Balance 4.25% with 4.25% glucose and calcium 1.25 mmol/l

Package leaflet: Information for the patient

balance 4.25% with 4.25% glucose and calcium 1.25 mmol/l, solution for peritoneal dialysis
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. The medicine may harm others, 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 of the leaflet:

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 take balance 4.25% with 4.25% glucose and calcium 1.25 mmol/l

• if blood potassium levels are very low
• if blood calcium levels are very low
• if body fluid volume is too low
• if blood pressure is too low
• if there are metabolic disorders known as lactic acidosis

Peritoneal dialysis must not be performed in the following cases:

• abdominal abnormalities, such as:
• previous abdominal surgeries or injuries
• burns
• severe skin inflammatory conditions
• 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 with metabolic waste 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); additional treatment with calcium-containing phosphate binders and/or vitamin D may be necessary.
• low blood calcium levels; additional treatment with calcium-containing phosphate binders and/or vitamin D or use of a dialysis solution with a higher calcium concentration may be necessary.
• significant loss of electrolytes due to vomiting and/or diarrhea.
• kidney disease (e.g. polycystic kidney disease)
• peritonitis, which manifests as cloudy dialysate and/or abdominal pain. The bag containing 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 that can be life-threatening.

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

Due to the high glucose concentration, balance 4.25% with 4.25% 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 dialysis may affect how medicines work, your doctor may need to adjust their dosage. This particularly applies to the following medicines:

• medicines used in heart failure, e.g. digoxin. Your doctor will monitor your blood potassium levels and take appropriate action if necessary.
• diuretics (medicines that increase urine production)
• oral antidiabetic medicines and insulin. Blood glucose levels should be monitored regularly. In diabetic patients, the daily insulin dose may need to be adjusted.

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

Driving and operating machinery
balance has no effect or only a negligible effect on the ability to drive and operate machinery.

3. How to use balance

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
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 a feeling of abdominal fullness occurs, 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 the child’s tolerance, age, and body surface area. The recommended initial dose is 600–800 ml/m² (up to 1000 ml/m² at night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD):
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 + 10 exchanges during the night (with the patient connected to the cycler for 8 to 10 hours), plus one or two daytime exchanges.
• Children: The exchange volume should be 800–1000 ml/m² (up to 1400 ml/m²) of body surface area, with 5–10 exchanges during the night.

The medicine balance must be used exclusively for intraperitoneal infusions. balance may only be used if the solution is clear and the bag is undamaged. balance is supplied in a dual-chamber bag. Before use, the solutions from both chambers must be mixed according to 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 using an appropriate bag warmer. The warming time depends on the bag volume and the type of warmer used (e.g., for a 2000 ml bag initially at 22°C, warming usually takes 120 minutes). More detailed information can be found in the bag warmer’s user manual.
Do not use a microwave oven to warm the solution, due to the risk of localized overheating.
After warming the solution, 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 and the disinfecting cap/closing cap packaging. Wash hands with an antiseptic agent. Roll the bag lying on the outer packaging foil from one side to open the interchamber seal line. The solutions from both chambers will mix automatically. Then continue rolling the bag from the top edge until the lower triangular seal line is fully opened. Check that all seal lines are completely open. Ensure the solution is clear and the bag is leak-free.

2. Preparing the bag exchange
Hang the bag on the upper hook of the IV stand. Unroll the drainage bag’s tubes and place the DISC connector into the stabilizing base. After unrolling the drainage bag’s tubes, hang the drainage bag on the lower hook of the IV stand. Insert the patient’s connecting tube end into one of the two holders on the stabilizing base. Insert a new disinfecting cap/closing cap into the other empty holder. Disinfect your hands and remove the protective cap from the DISC. Connect the patient’s connecting tube end to the DISC.

3. Drainage
Open the clamp on the patient’s connecting tube. Drainage begins. Position 

4. Rinsing
After drainage is complete, allow fresh solution to flow into the drainage bag for approximately 5 seconds. Position 

5. Infusion
Begin infusion by turning the dial to Position 

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

7. Disconnection
Remove the protective cap from the new disinfecting cap/closing cap and place it over the old cap. Unscrew the patient’s connecting tube from the DISC and screw it onto the new disinfecting cap/closing cap.

