CAPD/DPCA 17 SOLUTION FOR PERITONEAL DIALYSIS

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

CAPD/DPCA 17 dialysis solution for peritoneal dialysis

Read the entire 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, consult 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, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

1. What CAPD/DPCA 17 is and what it is used for
2. What you need to know before using CAPD/DPCA 17
3. How to use CAPD/DPCA 17
4. Possible adverse effects
5. Storage of CAPD/DPCA 17
6. Contents of the pack and other information

1. What CAPD/DPCA 17 is and what it is used for

CAPD/DPCA 17 is used to clean the blood via 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 17

Do not use CAPD/DPCA 17

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

In general, peritoneal dialysis should not be initiated if you have

• abdominal conditions such as

  • wounds, or after surgical intervention
  • severe burns
  • significant inflammatory skin reactions
  • peritonitis
  • unhealed, infected wounds
  • umbilical, inguinal or diaphragmatic hernia
  • abdominal or intestinal tumors

• intestinal inflammation

• intestinal obstruction

• lung disease, especially pneumonia

• generalized bacterial blood infection (sepsis)

• 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 increased parathyroid gland activity or low blood calcium levels. It may be necessary to take additional phosphate-binding calcium-containing agents and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a higher calcium concentration should be used.
• in case of peritonitis, recognizable by cloudy dialysis fluid draining from your peritoneum, abdominal pain, fever, malaise, 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 which may be life-threatening.

Peritoneal dialysis may lead to 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 (salt) balance, blood cell count, kidney function, body weight, and nutritional status.

CAPD/DPCA 17 contains 15 g of glucose in 1000 ml of solution. Depending on the dosing instructions and the bag size used, up to 45 g of glucose (CAPD, 3000 ml stay•safe) or up to 75 g of glucose (APD, 5000 ml sleep•safe) is administered per bag. This should be taken into account when treating patients with diabetes mellitus.

Use of CAPD 17 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 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 CAPD/DPCA 17 in pregnant or breastfeeding women. If you are pregnant, you should not use CAPD/DPCA 17 unless your doctor considers it absolutely necessary.

It is unknown whether the active substances of CAPD/DPCA 17 or their metabolites are excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and use of machines

The influence of CAPD/DPCA 17 on the ability to drive and operate machinery is negligible or none.

3. How to use CAPD/DPCA 17

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 dwell time in the peritoneal cavity.

If you experience abdominal discomfort or pressure, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: The usual dose is between 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 of body surface area four times daily (up to 1000 ml/m² at night).

Automated Peritoneal Dialysis (APD)

Bag exchanges are automatically controlled by a machine during the night. This type of dialysis uses the sleep•safe system of CAPD/DPCA.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3–10 exchanges during the night, a 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 CAPD/DPCA 17 only in the peritoneal cavity.

Use only CAPD/DPCA 17 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 up to 3000 ml, this should be done using an appropriate bag warmer. The warming time depends on the bag volume and the type of bag warmer used (for a 2000 ml bag with an initial temperature of 22°C, warming time is typically about 120 minutes). More detailed information can be found in the manual of your bag warmer. Do not use microwave ovens 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, expiration date, clarity of solution, integrity of the bag and overwrap) – open the overwrap and the disinfection cap/closing cap packaging.
2. Wash hands with an antimicrobial hand-wash solution.
3. Place the DISC in the organizer (hang the solution bag on the upper hanger of the infusion stand – unroll the “DISC-solution bag” line – place the DISC in the organizer – hang the drain bag on the lower hanger of the infusion stand).
4. Place the catheter extension into one of the two inserts of the organizer. Place the new disinfection cap/closing cap into the other free insert.
5. Disinfect hands and remove the protective cap from the DISC.
6. Connect the catheter extension to the DISC.
7. Open the clamp on the extension – Position “?” – outflow begins.
8. After completion of drainage: Purge – position “??” – purge the drain bag with clean solution (approximately 5 seconds).
9. Inflow phase – position “???” – connect the solution bag to the catheter.
10. Safety phase – position “????” – automatic closure of the catheter extension with the PIN.
11. Disconnection (remove the protective cap from the new disinfection cap/closing cap and screw it onto the old one. Unscrew the catheter extension from the DISC and screw it onto the new disinfection cap/closing cap).
12. Close the DISC with the open end of the used disinfection cap/closing cap (which has been kept in the other hole of the organizer).
13. Check the clarity and weight of the drained dialysate, and if the fluid is clear, discard it.

sleep•safe System for Automated Peritoneal Dialysis (APD)

For setup of the sleep-safe system, refer to your instruction manual. Preparation of the solution

• Check the solution bag (label, expiration date, clarity of solution, integrity of the bag and overwrap).
• Place the bag on a solid surface.
• Open the overwrap.
• Wash hands using an antimicrobial hand-wash lotion.
• 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 17 can 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 17 than you should

Excess dialysis solution infused into the peritoneal cavity can be drained. If you have used too many bags, please contact your doctor, as this may cause electrolyte and/or fluid imbalance.

If you forget to use CAPD/DPCA 17

Try to achieve the prescribed dialysate volume for 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.

The following adverse effects may occur as a result of peritoneal dialysis treatment in general:

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

• Peritonitis (inflammation of the peritoneum), indicated by cloudy peritoneal dialysis fluid, abdominal pain, fever, malaise, or, very rarely, blood contamination.

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 include:

Common (may affect up to 1 in 10 people)

• Problems with inflow or outflow of dialysis fluid.
• Feeling of abdominal stretching or fullness.
• Shoulder pain.

Uncommon (may affect up to 1 in 100 people)

• Diarrhea.
• Constipation.

Unknown 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/PD 17:

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.
• Dizziness.
• Decreased 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.

Unknown 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 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 CAPD/DPCA 17

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 refers to 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 opening.

6. Contents of the container and other information

Composition of CAPD/DPCA 17

• The active substances in one liter of solution are:

These quantities of active substance are equivalent to:

1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 102.5 mmol/l chloride, 35 mmol/l (S)-lactate and 83.2 mmol/l glucose.

• The other components of CAPD/DPCA 17 are water for injections, hydrochloric acid, sodium hydroxide.

Appearance of the medicinal product and contents of the container

The solution is clear and colourless to slightly yellowish.

The theoretical osmolarity of the solution is 356 mOsm/l, and the pH is above 5.5.

CAPD/DPCA 17 is available in the following administration systems and container sizes:

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Str. 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.
Ronda de Poniente, n° 8, planta baja, Parque Empresarial Euronova
28760-Tres Cantos (Madrid)
Spain

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 leaflet.

Date of the most recent review of this leaflet: 12/2022

Detailed and up-to-date 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/

Annex: Last page of the multilingual leaflet:

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

BG ????/???? 17 ??????? ?? ???????????? ???????
DE CAPD/DPCA 17, Peritonealdialyselösung
EL CAPD/DPCA 17/FRESENIUS, 1,5% γλυκόζη, Διάλυμα για περιτοναϊκή κάθαρση
ES CAPD/DPCA 17, Solución para diálisis peritoneal
HR CAPD/DPCA 17, otopina za peritonejsku dijalizu
HU CAPD/DPCA 17 Stay Safe peritoneális dializáló oldat
IT CAPD 17, Soluzione per dialisi peritoneale
NL CAPD/DPCA 17 met 1,5% glucose, oplossing voor peritoneale dialyse
UK(XI) CAPD/DPCA 17, Solution for peritoneal dialysis