Composition, form of production and packaging
Solution for peritoneal dialysis 1 liter
dextrose monohydrate 25 g
calcium chloride dihydrate 3.925 g
magnesium chloride hexahydrate 101.7 mg
sodium lactate 7.85 g
Sodium chloride 5.786 g
2 l - plastic systems "Stay Safe" (4) - cardboard boxes.
2.5 l - plastic systems "Stay Safe" (4) - cardboard boxes.
5 l - plastic bags (2) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
KAPD / DPKA 4 is a solution of electrolytes containing dextrose and lactate buffer, injected intraperitoneally to treat the terminal stage of chronic renal failure of various genesis by peritoneal dialysis (PD).
The method of permanent ambulatory peritoneal dialysis (CAPD) is characterized by a more or less constant presence of dialysis solution (usually 2 liters) in the abdominal cavity, which is replaced with fresh solution from 3 to 5 times a day.
The basic principle underlying any technique of peritoneal dialysis is the use of the peritoneum as a semipermeable membrane through which it is possible to exchange dissolved substances and water between the blood and the dialysis solution by diffusion in accordance with their physico-chemical properties.
The electrolyte composition of the solution is essentially the same as physiological, although it is adapted (eg, potassium content) for use in patients with uremia in order 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
- terminal (decompiled) stage of chronic renal failure;
- Acute renal failure of various genesis.
DOSING MODE
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 1500-2000 ml with equal intervals of time between the exchange of solution in the abdominal cavity. Treatment is carried out every day, according to the prescribed dose, 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. 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 EFFECT
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.
With concomitant diabetes, the development of hyperglycemia is possible due to the additional glucose load. Therefore, it is necessary to regularly monitor the concentration of glucose in the blood.
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 is not amenable to peritoneal dialysis therapy;
- severe 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 this particular solution:
- pronounced hypokalemia;
- pronounced 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.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is used in the terminal (decompensated) stage of chronic renal failure, with acute renal failure of various genesis.
APPLICATION FOR CHILDREN
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.
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 the body weight and the balance of the volumes of introduced 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 LCs to the solution should be carried out in strictly aseptic conditions.Because of the existing risk of incompatibility, other drugs can be added to the peritoneal solution only for the purpose of the attending physician (see "Interaction with other drugs"). 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.
OVERDOSE
Overdose can cause hypervolemia, hypovolemia, electrolyte metabolism disorder, hyperglycemia in patients with diabetes mellitus. Treatment is symptomatic.
DRUG 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, since 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, it is necessary to check their compatibility. To avoid fibrin deposition in the catheter, heparin can be added to the peritoneal solution.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
