Balance 1.5% with 1.5% glucose and calcium 1.25 mmol/l

Package leaflet: Information for the patient

balance 1.5% with 1.5% glucose and calcium 1.25 mmol/l, solution for peritoneal dialysis
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This 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. Information before using the medicine balance

When not to take the medicine balance 1,5% with 1,5% 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 abnormalities, 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 with metabolic waste products that cannot be treated by blood purification
• severe malnutrition and weight loss, especially if adequate intake of protein-containing food is not possible

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 diarrhoea.
• kidney disorder (polycystic kidney disease)
• peritonitis, which may present with 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 treatment which may 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 nutrients should be ensured. Your doctor will monitor your electrolyte balance, kidney function, body weight and nutritional status.

Medicine 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 the action of certain medicines, 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 potassium levels in the blood and, if necessary, take appropriate measures.
• diuretics (medicines that increase urine output)
• 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 or breastfeeding, suspect you may be pregnant, or are planning to have a child, you should consult your doctor before using this medicine. There are insufficient data on the use of the medicine balance in pregnant and breastfeeding women. During pregnancy or breastfeeding, the medicine balance should be used only if the doctor considers it absolutely necessary.

Driving and operating machinery

The medicine 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 directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
Your doctor will determine the method, duration, frequency, required volume of solution, and dwell
time in the peritoneal cavity.
If you experience a sensation of abdominal fullness, your doctor may recommend reducing the
volume of solution.
Continuous ambulatory peritoneal dialysis (CAPD):

• Adults: The usual dose is 2000 - 3000 ml of solution 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. The recommended initial dose is 600 - 800 ml/m² (up to 1000 ml/m² at night) of body surface area, 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) and 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
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 to warm the
solution due to the risk of localized overheating. After warming, the bag exchange may begin.
1. Preparing the solution
Check the warmed solution bag (label, expiry date, clarity of solution, absence of bag or outer
packaging damage, and no damage to the seal line separating the chambers). Place the bag on a
stable surface.
Open the outer packaging of the bag and the disinfecting cap/stopper cap packaging. Wash hands
with an antiseptic agent. Roll the bag lying on the outer packaging foil, starting from one side, so
that the interchamber seal line opens. The solutions from both chambers will mix automatically.
Then roll the bag from the top edge so that the lower triangle seal line opens completely. Check
that all seal lines are fully open. Ensure 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, unfold the drainage bag’s tubes, and
place the DISC connector in the stabilizing base. After unfolding the drainage bag’s tubes, hang
the drainage bag on the lower hook of the infusion stand. Insert the patient’s connecting tube
end into one of the two holders of the stabilizing base. Insert a new disinfecting cap/stopper cap
into the other empty holder. Disinfect 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. Rinse
After drainage is complete, allow fresh solution to flow into the drainage bag (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 needle plug seal (PIN). Position 
7. Disconnection
Remove the protective cap from the new disinfecting cap/stopper cap and place it onto the old
cap. Unscrew the patient’s connecting tube end from the DISC and screw it onto the new
disinfecting cap/stopper cap.
8. Closing the DISC
Close the DISC with the open end of 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.

sleep•safe system for automated peritoneal dialysis (APD):
To set up the sleep•safe system, refer to its user manual.
sleep•safe system 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 connector into the free guide of the cycler tray.
5. The bag is now ready for use with the sleep•safe set.
sleep•safe system 5000 ml and 6000 ml
1. Preparing the solution
Check the solution bag (label, expiry date, clarity of solution, absence of bag or outer packaging
damage, and no damage to the seal lines separating the chambers).
Place the bag on a stable surface.
Open the outer packaging of the bag.
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 bag’s connector end.
The central seal line will open.
Continue until the small chamber’s seal line opens.
Check that all seal lines are fully open.
Ensure the solution is clear and the bag is not leaking.
2.– 5.: see sleep•safe system 3000 ml
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

2. Remove the protective cap from the end (connector) of the connecting tube.
3. Connect the tubes to the bag.
4. Break the internal lock by bending the tube and needle plug (PIN) 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, 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 remaining in the peritoneal cavity can be drained.
If too many bags have been used, contact your doctor, as fluid and/or electrolyte imbalances may
occur.
Missing a 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 regarding 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 occur in more than 1 in 10 patients):

• Peritonitis, characterized by cloudy dialysate fluid, 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, leakage or crusts.
• Abdominal wall hernia.

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

• Difficulty in introducing the solution into the peritoneal cavity or draining it out
• A feeling of abdominal tension and fullness
• 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 peritonitis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

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

• Potassium deficiency

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

• High blood sugar levels
• High blood lipid levels
• Increase in body weight

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

• Calcium deficiency
• Dehydration, which may be recognized by rapid weight loss, low blood pressure, and increased heart rate
• Fluid overload, which may be recognized by accumulation of water 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 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 through the "national reporting system" listed in Annex V. Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine balance

The medicine should be stored in a place inaccessible and out of sight 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 below 4 °C.
The ready-to-use solution should be used immediately, and no later than within 24 hours after mixing the solutions from both chambers.

6. Contents of the package 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 16.5 g
(15.0 g glucose)
These amounts 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 83.2 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 356 mOsm/l, pH 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 numbers 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 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 medicine is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
see the last page of this multilingual package leaflet.
This medicine is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

CZ balance 1.5% glucose, 1.25 mmol/l calcium solution for peritoneal dialysis
DE, AT, LU balance 1.5% Glucose, 1.25 mmol/l Calcium, Peritonealdialyselösung
DK balance 1.5 % glucose, 1.25 mmol/l calcium, peritoneal dialysis solution
EE balance 1.5% glükoos, 1.25 mmol/l kaltsium, peritoneaaldialüüsilahus
EL, CY balance 1.5% γλυκόζη, 1.25 mmol/l ασβέστιο, διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
ES balance 1.5% glucosa, 1.25 mmol/l de calcio, solución para diálisis peritoneal
FI balance 1.5 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
FR Neutravera glucose 1.5%, calcium 1.25 mmol/l, solution pour dialyse péritonéale
HR balance 1.5% glukoze, 1.25 mmol/l kalcija, otopina za peritonejsku dijalizu
HU balance 1.5% glükóz, 1.25 mmol/l kalcium peritoneális dializáló oldat
IS balance 1.5% glúkósi, 1.25 mmól/l kalsíum, kviðskilunarlausn
IT balance 1.5% glucosio, 1.25 mmol/l calcio, soluzione per dialisi peritoneale
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
NL, BE balance 1.5% glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
NO balance 1.5 % glukose, 1.25 mmol kalsium/l, peritonealdialysevæske
PL balance 1.5% z 1.5% glukozą i wapniem 1.25 mmol/l, roztwór do dializy otrzewnowej
PT balance 1.5% glucose, 1.25 mmol/l de cálcio, solução para diálise peritoneal
SE balance 1.5 % glucose, 1.25 mmol/l calcium, peritonealdialysvätska
SI balance 15 mg/ml glukoze, 1.25 mmol/l kalcija, raztopina za peritonealno dializo
SK balance 1.5% glucose, 1.25 mmol/l calcium, roztok na peritoneálnu dialýzu
UK(XI) balance 1.5% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis