Bicavera with 4.25% glucose and calcium 1.25 mmol/l

Package leaflet: Information for the patient

bicaVera with 4.25% glucose and calcium 1.25 mmol/l
Please read carefully the entire leaflet before use, 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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 bicaVera is and what it is 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 pack and other information

1. What bicaVera is and what it is used for

bicaVera 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. Important information before using bicaVera

Do not use bicaVera with 4.25% glucose and calcium 1.25 mmol/l

• if blood potassium levels are very low;
• if blood calcium levels are very low;
• if body fluid volume is too low;
• if blood pressure is low.

Peritoneal dialysis must not be performed in patients with the following conditions:

• abdominal abnormalities such as:
• abdominal trauma or previous abdominal surgery;
• severe burns;
• extensive inflammatory skin conditions of the abdominal wall;
• peritonitis;
• non-healing, draining wounds;
• umbilical, inguinal or diaphragmatic 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;
• significant accumulation of uremic toxins in the blood that cannot be treated by peritoneal dialysis;
• severe malnutrition and weight loss, particularly if adequate intake of protein-containing food is not possible.

Warnings and precautions

Inform your doctor immediately if any of the following occur:

• significant loss of electrolytes (salts) caused by vomiting and (or) diarrhoea;
• hyperparathyroidism or low blood calcium levels; supplementation with calcium-containing phosphate binders and (or) vitamin D may be necessary. If this is not possible, dialysis solution with a higher calcium concentration may be required;
• peritonitis, which may present as cloudy dialysate, abdominal pain, fever, malaise, or, in very rare cases, sepsis (blood infection). The bag containing drained dialysate should be shown to your treating physician;
• polycystic kidney disease;
• 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, appropriate dietary intake or supplementation should be ensured. Your treating physician will monitor electrolyte balance (salts), blood count, kidney function, body weight, and nutritional status.

bicaVera and other medicines

Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take. Since peritoneal dialysis may affect the action of medicines, your treating physician 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 blood calcium levels, such as calcium-containing medicines or vitamin D;
• increasing urine excretion, such as diuretics;
• medicines lowering blood glucose levels, including oral antidiabetic drugs and insulin. Regular monitoring of blood glucose levels is required.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

There are insufficient data on the use of bicaVera in pregnant or breastfeeding women.
During pregnancy or breastfeeding, bicaVera should only be used if the physician
considers it absolutely necessary.

Driving and operating machinery
bicaVera has no effect or only a negligible effect on the ability to drive and
operate machinery.

3. How to use bicaVera

This medicine should always be used exactly as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Your doctor will determine the method, duration and frequency of administration, the required volume
of solution, and the dwell time in the peritoneal cavity.
If you experience a feeling of abdominal fullness, your doctor may recommend reducing
the volume of the solution.

Continuous Ambulatory Peritoneal Dialysis (CAPD):

• Adults: The usual dose is 2000–2500 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: Your doctor will determine the required volume of dialysis solution based 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, administered four times daily.

Automated Peritoneal Dialysis (APD):
In this dialysis method, the sleep•safe system is used. Bag exchanges are automatically controlled
by a cycler during the night.

• Adults: The usual prescribed dose is 2000 ml (max. 3000 ml) per exchange, with 3 to 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 to 10 exchanges during the night.
  The medicine bicaVera must be used exclusively for intraperitoneal infusions.

bicaVera may only be used if the solution is clear and the bag is undamaged.
bicaVera is supplied in a dual-chamber bag. Before use, the solutions from both chambers
must be mixed according to the instructions.

Instructions for Use

System stay•safe for Continuous Ambulatory Peritoneal Dialysis (CAPD):
The bag containing the solution 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 takes approximately 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. Once the solution has been warmed, you may begin the bag exchange procedure.

1. Preparing the solution
Check the warmed solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging, absence of damage to seal lines). Place the bag on a stable surface. Open the outer packaging of the bag and the disinfecting cap/closing cap packaging. Wash your hands with an antiseptic agent. Roll the bag lying on the outer packaging, starting from one side, so that the central seal line opens. The solutions from both chambers will mix automatically. Then continue rolling the bag from the top edge so that the lower triangular seal line opens completely. Check that all seal lines are fully open. Ensure that the solution is clear and the bag is not leaking.

2. Preparing for bag exchange
Hang the bag on the upper hook of the IV pole, unroll the drainage lines, and place the DISC connector (disk) into the stabilizing base. After unrolling the drainage bag lines, hang the drainage bag on the lower hook of the IV pole. Insert the patient’s connecting tube end into one of the two holders on the stabilizing base. Insert the new disinfecting cap/closing cap into the second, empty holder. Disinfect your hands and remove the protective cap from the disk. Connect the patient’s connecting tube end to the disk.

3. Drainage (Effluent)
Open the clamp on the patient’s connecting tube. Drainage begins. Position 

4. Rinse
After completion of drainage, allow fresh solution to flow into the drainage bag (approximately 5 seconds). Position 

5. Infusion
Begin infusing the solution by turning the valve to position 

6. Safety procedure
Automatic closure of the patient’s connecting tube via the needle plug with seal (PIN). Position 

7. Disconnection
Remove the protective cap from the new disinfecting cap/closing cap and place it onto the old cap. Unscrew the patient’s connecting tube from the disk and screw the patient’s connecting tube onto the new disinfecting cap/closing cap.

8. Closing the disk
Close the disk by placing the open end of the protective cap, which remained in the other holder of the stabilizing base, over it.

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

System sleep•safe for Automated Peritoneal Dialysis (APD):
To set up the sleep•safe system, refer to its user manual.

System sleep•safe 3000 ml

1. Preparing the solution: see stay•safe system.

2. Unroll the bag’s drainage line.
3. Remove the protective cap.
4. Insert the end (connector) of the bag’s drainage line into the empty guide of the cycler tray.
5. The bag is now ready for use with the sleep•safe set.

System sleep•safe 5000 ml

1. Preparing the solution
Check the solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging, absence of damage to seal lines). Place the bag on a stable surface. Open the outer packaging of the bag. Wash your hands with an antiseptic agent. Unfold the bag with the central seal line and the drainage line with connector. Roll the bag lying on the outer packaging diagonally towards the end (connector) of the bag. The central seal line will open. Continue until the small chamber’s seal line opens. Check that all seal lines are fully open. Ensure that the solution is clear and the bag is not leaking.

2. – 5. See System sleep•safe 3000 ml

Each bag may be used only once, and any unused solution remaining must be discarded.
After proper training, bicaVera may be self-administered 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 “Important information before using bicaVera”.

Use of a higher than recommended dose of bicaVera
Excess dialysis solution remaining in the peritoneal cavity can be drained.
If too many bags have been used, contact your doctor, as disturbances in fluid and/or electrolyte balance may occur.

Missed administration of bicaVera
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 doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 drainage fluid, abdominal pain, fever, malaise, and, in very rare cases, sepsis (blood infection). The bag containing drained dialysate should be shown to the treating physician;
• Skin infection at the catheter exit site or along the catheter tunnel, characterized by redness, swelling, pain, discharge, or crusts;
• Abdominal wall hernia. If any of these adverse symptoms occur, the treating physician should be notified immediately. Other adverse symptoms related to the procedure are: Common (may occur in up to 1 in 10 patients):
• Difficulty in infusing the solution into the peritoneal cavity or in draining it out
• Sensation of pressure and fullness in the abdomen
• Shoulder pain Uncommon (may occur in up to 1 in 100 patients):
• Diarrhea
• Constipation Frequency not known (cannot be estimated from available data):
• Difficulty breathing due to elevation of the diaphragm
• Sclerosing peritoneal thickening; possible symptoms include abdominal pain, abdominal distension, or vomiting. During treatment with bicaVera, the following adverse reactions may occur: Very common (may occur in more than 1 in 10 patients):
• Hypokalemia (potassium deficiency) Common (may occur in up to 1 in 10 patients):
• High blood sugar levels
• High blood lipid levels
• Weight gain Uncommon (may occur in up to 1 in 100 patients):
• Hypocalcemia (calcium deficiency)
• Hypovolemia (insufficient body fluids), which may be recognized by rapid weight loss
• Low blood pressure
• Rapid heart rate (tachycardia)
• Hypervolemia (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 available data):
• Hyperparathyroidism, which may lead to bone disorders Reporting suspected adverse reactions If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Adverse reactions can also be reported to the marketing authorization holder. Reporting suspected adverse reactions helps to increase knowledge about 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 expiry date stated on the bag and the cardboard
box after "EXP". The expiry date refers to the last day of the stated month.
bicaVera stay • safe / sleep • safe: do not store below 4 °C.
bicaVera sleep • safe combo: store at 5 °C – 30 °C.
The ready-to-use solution should be used immediately, no later than within 24 hours after
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 pack and other information

What bicaVera contains
The active substances contained in 1 litre of ready-to-use bicaVera solution are:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.786 g
Sodium hydrogen carbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 46.75 g
(glucose 42.5 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 235.9 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 pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution is 509 mOsm/l, pH value approximately 7.4.
bicaVera is supplied in a dual-chamber bag. One chamber contains an alkaline sodium bicarbonate
solution, and the other chamber contains an acidic electrolyte and glucose solution in a 1:1 ratio.
bicaVera is available in the following administration systems (bag volumes and number of bags per
cardboard box are given):
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•safe Set Plus
Not all pack types may be marketed.

Marketing Authorisation Holder:
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H.,
Germany

Manufacturer:
bicaVera stay•safe / sleep•safe:
Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel, Germany
bicaVera 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 medicinal product is authorised 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 package leaflet.

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
CZ bicaVera 4.25 % glucose, 1.25 mmol/l calcium solution for peritoneal dialysis
DE, AT, BE bicaVera 4.25 % Glucose, 1.25 mmol/l Calcium Peritonealdialyselösung
DK bicaVera 4.25 % Glucose, 1.25 mmol/l calcium, peritonealdialysevæske
EL, CY bicaVera 1.25 mmol/l ασβέστιο, 4.25% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
ES bicaVera Glucosa 4.25%, Calcio 1.25 mmol/l solución para diálisis peritoneal
FI bicaVera 4.25 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
FR, BE, LU bicaVera 4.25 % glucose, 1.25 mmol/L calcium solution pour dialyse péritonéale
HR bicaVera 4.25 % glukoze, 1.25 mmol/l kalcija Otopina za peritonejsku dijalizu
IT equiVera 4.25 % Glucosio, 1.25 mmol/l Calcio Soluzione per dialisi peritoneale
LV bicaVera 4.25 % glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
NL, BE bicaVera 4.25 % glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
NO bicaVera 4.25 % glukose, 1.25 mmol/l kalsium peritonealdialysevæske
PL bicaVera z 4,25% glukozą i wapniem 1,25 mmol/l
PT bicaVera 4.25% Glucose 1.25 mmol/l Cálcio, Solução para diálise peritoneal
SE bicaVera 4.25% Glucose, 1.25 mmol/l Calcium, peritonealdialysvätska
UK(XI) bicaVera 4.25 % Glucose, 1.25 mmol/l Calcium Solution for peritoneal dialysis