Bicavera glucose 1.5%, calcium 1.75 mmol/l solution for peritoneal dialysis

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

bicaVera Glucose 1.5%, Calcium 1.75 mmol/l solution for peritoneal dialysis

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What bicaVera is and what it is used for
2. What you need to know 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 to clean the blood through the peritoneum in patients with end-stage chronic renal failure. This type of blood cleansing is known as peritoneal dialysis.

2. What you need to know before starting to use bicaVera

Do not use bicaVera Glucose 1.5%, Calcium 1.75 mmol/l

• if your blood potassium level is very low
• if your blood calcium level is very high

Peritoneal dialysis must not be started if you have

• abdominal disorders such as

• wounds, or following surgical intervention

• severe burns

• extensive inflammatory skin reactions

• peritonitis

• non-healing, suppurating wounds

• umbilical, inguinal, or diaphragmatic hernias

• tumors in the abdomen or intestine

• inflammatory bowel diseases

• intestinal obstruction

• lung disease, especially pneumonia

• generalized bacterial blood infection (sepsis)

• very high levels of fat in the blood (hyperlipidemia)

• accumulation in the blood of toxins originating from urine that cannot be eliminated by peritoneal dialysis

• malnutrition and severe weight loss, especially when adequate protein nutrition is not possible

Warnings and precautions

Contact your doctor immediately:

• in case of severe loss of electrolytes (salts) caused by vomiting and/or diarrhea
• if you have peritonitis, which may be recognized by cloudy dialysis fluid draining from your abdomen, abdominal pain, fever, feeling unwell, or, very rarely, blood infection (sepsis).

Please show your doctor the bag containing the drained solution.

• if you experience severe abdominal pain, abdominal distension, or vomiting. These symptoms may indicate encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that may be life-threatening.

Peritoneal dialysis may cause loss of proteins and water-soluble vitamins. It is recommended that you follow an adequate diet or take nutritional supplements to prevent nutritional deficiencies.

Your doctor should monitor your electrolyte (salts) balance, blood cell counts, kidney function, body weight, and nutritional status.

Use of bicaVera with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Peritoneal dialysis may alter the effect of certain medicines, so your doctor may need to adjust the dose of some of them, especially the following:

• Medicines for heart failure, such as digitoxin.

Your doctor will determine your blood potassium level and, if necessary, take appropriate measures.

• Medicines affecting calcium levels, such as those containing calcium or vitamin D.
• Medicines that increase urine excretion, such as diuretics.
• Insulin or oral medicines that lower blood sugar levels. Your blood glucose level should be monitored regularly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There are insufficient data on the use of bicaVera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, bicaVera should only be used if your doctor considers it absolutely necessary.

Driving and using machines

The effect of bicaVera on the ability to drive and use machines is none or negligible.

3. How to use bicaVera

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the method, duration and frequency of use, as well as the required volume of solution and the dwell time in the peritoneal cavity.

If you have abdominal discomfort or pressure, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: The usual dose is 2000 – 2500 ml of solution four times daily, depending on body weight and renal function.

The solution is drained after a dwell time of 2 to 10 hours.

• Children: The physician will determine the required dialysis solution volume based on the child's tolerance, age, and body surface area.

The recommended initial dose is 600 – 800 ml/m² body surface area four times daily (up to 1000 ml/m² at night).

Automated Peritoneal Dialysis (APD)

For this type of dialysis, the sleep•safe system is used. Bag exchanges are automatically controlled overnight by the sleep•safe cycler.

• Adults: The typical prescription is 2000 ml (maximum 3000 ml) per exchange, with 3–10 exchanges overnight and cycler time of 8 to 10 hours, plus one or two daytime exchanges.

• Children: The volume per exchange should be 800–1000 ml/m² (up to 1400 ml/m²) body surface area, with 5–10 exchanges overnight.

Use bicaVera only in the peritoneal cavity.

Use bicaVera only if the solution is clear and the bag is undamaged.

bicaVera is supplied in a dual-chamber bag. Before use, the solutions from the two chambers must be mixed as described.

Instructions for use:

For use of thestay•safe** system in Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the solution bag to body temperature. This should be done using an appropriate heating plate. Heating time depends on the bag volume and the specific bag warmer used (for a 2000 ml bag starting at 22 °C, approximately 120 minutes). More detailed information can be found in your warmer’s instruction manual. Do not use a microwave oven to heat the solution due to the risk of local overheating. Bag exchange may be performed after the solution has been warmed.

1. Preparation of the solution

? Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overwrap, integrity of seals)
? Place the bag on a solid surface.
? Open the overwrap and remove the disinfection cap/closure cap.
? Wash hands using an antimicrobial hand wash.
? Roll the bag, placed horizontally on the overwrap, from one side edge until the intermediate seal opens. The solutions from the two chambers mix automatically.
? Then roll the bag from the top edge until the lower triangular seal is fully opened.
? Check that all seals are completely open.
? Check that the solution is clear and the bag is leak-free.

2. Preparation for bag exchange

? Hang the solution bag on the upper hanger of the infusion stand. Unroll the tubes from the solution bag and place the DISC connector in the organizer. After unrolling the drainage bag tubes, hang the drainage bag on the lower hanger of the infusion stand.
? Connect the catheter connector to one of the two ports in the organizer.
? Attach the new disinfection cap/closure cap to the remaining free port.
? Disinfect hands and remove the protective cap from the DISC connector.
? Connect the catheter connector to the DISC.

3. Drainage phase (outflow)

? Open the extension line clamp. Outflow begins.
? Position ?

4. Purge

? After outflow is complete, purge fresh solution into the drainage bag (approximately 5 seconds).
? Position ??

5. Inflow phase (inflow)

? Start inflow by turning the control switch to the
? Position ???

6. Safety phase

? Automatic closure of the catheter extension line by the PIN.

? Position ????

7. Disconnection

? Remove the protective cap from the new disinfection cap/closure cap and screw it on to the old one.
? Unscrew the catheter connector from the DISC and screw the catheter connector onto the new disinfection cap/closure cap.

8. Closing the DISC

? Close the DISC using the open end of the protective cap, which remains in the other slot of the organizer.

9. Check the clarity and weight of the drained dialysate. If the effluent is clear, discard it.

For use of the sleep•safe system in Automated Peritoneal Dialysis (APD)

For setup of the sleep•safe system, refer to its instruction manual.

sleep•safe system 3000 ml

1. Solution preparation: see stay•safe system

2. Unroll the bag tubing

3. Remove the protective cap

4. Insert the connector into the free port of the cycler tray

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

sleep•safe system 5000 ml

sleep•safe system for Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the device automatically heats the solution.

1. Solution preparation

? Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overwrap, integrity of seals)
? Place the bag on a solid surface.
? Open the overwrap of the bag.
? Wash hands using an antimicrobial hand wash.
? Unfold the intermediate seal and the bag connector.
? Roll the bag, placed horizontally on the overwrap, diagonally toward the bag connector. The intermediate seal will open.
? Continue rolling until the seal of the small chamber also opens.
? Check that all seals are fully open.
? Check that the solution is clear and the bag is leak-free.

Steps 2–5: see sleep•safe 3000 ml system.

Bags are for single use only, and any unused solution must be discarded.

After proper training, bicaVera may be used independently at home. Ensure you follow all steps learned during training and maintain appropriate hygiene when exchanging bags.

Always check the dialysate drainage for cloudiness. See section 2 “Warnings and precautions”.

If you use more bicaVera than you should

If an excess of dialysis solution is infused into the peritoneal cavity, it can be drained out. If too many bags have been used, contact your doctor, as this may cause electrolyte and/or fluid imbalance.

If you forget to use bicaVera

Try to achieve the total prescribed volume over 24 hours to avoid life-threatening consequences. Consult your doctor if you are unsure.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may experience the following adverse effects as a result of peritoneal dialysis treatment in general:

very common (may affect more than 1 in 10 people):

• peritonitis (inflammation of the peritoneum), indicated by cloudy dialysis fluid drained from your peritoneum, abdominal pain, fever, feeling unwell, or, very rarely, blood infection.

Please show your doctor the bag containing the drained dialysis fluid.

• inflammation of the skin at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, exudate, or crusting.
• abdominal wall hernia.

Contact your doctor immediately if you experience any of these adverse effects.

Other adverse effects of the treatment are:

common (may affect up to 1 in 10 people):

• problems with inflow or outflow of dialysis fluid
• sensation of abdominal stretching or fullness
• shoulder pain

uncommon (may affect up to 1 in 100 people):

• diarrhoea
• constipation

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

• breathing difficulties due to elevation of the diaphragm
• encapsulating peritoneal sclerosis, whose symptoms may include abdominal pain, abdominal distension, or vomiting

You may experience the following adverse effects when using bicaVera:

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 blood fat levels
• weight gain

uncommon (may affect up to 1 in 100 people):

• excess calcium if calcium intake is too high
• too low body fluid level, which may be recognized by rapid weight loss,
• low blood pressure,
• rapid pulse
• too high body fluid level, which may be recognized by rapid weight gain
• fluid accumulation in tissues and lungs,
• high blood pressure,
• breathing difficulties

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the box after EXP. The expiry date refers to the last day of the month indicated.

Do not store below 4°C.

The solution for use should be used immediately and within a maximum of 24 hours after mixing.

Do not use this medicine if the solution is not clear or if the bag is damaged.

6. Contents of the container and other information

Composition of bicaVera

The active ingredients in one liter of ready-to-use solution are

These quantities of active substance are equivalent to:

1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 104.5 mmol/l chloride, 34 mmol/l bicarbonate, and 83.25 mmol/l glucose.

The other components of bicaVera are water for injections, hydrochloric acid, sodium hydroxide, carbon dioxide.

Appearance of the product and contents of the container

The solution is clear and colourless.

The theoretical osmolarity of the ready-to-use solution is 358 mOsm/l; the pH is approximately 7.40.

bicaVera is available in a dual-chamber bag. One chamber contains the alkaline solution of sodium bicarbonate and the other chamber contains the acidic solution with glucose and electrolytes in a 1:1 ratio.

bicaVera is available in the following administration systems and container sizes:

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

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

Local Representative

Fresenius Medical Care España S.A.
C/ Ronda de Poniente, 8, planta baja, Parque Empresarial Euronova,
28760 Tres Cantos (Madrid), Spain

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

See end of this multilingual summary.

Date of latest revision of this summary: 11/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.

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

DE, AT, BE: bicaVera 1,5 % Glucose, 1,75 mmol/l Calcium, Peritoneal dialysis solution
DK: bicaVera 1,5% glucose, 1,75 mmol/l calcium, Peritoneal dialysis solution
EL, CY: bicaVera 1,5% γλυκ?ζη, 1,75 mmol/l ασβ?στιο, Δι?λυμα περιτονα?κ?ς διαπ?δυσης (κ?θαρσης)
ES: bicaVera Glucosa 1,5% Calcio 1,75 mmol/l, solución para diálisis peritoneal
FI: bicaVera 1,5 % glukoosi, 1,75 mmol/l kalsium, peritoneaalidialyysineste
FR, BE, LU: bicaVera 1,5 % glucose, 1,75 mmol/l calcium, solution pour dialyse péritonéale
IT: bicaVera 1,5 % Glucosio, 1,75 mmol/l Calcio, Soluzione per dialisi peritoneale
NL, BE: bicaVera 1,5 % glucose, 1,75 mmol/l calcium, oplossing voor peritoneale dialyse
NO: bicaVera 1,5 % glukose, 1,75 mmol/l kalsium, peritonealdialysevæske
PT: bicaVera 1,5% Glucose 1,75 mmol/l Cálcio, Solução para diálise peritoneal
SE: bicaVera 1,5% Glucose, 1,75 mmol/l Calcium, peritonealdialysvätska
UK(XI): bicaVera 1.5 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis