2 to 10 hours, the solution is drained.
Children: The doctor will determine the required dialysis solution volume based on tolerance, age, and body surface area. The recommended initial dose is 600–800 ml/m (up to 1000 ml/m at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD)
For this dialysis, the equiVera 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 2000 ml (maximum 3000 ml) per exchange, with 3–10 exchanges during the night and connection time to the device of 8–10 hours, and one or two daytime exchanges.
Children: The volume per exchange should be 800–1000 ml/m (up to 1400 ml/m) of body surface area, with 5–10 exchanges during the night.

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

Instructions for use
For use of the stay•safe system in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Warm the solution bag to body temperature.
This should be done using a dedicated bag warmer. The warming time for a 2000 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.
Microwave ovens must not be used to warm the bags due to the risk of localized overheating. After warming, the solution can be used for dialysis exchanges.

1. Preparation of the solution

Check the heated bag containing the solution (label, expiration date, clarity of the
solution, absence of damage to the bag and outer packaging, integrity of the weld).
Place the bag on a hard surface. Open the outer packaging of the bag and the disinfection cap package.
Wash hands with an antibacterial lotion. Roll the bag, resting it on the protective packaging sheet, from one of the upper edges until the central seam opens. The solutions contained in the two compartments will automatically mix. Now roll the bag from the upper edge until the weld on the lower side of the triangle is completely opened. Check whether all welds are fully opened. Check whether the solution is clear and the bag is free of leaks.

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 insert the DISC into the organizer. After unrolling the line from the drainage bag, hang the drainage bag on the lowermost hook of the IV pole.
Place the catheter adapter into one of the two slots in the organizer. Place the new disinfection cap into the other empty slot. Disinfect your hands and remove the protective cap from the DISC.
Connect the cath setter adapter to the DISC.

3. Drainage

Open the clamp on the extension line. Drainage begins. Position ●

4. Washing

At the end of the drainage, allow the fresh solution to flow into the drainage bag (approximately 5 seconds). Position

●

5. Infusion

Start the infusion by turning the control switch to Position ○ ◑ ●

6. Safety position

Close the catheter extension set by inserting the PIN into the catheter adapter. Position

●●● Close the clamp on the catheter extension set.

7. Disconnection

Remove the protective cap from the new disinfection cap and screw it onto the old one.
Unscrew the catheter from the DISC and screw the catheter adapter onto the new disinfection cap.

8. Closing the DISC:

Close the DISC using the open end of the used disinfection cap, left in the right hole of the organizer.
9 . Check the clarity and weight of the drained dialysate and proceed with disposal if it appears clear.

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

sleep•safe system 3000 ml:
6. Preparation of the solution: see stay•safe system
7. Unroll the infusion line of the bag.
8. Remove the protective cap.
9. Insert the bag connector into the free port of the sleep•safe device.
10. The bag is now ready for use with the sleep•safe set.

sleep•safe system 5000 ml:

1. Preparation of the solution:

Check the bag containing the solution (label, expiration date, clarity of the solution, integrity of the bag and outer pouch, and ensure that all seals are intact). Place the bag on a firm, flat working surface. Open the outer pouch of the bag. Wash hands with an antiseptic hand gel. Unroll the middle seal and the connector of the bag. Roll the bag, laid out on the outer pouch, from the diagonal end toward the bag connector. The middle seal will open. Continue rolling until the seal of the small chamber also opens. Check that all seals are fully open. Verify that the solution is clear and that there are no leaks from the bag.
2-5. see the sleep•safe 3000 ml system
Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, equiVera may be used independently at home. Ensure that all procedures learned during training are followed and maintain adequate hygiene when performing dialysis exchanges.
Always check the clarity of the drained dialysate. See section 2. "Warnings and precautions".
If you use more equiVera 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 equiVera
Try to achieve the total volume of dialysate prescribed within 24 hours, to avoid potentially life-threatening consequences. Consult your doctor if you are unsure.
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Inflammation of the peritoneum with signs of cloudy dialysate fluid, abdominal pain, fever, feeling unwell, or, in very rare cases, blood poisoning. Please show the drainage bag to your doctor.
Inflammation of the skin 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
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 equiVera:
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 levels of fats in the blood
Increase in body weight
Uncommon (may affect up to 1 in 100 people):
Calcium deficiency
Too low levels of body fluids, which may be indicated by rapid weight loss
Low blood pressure
Rapid heartbeat
Too high levels of body fluids, which may be indicated by rapid weight gain
Fluid retention in tissues and lungs
High blood pressure
Breathing difficulties
Not known (frequency cannot be estimated from the available data):
Overactive parathyroid gland with potential disturbances in bone metabolism

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 equiVera

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 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 equiVera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.786 g
Sodium bicarbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 25.0 g
(equivalent to 22.73 g of glucose)
These amounts of active substances are equivalent to:
1.25 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mmol/l of magnesium, 103.5 mmol/l of chloride, 34 mmol/l of
bicarbonate and 126.1 mmol/l of glucose.
The other components of equiVera are water for injections, hydrochloric acid, sodium hydroxide,
carbon dioxide.

Description of the appearance of equiVera and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 399 mOsm/l; the pH is approximately 7.4.
equiVera is available 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.
equiVera is a solution for peritoneal dialysis and is available in the following administration systems and pack sizes:
stay•safe : sleep•safe :
4 bags containing 2000 ml 4 bags containing 3000 ml
4 bags containing 2500 ml 2 bags containing 5000 ml
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the European Economic Area member states under the following names:
B & NL: bicaVera 2.3 % glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 2.3 % Glucose, 1.25 mmol/l Calcium Peritonealdialyselösung
CZ: bicaVera 2.3 % glucose, 1.25 mmol/l calcium roztok pro peritoneální dialýzu
DK: bicaVera 2.3 % Glucose, 1.25 mmol/l calcium, peritonealdialysevæske
E: bicaVera Glucosa 2.3%, Calcio 1.25 mmol/l solución para diálisis peritoneal
F, B & L: BICAVERA 2.3 % GLUCOSE, 1.25 mmol/L calcium, solution pour dialyse péritonéale
FIN: bicaVera 2.3 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 2.3 % Glucose, 1.25 mmol/l Calcium Solution for peritoneal dialysis
GR & CY: bicaVera 1.25 mmol/l ασβέστιο, 2.3% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης
(κάθαρσης)
I: equiVera 2.3 % Glucosio, 1.25 mmol/l Calcio Soluzione per dialisi peritoneale
IS: bicaVera 2.3% Glucose, 1.25 mmol/l Calcium Kviðskilunarlausn
LV: Bicavera 2.3 % glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
N: bicaVera 2.3 % glukose, 1.25 mmol/l kalsium peritonealdialysevæske
P: Bicavera 2.3% Glucose 1.25 mmol/l Cálcio, Solução para diálise peritoneal
PL: bicaVera z 2.3% glukozą i wapniem 1.25 mmol/l
S: bicaVera 2.3% Glucose, 1.25 mmol/l Calcium, peritonealdialysvätska

Package leaflet: information for the user

equiVera 4.25% Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution

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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What equiVera is and what it is used for
What you need to know before using equiVera
How to use equiVera
Possible side effects
How to store equiVera
Contents of the pack and other information

1. What equiVera is and what it is used for

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

2. What you should know before using equiVera

Do not use equiVera 4.25% Glucose, 1.25 mmol/l Calcium if:

Your blood potassium level is very low;
Your blood calcium level is very low;
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,
Non-healing exudative lesions,
Umbilical, inguinal or diaphragmatic hernias,
Abdominal or intestinal tumors,
Intestinal inflammations,
Intestinal obstruction,
Lung diseases, especially pneumonia,
Blood poisoning caused by bacteria,
Very high levels of fats in the blood,
Blood intoxication due to waste products of urine that cannot be removed by peritoneal dialysis,
Severe malnutrition and weight loss, particularly if an adequate diet containing sufficient protein cannot be maintained.

Warnings and precautions
Inform your doctor immediately:

If you experience severe loss of electrolytes (salts) due to vomiting and/or diarrhea;
If you suffer from hyperparathyroidism or have low blood calcium levels. You may need to take phosphate binders containing calcium and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a high calcium concentration should be used;
If you develop peritonitis, which may present with cloudy dialysate, abdominal pain, fever, or feeling unwell, or in very rare cases, blood poisoning. Please show the bag containing the drained dialysate to your doctor;
If you have polycystic kidneys;
If you experience severe abdominal pain, abdominal distension, or vomiting. These may be signs of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy that can be fatal.

Peritoneal dialysis may lead to 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, kidney function, body weight, and nutritional status.

Other medicines and equiVera
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 in the case of:

Medicines for heart failure, such as digoxin; your doctor will periodically check your blood potassium levels and take appropriate corrective measures if necessary;
Medicines affecting calcium levels, such as those containing calcium or vitamin D;
Medicines that increase 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 might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
There are insufficient data on the use of equiVera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should use equiVera only if your doctor considers it absolutely necessary.

Driving and using machines:
equiVera does not affect or has negligible effect on your ability to drive or operate machinery.

3. How to use equiVera

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, required volumes of solution, and dwell times of the fluid in the peritoneal cavity.
If abdominal discomfort occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

Adults: The usual dose is 2000–2500 ml of solution administered four times daily, depending on body weight and renal function. After a dwell time of 2 to 10 hours, the solution is drained.
Children: The 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 1000 ml/m² at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD)
For this dialysis, the equiVera 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 2000 ml (maximum 3000 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 800–1000 ml/m² (up to 1400 ml/m²) of body surface area, with 5–10 exchanges during the night.

Infuse equiVera only into the peritoneal cavity.
Use equiVera only if the solution is clear and the bag is undamaged.
The equiVera solution is supplied in a double-chamber bag. The solutions from the two chambers must be mixed as described prior to use.

Instructions for use
For using the stay•safe system in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Warm the solution bag to body temperature.
This should be done using a dedicated bag warmer. The warming time for a 2000 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 localized overheating. After warming, the solution may be used for dialysis exchanges.

1. Preparation of the solution

Check the heated bag containing the solution (label, expiration date, clarity of the solution, absence of damage to the bag and the outer wrapper, integrity of the seals).
Place the bag on a firm surface. Open the outer wrapper of the bag and the disinfection cap package. Wash hands with an antiseptic lotion.
Roll the bag, placed on the protective wrapper sheet, from one of the upper edges until the central seam opens. The solutions contained in the two compartments will automatically mix.
Now roll the bag from the upper edge until the seal on the lower side of the triangle is completely opened. Check that all seals are fully open. Check that the solution is clear and that the bag shows no signs of leakage.

2. Preparing the 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 insert the DISC into the organizer. After unrolling the line of the drainage bag, hang the drainage bag on the lowest hook of the IV pole.
Place the catheter adapter into one of the two inserts of the organizer. Place the new disinfection cap into the other empty insert. Disinfect hands and remove the protective cap from the DISC.
Connect the catheter adapter to the DISC.

3. Drainage

Open the clamp on the extension line. Drainage begins. Position ●

4. Washing

At the end of the drainage, allow the fresh solution to flow into the drainage bag (approximately 5 seconds). Position

●

5. Infusion

Start the infusion by turning the control switch towards Position ○ ◑ ●

6. Safety position

Close the catheter extension line by inserting the PIN into the catheter adapter. Position

●●● Close the clamp on the catheter extension line.

7. Disconnection

Remove the protective cap from the new disinfection cap and screw it onto the old one.
Unscrew the catheter from the DISC and screw the catheter adapter onto the new disinfection cap.

8. Closing the DISC:

Close the DISC using the open end of the used disinfection cap, which remains in the right hole
of the organizer.
9. Check the clarity and weight of the drained dialysate and proceed with disposal if it appears
clear.

