BICAVERA GLUCOSA 4.25%, Calcio 1.75 mmol/l SOLUTION FOR PERITONEAL DIALYSIS

Introduction

Package Leaflet: Information for the User

bicaVera Glucose 4.25%, Calcium 1.75 mmol/lsolution 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What bicaVera is and what it is used for
2. What you need to know before you use bicaVera
3. How to use bicaVera
4. Possible side effects
5. Storage of 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 via the peritoneum in patients with chronic renal failure in the terminal phase. The type of blood cleaning is known as peritoneal dialysis.

2. What you need to know before you use bicaVera

Do not use bicaVera Glucose 4.25%, Calcium 1.75 mmol/l

• if your blood potassium level is too low
• if your blood calcium level is too high
• if your body fluid volume is too low
• if your blood pressure is low

Peritoneal dialysis should not be started if you have

• abdominal disorders such as

• wounds, or after surgery
• severe burns
• extensive skin inflammatory reactions
• peritonitis
• unclosed suppurating wounds
• umbilical, inguinal, or diaphragmatic hernias
• tumors in the abdomen or intestine

• inflammatory bowel diseases
• intestinal obstruction
• lung disease, especially pneumonia
• generalized blood infection caused by bacteria
• very high levels of fat in the blood
• accumulation in the blood of toxins from urine whose elimination cannot be carried out by peritoneal dialysis
• malnutrition and severe weight loss, especially when adequate protein nutrition is not possible

Warnings and precautions

Consult your doctor immediately:

• in case of intensive loss of electrolytes (salts)caused by vomiting and/or diarrhea
• in case of having peritonitis, recognizable by the cloudy dialysate solution coming out of your peritoneum, abdominal pain, fever, malaise, or, in very rare cases, blood infection.

Please show your doctor the bag containing the drained dialysate solution.

• in case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication derived from peritoneal dialysis treatment that can lead to death.

Peritoneal dialysis may cause loss of proteinsand water-soluble vitamins. It is recommended to follow an adequate diet or take nutritional supplements in order to avoid deficiency states.

Your doctor should check the balance of electrolytes (salts), blood cell count, kidney function, body weight, and nutritional status.

Using bicaVera with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Peritoneal dialysis may alter the effect of some medicines, so it may be necessary for your doctor to change the dose for some of them, especially the following:

• Medicines for heart failure, such as digoxin.

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

• Medicines that affect calcium levels, such as those containing calcium or vitamin D.
• Medicines that increase urine excretion, such as diuretics.
• Insulin or medicinestaken orally and that lower blood sugar levels. Your blood sugar level should be checked regularly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

There are no adequate data on the use of bicaVera in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should only use bicaVera if your doctor considers it absolutely necessary.

Driving and using machines

bicaVera has no influence or negligible influence on the ability to drive and use machines.

3. How to use bicaVera

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 tension in the abdominal region, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults:The usual dose is between 2000 - 2500 ml of solution four times a day, depending on body weight and renal function.

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

• Children:The doctor will determine the required volume of dialysis solution depending on tolerance, age, and body surface area of the child.

The recommended initial dose is 600 - 800 ml/m2 of body surface area four times a day (up to 1000 ml/m2 at night).

Automated Peritoneal Dialysis (APD)

For this type of dialysis, the sleep•safesystem is used. The exchange of bags is controlled automatically by the cycler during the night.

• Adults:The normal prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and the cycler time of 8 to 10 hours, and one or two exchanges during the day.

• Children:The volume per exchange should be 800-1000 ml/m2 (up to 1400 ml/m2) of body surface area with 5-10 exchanges during the night.

Use bicaVera only in the peritoneal cavity.

Use only bicaVera if the solution is clear and the bag is not damaged.

bicaVera is available in a double-chamber bag. Before using it, mix the solutions from the two chambers as described.

Instructions for use:

Forthe use of thestay•safesystem for Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, heat the bag with the solution to body temperature. This should be done using a suitable heating plate. The heating time depends on the volume of the bag and the bag warmer used (for a 2000 ml bag with an initial temperature of 22 °C, it is approximately 120 minutes). You can obtain more detailed information in the instruction manual of your warmer. Do not use a microwave oven to heat the solution due to the risk of local overheating. The exchange of bags can be carried out after heating the solution.

1. Preparation of the solution

? Check the bag of the tempered solution (label, expiration date, transparency of the solution, integrity of the bag and overbag, integrity of the weld). ? Place the bag on a solid surface. ? Open the overbag of the bag and the package of the disinfection plug/closure plug. ? Wash your hands using an antimicrobial washing lotion. ? Roll up the bag, which is placed horizontally on the overbag, from one of the lateral edges until the intermediate weld opens. The solutions from the two chambers are automatically mixed. ? Then, roll up the bag from the upper edge until the weld of the lower triangle opens. ? Check that all welds are completely open. ? Check that the solution is clear and that the bag has no leaks.

1. Preparation of the bag exchange

? Hang the bag with the solution on the upper hanger of the infusion stand, unroll the tubes of the bag with the solution, and place the DISC connector in the organizer. After unrolling the tubes of the drainage bag, hang the bag on the lower hanger of the infusion stand ? Place the catheter connector in one of the two connections of the organizer. ? Put the new disinfection plug/closure plug in the other free connection. ? Disinfect your hands and remove the protective cap from the DISC connector. ? Connect the catheter connector to the DISC.

1. Outflow

? Open the extension valve. The outflow starts. ? Position ? .

1. Purge

? Once the outflow is complete, purge new solution to the drainage bag (approximately 5 seconds).

? Position ??

1. Inflow

? Start the inflow by turning the control switch to the bag with the solution to the catheter.

? Position ???

1. Safety phase

? Automatic closure of the catheter extension with the PIN.

? Position ????

1. Disconnection

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

1. Closure of the DISC

? Close the DISC with the open end of the protective cap, which has remained in the other insert of the organizer.

1. Check the transparency and weight of the drained dialysate and if the effluent is clear, discard it

To use thesleep•safesystem for Automated Peritoneal Dialysis (APD)

For the start-up of the sleep-safesystem, consult its instruction manual.

sleep-safesystem of 3000 ml

1. Preparation of the solution: see stay-safesystem
2. Unroll the tube of the bag
3. Remove the protective cap
4. Place the connector in the free port of the cycler tray
5. The bag is ready to use with the sleep-safeequipment

sleep-safesystem of 5000

1. Preparation of the solution

? Check the bag of the solution (label, expiration date, transparency of the solution, integrity of the bag and overbag, integrity of the weld). ? Place the bag on a solid surface. ? Open the overbag of the bag. ? Wash your hands using an antimicrobial washing solution. ? Unfold the intermediate weld and the bag connector.? Roll up the bag, which is placed horizontally on the overbag from the diagonal end to the bag connector. The intermediate weld will open. ? Continue until the weld of the small chamber also opens . ? Check that all welds are completely open. ? Check that the solution is clear and that the bag has no leaks.

2 - 5.: see sleep-safesystem 3000 ml.

The bags are for single use and any unused solution should be discarded.

After proper training, bicaVera can be used independently at home. Make sure to follow all the steps you have learned during training and maintain adequate hygiene conditions when exchanging bags.

Always check the turbidity of the drained dialysate. See section 2 "Warnings and precautions"

If you use more bicaVera than you should

If you infuse an excess of dialysis solution into the peritoneal cavity, it can be drained. If you use too many bags, contact your doctor, as it may cause electrolyte and/or fluid imbalance.

If you forget to use bicaVera

Try to reach the total prescribed volume for 24 hours to avoid consequences that may endanger your life. Check with your doctor if you are unsure.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• peritonitis, which is noticeable by a cloudy dialysate solution coming out of your peritoneum, abdominal pain, fever, malaise, or, in very rare cases, blood infection.

Please show your doctor the bag containing the drained dialysate solution.

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

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

Other side effects of the treatment are the following:

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

• problems with the entry or exit of dialysate
• feeling of stretching or fullness of 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 an elevation of the diaphragm
• encapsulating peritoneal sclerosis, whose symptoms could be abdominal pain, abdominal distension, or vomiting

You may experience the following side 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 levels of fat in the blood
• weight gain

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

• excess calcium if calcium intake is too high
• body fluid volume too low, which can be recognized by rapid weight loss,
• low blood pressure,
• rapid pulse
• body fluid volume too high, which can be recognized by rapid weight gain
• presence of water in tissues and lungs,
• high blood pressure,
• breathing difficulties

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the bag and carton after EXP. The expiry date is the last day of the month stated.

Do not store below 4°C.

The solution ready for use should be used immediately, 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. Container contents and additional information

Composition of bicaVera

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

These amounts 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 235.9 mmol/l glucose.

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

Appearance of the product and container contents

The solution is clear and colorless.

The theoretical osmolarity of the ready-to-use solution is 511 mOsm/l, and the pH is approximately 7.40.

bicaVera is available in a double-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 application systems and container sizes:

Only some container sizes may 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)

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

See the end of this multilingual prospectus.

Date of the last revision of this prospectus: 11/2023

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

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

DE, AT, BE: bicaVera 4.25 % Glucose,1.75 mmol/l Calcium, Peritonealdialyselösung

DK: bicaVera 4.25% glucose, 1.75 mmol/l calcium, Peritonealdialysevæske

EL, CY: bicaVera 4.25% γλυκ?ζη, 1.75 mmol/l ασβ?στιο, Δι?λυμα περιτονα?κ?ς διαπ?δυσης (κ?θαρσης)

ES: bicaVera Glucosa 4.25% Calcio 1.75 mmol/lsolución para diálisis peritoneal

FI: bicaVera4.25 % glukoosi, 1.75 mmol/l kalsium, peritoneaalidialyysineste

FR, BE, LU: bicaVera 4.25 % glucose,1.75 mmol/l calcium, solution pour dialyse péritonéale

IT: bicaVera 4.25 % Glucosio, 1.75 mmol/l Calcio, Soluzione per dialisi peritoneale

NL, BE: bicaVera 4.25 % glucose,1.75 mmol/l calcium, oplossing voor peritoneale dialyse

NO: bicaVera 4.25 % glukose, 1.75 mmol/l kalsium, peritonealdialysevæske

PT: bicaVera 4.25% Glucose 1.75 mmol/l Cálcio, Solução para diálise peritoneal

SE: bicaVera4.25% Glucose, 1.75 mmol/l Calcium, peritonealdialysvätska

UK(XI): bicaVera 4.25 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis