Balance

Package leaflet: Information for the user

balance 4.25% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis

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

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

Contents of this leaflet:

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

1. What balance is and what it is used for

balance 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 balance

Do not use balance 4.25% glucose, 1.25 mmol/l calcium:

• If your blood potassium level is very low
• If your blood calcium level is very low
• 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 abnormalities such as:
recent abdominal surgery or abdominal injuries,
burns,
extensive inflammatory conditions of the abdominal wall,
peritonitis,
non-healing exudative 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 your parathyroid gland is overactive. Additional intake of calcium-containing phosphate binders and/or vitamin D may be required,
• if your calcium level is too low. Additional intake of calcium-containing phosphate binders and/or vitamin D or use of peritoneal dialysis solutions with higher calcium concentration may be necessary,
• if you have experienced 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 experience severe abdominal pain, abdominal distension, or vomiting. These may be signs of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis therapy that can be fatal.

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 levels (salts), kidney function, body weight, and nutritional status.
Due to the high glucose concentration, balance 4.25% glucose, 1.25 mmol/l calcium must be used with caution and under medical supervision.

Other medicines and balance
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 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 take appropriate measures if necessary,
• medicines that increase urine excretion, such as diuretics,
• oral medicines that lower blood sugar levels or insulin. Your blood glucose should 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 to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. There are insufficient data on the use of balance in pregnant or breastfeeding women. You may use balance only if your doctor considers it absolutely necessary.

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

3. How to use balance

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 administered 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/m (up to 1,000 ml/m 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/m (up to 1,400 ml/m) of body surface area, with 5–10 exchanges during the night. Infuse balance into the peritoneal cavity only.

Use balance only if the solution is clear and the container is undamaged.
balance 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 fluid warmer 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 instruction manual of the fluid warmer device.
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 (label, expiration date, clarity of the solution, absence of
damage to the bag and outer pouch, integrity of the welds).
Place the bag on a firm surface. Open the outer pouch of the bag and the
disinfection cap package. Wash hands with an antiseptic product.
Roll the bag, resting it 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 automatically mix. Then roll the bag from the upper edge until the lower triangular seal is completely opened. Check that all seals have fully opened.
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 from the solution bag, and place the DISC into the organizer. After unrolling the line of the drain bag, hang the drain 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 your 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 washing, let fresh solution flow into the drainage bag (about 5 seconds).
Position 

5. Infusion

Start the infusion by rotating the control switch to 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 cap. Remove the catheter adapter from the DISK and screw it onto the new disinfection
cap.

8. Closing the DISK

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

9. Check the clarity and weight of the drained dialysate and proceed with disposal if it appears clear.
   sleep•safe system for automated peritoneal dialysis (APD)
   During automated peritoneal dialysis (APD), the solution is automatically warmed by the device.

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's 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 system 5,000 ml and 6,000 ml

1. Preparation of the solution

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 firm surface. Open the protective overwrap of the bag. Wash hands with an antibacterial agent. Unfold the middle seal and the connector of the bag. Roll the bag, resting on the protective overwrap, from the end of the diagonal towards the bag connector. The middle seal is now open. Continue until the seal of the small chamber opens. Check that all seals have fully opened. Check that the solution is clear and that the bag shows no signs of 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 warmed by the equipment.

1. Preparation of the solution: see sleep•safe 5.000 ml and 6.000 ml systems

2. Remove the protective cap from the connector of the tubing set
3. Connect the tubing sets to the bag
4. Break the internal closure by bending the tubing and the PIN more than 90° from both sides
5. 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, balance may be used independently at home. Therefore, it is essential to ensure that each step has been fully understood during training, as well as 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 balance 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 could lead to dehydration and/or electrolyte imbalance.

If you forget to use balance
Try to achieve the total volume of dialysate prescribed over 24 hours, in order to avoid potential health risks. If in doubt, consult your doctor.

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

4. 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 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, oozing, or crusting
• abdominal wall hernia

Contact your doctor immediately if any of these side effects occur.
Other side effects due 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 balance is used:
Very common (may affect more than 1 in 10 people):

• potassium deficiency

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

• high blood sugar levels
• high levels of fats in the blood
• weight gain

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

• calcium deficiency
• 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
  Not known (frequency cannot be estimated from the available data):
• overactive parathyroid gland leading to possible bone disorders

Reporting of side effects
If you get any side effects, 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 balance

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

6. Package contents and other information

What balance contains
Active substances in 1 litre of ready-to-use solution:
Calcium chloride dihydrate 0.1838 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:
1.25 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mmol/l of magnesium, 100.5 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 balance and package contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 509 mOsm/l, and the pH is approximately 7.0.
balance is supplied in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.
balance 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 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
CZ balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
D, A, L balance 4.25 % glucose, 1.25 mmol/l calcium, Peritonealdialyselösung
DK balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
E balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
EST balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
F Neutravera glucose 4.25 %, calcium 1.25 mmol/l, solution for peritoneal dialysis
FIN balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
GB, M balance 4.25% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
H balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
HR balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
I balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
IS balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
LT balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
LV balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
N balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
P balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
PL balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
S balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
SK balance 4.25 % glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
SLO balance 42.5 mg/ml glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis

Package leaflet: Information for the user

balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis

Please read this entire 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 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 side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What balance is and what it is used for

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

2. What you need to know before using balance

Do not use balance 2.3% glucose, 1.25 mmol/l calcium:

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

Peritoneal dialysis must not be performed if you suffer from:
abdominal abnormalities such as:
recent abdominal surgery or abdominal injuries,
burns,
extensive inflammatory conditions of the abdominal wall,
inflammation of the peritoneum,
exuding wounds that do not heal,
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,
very high levels of lipids in the blood,
in cases of 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 foods is not possible.

Warnings and precautions
Inform your doctor immediately:

• if your parathyroid gland is overactive. You may need additional intake of calcium-containing phosphate binders and/or vitamin D,
• if your calcium level is too low. You may need additional intake of calcium-containing phosphate binders and/or vitamin D or use peritoneal dialysis solutions with a higher calcium concentration,
• if you have experienced severe loss of electrolytes (salts) due to vomiting and/or diarrhea,
• if you have 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, 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 levels (salts), kidney function, body weight, and nutritional status.
Due to the high glucose concentration, balance 2.3% glucose, 1.25 mmol/l calcium must be used with caution and under medical supervision.

Other medicines and balance
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 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 taking this medicine. There are inadequate data on the use of balance in pregnant or breastfeeding women. You may use balance only if your doctor considers it absolutely necessary.

Driving and use of machines
balance does not affect or affects negligibly the ability to drive vehicles or operate machinery.

3. How to use balance

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

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

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 can be found in the instruction manual of the warming device.
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 (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 flat, 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 compartments will automatically mix. Then, roll the bag from the upper edge until the lower triangular seal is completely opened. Check that all seals have fully opened. Verify 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 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 washing, allow fresh solution to flow into the drainage bag (approximately 5 seconds).
Position 

6. Infusion

Start the infusion by turning the control switch to 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 one.
Remove the catheter adapter from the DISK and screw it onto the new disinfection cap.

11. Closing the DISCO

Close the DISCO using the open end of the used disinfection cap, left 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 warmed 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 system 5,000 ml and 6,000 ml

1. Preparation of the solution

Check the bag containing the solution (label, expiration date, clarity of the solution,
absence of damage to the bag and the outer wrapper, integrity of the seals).
Place the bag on a rigid surface. Open the protective outer wrapper of the bag. Wash
hands with an antibacterial product. Unseal the central seal and the connector of the bag.
Roll the bag, resting it on the protective wrapper, from the end of the diagonal towards the
connector of the bag. The central seal will now 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 leaks.

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 dialysis machine.

6. Preparation of the solution: see sleep•safe 5.000 ml and 6.000 ml systems

7. Remove the protective cap from the connector of the tubing set
8. Connect the tubing sets to the bag
9. Break the internal closure by bending the tubing and the PIN more than 90° on both sides
10. 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, balance can be used independently at home.
Therefore, it is essential to ensure that each step has been fully understood during training, as well as strict adherence to proper hygiene conditions during bag exchanges.
Always check the drained dialysate for possible cloudiness. See section 2.
If you use more balance than you should
If an excessive volume 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 electrolyte imbalances.
If you forget to use balance
Try to achieve the total volume of dialysate prescribed within 24 hours to avoid potential health risks.
If in doubt, consult your doctor.
If you have any questions about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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, 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, discharge, 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 balance is used:
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
• 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

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

• overactive parathyroid gland leading to possible bone disorders

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 the website 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 balance

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 box 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 balance contains
The active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.1838 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 quantities of active substances are equivalent to:
1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 100.5 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 balance and package contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 399 mOsm/l; the pH is approximately 7.0.
balance is supplied in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.

balance 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 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 authorised in the EEA member states under the following names:
B, NL balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
CZ balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
D, A, L balance 2.3% glucose, 1.25 mmol/l calcium, Peritonealdialyselösung
DK balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
E balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
EST balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
F Neutravera glucose 2.3%, calcium 1.25 mmol/l, solution for peritoneal dialysis
FIN balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
GB, M balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
H balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
HR balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
I balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
IS balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
LT balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
LV balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
N balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
P balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
PL balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
S balance 2.3% glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
SK balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
SLO balance 23 mg/ml glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis

Package leaflet: Information for the user

balance 1.5% glucose, 1.25 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this instruction leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What balance is and what it is used for

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

2. What you need to know before using balance

Do not use balance 1.5% glucose, 1.25 mmol/l calcium:

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

Peritoneal dialysis must not be performed if you have:
Abdominal abnormalities such as:

• abdominal surgery or abdominal injuries,
• burns,
• extensive inflammatory conditions of the abdominal wall,
• peritonitis (inflammation of the peritoneum),
• oozing wounds that do not heal,
• 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 your parathyroid gland is overactive. Additional intake of calcium-containing phosphate binders and/or vitamin D may be required.
• if your calcium level is too low. Additional intake of calcium-containing phosphate binders and/or vitamin D or the use of peritoneal dialysis solutions with a higher calcium concentration may be necessary.
• if you have experienced severe loss of electrolytes (salts) due to vomiting and/or diarrhea.
• if you have enlarged kidneys (polycystic kidneys).
• if you suffer from 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. 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 levels (salts), kidney function, body weight, and nutritional status.

Other medicines and balance
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 take appropriate measures if necessary.
• medicines that increase urine excretion, such as diuretics.
• oral medicines that lower blood sugar levels or insulin. Your blood glucose levels should 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 to become pregnant, or are breastfeeding, consult your doctor before using this medicine. There are insufficient data on the use of balance in pregnant or breastfeeding women. You may use balance only if your doctor considers it absolutely necessary.

Driving and operating machinery
balance does not affect or affects negligibly the ability to drive vehicles or operate machinery.

3. How to use balance

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 tension, 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 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 balance into the peritoneal cavity only.
Use balance only if the solution is clear and the container is undamaged.
balance 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 Peritoneal Dialysis System for Continuous Ambulatory Peritoneal Dialysis (CAPD)
First, warm the bag containing the solution to body temperature.
This operation must be performed using a dedicated bag-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 is available in the instruction manual of the bag-warming device.
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 be started.

1. Preparation of the solution

Check the bag (label, expiration date, clarity of the solution, absence of damage to the bag and the outer packaging, integrity of the welds). Place the bag on a firm surface. Open the outer bag wrapper and the disinfection cap package. Wash hands with an antibacterial product. Roll the bag, resting it 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 fully opened. Check that the solution is clear and that there are no leaks from the bag.

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 in 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 set. 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 

7. Infusion

Start the infusion by turning the control switch to 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 DISCO and screw it onto the new disinfection
cap.

14. Closing the DISC

Close the DISC using the open end of the used disinfection cap left 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. Prepare the solution: refer to the stay•safe system.
12. Unroll the infusion line of the bag.
13. Remove the protective cap.
14. Insert the bag connector into the dedicated 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 welds).
Place the bag on a firm surface. Open the protective overwrap of the bag. Wash hands
with an antiseptic product. Unseal the central weld and the connector of the bag.
Roll the bag, resting it on the protective overwrap, from the end of the diagonal towards the
bag connector. The central weld is now open. Continue until the weld of the small chamber
has opened. Check that all welds have fully opened. Check that the solution is clear and that
the bag shows no leaks.

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

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

11. Solution preparation: see sleep•safe system 3.000 ml, 5.000 ml and 6.000 ml

12. Remove the protective cap from the connector of the tubing set
13. Connect the tubing set to the bag
14. Break the internal seal by bending the tubing and the 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 residual solution must be discarded.
After appropriate training, balance can 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 the drained dialysate for possible cloudiness. See section 2.

If you use more balance than you should
If an excessive amount of solution has been 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 electrolyte imbalance.

If you forget to use balance
Try to achieve the total volume of dialysate prescribed within 24 hours in order to avoid potential health risks. If in doubt, consult your doctor.

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

6. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may generally occur 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 due to 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

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

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

The following side effects may occur when balance is used:
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
• 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

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

• overactive parathyroid gland leading to possible bone disorders

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 the website 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 balance

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 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 balance Contains
Active substances in 1 litre of ready-to-use solution are:
Calcium chloride dihydrate 0.1838 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 16.5 g
(15.0 g of anhydrous glucose)
These quantities of active substances are equivalent to:
1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 100.5 mmol/l chloride, 35
mmol/l lactate and 83.2 mmol/l glucose.
The excipients are water for injections, hydrochloric acid, sodium hydroxide and sodium
hydrogen carbonate.

Description of the Appearance of balance and Package Contents
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 356 mOsm/l, and the pH is approximately 7.0.
balance is supplied in a dual-chamber bag. One chamber contains the alkaline sodium lactate solution, while the other contains the acidic electrolyte solution with glucose.

balance 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 authorised in 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 authorised in EEA Member States under the following names:
B, NL balance 1.5 % glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
CZ balance 1.5 % glucose, 1.25 mmol/l calcium, roztok pro peritoneální dialýzu
D, A, L balance 1.5 % Glucose, 1.25 mmol/l Calcium, Peritonealdialyselösung
DK balance 1.5 % glucose, 1.25 mmol/l calcium, peritonealdialysevæske
E balance 1.5 % glucosa, 1.25 mmol/l de calcio, solución para diálisis peritoneal
EST balance 1.5 % glükoos, 1.25 mmol/l kaltsium, peritoneaaldialüüsilahus
F Neutravera glucose 1.5 %, calcium 1.25 mmol/l, solution pour dialyse péritonéale
FIN balance 1.5 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
GB, M balance 1.5% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis
GR, CY balance 1.5 % γλυκόζη, 1.25 mmol/l ασβέστιο, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
H balance 1.5 % glükóz, 1.25 mmol/l kalcium, peritoneális dializáló oldat
HR balance 1.5% glukoze, 1.25 mmol/l kalcija, otopina za peritonejsku dijalizu
I balance 1.5 % glucosio, 1.25 mmol/l calcio, soluzione per dialisi peritoneale
IS balance 1.5 % glúkósi, 1.25 mmól/l kalsíum, kviðskilunarlausn
LT balance 1.5 % gliukozės, 1.25 mmol/l kalcio, pilvaplėvės ertmės dializės tirpalas
LV balance 1.5 % glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
N balance 1.5 % glukose, 1.25 mmol kalsium/l, peritonealdialysevæske
P balance 1.5 % glucose, 1.25 mmol/l de cálcio, solução para diálise peritoneal
PL balance 1.5 % z 1.5 % glukozą i wapniem 1.25 mmol/l, roztwór do dializy otrzewnowej
S balance 1.5 % glucose, 1.25 mmol/l calcium, peritonealdialysvätska
SK balance 1.5 % glucose, 1.25 mmol/l calcium, roztok na peritoneálnu dialýzu
SLO balance 15 mg/ml glukoze, 1.25 mmol/l kalcija, raztopina za peritonealno dializo