Bicavera glucose 4.25%, calcium 1.25 mmol/l solution for peritoneal dialysis

Patient Information Leaflet

Introduction

Patient Information Leaflet

bicaVera Glucose 4.25%, Calcium 1.25 mmol/l solution for peritoneal dialysis

Read all of this leaflet carefully before you start using this medicine, as 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 could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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 using bicaVera

Do not use bicaVera Glucose 4.25%, Calcium 1.25 mmol/l

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

Peritoneal dialysis must not be started if you have

• abdominal disorders such as

• wounds, or after surgical operations

• severe burns

• extensive inflammatory skin reactions

• peritonitis

• non-healing suppurative wounds

• umbilical, inguinal, or diaphragmatic hernias

• abdominal or intestinal tumors

• 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 that cannot be removed 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 severe loss of electrolytes (salts) caused by vomiting and/or diarrhoea

• if you have hyperparathyroidism or low blood calcium levels. It may be necessary to take calcium binders containing additional phosphates and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a higher calcium concentration may be used.

• if you have peritonitis, recognizable by cloudy dialysis fluid draining from your abdomen, abdominal pain, fever, malaise, or, very rarely, blood infection. Please show your doctor the bag containing the drained fluid.

• if you have polycystic kidneys.

• if you have severe abdominal pain, abdominal distension, or vomiting. This may be a sign of 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 (salt) balance, blood cell count, kidney function, body weight, and nutritional status.

Use of bicaVera with other medicines

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

Driving and using machines

The influence 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 of 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. 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 over a 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) 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 undamaged.

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

Instructions for use:

For use of the stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)

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

1. Preparation of the solution

? Check the warmed solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch, integrity of seals). ? Place the bag on a solid surface. ? Open the overpouch of the bag and the package containing the disinfection cap/closing cap. ? Wash your hands using an antimicrobial hand wash solution. ? Roll the bag, placed horizontally on the overpouch, from one of the side edges until the intermediate seal opens. The solutions from the two chambers will 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 that the bag has no leaks.

2. Preparation for bag exchange

? Hang the solution bag on the upper hanger of the infusion stand. Unroll the tubing from the solution bag and place the DISC connector into the organizer. After unrolling the tubing from the drain bag, hang this bag on the lower hanger of the infusion stand. ? Attach the catheter connector to one of the two ports on the organizer. ? Place the new disinfection cap/closing cap on the remaining free port. ? Disinfect your hands and remove the protective cap from the DISC connector. ? Connect the catheter connector to the DISC.

3. Drainage phase (outflow)

? Open the clamp on the extension set. The outflow begins. ? Position ?

4. Purge

? After completion of outflow, purge new solution into the drain bag (approximately 5 seconds). ? Position ??

5. Inflow phase

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

6. Safety phase

? Automatic closure of the catheter extension set by the PIN. ? Position ????

7. Disconnection

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

8. Closing the DISC connector

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

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

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

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

sleep•safe system 3000 ml

1. Preparation of the solution: see stay•safe system
2. Unroll the tubing from the bag
3. Remove the protective cap
4. Insert the connector into the free port of the cycler tray
5. The bag is ready for use with the sleep•safe equipment

sleep•safe system 5000 ml

? Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch, integrity of seals). ? Place the bag on a solid surface. ? Open the overpouch of the bag. ? Wash your hands using an antimicrobial hand wash solution. ? Unfold the intermediate seal and the connector of the bag. ? Roll the bag, placed horizontally on the overpouch, from the diagonal end toward the bag connector. The intermediate seal will open. ? Continue until the seal of the small chamber also opens. ? Check that all seals are completely open. ? Check that the solution is clear and that the bag has no leaks.

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

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

After proper training, bicaVera can be used independently at home. Be sure to 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 for 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, indicated by cloudy dialysis fluid drained from your peritoneum, abdominal pain, fever, malaise, 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, exudation, 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 dialysate
• Sensation of abdominal stretching or fullness
• Shoulder pain

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

• Diarrhea
• 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 bicaVera is used:

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):

• Calcium deficiency
• 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

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

• Increased parathyroid gland activity with potential disturbances in bone metabolism

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 can 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the pouch and the carton after EXP. The expiry date refers to the last day of the month indicated.

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 and within a maximum of 24 hours after mixing.

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

6. Contents of the container and additional information

Composition of bicaVera

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

These quantities of active substance are equivalent to:

1.25 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 bicaVera are water for injections, hydrochloric acid, sodium hydroxide, carbon dioxide.

Appearance of the medicinal product and contents of the container

The solution is clear and colourless.

The theoretical osmolarity of the ready-to-use solution is 357 mOsm/l; the pH is approximately 7.4.

bicaVera is available in a dual-chamber bag. One chamber contains the alkaline sodium bicarbonate solution 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:

sleep*•*safe combo :

2 bags of 5000 ml + disinfection cap + sleep•safe Set Plus

Only certain package 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

bicaVera sleep•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 European Economic Area and the United Kingdom (Northern Ireland) under the following names:

See end of this multilingual package leaflet.

Date of latest review of this leaflet: 11/2022

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 and the United Kingdom (Northern Ireland) under the following names: