CAPD / PDKA 3 - instructions for use, dose, side effects, contraindications

Sodium lactate 50% solution		7.850 g
= Sodium lactate		3.925 grams
Calcium chloride 2 N20		0.253 g
Magnesium chloride 6 N20		0.1017 g
Glucose monohydrate		46.75 g
= glucose anhydrous		42.50 grams
Water for Injection		To 1 liter
Ionic composition:
Na⁺	134 mmol / l,
Ca⁺⁺	1.75 mmol / l,
Mg⁺⁺	0.5 mmol / l,
Cl-	103.5 mmol / L,
Lactate	35.0 mmol / l

Theoretical osmolality =511 Mohm / L

As auxiliary substances: for correction of pH, solutions of hydrochloric acid and sodium hydroxide

Description:

Transparent colorless or slightly yellowish solution

Pharmacotherapeutic group:Solution for peritoneal dialysis.

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

CAPD / DPPC 2,3,4 is a solution of electrolytes containing glucose and a lactate buffer administered intraperitoneally for the treatment of the terminal stage of chronic renal failure of different genesis by the so-called " peritoneal dialysis (PD).

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

The basic principle,the basis of any technique of peritoneal dialysis is the use of a peritoneum (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 and convection in accordance with their physico-chemical properties.

The electrolyte composition of the solution is essentially the same as the physiological one, although it is adapted (eg potassium content) for use in uremic patients in order to make possible 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 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 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 rare cases, uremia, which can not be treated with peritoneal dialysis; Expressed hyperlipidemia;

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

Contraindications for these specific solutions:

For CAPD / DPKA 2,3 and 4: pronounced hypokalemia, pronounced hypercalcemia.

For KAPD / DPKA 3 additionally: hypovolemia, arterial hypotension.

Pregnancy and lactation:

Peritoneal dialysis can be prescribed only in the late stages of pregnancy after a thorough analysis of the possible benefits and risks.

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.

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 1500-2000 ml with equal intervals of time between the exchange of solution in the abdominal cavity. Treatment is carried out every day, according to the dose prescribed by the doctor and lasts as long as required for replacement renal therapy.

CAPD / PDKA 3, the solution for peritoneal dialysis is used as a separate method when achieving the desired ultrafiltration and electrolyte composition, and in combination with other solutions for peritoneal dialysis. In order to control the effectiveness of treatment, the values of creatinine and urea should be checked at regular intervals.

If there are no other prescriptions, use 1500 to 2000 ml of solution per treatment session. If at the beginning of the procedure the patient suffers from abdominal wall tension, the dose can be temporarily reduced to 500 - 1500 ml per procedure. For children, a dose of between 30-40 ml per kg of body weight per procedure should be used, depending on age, 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 application . 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) with peritoneal dialysis is unavoidable, and losses of water-soluble vitamins are also possible. Deficiency of these substances must be supplemented by an adequate diet. In case of insufficient food compensation for protein loss, hypoproteinemia may occur.

Hypokalemia.

A sensation of swelling 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.

With concomitant diabetes, it is necessary to monitor the sugar level in accordance with the additional glucose load.

Overdose:

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

Interaction:

Not registered.

It should be remembered that the medications taken can be passed into the dialysate and, together with it, can be excreted from the body; because their dosage may require adjustment.

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

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

Special instructions:

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

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

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

In patients with 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 dextrose and Ca²⁺, should be carried out individually in each specific case.

To reduce the risk of infection, aseptic conditions should be maintained during the replacement of the solution. It is necessary to pay attention to the transparency and appearance of the withdrawn solution.If the solution is muddy then dialysis should be stopped immediately and consult your doctor.

Plastic bags with a solution can be damaged during transportation from the supplier to the dialysis center or inside the hospital. This can lead to infection of the dialysis solution. 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.

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.

With concomitant diabetes it is necessary to monitor the level of sugar in accordance with the additional glucose load

Form release / dosage:

Plastic bags containing 5000 ml and plastic bags "stay safe", containing 1500 ml, 2000 ml and 2500 ml of the preparation, in a cardboard box with instructions for use. Plastic bags (PVC) for 2 bags of 5000 ml each, in one carton Plastic bags "stay safe" (from polypropylene):

4 bags of 2500 ml each, in one box 4 bags of 2000 ml each, in one box 6 bags of 1500 ml each, in one box

Packaging:

4 bags of 2500 ml each, in one box 4 bags of 2000 ml each, in one box 6 bags of 1500 ml each, in one box

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. After the expiration date, the drug should not be used.

Terms of leave from pharmacies:On prescription

Registration number:П N010345

Date of registration:16.06.2009

The owner of the registration certificate:Fresenius Medical Kea Deutschland GmbHFresenius Medical Kea Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS MEDICAL CARE DEUTSCHLAND, GmbH Germany

Representation: & nbspFresenius Kabi, OOOFresenius Kabi, OOORussia

Information update date: & nbsp16.06.2009

Illustrated instructions

Instructions

CAPD / DPC3 (CAPD / DPCA 3)