bicavera z 1,5% glukozom i vapniem 1,25 mmol/l

Leaflet accompanying the packaging: patient information

bicaVera with 1.5% glucose and calcium 1.25 mmol/l

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 or pharmacist.
• 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is bicaVera and what is it used for
• 2. Important information before using bicaVera
• 3. How to use bicaVera
• 4. Possible side effects
• 5. How to store bicaVera
• 6. Contents of the packaging and other information

1. What is bicaVera and what is it used for

bicaVera 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 bicaVera

Do not use bicaVera with 1.5% 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.

Peritoneal dialysis should not be performed in the following cases:

• abdominal changes, such as:
• injuries or previous abdominal surgery;
• severe burns;
• extensive skin inflammation of the abdominal walls;
• peritonitis;
• non-healing, draining wounds;
• umbilical, inguinal, or diaphragmatic hernia;
• tumors in the abdominal cavity or intestines;
• inflammatory bowel disease;
• intestinal obstruction;
• pulmonary diseases (especially pneumonia);
• bacterial blood infection;
• very high levels of lipids in the blood;
• accumulation of uremic toxins in the blood that cannot be treated with peritoneal dialysis;
• severe malnutrition and weight loss, especially if it is not possible to consume an adequate amount of protein-rich food.

Warnings and precautions

Inform your doctor immediately if you experience:

• significant loss of electrolytes (salts)due to vomiting and/or diarrhea;
• hyperparathyroidism or low calcium levels in the blood; additional intake of phosphate-binding agents containing calcium and/or vitamin D may be necessary. If this is not possible, a dialysis solution with a higher calcium concentration may be used;
• peritonitis, which manifests as cloudy dialysate, abdominal pain, fever, malaise, or, in very rare cases, sepsis (blood infection). The bag with the drained dialysate should be shown to the attending physician;
• polycystic kidney disease;
• severe abdominal pain, abdominal distension, or vomiting.These may be signs of sclerosing encapsulating peritonitis, a complication of peritoneal dialysis that can be fatal. Peritoneal dialysis can cause loss of protein and water-soluble vitamins. To prevent deficiencies, a proper diet or supplementation of lost components should be ensured. The attending physician will monitor electrolyte balance (salts), blood morphology, kidney function, body weight, and nutritional status.

bicaVera 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 attending physician may change their dosage. This applies particularly to the following medicines:

• used in heart failure, e.g., digoxin. The attending physician will monitor potassium levels in the blood and, if necessary, take appropriate action;
• affecting calcium levels in the blood, such as calcium-containing medicines or vitamin D;
• increasing urine excretion, such as diuretics;
• lowering blood sugar levelsof oral medicines and insulin .Regular monitoring of blood sugar levels is necessary.

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 bicaVera in pregnant and breastfeeding women. During pregnancy or breastfeeding, bicaVera should only be used if the doctor considers it absolutely necessary.

Driving and operating machinery

bicaVera has no influence or negligible influence on the ability to drive and operate machinery.

3. How to use bicaVera

This medicine should always be used according to the doctor's or pharmacist's instructions. In case of doubts, consult your doctor or pharmacist.
The attending physician 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, the attending physician may recommend reducing the volume of the solution.

Continuous ambulatory peritoneal dialysis (CAPD):

• Adults: The usual dose is 2000 - 2500 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 attending physician will determine the required volume of the dialysis solution, depending on tolerance, age, and body surface area of the child. The recommended initial dose is 600 to 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 of dialysis, the sleep•safesystem is used. Bag exchanges are controlled automatically by the cycler at night.

• Adults:The usual prescribed dose of the solution is 2000 ml (max. 3000 ml) per exchange, with 3 to 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 to 10 exchanges at night. bicaVera should only be used for intraperitoneal infusions.

bicaVera can only be used if the solution is clear and the bag is not damaged.
bicaVera is supplied in a two-chamber bag. Before use, the solutions from both chambers must be mixed, according to the instructions.

Instructions for using the stay•safeSystem 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 warmer used (for a 2000 ml bag with an initial temperature of 22 °C, it takes approximately 120 minutes). More detailed information is contained in the bag warmer's instruction manual. 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 solution bag (label, expiration date, clarity of the solution, no damage to the bag and outer packaging, no damage to the weld seam).  Place the bag on a stable surface.  Open the outer packaging of the bag and the packaging of the disinfecting cap/closing cap.  Wash your hands with a bactericidal agent.  Roll up the bag lying on the outer packaging, starting from one side, so that the central weld seam opens. The solutions from both chambers will mix automatically.  Then roll up the bag starting from the top edge, so that the lower triangle's weld seam is completely opened.  Check that all weld seams 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/closing cap into the other 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 connector. Drainage begins.  Position 

4. Flush

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

5. Infusion

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

6. Safety procedure

 Automatic closure of the patient's drain connector using a needle plug with a seal (PIN).  Position 

7. Disconnection

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

8. Closing the disc.

 Close the disc with the open end of the protective cap that remained in the other holder of the stabilizing base.

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

System sleep•safefor automated peritoneal dialysis (APD):
To set up the sleep•safesystem, refer to its instruction manual.
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's connector into the free guide of the cycler tray.

• 5. The bag is now ready for use with the sleep•safeset.

System sleep•safe 5000 ml

1. Preparing the solution

 Check the solution bag (label, expiration date, clarity of the solution, no damage to the bag and outer packaging, no damage to the weld seam).  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 seam and the drain with the connector.  Roll up the bag lying on the outer packaging diagonally, towards the connector end. The central weld seam will open.  Continue until the small chamber's weld seam is opened.  Check that all weld seams are completely open.  Make sure the solution is clear and the bag does not leak.

• 2.– 5.See System sleep safe3000 ml

Each bag can only be used once, and any unused solution should be discarded.
After proper training, bicaVera can be used by the patient independently at home.
During bag exchanges, all procedures provided during training should be strictly followed, and proper hygiene conditions should be ensured.
Always check that the drained dialysate is not cloudy. See section 2 "Important information before using bicaVera ”.

Using a higher dose of bicaVera than recommended

Excess dialysis solution that has entered the peritoneal cavity can be drained.
In case of using too many bags, contact the attending physician, as fluid and/or electrolyte imbalances may occur.

Missing a dose of bicaVera

Try to take the prescribed dose of dialysis solution for each 24-hour period to avoid potentially life-threatening consequences. In case of doubts, consult the attending physician.
In case of any further doubts about using this medicine, consult your doctor, 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 dialysate, abdominal pain, fever, malaise, and, in very rare cases, sepsis (blood infection). The bag with the drained dialysate should be shown to the attending physician;
• skin inflammation at the catheter exit site or along the catheter, characterized by redness, swelling, pain, discharge, or scabs;
• abdominal wall hernia. If you experience any of these side effects, inform your doctor immediately. Other side effects of the treatment 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 frequency not known(cannot be estimated from the available data):
• breathing difficulties due to diaphragm elevation
• sclerosing encapsulating peritonitis; possible symptoms may include abdominal pain, abdominal distension, or vomiting. During the use of bicaVera, 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 lipids in the blood
• weight gain uncommon(may affect up to 1 in 100 people):
• calcium deficiency
• insufficient body fluids, which may be recognized by rapid weight loss
• low blood pressure
• rapid heart rate (rapid pulse)
• excessive body fluids, which may be recognized by rapid weight gain
• fluid accumulation in peripheral tissues and lungs
• high blood pressure
• breathing difficulties frequency not known(cannot be estimated from the available data):
• hyperparathyroidism, which may lead to bone disorders

Reporting suspected side effects

If you experience any side effects, including any not listed in this leaflet, inform 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,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store bicaVera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the bag and the carton after "EXP". The expiration date refers to the last day of the month.
bica Verastay•safe/ sleep•safe: do not store below 4 °C.
bica Verasleep•safe combo: store at 5 °C – 30 °C.
The ready-to-use solution should be used immediately, at the latest within 24 hours of mixing the solutions from both chambers.
Do not use this medicine if the solution is not clear or if the bag is damaged.

6. Contents of the packaging and other information

What bicaVera contains

The active substances in 1 liter of bicaVera solution ready for use are:

Calcium chloride dihydrate 0.1838 g

Sodium chloride
5.786 g
Sodium bicarbonate
2.940 g
Magnesium chloride hexahydrate
0.1017 g
Glucose monohydrate
16.5 g
(glucose 15.0 g)
These amounts of active substances correspond to:
1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 103.5 mmol/l chloride, 34 mmol/l bicarbonate, and 83.25 mmol/l glucose.
Other components of bicaVera are: water for injections, hydrochloric acid, sodium hydroxide, carbon dioxide.

What bicaVera looks like and contents of the packaging

The solution is clear and colorless.
The theoretical osmolality of the ready-to-use solution is 357 mOsm/l, pH value around 7.4.
bicaVera is supplied in a two-chamber bag. One chamber contains a basic sodium bicarbonate solution, and the other contains an acidic electrolyte and glucose solution in a 1:1 ratio.
bicaVera is available in the following application systems (bag volumes and numbers in cartons are listed):
stay•safe
sleep•safe
4 bags of 2000 ml
4 bags of 3000 ml
4 bags of 2500 ml
2 bags of 5000 ml
sleep•safe combo
2 bags of 5000 ml + disinfecting cap + sleep•safeSet Plus
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:

bica Vera stay•safe / sleep•safe:
Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel, Germany
bica Vera sleep•safe combo:
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H.,
Germany

Distributor:

Fresenius Medical Care Polska S.A.
tel.: +48 61 83 92 600

This medicine is authorized 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.
Date of last revision of the leaflet:02/2023

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

CZ

bicaVera1,5 % glucose, 1,25 mmol/l calciumsolution for peritoneal dialysis

DE, AT, BE

bicaVera1,5 % Glucose, 1,25 mmol/l CalciumPeritonealdialyselösung

DK

bicaVera1,5% Glucose, 1,25 mmol/l calcium, peritonealdialysevæske

EL, CY

bicaVera1,25 mmol/l ασβέστιο, 1,5% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)

ES

bicaVeraGlucosa 1,5%, Calcio 1,25 mmol/lsolución para diálisis peritoneal

FI

bicaVera1,5 % glukoosi, 1,25 mmol/l kalsium, peritoneaalidialyysineste

FR, BE, LU

bicaVera1,5 % glucose, 1,25 mmol/L calciumsolution pour dialyse péritonéale

HR

bicaVera1,5 % glukoze, 1,25 mmol/l kalcijaOtopina za peritonejsku dijalizu

IT

equiVera1,5 % Glucosio, 1,25 mmol/l CalcioSoluzione per dialisi peritoneale

LV

bicaVera1,5 % glikoze, 1,25 mmol/l kalcijs, šķīdums peritoneālai dialīzei

NL, BE

bicaVera1,5 % glucose, 1,25 mmol/l calcium, oplossing voor peritoneale dialyse

NO

bicaVera1,5 % glukose, 1,25 mmol/l kalsiumperitonealdialysevæske

PL bicaVerawith 1.5% glucose and calcium 1.25 mmol/l

PT

bicaVera1,5% Glucose 1,25 mmol/l Cálcio, Solução para diálise peritoneal

SE

bicaVera1,5% Glucose, 1,25 mmol/l Calcium, peritonealdialysvätska

UK(XI)

bicaVera1.5 % Glucose, 1.25 mmol/l CalciumSolution for peritoneal dialysis