CAPD 19

Package leaflet: Information for the user

CAPD 19 solution for peritoneal dialysis

Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What CAPD 19 is and what it is used for
2. What you need to know before using CAPD 19
3. How to use CAPD 19
4. Possible side effects
5. How to store CAPD 19
6. Contents of the pack and other information

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

CAPD 19 is a dialysis solution for blood purification through the peritoneal membrane in patients with end-stage chronic renal failure. This type of blood purification is called: peritoneal dialysis.

2. What you should know before using CAPD 19

Do not use CAPD 19:

• If your potassium level is very low;
• If your calcium level is very low;
• If you suffer from lactate metabolism disorders;
• If you suffer from fructose metabolism disorders (hereditary fructose intolerance);
• In case of dehydration;
• In case of hypotension.

Peritoneal dialysis in general should not be started if

• You have suffered from an abdominal disorder such as:
• Injury or abdominal surgery,
• Severe burns,
• Extensive skin inflammatory reactions,
• Peritonitis,
• Abdominal fistula (draining wounds that do not heal),
• Umbilical, inguinal or diaphragmatic hernias,
• Tumors in the abdomen or intestines,
• Intestinal inflammations,
• Intestinal obstruction,
• Lung diseases, especially pneumonia,
• Bacterial intoxication,
• Very high levels of lipids in the blood,
• Blood intoxication due to urine that cannot be eliminated through blood purification,
• Severe malnutrition and weight loss, particularly if adequate intake of protein-containing foods is not possible.

Warnings and precautions
Inform your doctor immediately:

• In case of severe loss of electrolytes (salts) due to vomiting and/or diarrhea;
• In case of hyperparathyroidism or low blood calcium levels. Administration of calcium-containing phosphate binders and/or vitamin D may be necessary. If this is not possible, a dialysis solution with a high calcium content should be used;
• In case of peritonitis, recognizable by cloudy dialysate, abdominal pain, fever, feeling unwell, or in rare cases blood intoxication. Please show the fluid from 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 therapy that can be fatal.

Peritoneal dialysis may cause loss of proteins and water-soluble vitamins. An adequate diet or use of nutritional supplements is recommended to prevent nutritional deficiencies.
Your doctor will periodically monitor your electrolyte balance (salts), total blood cell count, residual kidney function, body weight, and nutritional status.
CAPD 19 contains 22.73 g of glucose per 1,000 ml of solution. Depending on the dosing instructions and the pack used, each bag delivers up to 68.2 g of glucose (CAPD, 3,000 ml stay•safe) or 113.65 g of glucose (APD, 5,000 ml sleep•safe) to the body. This must be taken into account in patients with diabetes mellitus.
Due to the high glucose concentration, CAPD 19 must be used with caution and under medical supervision.

Other medicines and CAPD 19:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since peritoneal dialysis may affect the effects of certain medicines, your doctor may adjust their dosage, especially in the case of:

• Medicines for heart diseases, such as digoxin. Your doctor will periodically check your blood potassium levels and, if necessary, recommend appropriate corrective measures;
• Medicines affecting blood calcium levels, such as those containing calcium or vitamin D;
• Diuretic medicines, such as diuretics;
• Oral medicines that lower blood sugar levels or affect insulin secretion. Blood glucose levels must be monitored regularly.

Pregnancy and breastfeeding:
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine. There are no adequate data on the use of CAPD 19 in pregnant or breastfeeding women. During pregnancy, you may use CAPD 19 only if your doctor considers it absolutely necessary.
It is not known whether the active substances/metabolites of CAPD 19 are excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and using machines:
CAPD 19 does not impair or impairs negligibly the ability to drive vehicles or operate machinery.

3. How to use CAPD 19

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the method, duration, frequency of use, volume of infused fluid, and dwell time of the fluid in the peritoneal cavity.
If excessive abdominal tension occurs, your doctor may reduce the volume of infused fluid.

Continuous Ambulatory Peritoneal Dialysis (CAPD):

• Adults: The usual dose is 2,000–3,000 ml of solution four times daily, depending on body weight and residual renal function. After a dwell time between 2 and 10 hours, the solution must be drained.
• Children: The physician will determine the dialysis solution volume based on tolerance, age, and body surface area. The recommended initial dose is 600–800 ml/m (up to 1,000 ml/m per night) of body surface area, administered four times daily.

Automated Peritoneal Dialysis (APD):
Exchanges of dialysis solution are automatically controlled by the equipment during the night.
For CAPD solutions, the sleep safe system is used.

• Adults: The usual prescription is 2,000 ml (maximum 3,000 ml) per exchange, with 3–10 exchanges per night and connection time to the equipment of 8–10 hours, plus one or two daytime exchanges.
• Children: The volume per exchange should be 800–1,000 ml/m (up to 1,400 ml/m) of body surface area, with 5–10 exchanges per night. Infuse CAPD 19 only into the peritoneal cavity.

Use CAPD 19 only if the solution is clear and the containers are undamaged.
Instructions for Use
stay•safe System for Continuous Ambulatory Peritoneal Dialysis (CAPD)
Warm the ready-to-use solution to body temperature. This must be done using a dedicated heating device for bags. The heating time for 2,000 ml bags starting at an initial temperature of 22°C is approximately 120 minutes. More detailed information is available in the heating device’s user manual. Do not use a microwave oven to heat the bag due to the risk of overheating. Once the solution is warmed, the bag exchange can begin.

1. Check the solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging). Open the outer bag packaging and the disinfection cap packaging.
2. Wash hands with an antibacterial solution.
3. Position the disc in the organizer (hang the solution bag on the upper hook of the bag stand, unroll the "solution bag–disc" line, place the disc in the organizer, hang the drainage bag on the lower hook of the bag stand).
4. Place the catheter extension into one of the two inserts in the organizer. Place the new disinfection 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 valve on the extension. Position "  " Drainage begins.
8. After drainage is complete: Flushing. Position "  " Flush the drainage bag with fresh solution (for about 5 seconds).
9. Infusion. Position "  " Connect the solution bag to the catheter.
10. Safety position. Position "  " Close the catheter extension by automatic insertion of the PIN.
11. Disconnection. Remove the protective cap from the new disinfection cap and screw it onto the old one. Unscrew the catheter extension from the disc and screw the catheter extension onto the new disinfection cap.
12. Close the disc with the open end of the used disinfection cap (which remains in the right hole of the organizer).
13. Check the clarity and weight of the drained dialysate, and if the effluent is clear, discard it.

sleep•safe System for Automated Peritoneal Dialysis (APD)
During automated peritoneal dialysis (APD), the solution is automatically warmed inside the machine.

1. Preparation of the solution
   • Check the solution bag (label, expiry date, clarity of solution, absence of damage to the bag and outer packaging).
   • Place the bag on a solid surface.
   • Open the protective outer wrapping of the bag.
   • Wash hands with an antibacterial product.
   • Check that the solution is clear and that the bag shows no signs of leakage.
2. Unroll the infusion line.
3. Remove the protective cap.
4. Insert the bag connector into the port of the sleep•safe device.
5. The bag is now ready for use with the sleep•safe set.

Each bag must be used only once, and any unused solution must be discarded.
After appropriate patient training, CAPD 19 bags may be used independently at home. Ensure you follow all procedures learned during training and maintain adequate hygiene during dialysis exchanges.
Always check the clarity of the drained dialysate. See paragraph 2.
If you use more CAPD 19 than you should
If an excess of solution is infused into the peritoneal cavity, it can be easily drained.
If you have used an excessive number of bags, consult your doctor, as electrolyte imbalances in the blood may occur.
If you forget to use CAPD 19
Try to obtain the prescribed volume of dialysate for each 24-hour interval to avoid potentially life-threatening consequences. If in doubt, contact your doctor.
If you have any questions about the use of this product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur during peritoneal dialysis treatment in general:
Very common (may affect more than 1 in 10 people):

• Peritoneal inflammation, indicated by cloudiness of the drained dialysate, abdominal pain, fever, persistent malaise, or, in very rare cases, blood poisoning. Please show the drainage bag to your doctor.
• Inflammation of the skin at the catheter exit site or along the catheter tract, recognizable by redness, swelling, pain, purulent skin discharge, or crusts.
• Abdominal hernia.

If you notice any of these side effects, inform your doctor immediately.
Other side effects related to dialysis treatment include:
Common (may affect up to 1 in 10 people):

• Problems with infusion or drainage of dialysis fluid;
• Sensation of abdominal stretching or fullness;
• Shoulder pain.
  Uncommon (may affect up to 1 in 100 people):
• Diarrhea;
• Constipation;
  Not known (frequency cannot be estimated from the available data):
• Breathing difficulties due to elevation of the diaphragm;
• Encapsulating peritoneal sclerosis; possible symptoms include abdominal pain, abdominal distension, or vomiting.

The following side effects may occur when using CAPD 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 blood fat levels;

• Increase in body weight.
  Uncommon (may affect up to 1 in 100 people):

• Calcium deficiency;

• Too low body fluid levels, which may be indicated by rapid weight loss;

• Dizziness;

• Hypotension;

• Arrhythmia;

• Too high body fluid levels, which may be indicated by rapid weight gain;

• Fluid retention;

• Hypertension;

• Breathing difficulties;

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

• Hyperparathyroidism with possible disturbances in bone metabolism.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CAPD 19

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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or freeze.
The solution should be used immediately after opening the packaging.

6. Package contents and other information

What CAPD 19 contains

• The active substances in 1 liter of ready-to-use solution are: Calcium chloride dihydrate 0.1838 g Sodium chloride 5.786 g Sodium (S)-lactate solution 7.85 g (3.925 g of sodium (S)-lactate) Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate 25.0 g (22.73 g of glucose) Fructose up to 1.1 g These quantities are equivalent to: 1.25 mmol/l of calcium, 134 mmol/l of sodium, 0.5 mmol/l of magnesium, 102.5 mmol/l of chloride, 35 mmol/l of (S)-lactate, and 126.1 mmol/l of glucose.
• The other components of CAPD 19 are water for injections, hydrochloric acid, sodium hydroxide.

Description of the appearance of CAPD 19 and package contents
The solution is clear with a slight yellowish tint.
The theoretical osmolarity of the solution is 399 mOsm/l; the pH is approximately 5.5.
CAPD 19 is available in the following delivery systems and pack sizes:
stay•safe: sleep•safe:
4 bags of 2,000 ml 2 bags of 5,000 ml
4 bags of 2,500 ml
4 bags of 3,000 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Fresenius Medical Care Italia S.p.a., Via Crema 8, 26020 Palazzo Pignano (CR) - Italy

Manufacturer:
Fresenius Medical Care Deutschland GmbH, Frankfurter Strasse 6-8, 66606 St. Wendel - Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
See the last page of the multilingual package leaflet.
This medicinal product is authorized in the European Economic Area Member States under the following names:
[stay safe system:]
D: CAPD/DPCA 19, Peritonealdialyselösung
GB: CAPD/DPCA 19, Solution for peritoneal dialysis
NL: CAPD/DPCA 19 met 2,3% glucose, oplossing voor peritoneale dialyse
E: CAPD/DPCA 19, Solución para diálisis peritoneal
GR: CAPD/DPCA 19/FRESENIUS, 2,3 % γλυκόζη, Διάλυμα για περιτοναϊκή κάθαρση
F: DIALYSE PERITONEALE CONTINUE AMBULATOIRE 19 Solution pour dialyse péritonéale
I: CAPD 19, Soluzione per dialisi peritoneale
CZ: CAPD/DPCA 19, Roztok pro peritoneální dialýzu
HR: CAPD/DPCA 19, otopina za peritonejsku dijalizu
BG: КАПД/ДПКА 19 разтвор за перитонеална диализа

[sleep safe system:]
D: CAPD/DPCA 19, Peritonealdialyselösung
GB: CAPD/DPCA 19, Solution for peritoneal dialysis
NL: CAPD/DPCA 19 met 2,3% glucose, oplossing voor peritoneale dialyse
E: CAPD/DPCA 19, Solución para diálisis peritoneal
GR: CAPD/DPCA 19/FRESENIUS, 2,3 % γλυκόζη, Διάλυμα για περιτοναϊκή κάθαρση
F: DIALYSE PERITONEALE CONTINUE AMBULATOIRE 19 Solution pour dialyse péritonéale
I: CAPD 19, Soluzione per dialisi peritoneale
CZ: CAPD/DPCA 19, Roztok pro peritoneální dialýzu
HR: CAPD/DPCA 19, otopina za peritonejsku dijalizu
BG: КАПД/ДПКА 19 разтвор за перитонеална диализа