Equibalance

Package leaflet: Information for the user

equibalance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What equibalance is and what it is used for

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

2. What you should know before using equibalance

Do not use equibalance 4.25% glucose, 1.75 mmol/l calcium:

• If your blood potassium level is very low
• If your blood calcium level is very high
• If you suffer from reduced body fluids
• If you suffer from hypotension
• If you have a known metabolic disorder called lactic acidosis

Peritoneal dialysis must not be performed if you suffer from: abdominal conditions such as:
surgical interventions or abdominal injuries, burns, extensive inflammatory conditions of the abdominal wall, peritonitis, non-healing exuding wounds, umbilical, inguinal or diaphragmatic hernias, abdominal or intestinal tumors

inflammatory bowel diseases,
intestinal obstruction,
lung diseases, particularly pneumonia,
blood poisoning caused by bacteria,
very high levels of lipids in the blood,
in cases of accumulation of uremic toxins in the blood (which cannot be removed
by dialysis),
severe malnutrition and weight loss, especially if adequate intake of
protein-containing foods is not possible.

Warnings and precautions
Inform your doctor immediately:

• if you have experienced a severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
• if you suffer from enlarged kidneys (polycystic kidneys),
• if you suffer from peritonitis, recognizable by cloudy dialysate fluid and/or abdominal pain. Show the bag containing the dialysate fluid to your doctor.
• if you have 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.

During peritoneal dialysis, a loss of proteins and water-soluble vitamins may occur. To prevent imbalances, an adequate diet or supplementation is recommended.
Your doctor will monitor your electrolyte (salt) levels, kidney function, body weight, and nutritional status.
Due to the high glucose concentration, equibalance 4.25% glucose, 1.75 mmol/l calcium
must be used with caution and under medical supervision.

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

• medicines for heart problems, such as digoxin. Your doctor will monitor your blood potassium levels and, if necessary, take appropriate measures.
• medicines affecting calcium levels, such as those containing calcium or vitamin D.
• medicines that increase urine excretion, such as diuretics.
• oral medicines that lower blood sugar levels or insulin. Your blood glucose must be monitored regularly. Diabetic patients may require adjustment of their daily insulin dose.

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

Driving and using machines
equibalance does not affect or affects negligibly the ability to drive vehicles or operate machinery.

3. How to use equibalance

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

Continuous Ambulatory Peritoneal Dialysis (CAPD)
Adults: The usual dose is 2,000–3,000 ml of solution four times daily, depending on body weight and renal function.
After a dwell time of 2–10 hours, the solution is drained.

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

Automated Peritoneal Dialysis (APD)
For this type of dialysis, the sleep•safe or Safe•Lock administration systems are used. Bag exchanges are automatically controlled by the device during the night.

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

Infuse equibalance only into the peritoneal cavity.
Use equibalance only if the solution is clear and the container is undamaged.
equibalance is supplied as a dual-chamber bag. Before use, the solutions contained in the two compartments must be mixed as described.

Instructions for Use
stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)
First, warm the bag containing the solution to body temperature. This should be done using a dedicated warming device. The warming time for 2,000 ml bags with an initial temperature of 22°C is approximately 120 minutes. More detailed information is provided in the warming device’s instruction manual.
Do not use a microwave oven to heat the bag due to the risk of local overheating.
Once the solution has been warmed, the bag exchange procedure may begin.

1. Preparation of the Solution

Check the bag for the label, expiration date, solution clarity, absence of damage to the bag and outer packaging, and integrity of the seals.
Place the bag on a rigid surface.
Open the outer bag wrapper and the disinfection cap package.
Wash hands with an antiseptic agent.
Roll the bag, placed on the protective wrapper sheet, from one of the upper edges until the central heat seal opens. The solutions contained in the two chambers will automatically mix.
Then, roll the bag from the upper edge until the lower triangular seal opens completely.
Check that all seals have opened completely.
Check that the solution is clear and that the bag shows no signs of leakage.

2. Preparation of the bag exchange

Hang the solution bag on the uppermost hook of the IV pole, unroll the infusion line of the solution bag, and place 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 empty 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. Washing

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

5. Infusion

Start the infusion by rotating the control switch towards the
 Position 

6. Safety position

Close the catheter adapter by automatically inserting the PIN into the catheter connector.
Position 

7. Disconnection Remove the protective cap from the new disinfection cap and screw it onto the old one. Remove the catheter adapter from the DISK and screw it onto the new disinfection cap.

8. Closing the DISCO

Close the DISCO 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 is clear. sleep•safe system for automated peritoneal dialysis (APD)

During automated peritoneal dialysis (APD), the solution is automatically heated
by the equipment.
sleep•safe 3.000 ml system

1. Solution preparation: see stay•safe system
2. Unroll the infusion line of the bag.
3. Remove the protective cap.
4. Insert the bag connector into the designated ports on the sleep•safe device.
5. The bag is now ready for use with the sleep•safe set.

sleep•safe 5.000 ml and 6.000 ml systems

1. Solution preparation: Check the bag containing the solution (label, expiration date, solution clarity, absence of damage to the bag and outer packaging, integrity of the seals). Place the bag on a rigid surface. Open the protective bag wrapper. Wash hands with an antibacterial product. Unfold the middle seal and the bag connector. Roll up the bag, resting it on the protective wrapper, from the end of the diagonal towards the bag connector. The middle seal will now be open.

Continue until the seal of the small chamber has opened.
Check that all seals have opened completely.
Check that the solution is clear and that the bag shows no leakage.

2. – 5.: see sleep•safe 3.000 ml system

Safe•Lock system for automated peritoneal dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically heated
by the equipment.

1. Solution preparation: see sleep•safe 5.000 ml and 6.000 ml systems
2. Remove the protective cap from the connector on the connection line
3. Connect the lines to the bag
4. Break the internal closure by bending the line and the PIN more than 90° on both sides
5. The bag is now ready for use. Each solution bag must be used only once, and any unused solution residue must be discarded. After appropriate training, equibalance may be used independently at home. For this reason, it is essential to ensure that every step has been fully understood during training, as well as strict adherence to proper hygiene conditions during bag exchanges. Always check for possible cloudiness of the drained dialysate. See section 2.

If you use more equibalance than you should:
If an excess of solution is infused into the peritoneal cavity, the surplus can be easily drained. If you have used too many bags, contact your doctor, as this may lead to dehydration and/or electrolyte imbalance.

If you forget to use equibalance
Try to achieve the total prescribed dialysate volume within 24 hours in order to avoid potential
health risks. In case of doubt, consult your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• inflammation of the peritoneum, indicated by the presence of cloudy dialysate, abdominal pain, fever, general malaise, or in very rare cases blood poisoning. In such cases, show the bag containing the dialysis fluid to your doctor
• inflammation of the skin at the catheter exit site or along the entire length of the catheter, recognizable by redness, swelling, pain, weeping, or crusting
• abdominal wall hernia

Contact your doctor immediately if any of these side effects occur.
Other side effects due to the treatment include:
Common (may affect up to 1 in 10 people):

• problems with infusion or drainage of the dialysate
• sensation of abdominal bloating or fullness
• shoulder pain

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

• diarrhoea
• constipation

Very rare (may affect up to 1 in 10,000 people):

• blood poisoning (septicaemia)
  Not known (frequency cannot be estimated from the available data):
• difficulty breathing
• feeling of malaise
• encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension or vomiting

The following side effects may occur when equibalance is used:
Very common (may affect more than 1 in 10 people):

• potassium deficiency

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

• hypercalcaemia if calcium intake is too high
• high blood sugar levels
• high blood fat levels
• weight gain

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

• excessively low body fluid levels, recognizable by rapid weight loss, low blood pressure, rapid pulse
• excessively high body fluid levels, recognizable by fluid accumulation in tissues and lungs, high blood pressure and breathing difficulties
• dizziness

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 equibalance

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 box 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 in any case within a maximum of
24 hours after mixing.

6. Package Contents and Other Information

What equibalance contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.640 g
Sodium (S)-lactate solution 7.85 g
(3.925 g of sodium (S)-lactate)
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 46.75 g
(42.5 g of anhydrous glucose)
These quantities of active substances are equivalent to:
1.75 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mmol/l of magnesium, 101.5 mmol/l of chloride, 35 mmol/l of lactate and 235.8 mmol/l of glucose.
The excipients are water for injections, hydrochloric acid, sodium hydroxide and sodium hydrogen carbonate.

