CAPD / DPC 19 (CAPD / DPCA 19)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSolutions for peritoneal dialysisSolutions for peritoneal dialysis
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    • Dosage form: & nbspperitoneal dialysis solution
    Composition:

    Composition per 1 liter:

    Sodium chloride - 5.786 g

    Glucose monohydrate (dextrose monohydrate) (recalculated to anhydrous) - 25.0 g (22.73 g)

    Calcium chloride hexahydrate - 0.2739g

    Sodium lactate 50% solution (in terms of sodium lactate) - 7.850g (-3.925g)

    Magnesium chloride hexahydrate 0.1017 g

    Water for injection - up to 1 liter

    To correct the pH, use solutions of hydrochloric acid (Hebrew Pharm.) And sodium

    hydroxide (Hebrew Farm.).

    Ionic composition:

    Sodium ion -134 mmol / l

    Calcium ion -1.25 mmol / l

    Magnesium ion - 0.50 mmol / l

    Chloride ion -102.50 mmol / l

    L-Actat ion-3 5.00 mmol / l

    Theoretical osmolarity: 399 mOsm / l

    Description:

    transparent solution, colorless or pale yellow in color.

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

    B.05.D   Solutions for peritoneal dialysis

    Pharmacodynamics:

    KAPD / DPKA 19 is a solution of electrolytes containing dextrose and a lactate buffer administered intraperitoneally for the treatment of the terminal stage of chronic renal failure and acute renal failure of various genesis by peritoneal dialysis (DC).

    The method of permanent ambulatory peritoneal dialysis (PAND) is characterized by a more or less constant presence in the abdominal cavity of a dialysis solution (usually 2 liters), which is replaced by fresh solution from 3 to 5 times a day.

    The basic principle underlying any technique of peritoneal dialysis is the use of peritoneum (peritoneum) as a semipermeable membrane through which the exchange of dissolved substances and water between blood and dialysis solution through diffusion and convection is possible in accordance with their physico-chemical properties.

    The electrolyte composition of the solution basically does not differ from the physiological, although it is adapted (the solution does not contain potassium) for use in patients with uremia in order to make possible renal replacement therapy by the method of 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.

    Water balance can be maintained by applying solutions with different concentrations of glucose, providing liquid removal (ultrafiltration).

    Secondary metabolic acidosis is balanced 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 abdominal cavity, such as: a fresh wound, burns or extensive inflammatory skin lesions (dermatitis) at the site of the catheter outlet, peritonitis; perforation of the hollow organs of the abdominal cavity; abdominal surgery in history with the development of fibrous adhesions, inflammatory bowel disease (Crohn's disease, ulcerative colitis, diverticulosis), intra-abdominal tumors, recent surgery on the abdominal cavity, paralytic intestinal obstruction, abdominal hernia; internal or external abdominal fistulas;

    Diseases of the respiratory system, especially pneumonia;

    Sepsis;

    Lactate acidosis;

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

    In cases where uremia is not given under peritoneal dialysis therapy;

    Severe hyperlipidemia;

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

    Contraindications for a solution for peritoneal dialysis KAPD / DPKA 19: severe hypokalemia, severe hypocalcemia, lactate metabolism disorders, hereditary fructose metabolism disorders, severe hypovolemia, arterial hypotension.

    Pregnancy and lactation:

    The pharmacological composition of the drug does not pose a risk with respect to the development of the fetus or the course of pregnancy, as well as in relation to the infant breastfed.

    Nevertheless, a solution for peritoneal dialysis should be used in pregnant women and breastfeeding women only after a thorough analysis of the 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 2000 ml with equal intervals of time between the exchange of solution in the abdominal cavity.Treatment is carried out every day, according to the established doctor dose and lasts for as long as is required for renal replacement therapy.

    Range / VCT 19, the peritoneal dialysis solution is used as a stand when the desired ultrafiltration and electrolyte composition, and in combination with other solutions for peritoneal dialysis In order to monitor the effectiveness of treatment should be tested 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 suffers from an abdominal wall tension, the dose can be temporarily

    reduce to 500-1500 ml per procedure. For children the dose should be used between 500 and 1500 ml (30-40 ml per kg body weight) for the procedure, depending on the age, body weight and height. For large adult patients and / or for large-volume-resistant fillings, 2500 or 3000 ml of solution may 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 infusion volumes depend on the body weight, tolerability and residual function of the kidneys and are appointed by the attending physician.

