Balance 2.3% with 2.3% glucose and calcium 1.25 mmol/l

Patient Information Leaflet

balance 2.3% with 2.3% glucose and calcium 1.25 mmol/l, peritoneal dialysis solution
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What balance is and what it is used for
2. Important information 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 in patients with end-stage, chronic renal failure for blood purification through the peritoneal membrane. This method of blood purification is called peritoneal dialysis.

2. Important information before using the medicine balance

When not to use balance 2.3% with 2.3% glucose and calcium 1.25 mmol/l

• if blood potassium levels are very low
• if blood calcium levels are very low
• if there are metabolic disorders known as lactic acidosis

Peritoneal dialysis must not be performed in patients with the following conditions:

• abdominal conditions such as:

• previous abdominal surgeries or injuries
• burns
• severe skin inflammation
• peritonitis
• non-healing, draining wounds
• umbilical, inguinal or hiatal hernia
• abdominal or intestinal tumors
  • inflammatory bowel diseases
  • intestinal obstruction
  • lung diseases (especially pneumonia)
  • blood infection caused by bacteria
• very high levels of fats in the blood
• poisoning by metabolic products that cannot be treated by blood purification
• severe malnutrition and weight loss, especially if it is not possible to consume an adequate amount of protein-containing food

Warnings and precautions

Inform your doctor immediately if any of the following occur:

• overactivity of the parathyroid glands (hyperparathyroidism); you may need to additionally take calcium-containing phosphate binders and/or vitamin D.
• low blood calcium levels; you may need to additionally take calcium-containing phosphate binders and/or vitamin D, or use a dialysis solution with a higher calcium concentration.
• significant loss of electrolytes due to vomiting and/or diarrhoea.
• kidney disease (polycystic kidney disease)
• peritonitis, which manifests as cloudy dialysate and/or abdominal pain. The bag with drained dialysate should be shown to your doctor.
• severe abdominal pain, bloating or vomiting. These may be signs of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis which can be life-threatening.

Peritoneal dialysis may lead to loss of protein and water-soluble vitamins. To prevent deficiencies, an appropriate diet or supplementation of lost components should be ensured. Your doctor will monitor your electrolyte balance, kidney function, body weight and nutritional status.

Due to the high glucose concentration, the medicine balance 2.3% with 2.3% glucose and calcium 1.25 mmol/l should be used cautiously and under medical supervision.

balance and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Since peritoneal dial游戏副本

3. How to use balance

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will determine the method, duration and frequency of administration, the required volume of solution and
the dwell time in the peritoneal cavity.
If you experience a feeling of abdominal fullness or tightness, your doctor may recommend reducing the volume
of the solution.

Continuous Ambulatory Peritoneal Dialysis (CAPD):

• Adults: The usual dose is 2000–3000 ml of solution administered four times daily, depending on body weight and kidney function. After a dwell time of 2 to 10 hours, the solution should be drained.
• Children: Your doctor will determine the required volume of dialysis solution based on tolerance, age and body surface area of the child. The recommended initial dose is 600–800 ml/m² (up to 1000 ml/m² at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD): This dialysis method uses the sleep•safe or Safe*•*Lock system. Bag exchanges are automatically controlled by a cycler throughout the night.

• Adults: The usual prescribed dose is 2000 ml (maximum 3000 ml) per exchange, with 3 to 10 exchanges during the night (while connected to the cycler for 8 to 10 hours), plus one or two daytime exchanges.
• Children: Exchange volume should be 800–1000 ml/m² (up to 1400 ml/m²) of body surface area, with 5 to 10 exchanges during the night.

The medicine balance must be used exclusively for intraperitoneal infusion.
The medicine balance may only be used if the solution is clear and the bag is undamaged.
The balance medicine is supplied in a dual-chamber bag. Before use, the solutions from both chambers must
be mixed as described in the instructions.

Instructions for use

The stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD):
The solution bag should first be warmed to body temperature. This is done using an appropriate bag warmer. The warming time depends on the bag volume and the type of warmer used (for a 2000 ml bag starting at 22°C, warming usually takes about 120 minutes). More detailed information is provided in the bag warmer's user manual. Microwave ovens must not be used for warming the solution due to the risk of localized overheating. Once the solution has been warmed, the bag exchange can begin.

1. Preparing the solution
Check the warmed solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging, and integrity of the seal line separating the chambers). Place the bag on a stable surface. Open the outer packaging of the bag and the disinfecting cap/locking cap packaging. Wash your hands with an antiseptic agent. Roll up the bag lying on the foil of the outer packaging, starting from one side, so that the interchamber seal line opens. The solutions from both chambers will mix automatically. Then continue rolling the bag from the top edge so that the lower triangular seal line opens completely. Check that all seal lines are fully open. Ensure that the solution is clear and the bag is not leaking.

2. Preparing the bag exchange
Hang the bag on the upper hook of the infusion stand, unroll the drain lines of the bag, and place the DISC connector (disk) into the stabilizing base. After unrolling the drain bag, hang the drain bag on the lower hook of the infusion stand. Insert the patient’s connecting drain end into one of the two holders on the stabilizing base. Insert a new disinfecting cap/locking cap into the other empty holder. Disinfect your hands and remove the protective cap from the disk. Connect the patient’s connecting drain end to the disk.

3. Drainage (outflow)
Open the clamp on the patient’s connecting drain line. Drainage begins. Position 

4. Rinse (flush)
After drainage is complete, allow fresh solution to flow into the drain bag (approximately 5 seconds). Position 

5. Infusion (inflow)
Begin infusing the solution by turning the dial to Position 

6. Safety procedure
Automatic closure of the patient’s connecting drain line with a PIN (plug with seal). Position 

7. Disconnection
Remove the protective cap from the new disinfecting cap/locking cap and place it over the old cap. Unscrew the patient’s connecting drain end from the disk and screw it onto the new disinfecting cap/locking cap.

8. Closing the disk
Close the disk by covering its open end with the protective cap that remained in the second holder of the stabilizing base.

9. Check the clarity of the drained dialysate, weigh it, and if the dialysate is clear, dispose of it.

The sleep•safe system for Automated Peritoneal Dialysis (APD): To set up the sleep•safe system, refer to its user manual.

The sleep•safe system 3000 ml

1. Preparing the solution: see stay•safe system

2. Unroll the bag drain line.
3. Remove the protective cap.
4. Insert the bag end into the free guide of the cycler tray.
5. The bag is now ready for use with the sleep•safe set.

The sleep•safe system 5000 ml and 6000 ml 1. Preparing the solution
Check the solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging, and integrity of the seal lines separating the chambers).
Place the bag on a stable surface.
Open the outer packaging of the bag.
Wash your hands with an antiseptic agent.
Unfold the bag with the central seal line and the drain connector.
Roll the bag, lying on the outer packaging, diagonally towards the connector end.
The central seal line will open.
Continue until the small chamber’s seal line is fully open.
Check that all seal lines are completely open.
Ensure that the solution is clear and the bag is not leaking.

2.–5.: see sleep•safe 3000 ml system

The Safe•Lock system for Automated Peritoneal Dialysis (APD):
To set up the Safe•Lock system, refer to its user manual.

1. Preparing the solution: see sleep•safe 5000 ml and 6000 ml systems

2. Remove the protective cap from the end (connector) of the patient’s connecting drain line.
3. Connect the drain lines to the bag.
4. Break the internal lock by bending the drain line and the PIN (plug) in both directions by more than 90°.
5. The bag is now ready for use.

Each bag should be used only once, and any unused solution should be discarded.
After proper training, the medicine balance may be used by the patient at home. During bag exchanges, all procedures taught during training must be strictly followed, and appropriate hygienic conditions must be ensured.
Always check whether the drained dialysate is cloudy. See section 2.

Use of a higher than recommended dose of balance
Excess dialysis solution present in the peritoneal cavity can be drained.
If too many bags have been used, contact your doctor, as disturbances in fluid and/or electrolyte balance may occur.

Missing a dose of balance
You should try to administer the dialysis solution dose recommended for each 24-hour period to avoid potentially life-threatening consequences. If in doubt, contact your treating doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur as a result of peritoneal dialysis procedure:
Very common (may occur in more than 1 in 10 patients):

• Peritonitis, characterized by cloudy dialysate drainage, abdominal pain, fever, malaise, and, in very rare cases, sepsis (blood infection). The bag containing drained dialysate should be shown to the doctor.
• Skin infection at the catheter exit site or along the catheter tunnel, characterized by redness, swelling, pain, discharge, or crusts.
• Abdominal wall hernia.

If any of these adverse reactions occur, a doctor should be informed immediately. Other adverse reactions associated with the procedure are:
Common (may occur in up to 1 in 10 patients):

• Difficulty in infusing or draining the solution from the peritoneal cavity
• A feeling of pressure and fullness in the abdomen
• Shoulder pain

Uncommon (may occur in up to 1 in 100 patients):

• Diarrhea
• Constipation

Rare (may occur in up to 1 in 10,000 patients):

• Sepsis (blood infection)

Frequency not known (cannot be estimated from available data):

• Difficulty breathing
• General malaise
• Sclerosing encapsulating peritonitis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

During treatment with balance, the following adverse reactions may occur:
Very common (may occur in more than 1 in 10 patients):

• Hypokalaemia (potassium deficiency)

Common (may occur in up to 1 in 10 patients):

• High blood sugar levels
• High blood lipid levels
• Weight gain

Uncommon (may occur in up to 1 in 100 patients):

• Hypocalcaemia (calcium deficiency)
• Hypovolaemia (too little body fluid), which may be recognized by rapid weight loss, low blood pressure, and increased heart rate
• Hypervolaemia (too much body fluid), which may be recognized by fluid accumulation in peripheral tissues or lungs, high blood pressure, and difficulty breathing
• Dizziness

Frequency not known (cannot be estimated from available data):

• Hyperparathyroidism, which may lead to bone disorders

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly via the "national reporting system" listed in Annex V. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine balance

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bag and the cardboard box. The expiry date refers to the last day of the stated month.
Do not store at temperatures below 4 °C.
The ready-to-use solution should be used immediately, or at the latest within 24 hours after mixing the solutions from both chambers.

6. Contents of the pack and other information

What the medicine contains balance
The active substances in 1 litre of ready-to-use balance solution are:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.640 g
Sodium (S)-lactate solution 7.85 g
(3.925 g sodium (S)-lactate)
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 25.0 g
(22.73 g glucose)

These quantities of active substances correspond 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.

Other components of balance are: water for injections, hydrochloric acid, sodium hydroxide, sodium bicarbonate.

What the medicine looks like and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 399 mOsm/l, pH value approximately 7.0.
The medicine balance is supplied in a dual-chamber bag. One chamber contains a basic solution of sodium lactate, and the other chamber contains an acidic solution of electrolytes and glucose.

balance is available in the following administration systems (bag volumes and quantities per cardboard box are given):
stay•safe sleep•safe Safe • Lock
4 x 2000 ml 4 x 3000 ml 2 x 5000 ml
4 x 2500 ml 2 x 5000 ml 2 x 6000 ml
4 x 3000 ml 2 x 6000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H.,
Germany

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

Distributor
Fresenius Medical Care Polska S.A.,
tel.: +48 61 83 92 600

This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
see the last page of this multilingual package leaflet.
02/2024

This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
CZ balance 2.3% glucose, 1.25 mmol/l calcium solution for peritoneal dialysis
DE, AT, LU balance 2.3% Glucose, 1.25 mmol/l Calcium, peritoneal dialysis solution
DK balance 2.3 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
EE balance 2.3% glükoos, 1.25 mmol/l kaltsium, peritoneal dialysis solution
EL, CY balance 2.3% γλυκόζη, 1.25 mmol/l ασβέστιο, solution for peritoneal dialysis
ES balance 2.3% glucosa, 1.25 mmol/l de calcio, solución para diálisis peritoneal
FI balance 2.3 % glukoosi, 1.25 mmol/l kalsium, peritoneal dialysis solution
FR Neutravera glucose 2.3%, calcium 1.25 mmol/l, solution for peritoneal dialysis
HR balance 2.3% glukoze, 1.25 mmol/l kalcija, otopina za peritonejsku dijalizu
HU balance 2.3% glükóz, 1.25 mmol/l kalcium peritoneális dializáló oldat
IS balance 2.3% glúkósi, 1.25 mmól/l kalsíum, kviđskilunarlausn
IT balance 2.3% glucosio, 1.25 mmol/l calcio, soluzione per dialisi peritoneale
LT balance 2.3 % gliukozės, 1.25 mmol/l kalcio pilvaplėvės ertmės dializės tirpalas
LV balance 2.3% glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
NL, BE balance 2.3% glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
NO balance 2.3 % glukose, 1.25 mmol kalsium/l, peritonealdialysevæske
PL balance 2.3% z 2.3% glukoza i wapniem 1.25 mmol/l, roztwór do dializy otrzewnowej
PT balance 2.3% glucose, 1.25 mmol/l de cálcio, solução para diálise peritoneal
SE balance 2.3 % glucose, 1.25 mmol/l calcium, peritoneal dialysis fluid
SI balance 23 mg/ml glukoze, 1.25 mmol/l kalcija, raztopina za peritonealno dializo
SK balance 2.3% glucose, 1.25 mmol/l calcium, roztok na peritoneálnu dialýzu
UK(XI) balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis