BICAVERA GLUCOSA 4.25%, CALCIO 1.25 mmol/L PERITONEAL DIALYSIS SOLUTION

Introduction

Package Leaflet: Information for the User

bicaVeraGlucose 4.25%, Calcium 1.25 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, 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 get 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 is bicaVeraand what is it 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 is bicaVera and what is it used for

bicaVerais used to clean the blood via the peritoneum in patients with end-stage chronic kidney failure. This type of blood cleaning is known as peritoneal dialysis.

2. What you need to know before you use bicaVera

Do not use bicaVeraGlucose 4.25%, Calcium 1.25 mmol/l

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

Peritoneal dialysis should not be started if you have

• abdominal region 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 of toxins from urine in the blood, which cannot be removed by peritoneal dialysis
• malnutrition and severe weight loss, especially when adequate protein intake is not possible

Warnings and precautions

Consult your doctor immediately:

• in case of severe loss of electrolytes (salts)caused by vomiting and/or diarrhea
• if you have hyperparathyroidismor if your blood calcium level is low. It may be necessary to take calcium chelators 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 of peritonitis, recognizable by cloudy dialysate 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.

• in case of polycystic kidneys.
• in case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that can be fatal.

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

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

Using bicaVerawith 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 your 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 plan to become pregnant, consult your doctor 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

The influence of bicaVera on the ability to drive and use machines is negligible.

3. How to use bicaVera

Follow exactly the administration instructions of this medicine 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 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 kidney 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 throughout 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 bicaVeraonly in the peritoneal cavity.

Use only bicaVeraif the solution is clear and the bag is not damaged.

bicaVerais available in a double-chamber bag. Before use, mix the solutions from the two chambers as described.

Instructions for use:

For the 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 manual of your bag 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 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 package of the disinfection plug/closure plug. Wash your hands using an antimicrobial washing solution. 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 mix 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 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 drain bag, hang the drain 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 drain bag (approximately 5 seconds). Position ...

1. Inflow

Start the inflow by turning the control switch to the ... 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 connector

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

1. Checkthe transparency and weight of the drained dialysateand if the effluent is clear, discard it.

For the use of thesleep•safesystem for Automated Peritoneal Dialysis (APD)

For the startup of the sleep-safe system, refer to its instruction manual.

sleep•safesystem of 3000 ml

1. Preparation of the solution:see stay•safesystem.
2. Unroll the tube of the bag

1. Remove the protective cap
2. Place the connector in the free port of the cycler tray
3. The bag is ready to use with the sleep•safe equipment

sleep•safesystem of 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 end towards 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.

1. – 5.: see sleep•safe system of 3000 ml.

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

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

Always check the turbidity of the drained dialysate. 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 forget to use bicaVera

Try to achieve 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, recognizable by cloudy dialysate 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.

• skin inflammation at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, exudation, 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 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):

• calcium deficiency
• 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

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

• increased activity of the parathyroid gland with potential disorders of bone metabolism

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 shown.

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, 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 Content 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:

1.25 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 injectable preparations, hydrochloric acid, sodium hydroxide, and carbon dioxide.

Appearance of the Product and Container Content

The solution is transparent and colorless.

The theoretical osmolarity of the ready-to-use solution is 357 mOsm/l, and 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 container sizes:

sleep•safe combo:

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

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

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, 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:11/2022

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: