EQUIVERA 1.5% ГЛЮКОЗА, 1.25 ММОЛ/Л КАЛЬЦИЙ Перитонеальный диализный раствор

Содержание инструкции

1. equiVera 1.5 % Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution
   1. What is equiVera and what is it used for
   2. What you need to know before using equiVera
   3. How to use equiVera
   4. Solution Preparation
   5. Preparation for bag exchange
   6. Drainage
   7. Flushing
   8. Infusion
   9. Safety Position
   10. Disconnection
   11. DISC Closure:
   12. Solution Preparation:
   13. Possible side effects
   14. How to store equiVera
   15. Package contents and other information
2. equiVera 2.3 % Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution
   1. What is equiVera and what is it used for
   2. What you need to know before using equiVera
   3. How to use equiVera
   4. Solution Preparation
   5. Preparation for bag exchange
   6. Drainage
   7. Flushing
   8. Infusion
   9. Safety Position
   10. Disconnection
   11. DISC Closure:
   12. Solution Preparation:
   13. Possible side effects
   14. How to store equiVera
   15. Package contents and other information
3. equiVera 4.25 % Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution
   1. What is equiVera and what is it used for?
   2. What you need to know before using equiVera
   3. How to use equiVera
   4. Solution Preparation
   5. Preparation for bag exchange
   6. Drainage
   7. Flushing
   8. Infusion
   9. Safety Position
   10. Disconnection
   11. DISC Closure:
   12. Solution Preparation:
   13. Possible side effects
   14. How to store equiVera
   15. Contents of the pack and other information

equiVera 1.5 % Glucose, 1.25 mmol/l Calcium, Peritoneal Dialysis Solution

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is equiVera and what is it used for

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

2. What you need to know before using equiVera

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

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

Peritoneal dialysis should not be started if you have:

• suffered from disorders at the abdominal level, such as:
• Wounds or surgery,
• Severe burns,
• Extensive skin inflammatory reactions,
• Inflammation of the peritoneum,
• Non-healing exudative lesions,
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors of the abdomen or intestine
• Intestinal inflammation,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning caused by bacteria,
• Very high levels of fats in the blood,
• Poisoning due to products of the urine in the blood that cannot be eliminated with peritoneal dialysis,
• Severe malnutrition and weight loss, especially if an adequate diet containing proteins is not possible.

Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts)due to vomiting and/or diarrhea,
• If you suffer from hyperparathyroidismor 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.
• In case of peritoneal inflammation, recognizable by a 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.
• If you have polycystic kidneys.
• 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 can be fatal.

Peritoneal dialysis can induce loss of proteinsand water-soluble vitamins.
An adequate diet or the use of food supplements is recommended, in order to avoid deficient nutritional
states.
Your doctor will monitor your electrolyte balance (salts), the total number of blood cells, the
renal function, body weight and nutritional status.

Other medicines and equiVera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Because peritoneal dialysis can affect the effects of some medicines, your doctor may need to
change their dosage, especially in the case of:

• medicines to treat heart failure, such as digoxin, your doctor will periodically check your blood potassium level and, if necessary, take appropriate corrective measures,
• medicines that affect calcium levels, such as those containing calcium or vitamin D,
• medicines that increase urinary excretionsuch as diuretics,
• medicinestaken orally that lower blood sugar levels,or insulin. Your blood sugar level should be measured regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
There are no adequate data regarding the use of equiVera in pregnant women or during the breastfeeding
period. 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 alter or alters negligibly your ability to drive vehicles or use machines.

3. How to use equiVera

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will establish the method, duration, frequency of use, the required solution volumes, and the dwell time of the fluid in the peritoneal cavity.
If abdominal tension 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 4 times a day depending on body weight and renal function. After a dwell time between 2 and 10 hours, the solution is drained.
• Children: the doctor will determine the required dialytic solution volume based on tolerance, age, and the child's body surface area. The recommended initial dose is 600-800 ml/m (up to 1000 ml/m at night) of body surface area four times a day.

Automated Peritoneal Dialysis (APD)
For this dialysis, the equiVera sleep•safesystem is used. The dialytic solution exchanges are
controlled automatically by the sleep•safedevice during the night.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a connection time to the device of 8-10 h, and during the day one or two exchanges.
• Children: The volume for each 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 available 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 for continuous ambulatory peritoneal dialysis (CAPD)
Warm the solution bag to body temperature.
This must be done using a special bag warmer. The heating time for a 2000 ml bag
with a starting temperature of 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 heat the bags, due to the risk of localized overheating.
After heating, the solution can be used for dialytic exchanges.

1. Solution Preparation

 Check the heated bag containing the solution (label, expiry 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 packaging.  Wash your hands with an antibacterial lotion.  Roll the bag, resting it on the protective packaging sheet, from one of the top edges until the median joint is opened. The solutions contained in the two compartments will mix automatically.  Now roll the bag from the top edge, until the seal on the lower side of the triangle is fully opened.  Check that all the seals are fully open.  Check that the solution is clear and that the bag has no leaks.

2. Preparation for bag exchange

 Hang the bag containing the solution in the highest hole of the bag holder pole, unroll the infusion line of the bag containing the solution and insert the DISC into the organizer. After unrolling the line of the drainage bag, hang the drainage bag in the lowest hole of the bag holder pole. 
Position the catheter adapter in one of the two inserts of the organizer.  Position the new disinfection cap in the other free insert.  Disinfect your hands and remove the protective cap of the DISC.
 Connect the catheter adapter to the DISC.

3. Drainage

 Open the clampon 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 rotating the control switch towards the  Position ○ ◑ ●

6. Safety Position

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

• ●●●  Close the clampin 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. DISC Closure:

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

• 9. Checkthe transparency and weight of the drained dialysateandproceed with disposalif it appears clear.

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

sleep•safe 3000 ml system:

1. Solution preparation: see the stay•safe system

2. Unroll the infusion line of the bag.

3. Remove the protective cap.

4. Insert the bag connector into the free port of the sleep•safe equipment.

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

sleep•safe 5000 ml system:

1. Solution Preparation:

 Check the bag containing the solution (label, expiry date, that the solution is clear, that the bag and outer packaging are undamaged, that the joints are intact).  Place the bag on a rigid work surface.  Open the outer packaging of the bag.  Wash your hands with an antibacterial lotion.  Unroll the median joint and the bag connector.  Roll the flattened bag onto the outer packaging, from the diagonal end towards the bag connector. The median joint will open.  Continue until the opening joint of the small chamber also opens.  Verify that all joints are completely open.  Check 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 remaining unused solution must be discarded.
After appropriate patient training, equiVera can be used independently at home.
Ensure that you have followed all the procedures learned during training and maintain adequate hygienic conditions when performing dialysis exchanges.
Always check the opacity of the drained dialysate. See paragraph 2. “Warnings and precautions”.

If you use more equiVera than you should
If an excess of solution is infused into the peritoneal cavity, this 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 equiVera
Try to achieve the total volume of dialysate prescribed in 24 hours, to avoid the risk of potentially life-threatening consequences. You should check with your doctor if you are unsure.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, equiVera can cause side effects, although not everybody gets them.
The following side effects may occur following peritoneal dialysis treatment in general:

very common(may affect more than 1 in 10 people):

• inflammation of the peritoneum with signs of opacity of the drained dialysate, 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 of the skin, swelling, pain, oozing or scabs.
• Hernia of the abdominal wall. If you notice these side effects, inform your doctor immediately.

Other side effects due to the treatment are:

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

• problems with the infusion or drainage of the dialysate
• feeling of stretching or fullness of the abdomen
• shoulder pain

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

• diarrhea
• constipation

not known(frequency cannot be estimated based on available data):

• difficulty breathing due to lifting of the diaphragm
• encapsulating peritoneal sclerosis, possible symptoms may 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
• weight gain

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

• calcium deficiency
• levels of body fluids that are too low, which can be deduced from rapid weight loss
• low blood pressure
• fast heartbeat
• levels of body fluids that are too high, which can be deduced from rapid weight gain
• fluid retention in tissues and lungs
• high blood pressure
• difficulty breathing

not known(frequency cannot be estimated based on available data):

• hyperactive parathyroid with potential disorders of bone metabolism

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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 the carton after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature 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 and the bag is damaged.

6. Package contents and other information

What equiVera contains
The active ingredients in 1 litre of ready-to-use solution are:

Calcium chloride dihydrate0.1838 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 ingredients 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 83.25 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 357 mOsm/l, the pH is approximately 7.4.
equiVera is available in a double-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other the acidic glucose electrolytic solution in a 1:1 ratio.
equiVera is a peritoneal dialysis solution and is available in the following application systems and in the
following packs:

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 Member States of the European Economic Area with the following
names:
B & NL: bicaVera 1.5 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
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

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

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is equiVera and what is it 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 need to know before using equiVera

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

• If your potassium level in the blood is very low;
• If your calcium level in the blood is very low.
• If the volume of your body fluids is too low;
• If your blood pressure is low.

Peritoneal dialysis should not be started if you have:

• suffered from disorders at the abdominal level, such as:
• Wounds or surgery,
• Severe burns,
• Extensive skin inflammatory reactions,
• Inflammation of the peritoneum,
• Non-healing exudative lesions,
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestine
• Intestinal inflammation,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning caused by bacteria,
• Very high levels of fats in the blood,
• Poisoning due to products of urine in the blood that cannot be eliminated with peritoneal dialysis,
• Severe malnutrition and weight loss, especially if an adequate diet containing proteins is not possible.

Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts)due to vomiting and/or diarrhea,
• If you suffer from hyperparathyroidismor have low levels of calcium in the blood. 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.
• In case of inflammation of the peritoneum, recognizable by a cloudy dialysate, abdominal pain, fever, feeling unwell, or in very rare cases of blood poisoning. Please show the bag containing the drained dialysate to your doctor.
• If you have polycystic kidneys.
• 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 can be fatal.

Peritoneal dialysis can induce a loss of proteinsand water-soluble vitamins.
An adequate diet or the use of food supplements is recommended, in order to avoid nutritional deficiencies.
Your doctor will monitor your electrolyte balance (salts), the total number of blood cells, renal function, body weight and nutritional status.

Other medicines and equiVera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Since peritoneal dialysis can affect the effects of some medicines, your doctor may need to change their dosage, especially in the case of:

• medicines to treat heart failure, such as digoxin, your doctor will periodically check your blood potassium level and, if necessary, take appropriate corrective measures,
• medicines that affect calcium levels, such as those containing calcium or vitamin D,
• medicines that increase urinary excretionsuch as diuretics,
• medicinestaken orally that lower blood sugar levels,or insulin. Your blood sugar level should be measured regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
There are no adequate data regarding the use of equiVera in pregnant women or during breastfeeding. 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 alter or alters negligibly your ability to drive vehicles or use machines.

3. How to use equiVera

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will establish the method, duration, frequency of use, the required solution volumes, and the dwell time of the fluid in the peritoneal cavity.
If abdominal tension 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 4 times a day depending on body weight and renal function. After a dwell time of between 2 and 10 hours, the solution is drained.
• Children: the doctor will determine the required dialytic solution volume based on tolerance, age, and the child's body surface area. The recommended initial dose is 600-800 ml/m (up to 1000 ml/m at night) of body surface area four times a day.

Automated Peritoneal Dialysis (APD)
For this dialysis, the equiVera sleep•safesystem is used. The dialytic solution exchanges are
controlled automatically by the sleep•safedevice during the night.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a connection time to the device of 8-10 h, and during the day one or two exchanges.
• Children: The volume for each 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 available 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 for continuous ambulatory peritoneal dialysis (CAPD)
Warm the solution bag to body temperature.
This must be done using a special bag warmer. The heating time for a 2000 ml bag
with a starting temperature of 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 heat the bags, due to the risk of localized overheating.
After heating, the solution can be used for dialytic exchanges.

1. Solution Preparation

 Check the heated bag containing the solution (label, expiry 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 packaging of the disinfection cap.  Wash your hands with an antibacterial lotion.  Roll the bag, resting it on the protective packaging sheet, from one of the top edges until the median junction is opened. The solutions contained in the two compartments will automatically mix.  Now roll the bag from the top edge, until the seal on the lower side of the triangle is fully opened.  Check that all the seals are completely open.  Check that the solution is clear and that the bag does not have any leaks.

2. Preparation for bag exchange

 Hang the bag containing the solution in the highest hole of the bag holder pole, unroll the infusion line of the bag containing the solution and insert the DISC into the organizer. After unrolling the line of the drainage bag, hang the drainage bag in the lowest hole of the bag holder pole. 
Position the catheter adapter in one of the two inserts of the organizer.  Position the new disinfection cap in the other free insert.  Disinfect your hands and remove the protective cap of the DISC.
 Connect the catheter adapter to the DISC.

3. Drainage

 Open the clampon 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 rotating the control switch towards the  Position ○ ◑ ●

6. Safety Position

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

• ●●●  Close the clampin 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. DISC Closure:

 Close the DISC with the open end of the used disinfection cap, remaining in the right hole
of the organizer.
9 Checkthe transparency and weight of the drained dialysateandproceed with disposalif it appears
clear.

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

sleep•safe 3000 ml system:

6. Solution preparation: see the 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 5000 ml system:

1. Solution Preparation:

 Check the bag containing the solution (label, expiry date, that the solution is clear, that the bag and outer packaging are undamaged, that the connections are intact).  Place the bag on a rigid work surface.  Open the outer packaging of the bag.  Wash your hands with an antibacterial lotion.  Unroll the median connection and the bag connector.  Roll the flattened bag on the outer packaging, from the diagonal end towards the bag connector. The median connection will open.  Continue until the opening connection of the small chamber is also opened.  Verify that all connections are completely open.  Check 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 remaining unused solution must be discarded.
After appropriate patient training, equiVera can be used independently at home.
Ensure that you have followed all the procedures learned during training and maintain adequate hygienic conditions when performing dialysis exchanges.
Always check the opacity of the drained dialysate. See paragraph 2. “Warnings and precautions”.

If you use more equiVera than you should
If an excess of solution is infused into the peritoneal cavity, this 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 equiVera
Try to achieve the total volume of dialysate prescribed in 24 hours, to avoid the risk of potentially life-threatening consequences. You should check with your doctor if you are unsure.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, equiVera can cause side effects, although not everybody gets them.
The following side effects may occur following peritoneal dialysis treatment in general:

very common(may affect more than 1 in 10 people):

• inflammation of the peritoneum with signs of opacity of the drained dialysate, 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 of the skin, swelling, pain, oozing or scabs.
• Hernia of the abdominal wall. If you notice these side effects, inform your doctor immediately.

Other side effects due to the treatment are:

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

• problems with the infusion or drainage of the dialysate
• feeling of stretching or fullness of the abdomen
• shoulder pain uncommon(may affect up to 1 in 100 people):
• diarrhea
• constipation not known(frequency cannot be estimated based on available data):
• difficulty breathing due to lifting of the diaphragm
• encapsulating peritoneal sclerosis, possible symptoms may 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
• weight gain uncommon(may affect up to 1 in 100 people):
• calcium deficiency
• levels of body fluids too low, which can be deduced from rapid weight loss
• low blood pressure
• fast heartbeat
• levels of body fluids too high, which can be deduced from rapid weight gain
• fluid retention in tissues and lungs
• high blood pressure
• difficulty breathing not known(frequency cannot be estimated based on available data):
• overactive parathyroid with potential bone metabolism disorders

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and the carton after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature 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 and the bag is damaged.

6. Package contents and other information

What equiVera contains
The active ingredients in 1 liter of ready-to-use solution are:

Calcium chloride dihydrate0.1838 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 ingredients 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 colorless.
The theoretical osmolarity of the ready-to-use solution is 399 mOsm/l, the pH is approximately 7.4.
equiVera is available in a double-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other the acidic glucose electrolytic solution in a 1:1 ratio.
equiVera is a peritoneal dialysis solution and is available in the following application systems and in the
following packs:

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 authorised in the Member States of the European Economic Area with the following
names:
B & NL: bicaVera 2.3 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
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

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

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is equiVera and what is it 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 need to know before using equiVera

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

• If your potassium level in the blood is very low;
• If your calcium level in the blood is very low.
• If the volume of your body fluids is too low;
• If your blood pressure is low.

Peritoneal dialysis should not be started if you have:

• suffered from abdominal disorders, such as:
• Wounds or surgery,
• Severe burns,
• Extensive skin inflammatory reactions,
• Inflammation of the peritoneum,
• Non-healing exudative lesions,
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestine
• Intestinal inflammation,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Blood poisoning caused by bacteria,
• Very high levels of fats in the blood,
• Poisoning due to urine products in the blood that cannot be eliminated with peritoneal dialysis,
• Severe malnutrition and weight loss, especially if an adequate diet containing protein is not possible.

Warnings and precautions
Tell your doctor immediately:

• In case of severe loss of electrolytes (salts)due to vomiting and/or diarrhea,
• If you suffer from hyperparathyroidismor have low calcium levels in the blood. 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.
• In case of peritoneal inflammation, recognizable by a cloudy dialysate, abdominal pain, fever, feeling unwell, or in very rare cases of blood poisoning. Please show the bag containing the drained dialysate to your doctor.
• If you have polycystic kidneys.
• 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 can be fatal.

Peritoneal dialysis can induce loss of proteinsand water-soluble vitamins.
An adequate diet or the use of food supplements is recommended, in order to avoid deficient nutritional states.
Your doctor will monitor your electrolyte balance (salts), the total number of blood cells, the
renal function, body weight and nutritional status.

Other medicines and equiVera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Since peritoneal dialysis can affect the effects of some medicines, your doctor may need to
change their dosage, especially in the case of:

• medicines to treat heart failure, such as digoxin, your doctor will periodically check your blood potassium level and, if necessary, take appropriate corrective measures,
• medicines that affect calcium levels, such as those containing calcium or vitamin D,
• medicines that increase urinary excretionsuch as diuretics,
• medicinestaken orally that lower blood sugar levels,or insulin. Your blood sugar level should be measured regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
There are no adequate data regarding the use of equiVera in pregnant women or during breastfeeding. 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 alter or alters negligibly your ability to drive vehicles or use machines.

3. How to use equiVera

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will establish the method, duration, frequency of use, the required solution volumes, and the dwell time of the fluid in the peritoneal cavity.
If abdominal tension 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 4 times a day depending on body weight and renal function. After a dwell time between 2 and 10 hours, the solution is drained.
• Children: the doctor will determine the required dialytic solution volume based on tolerance, age, and the child's body surface area. The recommended initial dose is 600-800 ml/m (up to 1000 ml/m at night) of body surface area four times a day.

Automated Peritoneal Dialysis (APD)
The equiVera sleep•safesystem is used for this dialysis. The dialytic solution exchanges are
automatically controlled by the sleep•safedevice during the night.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a connection time to the device of 8-10 h, and during the day one or two 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 available 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 for continuous ambulatory peritoneal dialysis (CAPD)
Warm the solution bag to body temperature.
This must be done using a special bag warmer. The warming time for a 2000 ml bag
with a starting temperature of 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 dialytic exchanges.

1. Solution Preparation

 Check the heated bag containing the solution (label, expiry 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 packaging of the disinfection cap.  Wash your hands with an antibacterial lotion.  Roll the bag, resting it on the protective packaging sheet, from one of the top edges until the median junction is opened. The solutions contained in the two compartments will mix automatically.  Now roll the bag from the top edge, until the seal on the lower side of the triangle is fully opened.  Check that all the seals are fully open.  Check that the solution is clear and that the bag does not have any leaks.

2. Preparation for bag exchange

 Hang the bag containing the solution in the highest hole of the bag holder pole, unroll the infusion line of the bag containing the solution and insert the DISC into the organizer. After unrolling the line of the drainage bag, hang the drainage bag in the lowest hole of the bag holder pole. 
Position the catheter adapter in one of the two inserts of the organizer.  Position the new disinfection cap in the other free insert.  Disinfect your hands and remove the protective cap of the DISC.
 Connect the catheter adapter to the DISC.

3. Drainage

 Open the clampon 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 rotating the control switch to the  Position ○ ◑ ●

6. Safety Position

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

• ●●●  Close the clampin 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. DISC Closure:

 Close the DISC with the open end of the used disinfection cap, remaining in the right hole
of the organizer.
9 Checkthe transparency and weight of the drained dialysateandproceed to disposalif it appears
clear.

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

sleep•safe 3000 ml system:

11.Solution preparation: see the 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 equipment.

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

sleep•safe 5000 ml system:

1. Solution Preparation:

 Check the bag containing the solution (label, expiry date, that the solution is clear, that the bag and outer packaging are undamaged, that the connections are intact).  Place the bag on a rigid work surface.  Open the outer packaging of the bag.  Wash your hands with an antibacterial lotion.  Unroll the median connection and the bag connector.  Roll the flattened bag on the outer packaging, from the diagonal end towards the bag connector. The median connection will open.  Continue until the opening connection of the small chamber also opens.  Verify that all connections 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 remaining unused solution must be discarded.
After appropriate patient training, equiVera can be used independently at home.
Make sure you have followed all the procedures learned during training and maintain adequate hygienic conditions when performing dialytic exchanges.
Always check the opacity of the drained dialysate. See paragraph 2. “Warnings and precautions”.

If you use more equiVera than you should
If an excess of solution is infused into the peritoneal cavity, this 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 equiVera
Try to achieve the total volume of dialysate prescribed in 24 hours, to avoid the risk of potentially life-threatening consequences. You should check with your doctor if you are unsure.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, equiVera can cause side effects, although not everybody gets them.
The following side effects may occur following peritoneal dialysis treatment in general:

very common(may affect more than 1 in 10 people):

• inflammation of the peritoneum with signs of opacity of the drained dialysate, 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 of the skin, swelling, pain, oozing or scabs.
• Hernia of the abdominal wall. If you notice these side effects, inform your doctor immediately.

Other side effects due to the treatment are:

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

• problems with the infusion or drainage of the dialysate
• feeling of stretching or fullness of the abdomen
• shoulder pain uncommon(may affect up to 1 in 100 people):
• diarrhea
• constipation not known(frequency cannot be estimated based on available data):
• difficulty breathing due to lifting of the diaphragm
• encapsulating peritoneal sclerosis, possible symptoms may 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
• weight gain uncommon(may affect up to 1 in 100 people):
• calcium deficiency
• levels of body fluids too low, which can be deduced from rapid weight loss
• low blood pressure
• fast heartbeat
• levels of body fluids too high, which can be deduced from rapid weight gain
• fluid retention in tissues and lungs
• high blood pressure
• difficulty breathing not known(frequency cannot be estimated based on available data):
• overactive parathyroid with potential bone metabolism disorders

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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 the carton after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature 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 and the bag is damaged.

6. Contents of the pack and other information

What equiVera contains
The active ingredients in 1 litre of ready-to-use solution are:

Calcium chloride dihydrate0.1838 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 ingredients 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 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 contents of the pack
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 double-chamber bag. One chamber contains the alkaline sodium bicarbonate solution and the other the acidic glucose electrolytic solution in a 1:1 ratio.
equiVera is a peritoneal dialysis solution and is available in the following application systems and in the
following packs:

stay•safe:sleep•safe:
4 bags containing 2000 ml 4 bags containing 3000 ml
4 bags containing 2500 ml 2 bags containing 5000 ml
It is possible that not all packs are 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 Member States of the European Economic Area with the following
names:
B & NL: bicaVera 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
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