Leaflet: information for the user

CAPD/DPCA 19solution for peritoneal dialysis

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Si tiene alguna duda, consulte a su médico, farmacéutico o enfermero.
• Este medicamento se le ha recetado solamente a usted y no debe dárselo a otras personas, aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
• Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

1.What is CAPD/DPCA 19 and how it is used

2.What you need to know before starting to use CAPD/DPCA 19

3.How to use CAPD/DPCA 19

4.Possible side effects

5Storage of CAPD/DPCA 19

6.Contents of the pack and additional information

CAPD/DPCA 19is used to clean the bloodvia the peritoneum in patients with end-stage chronic kidney disease. This type of blood cleaning is known as peritoneal dialysis.

No use CAPD/DPCA 19

• if your blood potassium level is very low
• if your blood calcium level is very low
• if you have alactate metabolism disorder
• if you have afructose metabolism disorder (hereditary fructose intolerance)
• if your body fluid volume is too low
• if your blood pressure is low

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

Warnings and precautions

Consult your doctor immediately:

• in case ofsevere electrolyte loss (salts)caused by vomiting and/or diarrhea.
• in case ofhigh parathyroid gland activityorlow blood calcium level.

You may need to take additional calcium phosphate-containing chelators and/or vitamin D. If this is not possible, a peritoneal dialysis solution with a higher calcium concentration should be used.

• in case ofperitonitis, recognizable by cloudy peritoneal dialysis solution, abdominal pain, fever, malaise, or, in rare cases, blood contamination.

Show your doctor the drainage solution bag.

• in case ofsevere 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 aloss of proteinsandwater-soluble vitamins. It is recommended to follow a suitable diet or take nutritional supplements to avoid nutritional deficiencies.

Your doctor should regularly check your electrolyte balance, blood cell count, renal function, body weight, and nutritional status.

CAPD/DPCA 19 contains 22.73 g of glucose in 1000 ml of solution. Depending on the dosing instructions and the size of the container used, up to 68.2 g of glucose (CAPD, 3000 ml) or up to 113.65 g of glucose (APD, 5000 ml) are administered with each bag. This should be taken into account in the treatment of patients with diabetes mellitus.

Due to the high glucose concentration, CAPD 19 should be used with caution and under the supervision of your doctor.

Use of CAPD 19 with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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:

• Cardiac failure medications, such as digoxin.
• Your doctor will check 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.
• Oral medicationsthat decrease blood sugar levels or insulin. Regular blood sugar level checks are necessary.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. There are no adequate data on the use of CAPD/DPCA 19 in pregnant women or during lactation. If you are pregnant, you should not use CAPD/DPCA 19unless your doctor considers it absolutely necessary.

The active principles of CAPD/DPCA 19 or their metabolites are unknown to be excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and operating machinery

The influence of CAPD/DPCA 19 on the ability to drive and operate machinery 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)

• Adults:The usual dose is between 2000 – 3000 ml of solution four times a day depending on body weight and renal function.

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

• 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)

The exchange of bags is controlled automatically by a machine throughout the night. For this type of dialysis, the CAPD/DPCA systemsleep•safeis used.

• Adults:The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a cyclator 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 19 only in the peritoneal cavity.

Use only CAPD/DPCA 19 if the solution is transparent and the container is not damaged.

Usage Instructions:

Sleep•safeSystem for Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the bag with the solution to body temperature. For bags with a volume of up to 3000 ml, this should be done using an appropriate bag warmer. The warming time depends on the volume of the bag and the bag warmer used (for a 2000 ml bag with an initial temperature of22ºC, it usually takes about 120 minutes of warming time). You can find more detailed information in the manual of your bag warmer. To warm the solution, ovens should not be used due to the risk of local overheating. After warming the solution, the exchange of bags can be performed.

1. Check the bag with the solution (label, expiration date, transparency of the solution, integrity of the bag and overbag) – open the overbag and the packaging of the disinfection plug/ closure plug.
2. Wash your hands with an antimicrobial washing solution.
3. Place the DISC in the organizer (hang the bag with the solution on the upper hanger of the infusion support – unroll the “DISC-bag solution” line – place the DISC in the organizer – place the drainage bag on the lower hanger of the infusion support).
4. Place the catheter extension in one of the two inserts of the organizer.Place the new disinfection plug/closure plug in the other free insert.
5. Disinfect your hands and remove the protective cap from the DISC.
6. Connect the catheter extension to the DISC.
7. Open the extension valve – Position “?” – initiate the outflow.
8. After the completion of drainage:Purge – Position “??”– purge the drainage bag with clean solution (approximately 5 seconds).
9. Flow entry – Position “?” “?” “?”– connect the bag with the solution to the catheter.
10. Security phase – Position “????” – automatic closure of the catheter extension with the PIN
11. Disconnection – remove the protective cap of the new disinfection plug/closure plug and screw it onto the old one. Unscrew the catheter extension from the DISC and screw on the new disinfection plug/closure plug.
12. Closing the DISC with the open end of the disinfection plug/closure plug used (which has been kept in the other hole of the organizer).
13. Check the transparency and weight of the drained dialysate and if the liquid is transparent, discard it.

Sleep•safeSystem for Automated Peritoneal Dialysis (APD)

For the configuration of the systemsleep-safe, consult your instructions manual Preparation of the solution

• Check the bag with the solution (label, expiration date, transparency of the solution, integrity of the bag and overbag).
• Place the bag on a solid surface.
• Open the overbag.
• Wash your hands using an antimicrobial washing solution.
• Check that the solution is transparent and that the bag has no leaks.

1. Unroll the tube of the bag
2. Remove the protective cap
3. Place the connector in the free port of the tray
4. The bag is ready to use with thesleep•safeequipment.

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

After proper training, CAPD/DPCA 19 can be used independently at home. Make sure you follow all the steps you learned during training and maintain the necessary hygiene conditions when exchanging bags.

Always check the turbidity of the drained dialysate. See section 2.

If you use more CAPD/DPCA 19 than you should

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

If you forgot to use CAPD/DPCA 19

Try to reach the prescribed dialysis volume for each 24-hour period to avoid consequences that may put your life at risk. You should consult your doctor if you have any doubts.

If you have any other questions 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 peritoneal dialysis solution draining from your peritoneum, abdominal pain, fever, malaise, or, in very rare cases, blood contamination.

Show your doctor the drainage bag containing the 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 as follows:

Common(may affect up to 1 in 10 people)

• Problems with the entry or exit of the drainage solution.
• Abdominal fullness or stretching sensation
• Shoulder pain

Uncommon(may affect up to 1 in 100 people)

• Diarrhea
• Constipation

Unknown(frequency 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 CAPD/DPCA 19:

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 fluid volume, which can be recognized by rapid weight loss
• Dizziness
• Low blood pressure
• Fast heart rate
• High fluid volume, which can be recognized by rapid weight gain
• Fluid accumulation in tissues and lungs
• Elevated 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

Do not store at a temperature above25°C. Do not refrigerate or freeze.

The solution should be used immediately after opening.

Composition of CAPD/DPCA 19

• The active principles in one liter of solution are:

These amounts 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 126.1 mmol/l glucose.

• The other components of CAPD/DPCA 19 are water for injection, hydrochloric acid, and sodium hydroxide.

Appearance of the product and contents of the package

The solution is transparent and colorless to slightly yellowish.

The theoretical osmolality of the solution is 399 mOsm/l, the pH is over 5.5.

CAPD/DPCA 19 is available in the following application systems and package sizes:

Only some package sizes may be commercially available.

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, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid)

Spain

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.

Last revision date of this package leaflet:12/2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Annex: Last page of the multilingual package leaflet:

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:

BG????/???? 19 ??????? ?? ???????????? ???????

DECAPD/DPCA 19, Peritonealdialyselösung

ELCAPD/DPCA 19/FRESENIUS, 2,3% γλυκ?ζη, Δι?λυμα γιαπεριτovα?κ? κ?θαρσn

ESCAPD/DPCA 19, Solución para diálisis peritoneal

HRCAPD/DPCA 19, otopina za peritonejsku dijalizu

ITCAPD 19, Soluzione per dialisi peritoneale

NLCAPD/DPCA19 met 2,3% glucose, oplossing voor peritoneale dialyse

UK(XI)CAPD/DPCA 19, Solution for peritoneal dialysis