CAPD/DPCA 19 PERITONEAL DIALYSIS SOLUTION

Introduction

Package Leaflet: Information for the User

CAPD/DPCA 19solution 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 and other information:

1. What CAPD/DPCA 19 is and what it is used for
2. What you need to know before you use CAPD/DPCA 19
3. How to use CAPD/DPCA 19
4. Possible side effects

5 Storage of CAPD/DPCA 19

1. Contents of the pack and further information

1. What CAPD/DPCA 19 is and what it is used for

CAPD/DPCA 19 is used to clean the bloodvia 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 CAPD/DPCA 19

Do not use CAPD/DPCA 19

• if your blood potassium level is too low
• if your blood calcium level is too low
• if you have a lactate metabolism disorder
• if you have a fructose 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 started if you have:

• abdominal disorders such as
• • wounds, or after surgery
  • severe burns
  • significant skin inflammatory reactions
  • peritonitis
  • unclosed suppurating wounds
  • umbilical, inguinal, or diaphragmatic hernia
  • tumors in the abdomen or intestine

• 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 the accumulation of uremic toxins in the blood that cannot be removed by cleaning the blood.
• severe malnutrition and weight loss, particularly if it is not possible to consume adequate protein-containing food

Warnings and precautions

Consult your doctor immediately:

• in case of severe loss of electrolytes (salts)caused by vomiting and/or diarrhea.
• in case of high parathyroid gland activityor low blood calcium level.

It may be necessary to take additional calcium chelators containing phosphate 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 a cloudy peritoneal dialysis solution, abdominal pain, fever, malaise, or, in very rare cases, blood contamination.

Show your doctor the bag containing the drainage solution.

• 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 life-threatening.

Peritoneal dialysis may cause loss of proteinsand water-soluble vitamins. It is recommended to follow a suitable diet or take nutritional supplements to avoid deficient nutritional states.

Your doctor should regularly check your electrolyte balance, blood cell count, kidney 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 bag used, up to 68.2 g of glucose (CAPD, 3000 ml stay•safe) or up to 113.65 g of glucose (APD, 5000 ml sleep•safe) 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 medical supervision.

Using CAPD 19 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 check 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.
• Medicinesgiven orally that lower blood sugar levelsor insulin. Blood sugar levels should be regularly monitored.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. There is no adequate data on the use of CAPD/DPCA 19 in pregnant or breastfeeding women. If you are pregnant, you should not use CAPD/DPCA 19 unless your doctor considers it absolutely necessary.

It is unknown whether the active substances of CAPD/DPCA 19 or their metabolites are excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and using machines

The influence of CAPD/DPCA 19 on the ability to drive and use machines is negligible or non-existent.

3. How to use CAPD/DPCA 19

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, 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 – 3000 ml of solution four times a day, depending on body weight and kidney function.

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

• Children:The doctor will determine the required volume of dialysis solution based on tolerance, age, and body surface area.

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)

The exchange of bags is automatically controlled by a machine overnight. For this type of dialysis, the sleep•safesystem of CAPD/DPCA is used.

• Adults:The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges overnight and a cycle 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 overnight.

Use CAPD/DPCA 19 only in the peritoneal cavity.

Use CAPD/DPCA 19 only if the solution is clear and the bag is not damaged.

Instructions for use:

System stay•safefor Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, heat the bag with the solution to body temperature. For bags with a volume of up to 3000 ml, this should be done using a suitable bag warmer. The warming time depends on the bag volume and the bag warmer used (for a 2000 ml bag with an initial temperature of 22°C, it is usually around 120 minutes of warming time). You can obtain more detailed information in the manual of your bag warmer. To heat the solution, microwaves should not be used due to the risk of local overheating. After heating the solution, the bag exchange can be carried out.

1. Check the bag with the solution (label, expiration date, clarity 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 by the upper hanger of the infusion stand – unroll the "DISC-bag of solution" line – place the DISC in the organizer – place the drainage bag in the lower hanger of the infusion stand).
4. Place the catheter extension in one of the two inserts of the organizer. Put 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 “?” – start the outflow.
8. After completion of drainage: Purge – position “??” – purge the drainage bag with clean solution (approximately 5 seconds).
9. Inflow – position “???” – connect the bag with the solution 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 plug and screw it into the old one. Unscrew the catheter extension from the DISC and screw it into the new disinfection plug/closure plug.
12. Close 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 clarity and weight of the drained dialysate and if the liquid is clear, discard it.

System sleep•safefor Automated Peritoneal Dialysis (APD)

For the setup of the sleep-safesystem, refer to your instruction manual.

Preparation of the solution

• Check the bag with the solution (label, expiration date, clarity 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 clear 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 the sleep•safeequipment.

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

After proper training, CAPD/DPCA 19 can be used independently at home. Make sure you follow all the steps you have learned during training and maintain adequate 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

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

If you forget to use CAPD/DPCA 19

Try to reach the prescribed dialysate volume for each 24-hour period to avoid life-threatening consequences. You should consult your doctor if you have any doubts.

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 in general:

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

• peritonitis, recognizable by a cloudy peritoneal dialysis solution, abdominal pain, fever, malaise, or, in very rare cases, blood contamination.

Show your doctor the bag containing the drainage solution.

• skin inflammation at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, discharge, 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 inflow or outflow of the dialysis solution.
• feeling of abdominal stretching or fullness
• shoulder pain

uncommon(may affect up to 1 in 100 people)

• diarrhea
• constipation

rare(frequency 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 CAPD/DPCA 19:

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, recognizable by rapid weight loss
• dizziness
• decreased blood pressure
• rapid pulse
• body fluid volume too high, recognizable by rapid weight gain
• fluid in the tissues and lungs
• high blood pressure
• breathing difficulties

rare(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. This includes any 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 CAPD/DPCA 19

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.

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

The solution should be used immediately after opening.

6. Container Content and Additional Information

Composition of CAPD/DPCA 19

• The active ingredients 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 injectable preparations, hydrochloric acid, and sodium hydroxide.

Appearance of the Product and Container Content

The solution is transparent and colorless to slightly yellowish.

The theoretical osmolarity of the solution is 399 mOsm/l, and the pH is above 5.5.

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

Only some container sizes may 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

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:12/2022

Detailed and updated 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/

Annex: Last page of the multilingual prospectus:

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:

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

DE CAPD/DPCA 19, Peritonealdialyselösung

EL CAPD/DPCA 19/FRESENIUS, 2.3% γλυκ?ζη, Δι?λυμα για περιτovα?κ? κ?θαρσn

ES CAPD/DPCA 19, Solución para diálisis peritoneal

HR CAPD/DPCA 19, otopina za peritonejsku dijalizu

IT CAPD 19, Soluzione per dialisi peritoneale

NL CAPD/DPCA 19 met 2.3% glucose, oplossing voor peritoneale dialyse

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