balance 2,3% z 2,3% glukozom i vapniem 1,25 mmol/l

Leaflet attached to the packaging: patient information

balance 2.3% with 2.3% 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 side effects 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 medicine and what is it used for
• 2. Important information before using balance medicine
• 3. How to use balance medicine
• 4. Possible side effects
• 5. How to store balance medicine
• 6. Package contents and other information
• 1. What is balance medicine and what is it used for Balance medicine is usedin 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 medicine

When not to take balance 2.3% with 2.3% 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 there are metabolic disorders, known as lactic acidosis

Peritoneal dialysis should not be performed on patients 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
• •bowel obstruction
• •lung disease (especially pneumonia)
• •blood infection caused by bacteria
• •very high levels of lipids 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

Inform your doctor immediately 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, abdominal distension, or vomiting.These may be signs of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that can be fatal.

Peritoneal dialysis may 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 medicine 2.3% with 2.3% glucose and calcium 1.25 mmol/l should be used with caution and under the control of the attending physician.
Balance medicine and other medicines
Inform 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, the doctor may change their dosage. This applies especially 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 medicines that lower blood sugar levelsand insulin .Regular blood sugar level 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, consult your doctor before using this medicine.
There is insufficient data on the use of balance medicine in pregnant and breastfeeding women. During pregnancy or breastfeeding, balance medicine should be used only if the doctor considers it absolutely necessary.

Driving and operating machines

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

• 3. How to use balance medicineThis medicine should always be used according to the doctor's or pharmacist's recommendations. 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 there is a feeling of tension in the abdominal area, 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, 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 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•safeor Safe •Lock system is used. 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 medicine should be used only for intraperitoneal infusions.
Balance medicine can only be used if the solution is clear and the bag is undamaged.
Balance medicine 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•safesystem 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 using 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. 
Roll up the bag lying on the outer packaging, starting from one side, so that the interchamber weld line opens. The solutions from both chambers will mix automatically. 
Then roll up the bag, starting from the top edge, so that the lower triangle weld line 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 bag's drains, hang the drainage bag on the lower hook of the infusion stand. 
Insert the patient 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 connector to the disc.

3. Drainage

 Open the clamp on the patient connector. Drainage begins.  Position 

4. Rinsing

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

5. Infusion

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

6. Safety procedure

 Close the patient connector by inserting the pin plug with a seal (PIN) into the end of the connector.  Position 

7. Disconnection

 Remove the protective cap from the new disinfecting cap and screw it onto the old one. 
Unscrew the patient connector from the disc and screw the patient connector 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.System sleep•safefor automated peritoneal dialysis (APD):During automated peritoneal dialysis (APD), the solution is warmed automatically by the cycler. System sleep•safe3000 ml
• 1. Preparing the solution:see stay•safesystem

2. Unfold the bag's drain.

3. Remove the protective cap.

• 4. Insert the bag connector into the free guide of the sleep•safecycler tray.
• 5. The bag is now ready for use with the sleep•safeset.System sleep•safe5000 ml and 6000 ml

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. 
Roll up the bag lying on the outer packaging diagonally, towards the end (connector) of the bag.
The central weld line will open. 
Continue until the small chamber weld line 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•safe3000 ml System Safe•Lockfor automated peritoneal dialysis (APD):During automated peritoneal dialysis (APD), the solution is warmed automatically by the cycler.
• 1. Preparing the solution:see sleep•safe5000 ml and 6000 ml

2. Remove the protective cap from the connector (patient connector) end.

3. Connect the drains to the bag.

4. Break the internal closure by bending the drain and pin plug (PIN) in both

sides 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 medicine 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 medicine 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 medicine
Try to take the recommended dose of dialysis solution for each 24-hour period to avoid potentially life-threatening consequences. In case of doubts, 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:

• 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 path, characterized by redness, swelling, pain, discharge, or scabs.
• abdominal wall hernia

Other side effects of the treatment are:
often(may occur in up to 1 in 10 patients):

• difficulty introducing the solution into the peritoneal cavity or draining it
• feeling of tension and fullness in the abdomen
• shoulder pain

not very often(may occur in up to 1 in 100 patients):

• diarrhea
• constipation

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

• sepsis (blood infection)

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

• breathing difficulties
• general malaise
• encapsulating peritoneal sclerosis; possible symptoms may include abdominal pain, abdominal distension, or vomiting.

During the use of balance medicine, the following side effects may occur:
very often(may occur in more than 1 in 10 patients):

• potassium deficiency

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

• high blood sugar levels
• high lipid levels in the blood
• weight gain

not very often(may occur in up to 1 in 100 patients):

• 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, difficulty breathing
• 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 side effects not listed in this leaflet, 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:
ndl@urpl.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

• 5. How to store balance medicineThe 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 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. Package contents and other information

What does balance medicine contain
Active substancescontained in 1 liter of balance medicine ready for use 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 anhydrous)
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 126.1 mmol/l glucose
Other ingredients of balance medicine are: water for injections, hydrochloric acid, sodium hydroxide, sodium bicarbonate.
What does balance medicine look like and what does the package contain
The solution is clear and colorless.
The theoretical osmolality of the ready-to-use solution is 399 mosm/l, and the pH value is approximately 7.0.
Balance medicine 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 medicine is available in the following application systems (bag volumes and numbers in cardboard boxes are indicated):
stay•safesleep•safeSafe•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 types of packaging may be available.

Responsible entity

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 for sale in the Member States of the European Economic Area under the following names:

see the last page of this multilingual package leaflet.

Date of last update of the leaflet

06/2019