Description of the appearance of equibalance and package contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 511 mOsm/l; the pH is approximately 7.0.
equibalance is available in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.

equibalance is available in the following administration systems and pack sizes:
stay•safe sleep•safe Safe • Lock
4 x 2,000 ml 4 x 3,000 ml 2 x 5,000 ml
4 x 2,500 ml 2 x 5,000 ml 2 x 6,000 ml
4 x 3,000 ml 2 x 6,000 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder
Fresenius Medical Care Italia S.p.A., Via Crema 8, 26020, Palazzo Pignano (Cremona), Italy

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

This medicinal product is authorized in the EEA Member States under the following names:
See the last page of the multilingual summary of product characteristics

Last page of the multilingual summary of product characteristics:
This medicinal product is authorized in the EEA Member States under the following names:
B, NL balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
CZ balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
D, A, L balance 4.25% glucose, 1.75 mmol/l calcium, Peritonealdialyselösung
DK balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
E balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
EST balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
F Dialyse Péritonéale Continue Ambulatoire 3, solution for peritoneal dialysis
FIN balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
GB, M balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
H balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
HR balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
I equibalance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
LT balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
LV balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
N balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
P balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
PL balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
RO balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
S balance 4.25% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
SK balance 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
SLO balance 42.5 mg/ml glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

Patient Information Leaflet

equibalance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine is 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:

1. What equibalance is and what it is used for
2. What you need to know before using equibalance
3. How to use equibalance
4. Possible side effects
5. How to store equibalance
6. Package contents and other information

1. What equibalance is and what it is used for

equibalance is used for blood purification through the peritoneum 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 equibalance

Do not use equibalance 2.3% glucose, 1.75 mmol/l calcium:

• If your blood potassium level is very low
• If your blood calcium level is very high
• If you have a known metabolic disorder called lactic acidosis

Peritoneal dialysis must not be performed if you have:
abdominal conditions such as:
previous abdominal surgery or abdominal injuries,
burns,
extensive inflammatory conditions of the abdominal wall,
peritonitis,
non-healing exuding wounds,
umbilical, inguinal or diaphragmatic hernias,
abdominal or intestinal tumors,
inflammatory bowel diseases,
intestinal obstruction,
pulmonary diseases, particularly pneumonia,
blood poisoning caused by bacteria (sepsis),
very high levels of lipids in the blood,
accumulation of uremic toxins in the blood that cannot be removed by dialysis,
severe malnutrition and weight loss, especially if adequate intake of protein-containing food is not possible.

Warnings and precautions
Inform your doctor immediately:

• if you have experienced a severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
• if you have enlarged kidneys (polycystic kidneys),
• if you have peritonitis, recognizable by cloudy dialysis fluid and/or abdominal pain. Show the bag containing the dialysis fluid to your doctor.
• if you have severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy that may be fatal.

During peritoneal dialysis, loss of proteins and water-soluble vitamins may occur. To prevent imbalances, an adequate diet or supplementation is recommended.
Your doctor will monitor your electrolyte (salt) levels, kidney function, body weight, and nutritional status.
Due to its high glucose concentration, equibalance 2.3% glucose, 1.75 mmol/l calcium must be used with caution and under medical supervision.

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

• medicines for heart problems, such as digoxin. Your doctor will monitor your blood potassium levels and, if necessary, take appropriate measures.
• medicines affecting calcium levels, such as those containing calcium or vitamin D.
• medicines that increase urine excretion, such as diuretics.
• oral medicines that lower blood sugar levels or insulin. Your blood glucose must be monitored regularly. Diabetic patients may require adjustment of their daily insulin dose.

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

Driving and using machines
equibalance does not affect or affects negligibly the ability to drive vehicles or operate machinery.

3. How to use equibalance

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration and frequency of use, the volume of solution, and the dwell time in the peritoneal cavity.
If you experience abdominal discomfort or a feeling of fullness, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)
Adults: The usual dose is 2,000–3,000 ml of solution four times daily, depending on body weight and renal function.
After a dwell time of 2–10 hours, the solution is drained.

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

Automated Peritoneal Dialysis (APD)
For this type of dialysis, the sleep•safe or Safe•Lock administration systems are used. Bag exchanges are automatically controlled by the device during the night.

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

Infuse equibalance into the peritoneal cavity only.
Use equibalance only if the solution is clear and the container is undamaged.
equibalance is supplied as a dual-chamber bag. Before use, the solutions contained in the two compartments must be mixed as described.

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

First, warm the solution bag to body temperature. This should be done using a dedicated warming device. The warming time for 2,000 ml bags with an initial temperature of 22°C is approximately 120 minutes. Further and more detailed information can be found in the warming device’s instruction manual.
Do not use a microwave oven to warm the bag due to the risk of local overheating.
Once the solution has been warmed, the bag exchange process may begin.

1. Preparation of the solution

Check the bag after warming (label, expiration date, clarity of the solution, absence of
damage to the bag and the outer pouch, integrity of the welds).
Place the bag on a hard, flat surface.
Open the outer pouch of the bag and the disinfectant cap package.
Wash hands with an antiseptic product.
Roll the bag, placed on the protective pouch sheet, from one of the upper edges until
the central heat seal opens. The solutions contained in the two chambers will mix
automatically.
Then, roll the bag from the upper edge until the lower triangular seal opens
completely.
Check that all seals have opened completely.
Check that the solution is clear and that the bag shows no signs of leakage.

2. Preparation of the bag exchange

Hang the solution bag on the uppermost hook of the IV pole, unroll the infusion line from the solution bag, and place 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 empty 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. Washing

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

6. Infusion

Start the infusion by turning the control switch to the
position 

9. Safety position

Close the catheter adapter by automatically inserting the PIN into the catheter connector.
Position 

10. Disconnection

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

11. Closing the DISC

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

10. Check the clarity and weight of the drained dialysate and proceed with disposal if it is clear.
    sleep•safe system for automated peritoneal dialysis (APD)

During automated peritoneal dialysis (APD), the solution is automatically heated
by the equipment.
sleep•safe 3.000 ml system

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 designated ports on the sleep•safe equipment.
10. The bag is now ready for use with the sleep•safe set.

sleep•safe 5.000 ml and 6.000 ml systems

1. Solution preparation: Check the 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 firm surface. Open the protective bag wrapper. Wash hands with an antibacterial product. Unfold the middle seal and the connector of the bag. Roll up the bag, resting it on the protective wrapper, from the end of the diagonal towards the bag connector. The middle seal will now be open. Continue until the seal of the small chamber opens. Check that all seals have fully opened. Verify that the solution is clear and that the bag shows no leakage.
2. – 5.: see sleep•safe 3.000 ml system
   Safe•Lock system for automated peritoneal dialysis (APD)

During automated peritoneal dialysis (APD), the solution is automatically heated
by the equipment.
6. Preparation of the solution: see sleep•safe 5.000 ml and 6.000 ml systems
7. Remove the protective cap from the connector on the connection line
8. Connect the lines to the bag
9. Break the internal closure by bending the line and the PIN more than 90° in both directions
10. The bag is now ready for use

Each solution bag must be used only once, and any unused residual solution must be discarded.
After appropriate training, equibalance may be used independently at home.
Therefore, it is essential to ensure that each step has been fully understood during training, as well as the strict adherence to proper hygiene conditions required during bag exchanges.
Always check the drained dialysate for possible cloudiness. See paragraph 2
If you use more equibalance than you should
If an excessive amount of solution is infused into the peritoneal cavity, the excess can be easily drained. If too many bags have been used, contact your doctor, as this may lead to dehydration and/or electrolyte imbalance.
If you forget to use equibalance
Try to achieve the total prescribed dialysate volume within 24 hours to avoid potential health risks. If in doubt, consult your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

5. Possible side effects

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

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

• Peritonitis, indicated by the presence of cloudy dialysate fluid, abdominal pain, fever, general malaise, or in very rare cases blood poisoning. In such cases, show the bag containing the dialysate fluid to your doctor
• Inflammation of the skin at the catheter exit site or along the entire length of the catheter, recognizable by redness, swelling, pain, weeping, or crusting
• Abdominal wall hernia

Contact your doctor immediately if any of these side effects occur.

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 bloating or fullness
• Shoulder pain

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

• Diarrhoea
• Constipation

Very rare (may affect up to 1 in 10,000 people):

• Blood poisoning (septicaemia)

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

• Difficulty breathing
• Feeling of malaise
• Encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting

The following side effects may occur when equibalance is used:

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

• Potassium deficiency

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

• Hypercalcaemia if calcium intake is too high
• High blood sugar levels
• High blood fat levels
• Increase in body weight

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

• Excessively low body fluid levels, recognizable by rapid weight loss, low blood pressure, rapid pulse
• Excessively high body fluid levels, recognizable by fluid accumulation in tissues and lungs, high blood pressure, and breathing difficulties
• Dizziness

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 equibalance

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 below 4 °C.
The ready-to-use solution must be used immediately and in any case within a maximum of
24 hours after mixing.

6. Package contents and other information

What equibalance contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.640 g
Sodium (S)-lactate solution 7.85 g
(3.925 g of sodium (S)-lactate)
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 25.0 g
(22.73 g of anhydrous glucose)
These amounts of active substances are equivalent to:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 101.5 mmol/l chloride, 35 mmol/l lactate and 126.1 mmol/l glucose.
The excipients are water for injections, hydrochloric acid, sodium hydroxide and sodium hydrogen carbonate.

Description of the appearance of equibalance and the contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 401 mOsm/l; the pH is approximately 7.0.
equibalance is available in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.
equibalance is available in the following administration systems and pack sizes:
stay•safe sleep•safe Safe • Lock
4 x 2,000 ml 4 x 3,000 ml 2 x 5,000 ml
4 x 2,500 ml 2 x 5,000 ml 2 x 6,000 ml
4 x 3,000 ml 2 x 6,000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Medical Care Italia S.p.A., Via Crema 8, 26020, Palazzo Pignano (Cremona), Italy

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

This medicinal product is authorised in EEA Member States under the following names:
See the last page of the multilingual summary of product characteristics

Last page of the multilingual summary of product characteristics:
This medicinal product is authorised in EEA Member States under the following names:
B, NL balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
CZ balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
D, A, L balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
DK balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
E balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
EST balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
F Dialyse Péritonéale Continue Ambulatoire 4, solution for peritoneal dialysis
FIN balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
GB, M balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
H balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
HR balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
I equibalance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
LT balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
LV balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
N balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
P balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
PL balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
RO balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
S balance 2.3% glucose, 1.75 mmol/l calcium, peritoneal dialysis solution
SK balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
SLO balance 23 mg/ml glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

Package leaflet: Information for the user

equibalance 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine is prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be dangerous.
• If you experience any adverse reactions, including those not listed in this instruction leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What equibalance is and what it is used for
2. What you need to know before using equibalance
3. How to use equibalance
4. Possible side effects
5. How to store equibalance
6. Package contents and other information

1. What equibalance is and what it is used for

equibalance is used for blood purification through the peritoneum 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 equibalance

Do not use equibalance 1.5% glucose, 1.75 mmol/l calcium:

• If your blood potassium level is very low
• If your blood calcium level is very high
• If you have a metabolic disorder known as lactic acidosis

Peritoneal dialysis must not be performed if you have:
abdominal disorders such as:
recent abdominal surgery or abdominal injuries,
burns,
extensive inflammatory conditions of the abdominal wall,
peritonitis (inflammation of the peritoneum),
non-healing, exuding wounds,
umbilical, inguinal or diaphragmatic hernias,
tumors in the abdomen or intestines,
inflammatory bowel diseases,
intestinal obstruction,
lung diseases, particularly pneumonia,
blood poisoning caused by bacteria (sepsis),
very high levels of lipids in the blood,
accumulation of uremic toxins in the blood that cannot be removed
by dialysis,
severe malnutrition and weight loss, especially if adequate intake of
protein-containing food is not possible.

Warnings and precautions
Inform your doctor immediately:

• if you have experienced a severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
• if you have enlarged kidneys (polycystic kidneys),
• if you have peritonitis, recognizable by cloudy dialysis fluid and/or abdominal pain. Show the dialysis fluid bag to your doctor.
• if you have 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.

During peritoneal dialysis, loss of proteins and water-soluble vitamins may occur. To prevent imbalances, an adequate diet or supplementation is recommended.
Your doctor will monitor your electrolyte (salt) levels, kidney function, body weight, and nutritional status.

Other medicines and equibalance

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since peritoneal dialysis may affect the effects of other drugs, your doctor may need to adjust their dosage, especially in the case of:

• medicines for heart problems, such as digoxin. Your doctor will monitor your blood potassium levels and, if necessary, take appropriate measures.
• medicines affecting calcium levels, such as those containing calcium or vitamin D.
• medicines that increase urine excretion, such as diuretics.
• oral medicines that lower blood sugar levels or insulin. Your blood glucose must be monitored regularly. Diabetic patients may require adjustment of their daily insulin dose.

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

Driving and using machines
equibalance does not affect or affects negligibly the ability to drive or use machinery.

3. How to use equibalance

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration and frequency of use, the volume of solution, and the dwell time in the peritoneal cavity.
If you experience abdominal discomfort or a feeling of fullness, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)
Adults: The usual dose is 2,000–3,000 ml of solution four times daily, depending on body weight and renal function.
After a dwell time of 2–10 hours, the solution is drained.

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

Automated Peritoneal Dialysis (APD)
For this type of dialysis, the sleep•safe or Safe•Lock administration systems are used. Bag exchanges are automatically controlled by the equipment during the night.

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

Infuse equibalance only into the peritoneal cavity.
Use equibalance only if the solution is clear and the container is undamaged.
equibalance is supplied as a dual-chamber bag. Before use, the solutions contained in the two compartments must be mixed as described.

Instructions for Use
stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)
First, warm the bag containing the solution to body temperature. This should be done using a dedicated warming device. The warming time for 2,000 ml bags with an initial temperature of 22°C is approximately 120 minutes. More detailed information is available in the warming device’s instruction manual.
Do not use a microwave oven to warm the bag due to the risk of local overheating.
Once the solution has been warmed, the bag exchange can begin.

1. Preparation of the solution

Check the bag for the label, expiration date, clarity of the solution, absence of damage to the bag and outer wrapper, and integrity of the seals.
Place the bag on a flat, rigid surface.
Open the outer wrapper of the bag and the disinfectant cap package.
Wash hands with an antiseptic product.
Roll the bag, placed on the protective wrapper sheet, from one of the upper edges until the central heat seal opens. The solutions contained in the two chambers will automatically mix.
Then, roll the bag from the upper edge until the lower triangular seal is completely opened.
Check that all seals have opened completely.
Check that the solution is clear and that the bag shows no leaks.

2. Preparation of the bag exchange

Hang the solution bag on the uppermost hook of the IV pole, unroll the infusion line of the bag containing the solution, and place 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 slots of the organizer. Place the new disinfection cap into the other empty 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. Washing

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

7. Infusion

Start the infusion by turning the control switch towards the
Position 

12. Safety position

Close the catheter adapter by automatically inserting the PIN into the catheter connector.
Position 

13. Disconnection

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

14. Closing the DISC

Close the DISC using the open end of the used disinfection cap that remained in the right hole of the organizer.

11. Check the clarity and weight of the drained dialysate and proceed with disposal if it is clear. sleep•safe System for Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the solution is automatically warmed by the equipment.
sleep•safe 3,000 ml System

11. Solution preparation: see stay•safe system
12. Unroll the infusion line of the bag.
13. Remove the protective cap.
14. Insert the bag connector into the designated ports on the sleep•safe equipment.
15. The bag is now ready for use with the sleep•safe set.

sleep•safe 5,000 ml and 6,000 ml Systems

1. Solution preparation: Check the bag containing the solution (label, expiration date, clarity of the solution, absence of damage to the bag and outer packaging, integrity of the seals). Place the bag on a hard, flat surface. Open the protective bag wrapper. Wash hands with an antibacterial product. Unfold the central seal and the connector of the bag. Roll up the bag, resting it on the protective wrapper, from the far end of the diagonal towards the bag connector. The central seal will now be open. Continue until the seal of the small chamber is open. Check that all seals are fully opened. Verify that the solution is clear and that there are no leaks from the bag.
2. – 5.: see sleep•safe 3,000 ml system

Safe • Lock System for Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the solution is automatically warmed by the equipment.
11. Solution preparation: see sleep•safe 5,000 ml and 6,000 ml systems
12. Remove the protective cap from the connector of the connection line
13. Connect the lines to the bag
14. Break the internal seal by bending the line and PIN more than 90° on both sides
15. The bag is now ready for use

Each solution bag must be used only once, and any unused solution must be discarded. After appropriate training, equibalance may be used independently in your home. For this reason, it is essential to ensure that every step has been fully understood during training, as well as strict adherence to proper hygiene practices during bag exchanges. Always check the drained dialysate for cloudiness. See paragraph 2

If you use more equibalance than you should

If an excessive amount of solution is infused into the peritoneal cavity, the excess can be easily drained. If you have used too many bags, contact your doctor, as this may lead to dehydration and/or disturbances in electrolyte balance.

If you forget to use equibalance

Try to achieve the total prescribed dialysate volume within 24 hours to avoid potential health risks. If in doubt, consult your doctor.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

6. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur in general during peritoneal dialysis treatment:

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

• inflammation of the peritoneum, indicated by the presence of cloudy dialysate, abdominal pain, fever, general malaise, or in very rare cases, blood poisoning. In such cases, show the bag containing the dialysis fluid to your doctor
• inflammation of the skin at the catheter exit site or along the entire length of the catheter, recognizable by redness, swelling, pain, weeping, or crusting
• abdominal wall hernia

Contact your doctor immediately if any of these side effects occur.

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 bloating or fullness
• shoulder pain

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

• diarrhoea
• constipation

Very rare (may affect up to 1 in 10,000 people):

• blood poisoning

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

• difficulty breathing
• feeling of malaise
• encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting

The following side effects may occur when equibalance is used:

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

• potassium deficiency

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

• hypercalcaemia if calcium intake is too high
• high blood sugar levels
• high blood fat levels
• weight gain

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

• excessively low body fluid levels, recognizable by rapid weight loss, low blood pressure, rapid pulse
• excessively high body fluid levels, recognizable by fluid accumulation in tissues and lungs, high blood pressure, and breathing difficulties
• dizziness

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 equibalance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bag and the 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 in any case within a maximum of
24 hours after mixing.

6. Contents of the pack and other information

What equibalance contains
The active substances in 1 litre of ready-to-use solution are:

These quantities of active substances are equivalent to:
1.75 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mmol/l of magnesium, 101.5 mmol/l of chloride, 35 mmol/l of lactate and 83.2 mmol/l of glucose.
The excipients are water for injections, hydrochloric acid, sodium hydroxide and sodium hydrogen carbonate.

Description of the appearance of equibalance and pack contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 358 mOsm/l; the pH is approximately 7.0.
equibalance is available in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.
equibalance is available in the following administration systems and pack sizes:
stay•safe sleep•safe Safe • Lock
4 x 2,000 ml 4 x 3,000 ml 2 x 5,000 ml
4 x 2,500 ml 2 x 5,000 ml 2 x 6,000 ml
4 x 3,000 ml 2 x 6,000 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder
Fresenius Medical Care Italia S.p.A., Via Crema 8, 26020, Palazzo Pignano (Cremona), Italy

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

This medicinal product is authorized in the EEA Member States under the following names:
See the last page of the multilingual package leaflet

Last page of the multilingual package leaflet:
This medicinal product is authorized in the EEA Member States under the following names:
B, NL balance 1.5% glucose, 1.75 mmol/l calcium, oplossing voor peritoneale dialyse
CZ balance 1.5% glucose, 1.75 mmol/l calcium, roztok pro peritoneální dialýzu
D, A, L balance 1.5% glucose, 1.75 mmol/l calcium, Peritonealdialyselösung
DK balance 1.5% glucose, 1.75 mmol/l calcium, peritonealdialysevæske
E balance 1.5% glucose, 1.75 mmol/l calcium, solución para diálisis peritoneal
EST balance 1.5% glucose, 1.75 mmol/l calcium, peritoneaaldialüüsilahus
F Dialyse Péritonéale Continue Ambulatoire 2, solution pour dialyse péritonéale
FIN balance 1.5% glucose, 1.75 mmol/l calcium, peritoneaalidialyysineste
GB, M balance 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 1.5% glucose, 1.75 mmol/l calcium, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
H balance 1.5% glucose, 1.75 mmol/l calcium, peritoneális dializáló oldat
HR balance 1.5% glucose, 1.75 mmol/l calcium, otopina za peritonejsku dijalizu
I equibalance 1.5% glucose, 1.75 mmol/l calcium, soluzione per dialisi peritoneale
LT balance 1.5% glucose, 1.75 mmol/l calcium, pilvaplėvės ertmės dializės tirpalas
LV balance 1.5% glucose, 1.75 mmol/l calcium, šķīdums peritoneālai dialīzei
N balance 1.5% glucose, 1.75 mmol/l calcium, peritonealdialysevæske
P balance 1.5% glucose, 1.75 mmol/l calcium, solução para diálise peritoneal
PL balance 1.5% glucose with 1.75 mmol/l calcium, roztwór do dializy otrzewnowej
RO balance 1.5% glucose, 1.75 mmol/l calcium, soluţie pentru dializă peritoneală
S balance 1.5% glucose, 1.75 mmol/l calcium, peritonealdialysvätska
SK balance 1.5% glucose, 1.75 mmol/l calcium, roztok na peritoneálnu dialýzu
SLO balance 15 mg/ml glucose, 1.75 mmol/l calcium, raztopina za peritonealno dializo