CAPD / DPC 4 (CAPD / DPCA 4)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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  • CAPD / DPC 4
    solution perit. dial. 
    Fresenius Medical Kea Deutschland GmbH     Germany
    • Dosage form: & nbsp

    Solution for peritoneal dialysis

    Composition:

    Composition per 1000 ml:

    Sodium chloride

    Heb. Farm.

    5,786 g

    Sodium lactate 50% solution

    Heb. Farm.

    7.850 g

    (= sodium lactate)


    (3.925 g)

    Calcium chloride dihydrate

    Heb. Farm.

    0.253 g

    Magnesium chloride hexahydrate

    Heb. Farm.

    0.1017 g

    Glucose Monohydrate

    Heb. Farm.

    25.00 grams

    (in terms of anhydrous)


    (22.73 g)

    Water for injections

    Heb. Farm.

    up to 1 liter

    To correct the pH, use solutions of hydrochloric acid and sodium hydroxide.

    Ionic composition:

    Sodium ion

    134.0 mmol / l

    Calcium ion

    1.75 mmol / l

    Chloride ion

    103.5 mmol / l

    Magnesium ion

    0.50 mmol / l

    Lactate ion

    35 mmol / l

    Theoretical osmolarity: 401 mOsm / l.


    Description:

    Transparent colorless or slightly yellowish solution.

    Pharmacotherapeutic group:Solution for peritoneal dialysis.
    ATX: & nbsp

    B.05.Z.A   Hemodialysates (concentrates)

    Pharmacodynamics:

    CAPD / DTPA 4 is an electrolyte solution containing dextrose and a lactate buffer administered intraperitoneally to treat the terminal stage of chronic renal failure of various genesis by peritoneal dialysis (PD).

    The electrolyte composition of the solution basically does not differ from the physiological, although it is adapted (eg.potassium content) for use in patients with uremia to allow renal replacement therapy by intraperitoneal metabolism and fluid.

    During the dialysis procedure, substances normally excreted in the urine, such as uremic toxins (urea, creatinine), inorganic phosphates, uric acid, other solutes, and water, are removed from the body with dialysate. The liquid balance can be maintained by applying solutions with different concentrations of glucose, which causes liquid removal (ultrafiltration). Secondary metabolic acidosis is compensated by the presence of lactate in the dialysis solution. Lactate is completely metabolized to bicarbonate.

    Indications:

    The terminal (decompensated) stage of chronic renal failure and acute renal failure of various genesis.

    Contraindications:

    Contraindications for peritoneal dialysis as a method:

    Diseases affecting the integrity of the abdominal wall or peritoneal cavity, such as: fresh wound, burns or other extensive inflammatory skin lesions (dermatitis) in the area of ​​the exit site of the catheter,peritonitis; abdominal perforation; abdominal operations with fibrous spikes in the anamnesis, inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulosis), intra-abdominal tumors, recent surgery on the abdominal cavity, ileus, abdominal hernia; internal or external abdominal fistulas;

    • Pulmonary diseases, especially pneumonia;

    • Sepsis;

    • Lactate acidosis;

    • Cachexia and significant weight loss, especially if adequate nutrition is not possible; .

    • In cases where uremia can not be treated with peritoneal dialysis;

    • Expressed hyperlipidemia;

    Use in patients who are physically or mentally (psychosis, dementia, etc.) are unable to comply with the doctor's instructions for peritoneal dialysis procedures.

    Contraindications for these specific solutions: pronounced hypokalemia, marked hypercalcemia.

    Pregnancy and lactation:

    Peritoneal dialysis can be prescribed only at late pregnancy and lactation periods, after a thorough analysis of possible benefits and risks.

    Dosing and Administration:

    The solution, after heating to body temperature, is injected intraperitoneally through a surgically installed peritoneal catheter. The administration time is from 5 to 20 minutes. The solution is in the abdominal cavity for 4-8 hours, as prescribed by the doctor, and then merged and replaced with fresh. Usually within a day apply 4-fold exchanges of 1500 to 2000 ml with equal intervals of time between the exchange of solution in the abdominal cavity. Treatment is conducted every day,

    according to the dose prescribed by the doctor, and lasts as long as required for renal replacement therapy.

    Solutions for peritoneal dialysis are used both separately to achieve the desired ultrafiltration and electrolyte composition, and in combination with other solutions for peritoneal dialysis. In order to control the effectiveness of treatment should be checked values ​​of creatinine and urea at constant intervals.

    If there are no other prescriptions, use 2000 ml of solution for the treatment session. If at the beginning of the procedure the patient notes discomfort due to the tension of the abdominal wall, the temporary dose can be reduced to 500 - 1500 ml per procedure.For children, a dose of 30-40 ml per kg of body weight per procedure should be used, depending on age, body weight and height. Adult patients for one procedure, as a rule, 2500 or 3000 ml of solution can be recommended.

