Bicavera with 2.3% glucose and calcium 1.25 mmol/l

Package leaflet: Information for the patient

bicaVera with 2.3% glucose and calcium 1.25 mmol/l
Please read all of this leaflet carefully before using the medicine, because 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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 2.3% 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 hiatal hernia;
• abdominal or intestinal tumors;
• inflammatory bowel diseases;
• intestinal obstruction;
• lung diseases (especially pneumonia);
• bacterial blood infection (sepsis);
• very high levels of fats in the blood;
• accumulation of uremic toxins in the blood that cannot be treated by peritoneal dialysis;
• severe malnutrition and weight loss, especially 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; additional use of calcium-containing phosphate binders and/or vitamin D may be necessary. If this is not possible, a dialysis solution with a higher calcium concentration may be required;
• peritonitis, which may present as cloudy dialysate, abdominal pain, fever, malaise, or, very rarely, sepsis (blood infection). The bag containing the drained dialysate should be shown to the 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 proteins and water-soluble vitamins. To prevent deficiencies, an appropriate diet or supplementation of lost components should be ensured. Your treating physician will monitor electrolyte (salt) balance, blood count, kidney function, body weight and nutritional status.

bicaVera with 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 certain drugs, 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 blood potassium levels and, if necessary, take appropriate measures;
• affecting blood calcium levels, such as calcium-containing drugs 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 you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should consult your doctor before using this medicine.

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

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

3. How to use bicaVera

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
please 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 the child's tolerance, age and body surface area. 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):
This dialysis method uses the sleep•safe system. Bag exchanges are automatically controlled
by a cycler during the night.

• Adults: The usual prescribed dose is 2000 ml (maximum 3000 ml) per exchange, with 3 to 10 exchanges during the night (with the patient connected to the cycler for 8 to 10 hours), plus 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 infusion.

The medicine 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
The stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD):
The solution bag should first be warmed to body temperature 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, warming takes approximately 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.
Once the solution has been warmed, the bag exchange can begin.

1. Preparing the solution
Check the warmed solution bag (label, expiry date, clarity of the solution, absence of damage to the bag and outer packaging, and integrity of the seal lines). Place the bag on a stable surface. Open the outer packaging and the disinfecting cap/closing cap packaging. Wash 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 seal line of the lower triangle opens completely. Check that all seal lines are fully open. Ensure the solution is clear and the bag is not leaking.

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

3. Drainage (Effluent)
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 dial to position 

6. Safety procedure
Automatic closure of the patient’s connecting tube by means of a needle plug with seal (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 from the DISC and screw it onto the new disinfecting cap/closing cap.

8. Closing the DISC
Close the DISC 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, discard it.

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

The sleep•safe 3000 ml system

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

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

The sleep•safe 5 000 ml system
1. Preparing the solution
Check the solution bag (label, expiry date, clarity of the solution, absence of damage to the bag and outer packaging, and integrity of the seal lines). Place the bag on a stable surface. Open the outer packaging. Wash hands with an antiseptic agent. Lay out the bag with the central seal line and the tube with connector. Roll the bag, lying on the outer packaging, diagonally towards the tube end (connector). The central seal line will open. Continue until the seal line of the small chamber opens. Check that all seal lines are fully open. Ensure the solution is clear and the bag is not leaking.

2. – 5. See sleep•safe 3000 ml system

Each bag may be used only once; any unused solution must be discarded.
After appropriate 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 dose of bicaVera
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, please 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 effluent, abdominal pain, fever, malaise, and, in very rare cases, sepsis (blood infection). The bag with 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, leakage, or crusts;
• Abdominal wall hernia. If any of these adverse symptoms occur, the treating physician should be notified immediately.

Other adverse symptoms associated with the procedure include:
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 abdominal tension and fullness
• Shoulder pain

Uncommon (may occur in up to 1 in 100 patients):

• Diarrhea
• Constipation

Frequency not known (cannot be estimated from available data):

• Breathing difficulty caused by elevation of the diaphragm
• Sclerosing encapsulating peritonitis; 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):

• Hypokalaemia (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):

• Hypocalcaemia (calcium deficiency)
• Hypovolaemia (low fluid volume), which may be recognized by rapid weight loss
• Low blood pressure
• Rapid heart rate (tachycardia)
• Hypervolaemia (excess fluid volume), 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 of 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 of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Phone: +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 adverse reactions helps provide more information on the safety of the 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 indicated 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 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 25 g
(glucose 22.73 g)
These quantities 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 126.1 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 399 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 an acidic electrolyte and glucose solution in a 1:1 ratio.
bicaVera is available in the following administration systems (bag volumes and numbers 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 sizes 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 2.3 % glucose, 1.25 mmol/l calcium solution for peritoneal dialysis
DE, AT, BE bicaVera 2.3 % Glucose, 1.25 mmol/l Calcium Peritonealdialyselösung
DK bicaVera 2.3 % Glucose, 1.25 mmol/l calcium, peritonealdialysevæske
EL, CY bicaVera 1.25 mmol/l ασβέστιο, 2.3% γλυκόζη, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
ES bicaVera Glucosa 2.3%, Calcio 1.25 mmol/l solución para diálisis peritoneal
FI bicaVera 2.3 % glukoosi, 1.25 mmol/l kalsium, peritoneaalidialyysineste
FR, BE, LU bicaVera 2.3 % glucose, 1.25 mmol/L calcium solution pour dialyse péritonéale
HR bicaVera 2.3 % glukoze, 1.25 mmol/l kalcija Otopina za peritonejsku dijalizu
IT equiVera 2.3 % Glucosio, 1.25 mmol/l Calcio Soluzione per dialisi peritoneale
LV bicaVera 2.3 % glikoze, 1.25 mmol/l kalcijs, šķīdums peritoneālai dialīzei
NL, BE bicaVera 2.3 % glucose, 1.25 mmol/l calcium, oplossing voor peritoneale dialyse
NO bicaVera 2.3 % glukose, 1.25 mmol/l kalsium peritonealdialysevæske
PL bicaVera z 2,3% glukozą i wapniem 1,25 mmol/l
PT bicaVera 2.3% Glucose 1.25 mmol/l Cálcio, Solução para diálise peritoneal
SE bicaVera 2.3% Glucose, 1.25 mmol/l Calcium, peritonealdialysvätska
UK(XI) bicaVera 2.3 % Glucose, 1.25 mmol/l Calcium Solution for peritoneal dialysis