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

sleep•safe system 3000 ml:
11. Prepare the solution: see stay•safe system
12. Unroll the infusion line of the bag.
13. Remove the protective cap.
14. Insert the bag connector into the free port of the sleep•safe device.

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

sleep•safe system 5000 ml:

1. Preparation of the solution:

Check the bag containing the solution (label, expiration date, clarity of the solution, integrity of the bag and outer pouch, and ensure the seals are intact). Place the bag on a firm, flat work surface. Open the outer pouch of the bag. Wash hands with an antiseptic hand lotion. Unroll the middle seal and the connector of the bag. Roll up the bag laid flat on the outer pouch, starting from the opposite corner towards the bag connector. The middle seal will open. Continue until the seal of the small chamber also opens. Check that all seals are fully open. Verify that the solution is clear and that there are no leaks from the bag.
2-5. see the sleep•safe 3000 ml system
Each bag must be used only once, and any unused solution remaining must be discarded.
After appropriate patient training, equiVera may be used independently at home. Make sure to follow all procedures learned during training and maintain adequate hygiene when performing dialysis exchanges.
Always check the clarity of the drained dialysate. See section 2. “Warnings and precautions”.
If you use more equiVera than you should
If an excess of solution is infused into the peritoneal cavity, it can 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 equiVera
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, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, equiVera 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 (sepsis). 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, discharge, 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
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 equiVera:

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
Increase in body weight

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

Calcium deficiency
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

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

Overactive parathyroid glands with potential disturbances in bone metabolism

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 equiVera

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 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 equiVera contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.786 g
Sodium bicarbonate 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:
1.25 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mm combustible/l of magnesium, 103.5 mmol/l of chloride, 34 mmol/l of bicarbonate and 235.9 mmol/l of glucose.
The other components of equiVera are water for injections, hydrochloric acid, sodium hydroxide, carbon dioxide.

Description of the appearance of equiVera and package contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 509 mOsm/l; the pH is approximately 7.4.
equiVera is available 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.
equiVera is a solution for peritoneal dialysis and is available in the following administration systems and pack sizes:
stay•safe : sleep•safe :
4 bags containing 2000 ml 4 bags containing 3000 ml
4 bags containing 2500 ml 2 bags containing 5000 ml
Not all pack sizes may be marketed.

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

This medicinal product is authorized in the European Economic Area countries under the following names:
B & NL: bicaVera 4.25 % glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
D, A & B: bicaVera 4.25 % Glucose, 1.25 mmol/l Calcium Peritonealdialyselösung
CZ: bicaVera 4.25 % glucose, 1.25 mmol/l calcium roztok pro peritoneální dialýzu
DK: bicaVera 4.25 % Glucose, 1.25 mmol/l calcium, peritonealdialysevæske
E: bicaVera Glucosa 4.25%, Calcio 1.25 mmol/l solución para diálisis peritoneal
F, B & L: BICAVERA 4.25 % GLUCOSE, 1.25 mmol/L calcium, solution pour dialyse péritonéale
FIN: bicaVera 4.25 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
GB: bicaVera 4.25 % Glucose, 1.25 mmol/l Calcium Solution for peritoneal dialysis
GR & CY: bicaVera 1.25 mmol/l ασβέστιο, 4.25% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
I: equiVera 4.25 % Glucosio, 1.25 mmol/l Calcio Soluzione per dialisi peritoneale
IS: bicaVera 4.25% Glucose, 1.25 mmol/l Calcium Kviðskilunarlausn
LV: Bicavera 4.25 % glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
N: bicaVera 4.25 % glukose, 1.25 mmol/l kalsium peritonealdialysevæske
P: Bicavera 4.25% Glucose 1.25 mmol/l Cálcio, Solução para diálise peritoneal
PL: bicaVera z 4,25% glukozą i wapniem 1,25 mmol/l
S: bicaVera 4.25% Glucose, 1.25 mmol/l Calcium, peritonealdialysvätska