Label: information for the user

bicaVeraGlucose 1.5%, Calcium 1.25 mmol/l solution for peritoneal dialysis

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

• Keep this label, as you may need to read 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 even if they 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 label. See section 4.

bicaVerais 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 Bica VeraGlucose 1.5%, Calcium 1.25 mmol/l

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

Do not start peritoneal dialysis if you have

• abdominal region alterations such as

• open wounds, or after a surgical operation
• severe burns
• widespread skin inflammatory reactions
• peritonitis inflammation
• unhealed suppurating wounds
• umbilical, inguinal, or diaphragmatic hernias
• abdominal or intestinal tumors

• inflammatory intestinal 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 byvomiting and/or diarrhea
• if you havehyperparathyroidismor ifyour blood calcium level is low. You may need to take calcium chelating agents containing additional phosphates and/or vitamin D. If this is not possible, you can use a peritoneal dialysis solution with a higher calcium concentration.
• in case ofperitonitis, recognizable by cloudy peritoneal dialysis solution, abdominal pain, fever, discomfort, or, in rare cases, bloodstream infection. Please show your doctor the drainage solution bag.

• in case ofpolycystic kidneys.
• in case ofsevere 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 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 Bica Vera 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 blood potassium level, and if necessary, take appropriate measures.
• Medications that affect calcium levels, such as those containing calcium or vitamin D.
• Diuretics that increase urine excretion.
• Insulin ororal medicationsthat decrease blood sugar levels. Your blood sugar level should be regularly monitored.

Pregnancy and breastfeeding

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

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

Driving and using machines

The influence of Bica Vera on the ability to drive and use 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)

• 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 automatically controlled by the cycler throughout 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.

Usebicaonly in the peritoneal cavity.

Use onlybicaif the solution is transparent and the bag is not damaged.

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

Usage Instructions:

For the use of thestay•safesystem for continuous 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 with an initial temperature of 22 °C, it is approximately 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 carried out after warming the solution.

1. Preparation of the solution:

?Check the bag with 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 washing solution.?Roll up the bag that 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 triangular weld opens completely.?Check that all welds are completely open.?Check that the solution is transparent 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 perfusion support, unwind the tubes of the solution bag, and place the DISC connector in the organizer. After unwinding the tubes of the drainage bag, hang the drainage 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 connector to the DISC.

1. Outflow:

?Open the extension valve. The dialysis flow starts.?Position ?

1. Flush:

?Once the outflow is complete, flush new solution into the drainage bag (approximately 5 seconds).?Position ??

5.Infusion:

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

6.Security 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 to the new disinfection plug/closure plug.

1. Closure of the DISC connector:

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

1. Check:the transparency and weight of thedialyzed effluent andif the effluent is transparent,discard it.

For the use of thessleep•safesystem for automated peritoneal dialysis (APD)

To start the sleep-safe system, consult your user manual.

ssleep•safeof 3000 ml

1. Preparation of the solution:see thesstay•safesystem.
2. Unwind 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 equipmentssleep•safe

ssleep•safeof 5000 ml

?Check the bag with 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 connector of the bag.?Roll up the bag, which is placed horizontally on the overbag, from the diagonal edge towards the bag connector. 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 thesstay•safesystem of 3000 ml.

The bags are for single use and any remaining solution without use must be discarded.

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

Always check the turbidity of the dialyzed effluent. See section 2 “Warnings and Precautions”

If you use more bicaVerathan 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 with your doctor if you are unsure.

Ifyou 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, discomfort, or, in very rare cases, blood infection.

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

• 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 the following:

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.

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

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

It may present the following side effects when using Bica Vera:

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):

• Calcium deficiency.
• Low body fluid levels, which may be recognized by rapid weight loss,
• Low blood pressure,
• Fast heart rate.
• High body fluid levels, which may be recognized by rapid weight gain
• Fluid accumulation in tissues and lungs,
• High blood pressure,
• Respiratory difficulties.

Unknown(frequency cannot be estimated from available data):

• Increased parathyroid gland activity with potential bone metabolism disorders.

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 them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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.

bicaVera stay•safe / sleep•safe:Do not storebelow 4°C.

bicaVerasleep•safe combo: Store at 5 °C – 30 °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:

1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 103.5 mmol/l chloride, 34 mmol/l bicarbonate, and 83.25 mmol/l glucose.

The other components of bicaVeraare water for injection, hydrochloric acid, sodium hydroxide, 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 357 mOsm/l, the pH is approximately 7.4.

bicaVerais 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.

bicaVerais available in the following application systems and package sizes:

sleep•safe combo:

2 bags of 5000 ml + disinfection cap +sleep•safeSet Plus

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, 61352 Bad Homburg v.d.H., Germany

Manufacturer responsible

bicaVera stay•safe / sleep•safe:

Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel, Germany

bicaVerasleep•safe combo:

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

Local representative

Fresenius Medical Care España S.A.

C/ Ronda de Poniente, 8, ground floor, 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 the end of this multilingual package leaflet.

Date of the last revision of this package leaflet:11/2022

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: