Package Insert: Information for the User

bicaVera Glucosa 2,3%, Calcio 1,75 mmol/lPeritoneal Dialysis Solution

Read this entire package insert carefully before starting to use this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

bicaVera is used to clean the blood through the peritoneum in patients with end-stage chronic kidney disease. The type of blood cleaning is known as peritoneal dialysis.

No use Bicavera Glucose 2.3%, Calcium 1.75 mmol/l

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

Peritoneal dialysis should not be initiated if you have

• abdominal region alterations such as

• wounds, or after a surgical operation
• severe burns
• widespread skin inflammatory reactions
• peritoneal inflammation
• non-healing suppurating wounds
• umbilical, inguinal, or diaphragmatic hernias
• abdominal or intestinal tumors

• inflammatory bowel diseases
• intestinal obstruction
• lung disease, especially pneumonia
• bloodstream infection caused by bacteria
• very high blood lipid levels
• blood accumulation of toxins from urine that cannot be eliminated through peritoneal dialysis
• malnutrition and severe weight loss, especially when adequate protein nutrition is not possible

Warnings and precautions

Consult your doctor immediately:

• in case ofintense loss of electrolytes (salts)caused by vomiting and/or diarrhea
• in case of havingperitoneal inflammation, recognizable by cloudy dialysis solution exiting your peritoneum, abdominal pain, fever, discomfort, or, in rare cases, bloodstream infection.

Please have your doctor inspect the bag containing the drainage solution.

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

Peritoneal dialysis may cause aloss of proteinsandwater-soluble vitamins. It is recommended to follow a suitable diet or take dietary supplements to avoid nutritional deficiencies.

Your doctor should check your electrolyte balance, blood cell count, renal function, body weight, and nutritional status.

Use of Bicavera with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Peritoneal dialysis may alter the effect of some medications, so your doctor may need to change the dose for some of them, especially the following:

• Heart failure medications, such as digoxin.

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

• Medications that affect calcium levels, such as those containing calcium or vitamin D.
• Diuretics that increase urine excretion. Your doctor should monitor your blood sugar level regularly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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

Driving and operating machines

The influence of Bicavera on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 time of residence in the peritoneal cavity.

If you have tension in the abdominal region, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

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

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

The initial recommended dose is 600 – 800 ml/m2of body surface area four times a day (up to 1000 ml/m2at night).

Automated Peritoneal Dialysis (APD)

This type of dialysis uses thesleep•safesystem.The exchange of bags is controlled automatically by the cycler during the night.

• Adults:The usual 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 bicaVeraonly in the peritoneal cavity..

Use bicaVera only if the solution is transparent 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:

For the use of the System stay•safeforContinuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the bag with the solution to body temperature. This should be done using a suitable warming plate. The warming time depends on the volume of the bag and the warming device used (for a 2000 ml bag at an initial temperature of 22°C, it will take about 120 minutes). You can find more detailed information in the instructions for your warming device. Do not use a microwave oven to warm the solution due to the risk of local overheating. The exchange of bags can be done after warming 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 container of the disinfection plug/ closure plug.?Wash your hands using an antimicrobial hand 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 mixed automatically.?Then, roll up the bag from the upper edge, until the lower triangle weld opens completely.?Check that all welds are completely open.?Check that the solution is transparent and that the bag has no leaks.

2. Preparation of the exchange of the bag

?Hang the bag with solution on the upper hanger of the perfusion support, unroll the tubes of the bag with 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 perfusion support?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 adapter to the DISC.

3. Outflow

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

4. Purge

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

?Position??

5. Inflow

?Startthe inflow by turning the switch to?Position???

6. Security phase

?Automatic closure of the extension of thecatheter with the PIN

?Position????

7. Disconnection

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

8. 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.

9. Check the transparency and weight of the drained dialysate and if the effluent is transparent, discard it.

For the use of the System Systemsleep•safeforAutomated Peritoneal Dialysis (APD)

For the start-up of the System sleep-safe, consult your user manual.

.

sistemasleep-safeof 3000 ml

1.Preparation of the solution:see systemstay-safe

2.Unroll the tube of the bag

3.Remove the protective cap

4.Place the connector in the free port of the free tray of the cycler

5.The bag is already ready to use with the equipmentsleep-safe

sistemasleep-safeof 5000

1. Preparation of the solution

?Check the bag of 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 hand lotion.?Unfoldthe intermediate weld and the connector of the bag.

?Roll up the bag, which is placed horizontally on the overbag from the diagonal end towards the connector of the bag. The intermediate weld will open.?Continue until the small chamber weld also opens.?Check that all welds are completely open.?Check that the solution is transparent and that the bag has no leaks.

2 - 5.:see the systemsleep-safe3000 ml.

The bags are for single use and any remaining solution not used must be discarded.

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

Always check the turbidity of the dialysate drainage. 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 forgot to use bicaVera

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It may present the following side effects as a result of general peritoneal dialysis treatment:

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

• Peritoneal inflammation, which is indicated by cloudy dialysate solution draining from your peritoneum, abdominal pain, fever, malaise, or, in very rare cases, blood infection.

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

• Peritoneal skin inflammation at the catheter exit site or along the catheter length, recognizable by redness, swelling, pain, exudation, or scabs.
• Abdominal wall hernia.

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

Other side effects of treatment are as follows:

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

• Problems with dialysate entry or exit.
• Abdominal fullness or stretching sensation.
• Shoulder pain.

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

• Diarrhea.
• Constipation.

Unknown frequency(cannot be estimated from available data):

• Respiratory difficulties due to diaphragmatic elevation.
• Encapsulating peritoneal sclerosis, whose symptoms may include abdominal pain, abdominal distension, or vomiting.

It may present 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):

• Elevated blood sugar levels.
• Elevated blood lipid levels.
• Weight gain.

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

• Excessive calcium if calcium intake is too high.
• Low fluid volume, which may be recognized by rapid weight loss,
• Low blood pressure,
• Fast heart rate.
• High fluid volume, which may be recognized by rapid weight gain
• Presence of water in tissues and lungs,
• High blood pressure,
• Respiratory difficulties.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report themdirectly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bag and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store below 4°C.

The ready-to-use solution must be used immediately, within a maximum of 24 hours after mixing.

Do not use this medication if the solution is not transparent or if the bag is damaged.

Composition of bicaVera

The active principles 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 126.1 mmol/l glucose.

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

Appearance of the product and contents of the package

The solution is transparent and colorless.

The theoretical osmolarity of the ready-to-use solution is 401 mOsm/l, the pH is approximately 7.40.

bicaVera is available in a double-chamber bag. One chamber contains the alkaline bicarbonate solution and the other chamber contains the acidic glucose and electrolyte solution in a 1:1 ratio.

bicaVera is available in the following application systems and package sizes:

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Fresenius Medical Care Deutschland GmbH,

Else-Kröner-Straße 1, 61352Bad Homburg v.d.H.,

Germany

Manufacturer responsible

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) with the following names:

See at the end of this multilingual package leaflet.

Last update of this package leaflet: 11/2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (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) with the following names:

DE, AT, BE:bicaVera 2.3 % Glucose,1.75 mmol/l Calcium, Peritonealdialyselösung

DK:bicaVera 2.3% glucose, 1.75 mmol/l calcium, Peritonealdialysevæske

EL, CY:bicaVera 2.3% γλυκ?ζη, 1.75 mmol/l ασβ?στιο, Δι?λυμα περιτονα?κ?ς διαπ?δυσης (κ?θαρσης)

ES:bicaVera Glucosa 2.3% Calcio 1.75 mmol/lsolución para diálisis peritoneal

FI:bicaVera2.3 % glukoosi, 1.75 mmol/l kalsium, peritoneaalidialyysineste

FR, BE, LU:bicaVera 2.3 % glucose,1.75 mmol/l calcium,solution pour dialyse péritonéale

IT:bicaVera 2.3 % Glucosio, 1.75 mmol/l Calcio, Soluzione per dialisi peritoneale

NL, BE:bicaVera 2.3 % glucose,1.75 mmol/l calcium, oplossing voor peritoneale dialyse

NO:bicaVera 2.3 % glukose, 1.75 mmol/l kalsium, peritonealdialysevæske

PT:bicaVera 2.3% Glucose 1.75 mmol/l Cálcio, Solução para diálise peritoneal

SE:bicaVera2,3% Glucose, 1.75 mmol/l Calcium, peritonealdialysvätska

UK(XI):bicaVera 2.3 % Glucose, 1.75 mmol/l Calcium, Solution for peritoneal dialysis