Capd/pdca 3
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CAPD/DPCA 3 (CAPD/DPCA 3)
Composition:
Active substances: 1 liter of solution contains:
sodium chloride 5.786 g;
sodium (S)-lactate solution 7.85 g (equivalent to sodium (S)-lactate 3.925 g);
calcium chloride dihydrate 0.2573 g;
magnesium chloride hexahydrate 0.1017 g;
glucose monohydrate 46.75 g (equivalent to anhydrous glucose 42.5 g);
Na+ 134.0 mmol/L,
Ca++ 1.75 mmol/L,
Mg++ 0.5 mmol/L,
Cl- 103.5 mmol/L,
lactate 35.0 mmol/L;
Excipients: hydrochloric acid diluted, sodium hydroxide, water for injections.
Pharmaceutical form. Solution for peritoneal dialysis.
Main physicochemical properties: clear solution ranging from light yellow to yellow in color, free from visible particles, with a theoretical osmolarity of 511 mOsm/L.
Pharmacotherapeutic group.
Solutions for peritoneal dialysis. Hypertonic solutions. ATC code B05DB.
Pharmacological Properties
Pharmacodynamics
CAPD/DPCA 3 is an electrolyte solution containing glucose and a lactate buffer, intended for intraperitoneal administration in the treatment of end-stage chronic renal failure of various etiologies by continuous ambulatory peritoneal dialysis (CAPD).
The CAPD method is characterized by a more or less constant presence of dialysis solution (usually 2 liters) in the peritoneal cavity, which is replaced with fresh solution 3 to 5 times daily.
The fundamental principle underlying any peritoneal dialysis technique is the use of the peritoneum as a semipermeable membrane, allowing exchange of solutes and water between blood and dialysis solution via diffusion and convection, according to their physicochemical properties.
The electrolyte composition of the solution is mainly similar to physiological levels, although it has been adapted (e.g., potassium content) for use in patients with uremia, enabling renal replacement therapy through intraperitoneal exchange of solutes and fluids. During dialysis, substances normally excreted in urine—such as urea, creatinine, inorganic phosphates, uric acid, other solutes, and water—are removed from the body via the dialysate. It should be noted that medications taken by the patient may also be removed during dialysis, so dose adjustments may be necessary.
Individual parameters (such as patient size, body weight, laboratory values, residual kidney function, and ultrafiltration) should be used to determine the dose and combination of solutions with different osmolarities (glucose content), and concentrations of potassium, sodium, and calcium. The effectiveness of therapy should be regularly monitored based on these parameters.
Peritoneal dialysis solutions with high glucose content (2.3% or 4.25%) are used when the patient's body weight exceeds the desired dry weight. Fluid removal from the body increases proportionally with increasing glucose concentration in the peritoneal dialysis solution.
Pharmacokinetics
Uremic substances such as urea, creatinine, and uric acid, inorganic phosphates, and electrolytes such as sodium, potassium, calcium, and magnesium are removed from the body via the dialysate through diffusion and convection.
Glucose in the dialysate, used as an osmotic agent in CAPD/DPCA 3, is slowly absorbed, thereby reducing the diffusion gradient between dialysate and extracellular fluid. Ultrafiltration is maximal at the beginning of the dwell time and peaks after 2–3 hours. Subsequently, absorption begins, leading to a progressive decline in ultrafiltration. Between 60% and 80% of the glucose is absorbed from the dialysate.
S-lactate, used as a buffer agent, is practically completely absorbed within 6 hours of dwell time. In patients with normal liver function, rapid metabolism of S-lactate is confirmed by normal levels of intermediate metabolites.
Calcium exchange depends on glucose concentration in the dialysate, volume of drained dialysate, serum ionized calcium levels, and calcium concentration in the dialysis solution. The higher the glucose concentration, volume of drained dialysate, and serum ionized calcium levels, and the lower the calcium concentration in the dialysis solution, the greater the amount of calcium removed from the body into the dialysate.
Preclinical Safety Data
No toxicological preclinical studies with CAPD/DPCA 3 have been conducted. However, clinical studies with similar peritoneal dialysis solutions have not shown high toxicity.
Clinical characteristics.
Indications.
Terminal (decompensated) stage of chronic renal failure of various etiologies, requiring treatment with peritoneal dialysis.
Contraindications.
For this specific solution.
CAPD/PDPA 3 should not be used in patients with lactic acidosis, severe hypokalemia, severe hypercalcemia, hypovolemia, and arterial hypotension.
Due to the presence of fructose, CAPD/PDPA 3 should not be used in patients with fructose intolerance (hereditary fructose intolerance). Hereditary fructose intolerance must be excluded before administration in children and infants.
For peritoneal dialysis as a method.
Peritoneal dialysis should not be performed in the following cases:
- recent abdominal surgery or trauma, abdominal operations with history of fibrous adhesions, severe abdominal burns, perforation of the peritoneum;
- extensive inflammatory skin lesions of the abdominal area (dermatitis);
- inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulitis);
- peritonitis;
- internal or external abdominal fistulas;
- umbilical, inguinal, or other abdominal wall hernias;
- intra-abdominal tumors;
- ileus;
- lung diseases (particularly pneumonia);
- sepsis;
- severe hyperlipidemia;
- cases where uremia is unresponsive to peritoneal dialysis treatment;
- cachexia and significant weight loss, especially when adequate protein intake is not possible;
- physical or mental inability of the patient to follow physician instructions regarding peritoneal dialysis procedures.
If any of the above conditions develop during peritoneal dialysis, the physician must make a decision regarding further management.
Special safety precautions.
Before using the peritoneal dialysis solution CAPD/PDPA 3, it is mandatory to read the instructions for use of the "stay-safe" continuous ambulatory peritoneal dialysis system.
Interaction with other medicinal products and other types of interactions.
The use of this peritoneal dialysis solution may reduce the efficacy of other medicinal products, as they may be removed from the body together with the dialysate; therefore, dose adjustments may be required.
Significant reduction in serum potassium levels may increase the frequency of dialysis-related adverse reactions. Potassium levels must be monitored particularly carefully during concomitant treatment with cardiac glycosides.
When prescribing medications containing calcium or vitamin D, the possibility of hypercalcemia should be considered.
Concomitant use of diuretics may be beneficial for maintaining residual diuresis, but may also lead to disturbances in water-electrolyte balance.
For patients with diabetes mellitus, the daily dose of insulin or oral hypoglycemic agents should be adjusted according to the increased glucose load.
Special precautions for use
The peritoneal dialysis solution should not be administered intravenously.
CAPD/PD solution 3 may be used after careful assessment of the benefit-risk ratio in the following cases:
- in the event of electrolyte loss due to vomiting and/or diarrhea (in such cases, temporary substitution with a peritoneal dialysis solution containing potassium may be required);
- in hypercalcemia, for example due to administration of calcium-containing phosphate binders and/or vitamin D, consideration should be given to temporarily or permanently switching to a peritoneal dialysis solution with a lower calcium concentration;
- in patients receiving cardiac glycoside therapy: serum potassium levels must be monitored particularly closely. In cases of severe hypokalemia, use of a potassium-containing dialysis solution and consultation with a dietitian may be necessary.
Peritoneal dialysis solutions with high glucose content (2.3% or 4.25%) should be used with caution to prevent dehydration and reduce osmotic load.
During peritoneal dialysis, loss of proteins, amino acids, and water-soluble vitamins occurs. To prevent deficiency, adequate dietary intake or supplementation with nutritional additives should be ensured.
During long-term peritoneal dialysis, transport characteristics of the peritoneal membrane may change, primarily indicated by lack of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.
The following parameters should be monitored regularly:
- body weight, to detect early signs of fluid overload or dehydration;
- serum concentrations of sodium, potassium, calcium, magnesium, phosphates, acid-base balance, and blood proteins;
- concentrations of creatinine and urea;
- blood glucose levels;
- parathyroid hormone and other markers of bone metabolism;
- residual kidney function, to adapt peritoneal dialysis treatment.
Adding other medicinal products to the peritoneal dialysis solution is not recommended, due to the risk of contamination and incompatibility between the peritoneal dialysis solution and the medicinal product.
To minimize the risk of infection, any addition of medicinal products to the solution must be performed under aseptic conditions. The solution, after thorough mixing and inspection for clarity, should be used immediately.
CAPD/PD 3 contains 42.5 g of glucose per 1000 ml of solution. Depending on dosage and the size of the container used, up to 106 g of glucose may be delivered into the body (CAPD/PD 3: 2500 ml in a "stay-safe" system). This should be taken into account in patients with diabetes mellitus.
The volume and clarity of the drained fluid should be monitored. Cloudiness of the effluent and/or abdominal pain are signs of possible peritonitis.
Use in elderly patients
Before initiating peritoneal dialysis, the increased incidence of hernias in elderly patients should be considered.
Use during pregnancy or breastfeeding
Pregnancy
There are no clinical data on the use of CAPD/PD 3 in pregnant women. No reproductive toxicity studies have been conducted in animals. CAPD/PD 3 is not recommended during pregnancy unless the woman's clinical condition requires treatment with CAPD/PD 3.
Breastfeeding
It is unknown whether active substances/metabolites of CAPD/PD 3 pass into breast milk. Breastfeeding is not recommended for women undergoing peritoneal dialysis.
Reproductive function
There are no data on the effect of CAPD/PD 3 on reproductive function.
Effect on ability to drive or operate machinery
CAPD/PD 3 has no or negligible effect on the ability to drive or operate machinery.
Method of Administration and Dosage
CAPD/PDCA 3 solution is intended exclusively for intraperitoneal use.
The method of peritoneal dialysis, frequency, and duration of exchanges are determined by the physician.
Continuous Ambulatory Peritoneal Dialysis (CAPD)
Adults
In the absence of other prescriptions, 2000 mL of solution per exchange is administered four times daily. After the dwell time in the abdominal cavity (2 to 10 hours), the solution is drained.
Dosage, volume of solution, and number of exchanges are individually adjusted for each patient.
If pain occurs at the initiation of peritoneal dialysis, temporarily reduce the volume per exchange to 500–1500 mL.
If the patient has excess body weight or residual kidney function is lost, the volume per exchange should be increased. For such patients and for patients who tolerate large volumes well, the volume per exchange may be increased up to 2500–3000 mL.
Children
For children, the volume of solution per exchange should be prescribed based on the child’s age and body surface area (BSA).
The initial dose per exchange should not exceed 600–800 mL/m² BSA, administered four times daily (sometimes three or five times). The volume per exchange may be increased up to 1000–1200 mL/m² BSA, depending on tolerability, the child’s age, and residual kidney function.
Elderly Patients
There are no specific dosage recommendations for elderly patients.
Peritoneal dialysis is a long-term therapy requiring regular use of individual solution bags.
Method and Duration of the Procedure
Before performing peritoneal dialysis at home, the patient must undergo appropriate training, practice the technique, and achieve adequate proficiency. Training must be conducted by qualified personnel. Before discharging a patient for home-based peritoneal dialysis, the physician must ensure that the patient has mastered the procedure. In case of any problems or uncertainties, consult the physician.
Dialysis using prescribed doses should be performed daily and continued as long as renal replacement therapy is required.
Continuous Ambulatory Peritoneal Dialysis (CAPD): "Stay-Safe" System
The solution must be warmed in advance to body temperature. The required dose is infused through the peritoneal catheter into the abdominal cavity over 5–20 minutes. According to the physician’s recommendations, the solution should remain in the abdominal cavity for 2–10 hours (dwell time), after which it is drained.
Depending on the required osmotic pressure, CAPD/PDCA 3 may be used sequentially with other peritoneal dialysis solutions with lower glucose content (i.e., lower osmolarity).
For single use only. Any unused solution must be discarded. There are no special requirements for disposal of the medicinal product.
Instructions for Using the Continuous Ambulatory Peritoneal Dialysis "Stay-Safe" System
The "Stay-Safe" system is a double-bag system consisting of a solution bag made of non-PVC multilayer polyolefin film, a transfer set also made of polyolefins, a system connector (DISC, polypropylene), a drain bag, and an outer bag also made of multilayer polyolefin film.
The solution should be warmed in advance to body temperature. For bags with a volume up to 3000 mL, this should be done using an appropriate heater. The warming time for a 2000 mL volume from an initial temperature of 22°C is approximately 120 minutes. Automatic temperature control is set at 39°C ± 1°C. More detailed information can be found in the heater’s operating instructions. Microwave heating is not recommended due to the risk of local overheating.
- Inspect the solution bag (labeling, expiration date, ensure the solution is clear) – open the outer protective bag and the disinfection cap packaging.
- Wash hands using an antimicrobial cleansing agent.
- Place the DISC into the organizer (hang the solution bag on the upper ring of the infusion stand – unroll the "solution bag-DISC" line – place the DISC into the organizer – then place the drain bag into the lower ring of the infusion stand).
- Place the catheter extension set into one of the two openings in the organizer. Place the new disinfection cap into the other free opening of the organizer.
- Disinfect hands and then remove the protective cap from the DISC.
- Connect the catheter extension set to the DISC.
- Open the clamp on the catheter extension set – switch position "●" – drainage procedure begins.
- After completion of drainage: Rinse – switch position "●●" – rinse with fresh dialysate into the drain bag (approximately 5 seconds).
- Fill – switch position "○●●" – connection between the solution bag and the catheter.
- Safety measures – switch position "●●●●" – automatic closure of the catheter extension set by inserting the PIN.
- Disconnection – remove the protective cap from the new disinfection cap and screw it onto the old cap. Unscrew the catheter extension set from the DISC and screw it onto the new disinfection cap.
- Close the DISC with the open end of the disinfection cap (which remains in the right opening of the organizer).
- Check the drained dialysate for clarity and weight. If the drained solution is clear, it should be discarded.
The plastic bag may be damaged during transport or storage, potentially leading to contamination of the dialysis solution and increased microbial growth. Therefore, the entire package must be carefully inspected for damage before connection and use of the peritoneal dialysis solution. Pay attention to any damage, even minor, to the connections, housing, seams, or corners of the bag to prevent contamination.
Damaged bags or bags containing cloudy solution must never be used! If in doubt, consult the physician regarding the use of this solution.
The peritoneal dialysis solution may be used only if the bag and seal are undamaged.
The peritoneal dialysis solution may be used only if it is clear and the bag is undamaged.
The outer packaging should be opened immediately before use.
To reduce the risk of infection during dialysate exchange, maintain sterile conditions.
Children
For children, the volume of solution per exchange should be prescribed based on the child’s age and body surface area.
Overdose
No incidents related to overdose have been reported.
Excess dialysis solution introduced into the abdominal cavity can be easily drained into the drain bag. However, if exchanges are performed too frequently, dehydration and electrolyte imbalances may develop, requiring immediate medical intervention. If an exchange has been missed, contact the physician or the dialysis center.
Incorrect dosing may lead to hyper- or dehydration and electrolyte imbalances.
The most likely consequence of overdose is dehydration.
Insufficient dosing, interruption, or discontinuation of treatment may lead to life-threatening hyperhydration with peripheral edema and cardiac decompensation and/or other uremic symptoms that may be life-threatening.
Standard emergency care and intensive therapy protocols must be applied. The patient may require immediate hemodialysis.
Adverse reactions.
Possible adverse reactions may be due to peritoneal dialysis as a method or may be caused by this specific solution.
The frequency of adverse reactions is defined as follows:
| very common |
(>1/10) |
| common |
(>1/100 to <1/10) |
| uncommon |
(>1/1000 to <1/100) |
| rare |
(>1/10000 to <1/1000) |
| very rare |
(<1/10000) |
| unknown |
(cannot be estimated from the available data) |
Potential adverse reactions associated with this specific solution
Metabolic and nutritional disorders:
- increased blood sugar levels (common);
- weight gain due to prolonged use of glucose from peritoneal dialysis solution (common);
- hyperlipidemia or worsening of pre-existing hyperlipidemia (common).
Cardiac disorders:
- hypotension (uncommon);
- tachycardia (uncommon);
- hypertension (uncommon).
Respiratory, thoracic and mediastinal disorders:
- dyspnea (uncommon).
Renal and urinary system disorders:
- electrolyte imbalance, e.g. hypokalemia (very common);
- hypercalcemia in combination with increased calcium absorption (common), e.g. when calcium-containing phosphate binders are administered.
General disorders and administration site conditions:
- dizziness (uncommon);
- edema (uncommon);
- fluid imbalance (uncommon), indicated by rapid weight loss (dehydration) or weight gain (hyperhydration). Severe dehydration may occur with the use of solutions with high glucose concentration.
Potential adverse reactions of peritoneal dialysis as a method
Infections and infestations:
- peritonitis (very common), indicated by clouding of the drained dialysate. Later, abdominal pain, fever, and general malaise may develop, or, in very rare cases, sepsis. In such cases, the patient must seek immediate medical attention. The bag with drained cloudy dialysate should be sealed with a sterile cap and submitted for microbiological examination and leukocyte count in blood;
- skin infections and tunnel infections (very common), indicated by redness, swelling, exudation, crusts, and pain at the catheter exit site.
In case of skin infection, prompt consultation with the treating physician is required.
Respiratory, thoracic and mediastinal disorders:
- dyspnea due to elevation of the diaphragm (frequency not known).
Gastrointestinal disorders:
- hernias (very common);
- bloating and sensation of fullness (common);
- diarrhea (uncommon);
- constipation (uncommon).
Injury, poisoning and procedural complications:
- difficulties with inflow and outflow of dialysis solution (common);
- shoulder pain (common).
Reporting of adverse reactions
It is very important to report adverse reactions occurring after administration of the medicinal product. This allows continuous monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals are requested to report any adverse reactions occurring during the use of this product.
Shelf life. 2 years.
Storage conditions
Store at temperatures not exceeding 25°C. Do not freeze.
Packaging
2000 ml or 2500 ml in a double-bag "stay-safe" system; 4 bags per cardboard box labeled in Ukrainian and other languages.
Prescription status. Prescription only.
Manufacturer
Fresenius Medical Care Deutschland GmbH.
Manufacturer's address
Frankfurter Strasse 6-8, 66606 St. Wendel, Germany.
Marketing Authorization Holder
Fresenius Medical Care Deutschland GmbH.
Address of the Marketing Authorization Holder
Else-Kroener-Strasse 1, 61352 Bad Homburg v.d.H., Germany.