8. Closing the DISC
Close the DISC 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, discard it.

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

sleep•safe 3000 ml
1. Preparing the solution: see stay•safe system

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

sleep•safe 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.
Wash hands with an antiseptic agent.
Unfold the bag with the central seal line and the tube with connector.
Roll the bag, lying on the outer packaging, diagonally toward the tube end (connector).
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 the solution is clear and the bag is leak-free.

2.–5.: see sleep•safe 3000 ml system

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 tube.
3. Connect the tubes to the bag.
4. Break the internal lock by bending the tube and luer plug (PIN) in both directions by more than 90°.
5. The bag is now ready for use.

Each bag should be used only once. Any unused solution must be discarded.
After proper training, 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 point 2.

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

Missed dose of balance
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 about the use of this medicine, consult your treating doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse symptoms may occur as a result of peritoneal dialysis procedure:
Very common (may affect more than 1 in 10 people):

• Peritonitis, with cloudy dialysate fluid, abdominal pain, fever, malaise and, very rarely, sepsis (blood infection). The bag with 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 symptoms occur, a doctor should be informed immediately.

Other adverse symptoms associated with the procedure include:
Common (may affect up to 1 in 10 people):

• Difficulty in infusing the solution into the peritoneal cavity or in draining it out
• Feeling of abdominal tension and fullness
• Shoulder pain

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

• Diarrhea
• Constipation

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

• Sepsis (blood infection)

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

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

During treatment with balance, the following adverse effects may occur:
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 lipid levels
• Increased body weight

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

• 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 breathing difficulties
• Dizziness

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

• Hyperparathyroidism, which may lead to bone disorders

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

5. How to store the medicine 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 cardboard box. The expiry date refers to the last day of the stated month.
Do not store below 4 °C.
The ready-to-use solution should be used immediately, no later than 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 solution of balance 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 46.75 g
(42.5 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 235.8 mmol/l glucose.
Other components of balance are: water for injections, hydrochloric acid, sodium hydroxide, sodium
bicarbonate.

What the medicine balance looks like and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 509 mOsm/l, pH value approximately 7.0.
The medicine balance is supplied in a dual-chamber bag. One chamber contains an alkaline sodium
lactate solution and the other an acidic solution of electrolytes and glucose.

balance is available in the following administration systems (bag volumes and number of bags per carton 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 types 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 in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
see the last page of this multilingual packaging leaflet.
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
CZ balance 4.25% glucose, 1.25 mmol/l calcium solution for peritoneal dialysis
DE, AT, LU balance 4.25% Glucose, 1.25 mmol/l Calcium, Peritonealdialyselösung
DK balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
EE balance 4.25% glükoos, 1.25 mmol/l kaltsium, peritoneal dialysis solution
EL, CY balance 4.25% γλυκόζη, 1.25 mmol/l ασβέστιο, solution for peritoneal dialysis
ES balance 4.25% glucosa, 1.25 mmol/l de calcio, solution for peritoneal dialysis
FI balance 4.25 % glukoosi, 1.25 mmol/l kalsium, peritoneal dialysis solution
FR Neutravera glucose 4.25%, calcium 1.25 mmol/l, solution for peritoneal dialysis
HR balance 4.25% glukoze, 1.25 mmol/l kalcija, otopina za peritonejsku dijalizu
HU balance 4.25% glükóz, 1.25 mmol/l kalcium, peritoneális dializáló oldat
IS balance 4.25% glúkósi, 1.25 mmól/l kalsíum, kviðskilunarlausn
IT balance 4.25% glucosio, 1.25 mmol/l calcio, soluzione per dialisi peritoneale
LT balance 4.25 % gliukozės, 1.25 mmol/l kalcio, pilvaplėvės ertmės dializės tirpalas
LV balance 4.25% glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
NL, BE balance 4.25% glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
NO balance 4.25 % glukose, 1.25 mmol kalsium/l, peritoneal dialysis solution
PL balance 4.25% z 4.25% glukoza i wapniem 1.25 mmol/l, roztwór do dializy otrzewnowej
PT balance 4.25% glucose, 1.25 mmol/l de cálcio, solução para diálise peritoneal
SE balance 4.25 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
SI balance 42.5 mg/ml glukoze, 1.25 mmol/l kalcija, raztopina za peritonealno dializo
SK balance 4.25% glucose, 1.25 mmol/l calcium, roztok na peritoneálnu dialýzu
UK(XI) balance 4.25% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis