Balance
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
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Balance is a solution used for peritoneal dialysis.
Release form and composition
The balance is produced in the form of a solution for peritoneal dialysis with various concentrations of active substances, which is a clear liquid from colorless to light yellow (2000 ml or 2500 ml each in plastic two-chamber systems Stay Safe), in a cardboard box 4 systems; 5000 ml in plastic two-chamber systems Sleep Safe ("Slip Safe"), in a cardboard box 2 systems).
Composition of 1 liter of solution:
- active ingredients: dextrose (glucose) - 16.5 g, 25 g or 46.75 g (which corresponds to the content of anhydrous dextrose - 15 g, 22.73 g or 42.5 g); sodium chloride - 5.64 g; calcium chloride dihydrate - 0.1838 g or 0.2573 g; sodium lactate - 3.925 g; magnesium chloride hexahydrate - 0.1017 g;
- auxiliary components: sodium hydroxide, water for injection, sodium bicarbonate, 25% hydrochloric acid.
Content of individual elements (mmol / l) and osmolarity (mOsm / l) of solutions Balance of various concentrations:
- solution for peritoneal dialysis with dextrose 1.5%, calcium 1.25 mmol / l: dextrose monohydrate - 83.2 mmol / l, calcium - 1.25 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 100.5 mmol / l; osmolarity of the solution - 356 mOsm / l;
- solution for peritoneal dialysis with dextrose 1.5%, calcium 1.75 mmol / l: dextrose monohydrate - 83.2 mmol / l, calcium - 1.75 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 101.5 mmol / l; osmolarity of the solution - 358 mOsm / l;
- solution for peritoneal dialysis with dextrose 2.3%, calcium 1.25 mmol / l: dextrose monohydrate - 126.1 mmol / l, calcium - 1.25 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 100.5 mmol / l; osmolarity of the solution - 399 mOsm / l;
- solution for peritoneal dialysis with dextrose 2.3%, calcium 1.75 mmol / l: dextrose monohydrate - 126.1 mmol / l, calcium - 1.75 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 101.5 mmol / l; osmolarity of the solution - 401 mOsm / l;
- solution for peritoneal dialysis with dextrose 4.25%, calcium 1.25 mmol / l: dextrose monohydrate - 235.8 mmol / l, calcium - 1.25 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 100.5 mmol / l; osmolarity of the solution - 509 mOsm / l;
- solution for peritoneal dialysis with dextrose 4.25%, calcium 1.75 mmol / l: dextrose monohydrate - 235.8 mmol / l, calcium - 1.75 mmol / l, sodium - 134 mmol / l, magnesium - 0.5 mmol / l, L-lactate - 35 mmol / l, chloride - 101.5 mmol / l; the osmolarity of the solution is 511 mOsm / l.
Indications for use
Balance solution is used in acute renal failure of various origins and in chronic renal failure in the decompensated (terminal) stage.
Contraindications
Contraindications to peritoneal dialysis as a method:
- diseases of the respiratory system, especially pneumonia;
- lactic acidosis;
- sepsis;
- significant decrease in body weight and extreme exhaustion of the body, especially in the absence of the possibility of adequate nutrition;
- severe hyperlipidemia;
- uremia that does not respond to peritoneal dialysis;
- diseases and conditions affecting the integrity of the peritoneal cavity or abdominal wall (extensive inflammatory skin lesions, burns or a fresh wound in the area of the catheter exit, perforation of the hollow organs of the abdominal cavity, peritonitis, inflammatory bowel disease, paralytic intestinal obstruction, recent surgery on the abdominal cavity, external or internal abdominal fistulas, intra-abdominal tumors, a history of indications of the development of fibrous adhesions during previous operations on the abdominal organs, hernia in the peritoneal region);
- dementia, psychosis and other physical or mental disorders in which the patient is unable to follow the doctor's instructions for the dialysis procedure.
Contraindication for the Balance solution with dextrose 1.5%, 2.3% and 4.25% - severe hypokalemia.
Additional contraindications for the solution with dextrose 4.25% are arterial hypotension, hypovolemia.
Contraindication for solution Balance with calcium 1.75 mmol / l - severe hypercalcemia.
Method of administration and dosage
The Balance solution is injected intraperitoneally using an installed peritoneal catheter for 5–20 minutes. The volume of infusion and the concentration of dextrose are determined by the physician and depend on the residual renal function, the patient's body weight and tolerance. The Balance solution is in the abdominal cavity from 4 to 8 hours (as prescribed by the doctor), after which it is drained and replaced with a fresh one. It is recommended to carry out such exchanges of 2000 ml per day 4 times with equal intervals of time between procedures. Treatment is carried out daily, the duration of the course is set by the doctor.
Balance solution can be used alone or in combination with other agents for peritoneal dialysis. The effectiveness of treatment is monitored by regularly determining the concentration of urea and creatinine in the blood plasma.
Unless otherwise prescribed, adult patients use 2000 ml of solution for one procedure. For children, the volume of the solution is determined by the doctor at the rate of 30–40 ml / kg of body weight. In addition, the child's age and height are taken into account, as well as the degree of tension in the abdominal wall. On average, one procedure in children requires 500-1500 ml.
The maximum volume of solution for one procedure of peritoneal dialysis is 2500-3000 ml.
For the cyclical or intermittent method of infusion of the Balance solution by means of a peritoneal dialysis machine, it is recommended to use 5000 ml bags.
Balance solutions are packed in plastic bags, which on the outside are a protective bag, and inside a two-chamber system (one inner chamber contains an alkaline solution of lactate, the other contains an acidic solution of electrolytes and glucose).
Instructions for use of the Stay Safe system
- System preparation: make sure the system is intact and not damaged; place the system on a solid surface; open the outer protective bag; open the packaging of the disinfection cap; disinfect your hands with an antimicrobial agent; start twisting the upper corner of any of the chambers until the middle lambda seam is opened and the solutions from the two chambers are mixed; start twisting the upper edge of the chamber with the finished solution until the next seam opens, which forms the lower triangle; use the prepared solution within 24 hours.
- Preparation of the solution replacement: fix the bag on the infusion stand, unscrew the packet line and place it in the Disk organizer, unscrew the drainage packet line; place a disinfection cap in the organizer; place the catheter extension in the organizer; disinfect your hands and then remove the protective cap from the Disk; attach the catheter extension to the disc.
- Draining: turn the switch to the "•" position and open the catheter extension clamp; will drain.
- Flushing: turn the switch to the “••” position and completely fill the line with liquid, then, after draining a small amount of solution into the drainage bag (for about 5 seconds), flush the line with fresh solution.
- Filling: turn the switch to the "•••" position and wait for the final filling of the assigned volume of solution.
- To close the system: turn the switch to the "••••" position, after which the lumen of the catheter extension will close automatically.
- Disconnection: remove the protective cap from the new disinfection cap and screw it onto the old cap; disconnect the catheter extension from the disc and screw it onto the new cap.
- Closing the disc: close the disc with the protective cap previously removed from the new disinfection cap.
After dialysis, check the drained dialysate and then dispose of it.
Sleep Safe System Instructions
- Open the outer protective bag of the system.
- Open the packaging of the disinfection cap.
- Disinfect hands with an antiseptic detergent.
- Start twisting the upper corner of any of the chambers until the middle lambda seam is opened and the solutions from the two chambers are mixed.
- Begin twisting the upper edge of the chamber with the ready-made mortar until the next seam opens, forming the lower triangle.
- Use the solution as soon as possible, no later than 24 hours after preparation.
At the beginning of the dialysis procedure, the system connector is inserted into the free ports of the cycler cassette, which automatically connect to the lines. After the cycler checks the barcode of the bags with the solution and if there are no discrepancies, it is necessary to connect the set line to the peritoneal catheter extension. Treatment will begin. During the entire infusion time, the solution is automatically heated by the cycler to body temperature. All data prescribed by the doctor (glucose concentration, solution residence time) are entered into the "memory" of the cycler.
Side effects
During peritoneal dialysis, a relative loss of amino acids (1.2–3.4 g per day) and proteins (5–15 g per day) inevitably occurs. In addition, loss of water-soluble vitamins and hypokalemia are possible.
To replenish the deficiency of proteins and vitamins, an adequate diet is prescribed, otherwise hypoproteinemia may develop.
When using Balance solution, the following side effects are also possible:
- diarrhea or constipation;
- abdominal pain during the introduction and drainage of dialysate;
- hernia;
- feeling of bloating;
- shortness of breath and pain in the shoulder joint due to raising the diaphragm;
- hyperglycemia (in patients with diabetes mellitus).
special instructions
During the dialysis procedure, the balance of body weight and fluid should be regularly monitored to prevent possible overhydration or dehydration.
Mandatory monitoring of physical parameters, as well as the concentrations of urea, creatinine, electrolytes, total protein and glucose is required.
In patients with diabetes mellitus, it is necessary to determine the glucose concentration and, if necessary, adjust the daily dose of insulin.
Replacement of the solution should be carried out under aseptic conditions. Attention should be paid to the characteristics of the withdrawn solution. If it is cloudy, the dialysis procedure should be discontinued and a doctor consulted.
Packages with opaque content cannot be used. All unused parts of the Balance solution should be discarded.
Peritoneal dialysis drugs should not be administered intravenously. Other medicines are added to the solution only as directed by a doctor. In this case, the solution must be used immediately after thorough mixing of the preparations and checking the transparency.
Despite the safety of the Balance solution for a fetus and a breastfed baby, in pregnant and lactating women, the dialysis drug is used only after the ratio of the expected benefit to the mother and the possible risk to the fetus or child.
Drug interactions
With the simultaneous use of Balance solution with a calcium content of 1.75 mmol / l and drugs that include vitamin D or calcium, hypercalcemia may occur.
Co-administration with diuretics is useful for maintaining residual renal excretion, but at the same time, it can lead to imbalance in water and electrolyte balance.
With concomitant treatment with cardiac glycosides, the concentration of potassium in the plasma should be especially carefully monitored, since against the background of hypokalemia, sensitivity to these drugs increases.
Medications taken can penetrate the dialysate and then be excreted with it from the body. In such cases, a dose adjustment may be required.
Terms and conditions of storage
Keep out of reach of children at a temperature not lower than 4 ° C.
Shelf life is 2 years.
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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