    In cases where the prescribed infusion is performed by means of a peritoneal dialysis apparatus in discontinuous or cyclic manner, it is recommended to use 5000 ml bags. The concentration of glucose and the volume of infusion depend on the body weight, tolerability and residual function of the kidneys, and are appointed by the attending physician.

    Maximum, for one dialysis procedure, it is recommended to use no more than 5000 ml of a solution for peritoneal dialysis.

    Duration of use. The drug can be used to treat emergency conditions, and also be used for a long time, according to the prescribing physician.

    Side effects:

    The relative loss of proteins (5-15 g / day) and amino acids (1.2-3.4 g / day) on peritoneal dialysis is unavoidable, and losses of water-soluble vitamins are also possible. Hypokalemia.

    Deficiency of these substances must be supplemented by an adequate diet. In the case of insufficient food compensation for protein losses, hypoproteinemia may occur.

    A sensation of bloating is also possible; abdominal pain in the bay and drain of dialysate; pain in the shoulder joint and dyspnoea due to the elevation of the diaphragm; dyspepsia; hernia, peritonitis, increase or decrease in blood pressure.

    Overdose:

    Overdose can cause hypervolemia, hypovolemia, electrolyte metabolism disorder, hyperglycemia in patients with diabetes mellitus. Treatment is symptomatic.

    Interaction:

    Not registered.

    It should be remembered that the medications taken can penetrate into the dialysate and, together with it, be excreted from the body, therefore, correction of their dose may be required.

    When appointing drugs containing calcium or vitamin D, you should take into account the possibility of hypercalcemia.

    Simultaneous administration of diuretics can cause disturbances in the water electrolyte balance. The potassium level should be controlled especially carefully with concomitant therapy with digitalis preparations, as the sensitivity to these drugs increases with hypokalemia.

    To decide whether to add various drugs to the solution for peritoneal dialysis, the doctor should pay attention to the pH value and the presence of salts, before combining necessarily check their compatibility.

    To avoid fibrin deposition in the catheter, heparin can be added to the peritoneal solution.

    Special instructions:

    One-time volume of the bay in children should be determined individually, in accordance with the age, height and weight of the child.

    To avoid hyper or hypohydration, it is necessary to control body weight and balance of volumes of injected and withdrawn liquids.

    Regular monitoring of physical parameters, concentrations of plasma electrolytes, creatinine and urea, plasma protein, monitoring of blood glucose concentration, in some cases other laboratory parameters (eg blood gases, acid-base balance) is mandatory.

    In diabetes, the daily dose of insulin should be adjusted in accordance with the increasing load of glucose. The choice of solutions for peritoneal dialysis, different in the concentration of glucose (dextrose) and calcium, should be carried out individually in each specific case.

    In order to reduce the risk of infection, the replacement of the solution or the addition of other drugs in the solution should be carried out in strictly aseptic conditions. Due to the existing risk of incompatibility, other drugs can be added to the peritoneal solution only for the intended purposethe attending physician (see "Interaction with other medicines"). In this case, the solution should be used immediately (without storage) after thorough mixing and checking for transparency.

    It is necessary to pay attention to the transparency and appearance of the withdrawn solution. If the withdrawn solution is cloudy, dialysis should be stopped immediately and consulted by your doctor.

    Visual inspection should be carried out before attaching the package and using the solution. Pay attention to the absence of damage to the package, even minor ones. Use the solution for peritoneal dialysis only if the package is not damaged.

    Never use packages with opaque content.

    All unused portions of the solution should be discarded.

    Solutions for peritoneal dialysis can not be administered intravenously.

    With concomitant diabetes it is necessary to control the glucose concentration in accordance with the additional load.

    Form release / dosage:

    Solution for peritoneal dialysis.

    For 5000 ml of solution in plastic bags made of polyvinyl chloride (PVC) or polypropylene "Biofine®", equipped with a connector and an injection port made of plastic, packed in an outer protective shell;

    By 2000 ml and by 2500 ml solution in plastic systems "stay * safe®" from polypropylene "Biofine®", equipped with a connector and a plastic injection port, a switch disc, connecting lines and a drainage bag of the appropriate capacity, with a sampling port packed in an outer protective shell.

    Cardboard boxes with instructions for use, containing plastic bags made of polyvinyl chloride (PVC) or polypropylene "Biofine®": 2 bags of 5000 ml each, in one box.

    Cardboard boxes with instructions for use, containing plastic systems "stay" safe® " from polypropylene "Biofine®": on 4 systems on 2000 ml or on 4 systems on 2500 ml.

    Packaging:
    • plastic bags (2), cardboard boxes
    • plastic systems "Stey Safe" (4) -Carboxes
    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.

    Shelf life:

    2 years.

    The drug should be used before the date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N010346
    Date of registration:24.06.2009
    The owner of the registration certificate:Fresenius Medical Kea Deutschland GmbHFresenius Medical Kea Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFresenius Kabi, OOOFresenius Kabi, OOORussia
    Information update date: & nbsp24.06.2009
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