Universal reference book for medicines
Product name: BALANCE

Active substance: comb.
drug
Type: Solution for peritoneal dialysis

Manufacturer: FRESENIUS MEDICAL CARE DEUTSCHLAND (Germany)
Composition, form of production and packaging
Solution for peritoneal dialysis [glucose 1.5%, calcium 1.25 mmol / l]
from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 16.5 g,

which corresponds to the content of dextrose anhydrous 15 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.1838 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 83.2 mmol / l sodium 134 mmol / l calcium 1.25 mmol / l magnesium 0.5 mmol / l chloride 100.5 mmol / L L-lactate 35 mmol / L osmolarity 356 mOsm / l

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

Solution for peritoneal dialysis [glucose 1.5%, calcium 1.75 mmol / l] from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 16.5 g,

which corresponds to the content of dextrose anhydrous 15 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.2573 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 83.2 mmol / l sodium 134 mmol / l calcium 1.75 mmol / l magnesium 0.5 mmol / l chloride 101.5 mmol / L L-lactate 35 mmol / L osmolarity 358 mOsm / l

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

Solution for peritoneal dialysis [glucose 2.3%, calcium 1.25 mmol / l] from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 25 g,

which corresponds to the dextrose content of anhydrous 22.73 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.1838 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 126.1 mmol / L sodium 134 mmol / l calcium 1.25 mmol / l magnesium 0.5 mmol / L chloride 100.5 mmol / L L-lactate 35 mmol / L osmolality 399 mOsm / l

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

Solution for peritoneal dialysis [glucose 2.3%, calcium 1.75 mmol / l] from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 25 g,

which corresponds to the dextrose content of anhydrous 22.73 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.2573 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 126.1 mmol / L sodium 134 mmol / l calcium 1.75 mmol / l magnesium 0.5 mmol / l chloride 101.5 mmol / L L-lactate 35 mmol / L osmolality 401 mOsm / l

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

Solution for peritoneal dialysis [glucose 4.25%, calcium 1.25 mmol / l] from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 46.75 g,

which corresponds to the content of dextrose anhydrous 42.5 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.1838 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 235.8 mmol / l sodium 134 mmol / l calcium 1.25 mmol / l magnesium 0.5 mmol / l chloride 100.5 mmol / L L-lactate 35 mmol / L osmolarity 509 mOsm / l

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

Solution for peritoneal dialysis [glucose 4.25%, calcium 1.75 mmol / l] from colorless to light yellow color, transparent.

1 l

dextrose (glucose) 46.75 g,

which corresponds to the content of dextrose anhydrous 42.5 g

Sodium Chloride 5.640 g

sodium lactate 3.925 g

calcium chloride dihydrate 0.2573 g

magnesium chloride hexahydrate 0.1017 g

Including: dextrose monohydrate 235.8 mmol / L sodium 134 mmol / l calcium 1.75 mmol / l magnesium 0.5 mmol / L chloride 101.5 mmol / L L-lactate 35 mmol / L osmolality 511 mOsm / L

Excipients: sodium hydrogen carbonate, sodium hydroxide, hydrochloric acid 25%, water d / u.

2000 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

2500 ml - two-chamber plastic systems "Stay Safe" (4) - cardboard boxes.

5000 ml - two-chamber plastic systems "Sleep Safe" (2) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Solution for peritoneal dialysis Balance with glucose concentration of 1.5%, 2.3% and 4.25% is a solution of electrolytes containing glucose and 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 (PD).

The method of permanent ambulatory peritoneal dialysis (CAPD) is provided by the presence of a 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 peritoneal dialysis is the use of the peritoneum as a semipermeable membrane through which the exchange of dissolved substances and water between the blood and the dialysis solution through diffusion is possible in accordance with their physico-chemical properties.

The electrolyte composition of the solution does not differ from the physiological one, although it is adapted (for example, the potassium content) for use in patients with uremia 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 the products of nitrogen metabolism (urea, creatinine), inorganic phosphates, uric acid, other solutes and water, are eliminated 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 compensated by the presence of lactate in the dialysis solution. Lactate is completely metabolized to bicarbonate.
PHARMACOKINETICS

Kinetics of the products of nitrogen metabolism.
The ratio of the urea concentration in the dialysate to the plasma concentration (D / P) achieves equilibrium after a 4-hour interaction with both 1.5% and 4.25% glucose solutions. The ratio (D / P) for creatinine is 0.6 to 0.7 by the 4th hour, and not reaching equilibrium. The same is true for other low molecular weight toxins, such as uric acid and inorganic phosphate, whose D / P ratio is 0.6 and 0.4-0.5, respectively.
Kinetics of sodium.
With constant (stable) ultrafiltration, the removal of sodium correlates with the serum sodium concentration. An increase in serum sodium concentration is accompanied by an increase in the sodium content in the "spent" dialysate solutions. In the case of an increase in the extracellular volume and the maintenance of identical concentrations of sodium in both plasma and dialysate, the removal of sodium can be divided into two phases. The sodium concentration in the ultrafiltrate remains lower than the concentration in the extracellular fluid. In the second phase of the exposure period, sodium diffuses into the dialysate solution.
Kinetics of potassium.
Potassium is removed like sodium, primarily by diffusion. Excretion of approximately 30 mmol of potassium is achieved by four 2-liter exchanges.
Kinetics of calcium.
The ratio of calcium concentration in dialysate to plasma concentration (D / P) achieves equilibrium with any standard concentrations. glucose solution and calcium content of 1.75 mmol / l in the dialysis solution.
Magnesium kinetics.
The ratio of magnesium concentration in dialysate to plasma concentration (D / P) does not reach equilibrium when using any standard concentrations of glucose solution and a magnesium content of 0.75 mmol / l in the dialysis solution.
Kinetics of glucose and liquid.
Glucose dialysate, used as an osmotic agent, is absorbed slowly, i.e. decreasing the osmotic gradient between the dialysis solution and the extracellular fluid. About 70-80% of the glucose received during the day with the dialysis solution is absorbed. Ultrafiltration is maximum at the beginning of the exposure and reaches a maximum after about 2-3 hours. By the end of the exposure, in connection with the absorption of glucose, "the rate of ultrafiltration is degraded.
Kinetics of lactate.
The rate of excretion of lactate is maximal at the beginning of exposure, and decreases in accordance with the decrease in lactate diffusion. Lactate is absorbed almost completely after a 6-hour exposure. When carrying out standard procedures for peritoneal dialysis, D- and L-lactate is metabolized within 30 minutes after absorption.
INDICATIONS

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

DOSING MODE

The solution is injected intraperitoneally through a surgically established peritoneal catheter.
The administration time is from 5 to 20 minutes. 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. The solution is in the abdominal cavity for 4-8 hours, according to the doctor's prescription, then merged and replaced with fresh. During the day it is recommended to conduct 4-fold exchanges but 2000 ml at equal intervals of time. Treatment is carried out every day, according to the dose and duration of treatment established by the doctor in charge.
To achieve the necessary ultrafiltration and electrolyte composition, the solution for peritoneal dialysis Balance can be used either alone or in combination with other solutions for peritoneal dialysis.
To monitor the effectiveness of treatment should monitor the concentration of creatinine and urea in blood plasma at constant intervals.
If there are no other prescriptions, use 2000 ml of solution per procedure.
Children the volume of the solution to be administered should be calculated by the doctor from the ratio: 30-40 ml per kg of body weight, and depending on the age, height and degree of abdominal wall tension, i.e. approximately 500 to 1500 ml per procedure.
Maximum for one dialysis procedure is recommended to use no more than 2500 or 3000 ml of solution for peritoneal dialysis.

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.

Instructions for using the "safe safe" system:

1. Preparation of the system

- Check the appearance of the solution system (label, expiration date, solution transparency), make sure there is no damage and integrity of the joint.

- Place the system on a firm surface.

- Open the outer protective bag by pulling the two lower free angles.

- Open the packaging of the disinfection cap.

- Disinfect hands with antimicrobial detergent.

- Twist one of the upper corners of either of the two chambers until the middle lambda seam opens, after which the solutions from the two chambers are mixed.

- Then, twist the upper edge of the chamber containing the finished solution until the next seam forming the lower triangle opens.

- The solution prepared in this way should be used as soon as possible, but no later than 24 hours after mixing.

2. Preparation of solution replacement

- Fix the package on the infusion rack, untwist the main package with the solution and place the Disk in the organizer.
Then untwist the main drainage bag.
- Place the disinfection cap in the organizer.

- Place the catheter extension into the organizer.

- Disinfect hands and then remove the protective cap from the disc.

- Attach the catheter extension to the Disk.

3. Draining

Switch position •

Open the catheter extension clamp.
A drain occurs.
4. Washing

Switch position ••

Fill the line completely with liquid and, by draining a small amount in the drainage bag, rinse with fresh solution (for about 5 seconds).

5. The Gulf

Switch position •••

After setting the Disc switch to this position, wait until the final filling of the prescribed solution volume is completed.

6. Closure of the system

Switch position ••••

There is an automatic closing of the lumen of the catheter extension.

7. Disconnection

Remove the protective cover from the new disinfection cap and screw it onto the old cap.

Disconnect the catheter extension from the Disk and screw it onto the new disinfection cap.

8. Close Disk

Close the disc with the protective cover that you previously removed from the new disinfection cap.

9. Checking of fused dialysate and destruction.

Instructions for using the system "slip safe" ("sleep" safe):

Open the outer protective bag by pulling the two lower free angles.

Open the package of the disinfection cap.

Disinfect hands with an antimicrobial detergent.

Twist one of the upper corners of either of the two chambers until the middle "Lambda" opens, after which the solutions from the two chambers are mixed.

Then, twist the top edge of the chamber containing the finished solution until the next seam forming the lower triangle opens.

The solution prepared in this way should be used as soon as possible, m no later than 24 hours after mixing.

To start the treatment, it is necessary to insert the system connector into the free ports of the cycle cassette and then automatically connect them to the trunks.
The cycler checks the bar code of the bags with the solution and gives an alarm in case of inconsistency with the prescriptions stored in the memory of the cycle. After this test, the main set must be connected to the patient's catheter extension and the treatment begins. The solution is heated automatically to the temperature of the body by a cycle during the entire time it is poured into the abdominal cavity. The residence time and choice of glucose concentration is determined in accordance with the medical prescriptions entered into the "memory" of the cycle.
SIDE EFFECT

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.

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 swelling is also possible;
abdominal pain in the bay and drain of dialysate; pain in the shoulder joint and shortness of breath due to the elevation of the diaphragm; diarrhea or constipation; hernia. 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 extensive inflammatory skin lesions (dermatitis) in the area of ​​the exit site of the catheter, 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 a significant decrease in body weight, especially if adequate nutrition is not possible;

- in cases when uremia, it is not amenable to therapy with peritoneal dialysis;
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 "Balance" with a glucose content of 1.5%, 2.3%, 4.25%:

- pronounced hypokalemia;

Contraindications for "Balance" with a glucose content of 4.25% in addition:

- hypovolemia;

- arterial hypotension.

Contraindications for "Balance" with a calcium content of 1.75 mmol / l:

severe hypercalcemia.

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, peritoneal dialysis solution should be used in pregnant and / or breast-feeding women only after careful comparison of the possible benefits for the mother and the risk to the fetus and the baby.

APPLICATION FOR FUNCTIONS OF THE LIVER

It is indicated in the terminal (decompensated) stage of chronic renal failure and acute renal failure of various genesis.

APPLICATION FOR CHILDREN

The one-time volume of the bay in children is calculated according to age, body weight and height.

SPECIAL INSTRUCTIONS

The solutions are packaged in plastic bags, which are the protective bag and a two-chamber system inside. One of the two internal chambers comprises an alkaline solution of lactate, another - glucose and acidic electrolyte solution. After release of the two-chamber system outer protective package, ready to use solution obtained by twisting one of the upper corners either of the two chambers, the interchamber "Lambda" -shov diverges and contents of the two chambers is mixed. A one-time amount of the Gulf of children is calculated according to age, weight and height.
It is necessary to constantly monitor fluid balance and body weight in order to prevent dehydration or overhydration.
Necessarily regular monitoring of physical parameters, concentrations of electrolytes, creatinine and urea, total plasma protein, blood glucose, in some cases, other laboratory parameters (e.g., blood gases, acid-base status).
Patients with diabetes need to control the concentration of glucose in the blood and if necessary to correct daily dose of insulin, in accordance with increasing load of glucose.
Selection of solutions for peritoneal dialysis, different concentrations of glucose and Ca 2+ , must be carried out individually in each case.
In order to reduce the risk of infection during the replacement of aseptic conditions must be supported solution. It is necessary to pay attention to the transparency and appearance of the extracted solution. If the derived solution is cloudy, then dialysis should be discontinued immediately and contact your doctor.
Visual inspection should be carried out prior to attachment of the package and use solution. Attention should be paid for damage to the package, even minor ones. Use solution for peritoneal dialysis only if the package is not damaged.
Never use bags with opaque contents. Any unused portion of the solution should be discarded. Solutions for peritoneal dialysis may not be used intravenously. Due to the incompatibility of existing microbial contamination and risk of other drugs may 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) and after thorough mixing verify transparency.
OVERDOSE

Until now there has been no cases of overdose.
DRUG INTERACTION

Not registered.
Keep in mind that taken drugs can penetrate into the dialysate, and with it excreted from the body, which may require adjustment of the dose. When assigning preparations containing calcium or vitamin D to take into account the possibility of hypercalcemia if applied simultaneously with the balance calcium 1.75 mmol / l.
The simultaneous use of diuretics may be useful for maintaining residual excretion by the kidneys, but at the same time, may cause a violation of water-electrolyte balance. The concentration of potassium in the blood plasma should be monitored carefully during concomitant therapy with cardiac glycosides, since sensitivity to these drugs is increasing against the background of hypokalemia.
TERMS OF RELEASE FROM PHARMACY

On prescription.
TERMS AND CONDITIONS OF STORAGE

Store at or below 4 ° C.
Keep out of the reach of children. Shelf life - 2 years.
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