Balance 1.5% with 1.5% glucose and calcium 1.75 mmol/l

Package leaflet: Information for the patient

balance 1.5% with 1.5% glucose and calcium 1.75 mmol/l, solution for peritoneal dialysis
Please read this leaflet carefully 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:

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 kidney 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 1.5% with 1.5% glucose and calcium 1.75 mmol/l

• if blood potassium levels are very low
• if blood calcium levels are very high
• 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
• extremely 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:

• significant loss of electrolytes caused by vomiting and/or diarrhoea.
• kidney disorder (e.g. polycystic kidney disease)
• peritonitis, which may manifest as cloudy dialysate and/or abdominal pain. The bag with drained dialysate should be shown to your doctor.
• severe abdominal pain, abdominal distension 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 components should be ensured. Your doctor will monitor your electrolyte balance, kidney function, body weight and nutritional status.

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 medicines, your doctor may adjust their dosage. This particularly applies to the following medicines:

• used in heart failure, e.g. digoxin. Your doctor will monitor potassium levels in the blood and, if necessary, take appropriate measures.
• affecting calcium levels, such as calcium-containing medicines or vitamin D.
• increasing urine excretion, such as diuretics.
• oral medicines lowering blood sugar levels and insulin. Regular monitoring of blood glucose levels is necessary. In diabetic patients, daily insulin dosage may need to be adjusted.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think 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 balance in pregnant and breastfeeding women. During pregnancy or breastfeeding, balance should be used only if the doctor considers it absolutely necessary.

Driving and operating machinery

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

3. How to use balance

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The 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, the 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: The 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):
In this dialysis method, the sleep•safe or Safe*•*Lock system is used. 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 exchanges during the day.
• 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.

Medicine balance must be used exclusively for intraperitoneal infusions.
Medicine 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. 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, it usually takes 120 minutes).
More detailed information is provided in the bag warmer’s user manual.
Do not use a microwave oven to warm the solution due to the risk of local overheating.
After warming the solution, the bag exchange can begin.

1. Preparing the solution
Check the warmed solution bag (label, expiry date, clarity of the 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/closing cap packaging.
Wash hands with an antiseptic agent.
Roll the bag lying on the outer packaging foil, starting from one side, so that the inter-chamber seal line opens.
The solutions from both chambers will mix automatically. Then roll the bag starting from the top edge so that the lower triangle seal line opens completely.
Check whether 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 IV stand, unroll the drainage bag’s tubes, and place the DISC connector (disk) 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 in the stabilizing base.
Insert a new disinfecting cap/closing cap into the second empty holder.
Disinfect hands and remove the protective cap from the disk. Connect the patient’s connecting tube end to the disk.

3. Drainage (Effluent flow)
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 (Inflow)
Begin infusion by turning the knob to position 

6. Safety procedure
Automatic closure of the patient’s connecting tube with a pin-and-seal plug (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 end from the disk and screw it onto the new disinfecting cap/closing cap.

8. Closing the disk
Close the disk using 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.

The 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 connector 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 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 the 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 whether all seal lines are completely open.
Ensure 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 tube.
3. Connect the tubes to the bag.
4. Break the internal seal by bending the tube and the pin 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, 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 not 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 are used, contact your doctor, as disturbances in fluid and/or electrolyte balance may occur.

Missed 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 doubts regarding the use of this medicine, 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 symptoms may occur as a result of peritoneal dialysis procedure:
Very common (may affect more than 1 in 10 people):

• Peritonitis, with 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, leakage, or crusts.
• Abdominal wall hernia. If any of these adverse symptoms occur, inform your doctor immediately. Other adverse symptoms related to the procedure include: Common (may affect up to 1 in 10 people):
• Difficulty in introducing the solution into the peritoneal cavity or draining it out
• Feeling of pressure and fullness in the abdomen
• 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):

• Difficulty breathing
• General malaise
• Sclerosing peritonitis; possible symptoms include abdominal pain, abdominal distension, or vomiting. During treatment with balance, the following adverse reactions may occur: Very common (may affect more than 1 in 10 people):
• Potassium deficiency

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

• Excess calcium, if too much calcium is taken
• High blood sugar levels
• High blood lipid levels
• Increased body weight

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

• Insufficient body fluids, which may be recognized by rapid weight loss, low blood pressure, and increased heart rate
• Excessive body fluids, which may be recognized by fluid accumulation in peripheral tissues or lungs, high blood pressure, and breathing difficulties
• Dizziness

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the "national reporting system" listed in Annex V. Reporting adverse reactions helps to 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 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, no later than within 24 hours after mixing the solutions from both chambers.

6. Contents of the packaging and other information

What the medicinal product balance contains
The active substances in 1 litre of ready-to-use solution of balance are:
Calcium chloride dihydrate 0.2573 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:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 101.5 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 hydrogen carbonate.

What balance looks like and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 358 mOsm/l, pH value is approximately 7.0.
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 (the volumes of bags and their numbers in cardboard boxes 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 in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
see the last page of this multilingual package leaflet.
This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
CZ balance 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
DE, AT, LU balance 1.5% Glucose, 1.75 mmol/l Calcium, Peritonealdialyselösung
DK balance 1.5 % glucose, 1.75 mmol/l calcium, peritonealdialysevæske
EE balance 1.5% glükoos, 1.75 mmol/l kaltsium, peritoneaaldialüüsilahus
EL, CY balance 1.5% γλυκόζη, 1.75 mmol/l ασβέστιο, διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
ES balance 1.5% glucosa, 1.75 mmol/l de calcio, solución para diálisis peritoneal
FI balance 1.5 % glukoosi, 1.75 mmol/l kalsium, peritoneaalidialyysineste
FR Dialyse Péritonéale Continue Ambulatoire 2, solution pour dialyse péritonéale
HR balance 1.5% glukoze, 1.75 mmol/l kalcija, otopina za peritonejsku dijalizu
HU balance 1.5% glükóz, 1.75 mmol/l kalcium, peritoneális dializáló oldat
IT equibalance 1.5% glucosio, 1.75 mmol/l calcio, soluzione per dialisi peritoneale
LT balance 1.5 % gliukozės, 1.75 mmol/l kalcio, pilvaplėvės ertmės dializės tirpalas
LV balance 1.5% glikoze, 1.75 mmol/l kalcijs, šķīdums peritoneālai dialīzei
NL, BE balance 1.5% glucose, 1.75 mmol/l calcium, oplossing voor peritoneale dialyse
NO balance 1.5 % glukose, 1.75 mmol kalsium/l, peritonealdialysevæske
PL balance 1.5% z 1.5% glukoza i wapniem 1.75 mmol/l, roztwór do dializy otrzewnowej
PT balance 1.5% glucose, 1.75 mmol/l de cálcio, solução para diálise peritoneal
RO balance 1.5% glucoză, 1.75 mmol/l calciu, soluţie pentru dializă peritoneală
SE balance 1.5 % glucose, 1.75 mmol/l calcium, peritonealdialysvätska
SI balance 15 mg/ml glukoze, 1.75 mmol/l kalcija, raztopina za peritonealno dializo
SK balance 1.5% glucose, 1.75 mmol/l calcium, roztok na peritoneálnu dialýzu
UK(XI) balance 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis