CAPD/DPCA 2 solution for peritoneal dialysis

Patient Information Leaflet

Introduction

Patient Information Leaflet

CAPD/DPCA 2 solution for peritoneal dialysis

Please 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents:

1. What CAPD/DPCA 2 is and what it is used for
2. What you need to know before using CAPD/DPCA 2
3. How to use CAPD/DPCA 2
4. Possible adverse effects
5. How to store CAPD/DPCA 2
6. Contents of the pack and other information

1. What CAPD/DPCA 2 is and what it is used for

CAPD/DPCA 2 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 starting to use CAPD/DPCA 2

Do not use CAPD/DPCA 2

• if your blood potassium level is very low
• if your blood calcium level is very high
• if you have a lactate metabolism disorder
• if you have a fructose metabolism disorder (hereditary fructose intolerance)

In general, peritoneal dialysis treatment should not be started if you have:

• abdominal disorders such as

• wounds, or after surgery

• severe burns

• significant inflammatory skin reactions

• peritonitis

• non-healing suppurative wounds

• umbilical, inguinal, or diaphragmatic hernia

• tumors in the abdomen or intestines

• intestinal inflammation

• intestinal obstruction

• lung disease, especially pneumonia

• generalized blood infection caused by bacteria

• very high levels of fat in the blood

• contamination due to accumulation of uraemic toxins in the blood that cannot be removed by blood cleansing

• severe malnutrition and weight loss, particularly if adequate intake of protein-containing food is not possible

Warnings and precautions

Consult your doctor immediately

• in case of severe loss of electrolytes (salts) caused by vomiting and/or diarrhoea.
• in case of peritonitis, recognizable by cloudy peritoneal dialysis fluid draining from your abdomen, abdominal pain, fever, feeling unwell, or, very rarely, blood contamination.

Show the drainage bag to your doctor.

• 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 may lead to death.

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

Your doctor should regularly monitor your electrolyte balance (salts), blood cell count, kidney function, body weight, and nutritional status.

CAPD/DPCA 2 contains 15 g of glucose in 1000 ml of solution. Depending on the dosing instructions and the bag size used, up to 38 g of glucose (CAPD, one 2500 ml stay•safe bag) or up to 75 g of glucose (APD, one 5000 ml sleep•safe bag) is administered with each bag. This should be taken into account when treating patients with diabetes mellitus.

Use of CAPD/DPCA 2 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 check 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.
• Orally administered medicines that lower blood sugar levels or insulin. Blood sugar levels should be monitored regularly.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 CAPD/DPCA 2 in pregnant or breast-feeding women. You should not use CAPD/DPCA 2 during pregnancy unless your doctor considers it absolutely necessary.

It is unknown whether the active substances of CAPD/DPCA 2 or their metabolites are excreted in breast milk. Breast-feeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and using machines

The influence of CAPD/DPCA 2 on the ability to drive and use machines is none or negligible.

3. How to use CAPD/DPCA 2

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please 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 experience abdominal fullness or discomfort, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD): stay•safe system

• Adults: The recommended dose is 2000 – 3000 ml of solution four times daily, depending on body weight and renal function.

After a dwell time of 2 to 10 hours, the solution is drained.

• 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 body surface area four times daily (up to 1000 ml/m² at night).

Automated Peritoneal Dialysis (APD): sleep•safe system

The exchange of bags is automatically controlled by a machine during the night. For this type of dialysis, the sleep•safe system of CAPD/DPCA is used.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3–10 exchanges during the night and 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) body surface area with 5–10 exchanges during the night.

Use CAPD/DPCA 2 only in the peritoneal cavity.

Use CAPD/DPCA 2 only if the solution is clear and the container is undamaged.

Instructions for use

stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the bag containing the solution to body temperature. For bags with a volume of up to 3,000 ml, an appropriate bag warmer should be used. The warming time depends on the bag volume and the type of bag warmer used (a 2000 ml bag at an initial temperature of 22°C will require approximately 120 minutes of warming time). More detailed information can be found in the instruction manual of your bag warmer. Microwave ovens must not be used to warm the solution due to the risk of local overheating. After warming the solution, the bag exchange can be performed.

1. Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch) – open the outer bag and disinfecting cap/closing cap wrapper.
2. Wash hands with an antimicrobial hand-wash solution.
3. Place the DISC into the organizer (hang the solution bag on the upper hanger of the infusion stand – unroll the "DISC-solution bag" line – place the DISC into the organizer – hang the drain bag on the lower hanger of the infusion stand).
4. Place the catheter extension set into one of the two inserts of the organizer – place the new disinfecting cap/closing cap into the other free insert.
5. Disinfect hands and remove the protective cap from the DISC.
6. Connect the catheter extension set to the DISC.
7. Open the tap on the extension set – position “?” – outflow begins.
8. After completion of drainage: Purge – position “??” – purge the drain bag with clean solution (approximately 5 seconds).
9. Inflow – position “???” – connect the solution bag to the catheter.
10. Safety phase – position "????" – automatic closure of the catheter extension by the PIN.
11. Disconnection – remove the protective cap from the new disinfecting cap/closing cap and screw it onto the old one – unscrew the catheter extension from the DISC and screw it onto the new disinfecting cap/closing cap.
12. Close the DISC with the open end of the protective cap (located in the other insert of the organizer).
13. Check the clarity and weight of the drained dialysate; if the fluid is clear, discard it.

sleep•safe system for Automated Peritoneal Dialysis (APD)

For assembly of the sleep•safe system, refer to the instructions for use.

1. Preparation of the solution

• Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch).
• Place the bag on a solid surface.
• Open the overpouch of the bag.
• Wash hands using an antimicrobial hand-wash solution.
• Check that the solution is clear and that the bag has no leaks.

1. Unroll the tubing from the bag.
2. Remove the protective cap.
3. Place the connector into the free port of the tray.
4. The bag is now ready for use with the sleep•safe equipment.

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

After adequate training, CAPD/DPCA 2 may be used independently at home. Ensure that you follow all steps learned during training and maintain appropriate hygiene conditions when exchanging bags.

Always check the dialysate drainage for cloudiness. See section 2.

If you use more CAPD/DPCA 2 than you should

Any excess dialysis solution that has entered the peritoneal cavity can easily be drained into the drain bag. If too many bags have been used, please contact your doctor, as this may cause electrolyte and/or fluid imbalance.

If you forget to use CAPD/DPCA 2

Try to achieve the prescribed dialysate volume over each 24-hour period to avoid potentially life-threatening consequences. Consult your doctor if you have any doubts.

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 experiences them.

You may experience the following adverse effects as a result of treatment:

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

• Peritonitis, observed as cloudiness of the drained dialysate, abdominal pain, fever, malaise, or, very rarely, blood infection.

Show the bag containing the drainage solution to your doctor.

• Skin inflammation at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, exudate, or crusting.
• Abdominal wall hernia.

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

Other adverse effects of treatment include:

Common (may affect up to 1 in 10 people)

• Problems with inflow or outflow of dialysis solution.
• Sensation of abdominal stretching or fullness.
• Shoulder pain.

Uncommon (may affect up to 1 in 100 people)

• Diarrhea.
• Constipation.

Frequency not known (frequency 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.

The following adverse effects may occur when using CAPD/APD 2:

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.
• Excess calcium if calcium intake is too high.

Uncommon (may affect up to 1 in 100 people)

• Too little body fluid, which may be recognized by rapid weight loss.
• Dizziness.
• Decreased blood pressure.
• Rapid pulse.
• Too much body fluid, which may be recognized by rapid weight gain.
• Fluid accumulation in tissues and lungs.
• High blood pressure.
• Breathing difficulties.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CAPD/DPCA 2

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

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

Do not store above 25°C. Do not refrigerate or freeze.

The solution should be used immediately after first opening.

6. Contents of the container and other information

Composition of CAPD/DPCA 2

The active substances in one liter of solution are:

These amounts of active substance are equivalent to:

1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 103.5 mmol/l chloride, 35 mmol/l (S)-lactate, and 83.2 mmol/l glucose.

The other components of CAPD/DPCA 2 are water for injections, hydrochloric acid, and sodium hydroxide.

Appearance of the medicinal product and contents of the container

The solution is clear and ranges from colorless to slightly yellowish.

The theoretical osmolarity of the solution is 358 mOsm/l; the pH is above 5.5.

CAPD/DPCA 2 is available in the following administration systems and container sizes:

Some pack sizes may not be marketed.

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),

Spain

Date of the latest revision of this leaflet: 03/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.