Capd/pdca 2
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CAPD/DPCA 2 (CAPD/DPCA 2)
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 16.5 g (equivalent to anhydrous glucose 15.0 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. Peritoneal dialysis solution.
Main physicochemical properties: clear solution ranging from light yellow to yellow in color, free from visible particles, with a theoretical osmolarity of 358 mOsm/L.
Pharmacotherapeutic group.
Solutions for peritoneal dialysis. Hypertonic solutions. ATC code B05D B.
Pharmacological Properties
Pharmacodynamics
CAPD/DPCA 2 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 the method of continuous ambulatory peritoneal dialysis (CAPD).
The CAPD method is characterized by the 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 dissolved substances 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 to enable renal replacement therapy through intraperitoneal exchange of solutes and fluids. During the dialysis procedure, substances normally excreted in urine—such as urea, creatinine, inorganic phosphates, uric acid, other dissolved substances, 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 dosage adjustments may be necessary.
Individual patient parameters (such as body 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 4.5%) are used when the patient's body weight exceeds the desired dry weight. Fluid removal from the body increases with higher 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 2, 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 within 2–3 hours. Thereafter, absorption begins, leading to a progressive decline in ultrafiltration. Between 60% and 80% of glucose is absorbed from the dialysate.
S-lactate, used as a buffer agent, is practically completely absorbed within a 6-hour 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, and calcium concentration in the dialysis solution. The higher the glucose concentration, volume of drained dialysate, and serum ionized calcium, and the lower the calcium concentration in the dialysis solution, the greater the amount of calcium removed from the body into the dialysate.
Non-clinical Safety Data
No toxicological non-clinical studies with CAPD/DPCA 2 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 2 should not be used in patients with lactic acidosis, severe hypokalemia, and severe hypercalcemia.
Due to the fructose content, CAPD/PDPA 2 is not recommended for patients with fructose intolerance (hereditary fructose intolerance). Hereditary fructose intolerance must be excluded before use in children and infants.
For peritoneal dialysis as a method.
Peritoneal dialysis should not be performed in the following cases:
- recent surgery or trauma to the abdominal cavity, 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 (including pneumonia);
- sepsis;
- severe hyperlipidemia;
- cases where uremia cannot be managed by peritoneal dialysis;
- cachexia and significant weight loss, especially if adequate protein intake is not possible;
- physical or mental inability of the patient to follow physician instructions for performing peritoneal dialysis procedures.
If any of the above conditions develop during peritoneal dialysis, the physician must make a decision regarding further treatment.
Special precautions.
Before using the peritoneal dialysis solution CAPD/PDPA 2, 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 forms of interaction.
The use of this peritoneal dialysis solution may lead to reduced efficacy of other medicinal products, as they may be removed from the body together with the dialysate; therefore, dose adjustment may be necessary.
Significant reduction in serum potassium levels may increase the frequency of dialysis-related adverse reactions. Potassium levels should be monitored particularly carefully during concomitant treatment with cardiac glycosides.
When prescribing medicinal products containing calcium or vitamin D, the possibility of hypercalcemia should be taken into account.
Concomitant administration of diuretics may be beneficial for maintaining residual diuresis, but at the same time may 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.
The CAPD/DPCA 2 solution may be used after careful assessment of the benefit-risk ratio in the following cases:
- in case of electrolyte loss due to vomiting and/or diarrhea (in such cases, temporary replacement 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 case 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 their deficiency, adequate dietary intake or nutritional supplementation should be ensured.
During long-term peritoneal dialysis, transport characteristics of the peritoneal membrane may change, primarily indicated by absence of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.
The following parameters should be monitored continuously:
- body weight for early detection of fluid overload and dehydration;
- concentrations of sodium, potassium, calcium, magnesium, phosphates, acid-base balance, and blood proteins;
- creatinine and urea concentrations;
- 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, as there is a risk of contamination and incompatibility between the peritoneal dialysis solution and the medicinal product.
To reduce the risk of infection, any addition of medicinal products to the solution should be performed under aseptic conditions. The solution, after thorough mixing and inspection for clarity, should be used immediately.
CAPD/DPCA 2 contains 15 g of glucose per 1000 ml of solution. Depending on dosage and the size of the container used, up to 38 g of glucose may be delivered into the body (CAPD/DPCA 2 in 2500 ml in a "stay-safe" system). This should be taken into account in diabetic patients.
The volume and clarity of the drained fluid should be monitored. Cloudiness of the fluid and/or abdominal pain may indicate development of peritonitis.
Patients of advanced age
The high incidence of hernias in elderly patients should be considered before initiating peritoneal dialysis.
Use during pregnancy or breastfeeding.
Pregnancy
There are no clinical data on the use of CAPD/DPCA 2 in pregnant women. No reproductive toxicity studies have been conducted in animals. CAPD/DPCA 2 should not be used during pregnancy unless the woman's clinical condition requires treatment with CAPD/DPCA 2.
Breastfeeding
It is unknown whether active substances/metabolites of CAPD/DPCA 2 pass into breast milk. Women undergoing peritoneal dialysis should not breastfeed.
Reproductive function
Data on the effect of CAPD/DPCA 2 on reproductive function are lacking.
Ability to affect reaction speed when driving or operating machinery.
CAPD/DPCA 2 has no or negligible influence on the ability to drive or operate machinery.
Administration and Dosage.
The CAPD/DPCA 2 solution is intended exclusively for intraperitoneal administration.
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, administer 2000 mL of solution per exchange four times daily. After the dwell time in the abdominal cavity (from 2 to 10 hours), the solution is drained.
Dosage, solution volume, and number of exchanges must be 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, the exchange volume should be increased. For such patients and for patients who tolerate large solution volumes well, the exchange volume may be increased up to 2500–3000 mL.
Children
For children, the exchange volume 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). Depending on tolerance, the child's age, and residual kidney function, the volume per exchange may be increased to 1000–1200 mL/m² BSA.
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, including practical experience and adequate mastery of the technique. Training must be conducted by qualified personnel. Before discharging a patient for home peritoneal dialysis, the physician must ensure that the patient has fully 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 prewarmed to body temperature. The prescribed dose is infused through the peritoneal catheter into the abdominal cavity over 5–20 minutes. Depending on 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/DPCA 2 may be used sequentially with other peritoneal dialysis solutions with higher glucose content (i.e., higher osmolarity).
For single use only. Any unused solution residues must be discarded. No special requirements for disposal of the medicinal product.
Instructions for Using the "Stay-Safe" Continuous Ambulatory Peritoneal Dialysis System
The "Stay-Safe" system is a double-bag system consisting of a solution bag made of non-PVC multilayer polyolefin film, a connecting tubing also made of polyolefins, a system connector (DISC, polypropylene), a drainage bag, and an outer bag also made of multilayer polyolefin film.
The solution should be prewarmed to body temperature. For bags with a volume up to 3000 mL, a suitable heater must be used. The warming time for a 2000 mL volume from an initial temperature of 22°C is approximately 120 minutes. The automatic temperature control is set at 39°C ± 1°C. For more detailed information, refer to the heater's user manual. Microwave heating is not recommended due to the risk of local overheating.
- Inspect the solution bag (labeling, expiry date, confirm 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 IV stand – unroll the "solution bag-DISC" tubing – place the DISC into the organizer – then place the drainage bag into the lower ring of the IV stand).
- Place the catheter extension set into one of the two organizer openings. Place the new disinfection cap into the other available 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 catheter extension set clamp – switch position "●" – drainage procedure begins.
- After completion of drainage: Rinse – switch position "●●" – rinse with fresh dialysate into the drainage bag (approximately 5 seconds).
- Fill – switch position "○●●" – connection between solution bag and catheter.
- Safety step – 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 protective cap (which remains in the right opening of the organizer).
- Check the used dialysate for clarity and weight. If the drained solution is clear, it should be discarded.
The plastic bag may become damaged during transport or storage, which could lead to contamination of the dialysis solution and increased microbial growth. Therefore, the entire package must be carefully inspected for damage before connecting and using 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 only be used if both the bag and seal are undamaged.
The peritoneal dialysis solution may only be used 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 exchange volume 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 drainage bag. However, if exchanges are performed too frequently, dehydration and electrolyte imbalances may develop, requiring immediate medical intervention. If an exchange has been missed, consult the physician or the appropriate 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, which 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 result directly from 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 based on 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).
Cardiovascular 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 use of solutions containing high glucose concentrations.
Potential adverse reactions of peritoneal dialysis as a method
Infections and infestations:
- peritonitis (very common), indicated by cloudy effluent 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 capped with a sterile cap and submitted for microbiological testing and leukocyte count assessment;
- 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 diaphragmatic elevation (frequency not known).
Gastrointestinal disorders:
- hernias (very common);
- abdominal distension and feeling 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 medicinal product.
Shelf life. 2 years.
Storage conditions
Store below 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 category. 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.