    Duration of use. According to the appointment of the attending 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 inevitable, and loss of water-soluble vitamins is also possible. In the case of insufficient food compensation for protein losses, hypoproteinemia may occur.

    Hypokalemia.

    Deficiency of these substances must be supplemented by an adequate diet.

    A sensation of bloating, abdominal pains in the bay and drain of dialysate, pain in the shoulder joint and dyspnoea due to diaphragm lift, dyspepsia or constipation, hernia are also possible.

    With concomitant diabetes mellitus may develop hyperglycemia due to the additional load glucose. Therefore, it is necessary to control the concentration of glucose in the blood.

    Overdose:

    To date, there have been no reported cases of overdose.

    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, so their dosage may require correction.

    Simultaneous administration of diuretics can be useful for maintaining residual excretion by the kidneys, but, at the same time, can cause disturbances in the water and electrolyte balance. The concentration of potassium should be controlled especially carefully with concomitant therapy with digitalis preparations, since sensitivity to these increases with hypokalemia.

    Special instructions:

    The one-time volume of the bay in children should be reduced in accordance with age, height and body weight.

    It is necessary to accurately record the fluid balance and body weight in order to prevent dehydration or hyperhydration.

    Regular monitoring of physical parameters, concentrations of electrolytes, creatinine and urea, total plasma protein, glucose in the blood, and in some cases other laboratory parameters (for example, blood gases, acid-base state) is mandatory.

    In patients with diabetes, it is necessary to monitor the concentration of glucose in the blood and, if necessary, adjust the daily dose of insulin in accordance with the increasing load of glucose.

    The choice of solutions for peritoneal dialysis, different in the concentration of glucose and Ca2+, should be carried out individually in each specific case.

    To reduce the risk of infection during the replacement of the solution, aseptic conditions must be maintained. It is necessary to pay attention to transparency and external tshd of the withdrawn solution. If the withdrawn solution is cloudy, dialysis should be stopped immediately and consulted by your doctor. Should be drawn toNimanie on the absence of damage to the package, even minor ones. Use a 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 destroyed.

    Solutions for peritoneal dialysis can not be used intravenously.

    Due to the existing risk of incompatibility and microbial contamination, other medicines can be added to the peritoneal solution only for the purpose of the attending physician. In this case, the solution should be used immediately (without storage) after thorough mixing and checking for transparency.

    Form release / dosage:

    Solution for peritoneal dialysis. By 2000 ml and 2500 ml of solution in plastic systems;"stay" safe® " from polypropylene "Biofine®", equipped with a connector and an injection port; | plastic, disk-switch, connecting lines and drainage package of the appropriate capacity, with a port for sampling, packed 'in an external protective shell "Biofine®".

    5000 ml solution in plastic systems "sleep * safe" from polypropylene "Biofine®", equipped with a connector, packed in an outer protective shell "B iofine® ".

    Cardboard boxes with instructions for use, containing 4 systems of plastic "stay" safe® " from polypropylene "Biofine®", or 2 systems of plastic << sleep "safe" from polypropylene "Biofine®".

    Packaging:

    By 2000 ml and 2500 ml of solution in plastic systems;"stay" safe® " from polypropylene "Biofine®", equipped with a connector and an injection port; | plastic, disk-switch, connecting lines and drainage package of the appropriate capacity, with a port for sampling, packed 'in an external protective shell "Biofine®".

    5000 ml solution in plastic systems "sleep * safe" from polypropylene "Biofine®", equipped with a connector, packed in an outer protective shell "B iofine® ".

    Cardboard boxes with instructions for use, containing 4 systems of plastic "stay" safe® "from polypropylene "Biofine®", or 2 systems of plastic << sleep "safe" from polypropylene"Biofine®".

    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:LP-000050
    Date of registration:23.11.2010
    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: & nbsp23.11.2012
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