balance 4,25% z 4,25% glukozom i vapniem 1,25 mmol/l

Leaflet accompanying the packaging: patient information

Balance 4.25% with 4.25% glucose and calcium 1.25 mmol/l, peritoneal dialysis solution

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Balance and what is it 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 packaging and other information
• 1. What is Balance and what is it used forBalance is used in patients with end-stage, chronic kidney failure to cleanse the bloodthrough the peritoneal membrane. This method of blood cleansing is called peritoneal dialysis.
• 2. Important information before using Balance

When not to use Balance 4.25% with 4.25% glucose and calcium 1.25 mmol/l

• if the potassium level in the blood is very low
• if the calcium level in the blood is very low
• if the volume of body fluids is too low
• if the blood pressure is too low
• if there are metabolic disorders, known as lactic acidosis

Peritoneal dialysis should not be performed in the following cases:

• abdominal changes, such as:
• previous abdominal surgery or injuries
• burns
• severe skin inflammation
• peritonitis
• non-healing, draining wounds
• umbilical, inguinal, or diaphragmatic hernia
• abdominal or intestinal tumors
• inflammatory bowel disease
• intestinal obstruction
• lung disease (especially pneumonia)
• bacterial blood infection
• very high levels of fats in the blood
• poisoning with metabolic products that cannot be treated with blood cleansing
• severe malnutrition and weight loss, especially if it is not possible to take an adequate amount of protein-rich food

Warnings and precautions

You should immediately inform your doctor if you experience:

• excessive parathyroid gland activity(hyperparathyroidism); additional intake of calcium-containing phosphate binders and/or vitamin D may be necessary.
• low calcium levels in the blood; additional intake of calcium-containing phosphate binders and/or vitamin D or the use of a dialysis solution with a higher calcium concentration may be necessary.
• significant loss of electrolytesdue to vomiting and/or diarrhea
• kidney damage(polycystic kidney disease)
• peritonitis, which is characterized by cloudy dialysate and/or abdominal pain. The bag with the drained dialysate should be shown to the 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 can cause loss of water-soluble vitamins. To prevent deficiencies, a proper diet or supplementation of lost components should be ensured. The attending physician will check the 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 with caution and under the control of the attending physician. Balance and other medicinesYou should 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 can affect the action of medicines, your doctor may change their dosage. This applies in particular to the following medicines:
• used in heart failure, such as digoxin. The doctor will check the potassium level in the blood and, if necessary, take appropriate action.
• increasing urine production, such as diuretics
• oral blood sugar-lowering medicinesand insulin. Regular blood sugar checks are necessary. In diabetic patients, it may be necessary to adjust the daily insulin dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
There is not enough 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 using machines

Balance has no or negligible influence on the ability to drive and use machines.

• 3. How to use BalanceThis medicine should always be used exactly as prescribed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist. The doctor will determine the method, duration, and frequency of use, the required volume of the solution, and the dwell time in the peritoneal cavity.

If you experience a feeling of tension in the abdominal area, your doctor may recommend reducing the volume of the solution.

Continuous ambulatory peritoneal dialysis (CAPD):

• Adults: The usual dose is 2000 - 3000 ml of the solution, four times a day, 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 the dialysis solution, depending 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, four times a day.

Automated peritoneal dialysis (APD):

In this method, the sleep•safesystem or Safe •Lock is used. The bag exchanges are controlled automatically by the cycler throughout the night.

• Adults: The usual prescribed dose of the medicine is 2000 ml (max. 3000 ml) per exchange, with 3
• 10 exchanges at night (when 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 at night.

Balance should be used exclusively for intraperitoneal infusions.
Balance can only be used if the solution is clear and the bag is undamaged.
Balance is supplied in a two-chamber bag. Before use, the solutions from both chambers must be mixed according to the description.

Instructions for using the Stay•Safe system for continuous ambulatory peritoneal dialysis (CAPD):

The bag with the solution should first be warmed to body temperature. This is done using an appropriate bag warmer. The warming time for a 2000 ml bag at an initial temperature of 22°C is approximately 120 minutes. More detailed information is contained in the bag warmer's instructions for use. The solution should not be warmed in a microwave oven due to the risk of local overheating.
After warming the solution, the bag exchange can be started.

1. Preparing the solution

 Check the warmed bag with the solution (label, expiration date, clarity of the solution, no damage to the bag and outer packaging, no damage to the weld line separating the bag chambers).  Place the bag on a stable surface. 
Open the outer packaging of the bag and the packaging of the disinfecting cap. 
Wash your hands with a bactericidal agent. 
Fold the bag lying on the foil of the outer packaging, starting from one side, so that the interchamber weld line opens. The solutions from both chambers will mix automatically.  Then fold the bag starting from the top edge, so that the weld line of the lower triangle is completely open.  Check that all weld lines are completely open.  Make sure the solution is clear and the bag does not leak.

2. Preparing the bag exchange

 Hang the bag on the upper hook of the infusion stand, unfold the bag's drains, and place the DISC (disc) connector in the stabilizing base. After unfolding the drains of the drainage bag, hang the drainage bag on the lower hook of the infusion stand.  Insert the patient's drain connector into one of the two holders of the stabilizing base.  Insert a new disinfecting cap into the second free holder. 
Disinfect your hands and remove the protective cap from the disc.  Connect the patient's drain connector to the disc.

3. Drainage

 Open the clamp on the patient's drain. Drainage begins.  Position 

4. Rinsing

 After completing the drainage, introduce fresh solution into the drainage bag (approx. 5 seconds).  Position 

5. Infusion

 Start infusing the solution by turning the knob to position  Position 

6. Safety procedure

 Close the patient's drain by inserting a needle plug with a seal (PIN) into the end of the drain.  Position 

7. Disconnection

 Remove the protective cap from the new disinfecting cap and screw it onto the old one.  Unscrew the patient's drain connector from the disc and screw it onto the new disinfecting cap.

8. Closing the disc.

 Close the disc with the open end of the used disinfecting cap, which remained in the right holder of the stabilizing base.

• 9. Checkthe clarity of the drained dialysate, weigh it, and if the dialysate is clear, discard it.

Sleep•Safe systemfor automated peritoneal dialysis (APD):
During automated peritoneal dialysis (APD), the solution is warmed automatically by the cycler.
Sleep•Safe system 3000 ml

• 1. Preparing the solution:see Stay•Safe system

2. Unfold the bag's drain.

3. Remove the protective cap.

• 4. Insert the bag's connector into the free guide of the Sleep•Safe cycler tray.
• 5. The bag is now ready for use with the Sleep•Safe set.

1. Preparing the solution

 Check the bag with the solution (label, expiration date, clarity of the solution, no damage to the bag and outer packaging, no damage to the weld lines separating the bag chambers). 
Place the bag on a stable surface. 
Open the outer packaging of the bag. 
Wash your hands with a bactericidal agent. 
Unfold the bag with the central weld line and the drain with the bag connector. 
Fold the bag lying on the outer packaging diagonally, towards the end (connector) of the bag.
The central weld line will open. 
Continue until the weld line of the small chamber is open. 
Check that all weld lines are completely open. 
Make sure the solution is clear and the bag does not leak.

• 2.– 5.:see Sleep•Safe system 3000 ml Safe•Lock systemfor automated peritoneal dialysis (APD):During automated peritoneal dialysis (APD), the solution is warmed automatically by the cycler.
• 1. Preparing the solution:see Sleep•Safe system 5000 ml and 6000 ml

2. Remove the protective cap from the drain connector.

3. Connect the drains to the bag.

4. Break the internal closure by bending the drain and the 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 can be used by the patient at home. During bag exchanges, all procedures transmitted during training should be strictly followed, and proper hygiene conditions should be ensured.
Always check that the drained dialysate is not cloudy. See point 2.
Using a higher dose of Balance than recommended
Excess dialysis solution that has entered the peritoneal cavity can be drained.
In case of using too many bags, contact your doctor, as fluid and/or electrolyte imbalances may occur.
Missing a dose of Balance
Try to take the recommended dose of the dialysis solution for each 24-hour period to avoid potentially life-threatening consequences. If in doubt, consult your attending physician.
In case of doubts about the use of this medicine, consult your attending physician, 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 as a result of peritoneal dialysis:
very common(may affect more than 1 in 10 people):

• peritonitis with cloudy drained dialysate, abdominal pain, fever, malaise, and, in very rare cases, sepsis (blood infection). The bag with the drained dialysate should be shown to the doctor.
• skin inflammation at the catheter exit site or along the catheter, characterized by redness, swelling, pain, discharge, or scabs.
• abdominal wall hernia

In case of any of these side effects, inform your doctor immediately.
Other side effects of peritoneal dialysis are:
common(may affect up to 1 in 10 people):

• difficulty introducing the solution into the peritoneal cavity or draining it
• feeling of tension 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 the available data):
• breathing difficulties
• general malaise
• encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, bloating, or vomiting.

During the use of Balance, the following side 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 levels of fats in the blood
• weight gain uncommon(may affect up to 1 in 100 people):
• calcium deficiency
• too little body fluid, which can be recognized by rapid weight loss, low blood pressure, rapid heart rate
• too much body fluid, which can be recognized by water accumulation in peripheral tissues or lungs, high blood pressure, breathing difficulties
• dizziness

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

• hyperparathyroidism, which can lead to bone disorders

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, PL-02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail:
[email protected].
By reporting side effects, you can help provide more information on the safety of this medicine.

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

6. Contents of the packaging and other information

What Balance contains
The active substancescontained in 1 liter of the 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 46.75 g
(42.5 g anhydrous 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 235.8 mmol/l glucose
Other components of Balance are: water for injections, hydrochloric acid, sodium hydroxide, sodium bicarbonate.
What Balance looks like and what the packaging contains
The solution is clear and colorless.
The theoretical osmolality of the ready-to-use solution is 509 mOsm/l, and the pH value is approximately 7.0.
Balance is supplied in a two-chamber bag. One chamber contains a basic sodium lactate solution, and the other contains an acidic electrolyte and glucose solution.
Balance is available in the following application systems (bag volumes and numbers in cardboard boxes are specified):
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 packaging types may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

see the last page of this multilingual packaging leaflet.

Date of last revision of the leaflet

06/2019