Balance - instructions for use, doses, side effects, contraindications

Dosage form: & nbspsolution for peritoneal dialysis, glucose 1.5% and calcium 1.25 mmol / L, glucose 1.5% and calcium 1.75 mmol / L, glucose 2.3% and calcium 1.25 mmol / L, glucose 2.3% and calcium 1.75 mmol / L, glucose 4.25% and calcium 1.25 mmol / L, glucose 4.25% and calcium 1.75 mmol / l.

Composition:For 1000 ml of ready-to-use solution:

	Glucose 1.5%		Glucose 2.3 %		Glucose 4.25 %
	Calcium	Calcium	Calcium	Calcium	Calcium		Calcium
	1.25	1.75	1.25	1.75	1.25		1.75
	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Active Ingredients
Sodium chloride	5.640 g / l	5.640 g / l	5.640 g / l	5.640 g / l	5.640 g / l		5.640 g / l
Sodium	3.925 g / l	3.925 g / l	3.925 g / l	3.925 g / l	3.925 g / l		3.925 g / l
lactate
Calcium	0.1838 g / l	0.2573 g / l	0.1838 g / l	0.2573 g / l	0.1838 g / l		0.2573 g / l
chloride dihydrate Magnesium	0.1017 g / l	0.1017 g / l	0.1017 g / l	0.1017 g / l	0.1017 g / l		0.1017 g / l
chloride hexahydrate Glucose	16.5 g / l	16.5 g / l	25.0 g / l	25.0 g / l	46.75 g / l		46.75 g / l
(in terms of anhydrous)	(15.0 g / l)	(15.0 g / l)	(22.73 g / l)	(22.73 g / l)	(42.5 g / l)		(42.5 g / l)
Auxiliary Ingredients
Sodiumand I bicarbonate, sodium hydroxide, acid hydrochloric 25%, water for injection
Osmolarity	356	358	399	401	509		511
	mOsm / l	mOsm / l	mOsm / l	mOsm / l	mOsm / l		mOsm / l
Ionic composition
	Glucose 1.5%		Glucose 2.3 %			Glucose 4.25 %
	Calcium	Calcium	Calcium	Calcium	Calcium		Calcium
	1.25	1.75	1.25	1.75	1.25		1.75
	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Sodium - ion	134.0	134.0	134.0	134.0	134.0		134.0
Sodium - ion	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Calcium ion	1.25	1.75	1.25	1.75	1.25		1.75
	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Chloride ion	100.5	101.5	100.5	101.5	100.5		101.5
Chloride ion	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Magnesium ion	0.5	0.5	0.5	0.5	0.5		0.5
	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Glucose	83.2	83.2	126.1	126.1	235.8		235.8
monohydrate	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l
Llactate	35	35	35	35	35		35
	mmol / l	mmol / l	mmol / l	mmol / l	mmol / l		mmol / l

Description:Transparent solution, from colorless to light yellow color.

Pharmacotherapeutic group:Solution for peritoneal dialysis

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:The solution for peritoneal dialysis "Balance" with a glucose concentration of 1.5%, 2.3% and 4.25% is an electrolyte solution containing glucose 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 (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 the 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, 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 excreted 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 the same 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 decreases.
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:The terminal (decompensated) stage of chronic renal failure and acute renal failure of various genesis.

Contraindications:For this PD solution:
-Balance 1.5% / 2.3% glucose, 1.25 mmol / l calcium should not be used in patients with severe hypokalemia and severe hypocalcemia.
- Balance 4.25% glucose, 1.25 mmol / l calcium should not be used in patients with severe hypokalemia and severe hypocalcemia, hypovolemia and arterial hypotension.
- Balance 1.5% / 2.3%, glucose, 1.75 mmol / l calcium should not be used in patients with severe hypokalemia and severe hypercalcemia.
- Balance 4.25% glucose, 1.75 mmol / l calcium should not be used in patients with severe hypokalemia and severe hypercalcemia, hypovolemia and arterial hypotension.
For the procedure of peritoneal dialysis as a whole:
- recent surgery or wounds of the abdominal cavity, abdominal operations with fibrous spikes in history, abdominal burns, intestinal perforation;
- extensive inflammatory lesions of the abdominal skin (dermatitis);
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis, diverticulosis); peritonitis;
- internal or external abdominal fistulas;
- umbilical, inguinal or other abdominal hernia;
- intra-abdominal tumors;
- ileus;
- Pulmonary diseases, especially pneumonia;
- sepsis;
lactate acidosis;
- severe hyperlipidemia;
- rare cases of uremia, not amenable to therapy with peritoneal dialysis;
- cachexia and significant weight loss, especially if adequate nutrition is not possible;
- use in patients who are physically or mentally (psychosis, dementia, etc.) are unable to comply with the doctor's instructions for peritoneal dialysis procedures. If any of the listed disorders develops during PD, the decision on further tactics of management is made by the attending physician.

Pregnancy and lactation:The pharmacological composition of the drug does not pose a risk for the development of the fetus or the course of pregnancy, as well as for the infant breastfed. However, the solution for peritoneal dialysis 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.

Dosing and Administration:

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 of 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 both separately and 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.

For single use only. Any unused portion of the solution must be disposed of.

Solution in the system "safe" preheat to body temperature. The preheating time for the 2000 ml reservoir with a starting temperature of 22 ° C is approximately 120 min. The thermostat operates automatically and is set at 39 ° C ± 1 ° C. More detailed information can be obtained from instructions for heating bags. The use of microwave ovens is not recommended because of the risk of local overheating of part of the solution. Systems "slip safe" and "safe lock" They are used in combination with a cycle. Heating is performed automatically by the cycle heater. After heating the solution, you can start replacing the bags.

Instructions for use of the "safe" system ("stay"●safe® "):

1. Preparation of the solution

Check the appearance of the system with the preheated solution (label, expiration date, solution transparency), make sure there is no damage to the package and the containment, the integrity of the joint).
Place the system on a firm surface.
Remove the protective cover from the bag and package 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 seam 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.
Make sure that all the seams are opened, the solution is transparent and the bag does not leak.

2. Preparing the replacement package

Secure the bag on the upper holder of the infusion rack stand, untwist the main package with the solution and place the DISK in the organizer. Then untwist the drainage bag main and fix it on the bottom holder of the infusion rack stand. Place the disinfection cap in the organizer.
Place the catheter connector in the organizer.
Disinfect hands and then remove the protective cap from the DISC.
Attach the catheter adapter to the Disk.

3. Draining

Open the clamp of the discharge catheter. A drain occurs.
Switch position ●

4. Washing

After draining is completed, fill the line completely with liquid and, by draining a small amount in the drainage bag, rinse with fresh solution (for about 5 seconds).
Switch position ●●

5. The Gulf

The gulf starts when the DISC switch is turned. Wait for the final filling of the entire prescribed volume of the solution.
Switch position �?� ●

6. Security Phase

Close the discharge catheter by placing the pin in the catheter adapter.
Switch position ●●●●

7. Detachment

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. Closure of the DISC

Close the DISC with the protective cap removed by you from the previously used disinfection cap, place it in the right pocket of the organizer.

9. Check the transparency and volume of the drained dialysate, and if the effluent is clear, destroy it.

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

1. Preparation of the solution

Check the package with the solution (label, shelf life, clarity of the solution, no damage to the package and the containment, integrity of the joints).
Place the bag on a hard surface.
Remove the protective cover from the bag.
Disinfect hands with an antimicrobial detergent.
Expand the middle seam and the bag connector
Twist the bag lying on the exposed outer shell from one of the edges until the middle seam opens. The solutions in the two chambers are mixed automatically.
Continue to twist until the seam near the small chamber also opens completely.
Check if the seams have opened completely.
Check if the solution is clear and the bag is not leaking.

2. Expand the bag tubes.

3. Remove the protective cap

4. Insert the bag connector into the free port of the sleep safe cycle.

5. The bag is ready for use in the sleep safe system.

The ports of the cycle cassette are automatically connected to the lines. 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 by the cycle automatically to the temperature of the body 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 in the "memory" of the cycle.

Instructions for using the "safe-lock" system:
1. Preparation of the solution

Check the package with the solution (label, shelf life, clarity of the solution, no damage to the package and the containment, integrity of the joints).
Place the bag on a hard surface.
Remove the protective cover from the bag.
Disinfect hands with an antimicrobial detergent.
Expand the middle seam and the bag connector.
Twist the bag lying on the exposed outer shell from one of the edges until the middle seam opens. The solutions in the two chambers are mixed automatically.
Continue to twist the bag until the seam of the surface layer of the small chamber also opens.
Check if the seams have opened completely.
Check if the solution is clear and the bag is not leaking.

2.Remove the protective cap from the connector.

3. Attach the tubes to the bag.

4. Break the internal lock by bending the line and pin more than 90 ° in both directions.

5. The bag is ready for use.

Only the following medicines can be added to the Balance solution for peritoneal dialysis (when completing any of the systems) at the indicated concentrations, if indicated by the attending physician: heparin 1000 M.E./L, insulin 20 M.E./L, vancomycin 1000 mg / l, teicoplanin 400 mg / l, cefazolin 500 mg / l, ceftazidime 250 mg / l, gentamicin 8 mg / l. After complete mixing and checking for the absence of turbidity or particles, the prepared solution should be used immediately.

Side effects:

The balance of 1.5%, 2.3% and 4.25% of glucose, 1.25 / 1.75 mmol / l of calcium is a solution of electrolytes - a composition similar to the composition of the blood. In addition, the solution has a neutral pH, which is close to the physiological pH value. Possible adverse effects may be associated with the peritoneal dialysis procedure, and may be caused by the administration of the PD solution itself.

Potential adverse drug reactions:

Balance 1.5% / 2.3% / 4.25% glucose, 1.25 mmol / l calcium

Endocrine: secondary hyperparathyroidism with violation of bone metabolism.

Metabolism and malnutrition: increase in glucose concentration; hyperlipidemia; increase in body weight as a result of long-term glucose uptake from the PD solution.

Cardiac and vascular: tachycardia, hypotension, hypertension.

Respiratory, thoracic, mediastinal: dyspnoea.

Balance 1.5% /2.3%/4.25% glucose, 1.25 mmol / L cal.

Kidney and urinary: electrolyte disturbances, incl. hypokalemia (very often (> 10%)), hypocalcemia.

Balance 1.5% / 2.3%/ 4.25% glucose, 1.75 mmol / l calcium

Kidney and urinary: electrolyte disturbances, incl. hypokalemia (very often (> 10%)), hypercalcemia in combination with increased calcium capture, e.g., when assigning fosforsvyazyvayuschih calcium-containing preparations.

Are common: dizziness; edema; dehydration, hyperhydration, weight gain. Severe dehydration can occur when solutions with a higher glucose concentration are used.

Potential side effects of the regime:

Infections and infestations:

Peritonitis (very often (> 10%)); skin and tunnel infections (very often (> 10%)); very rarely sepsis (<0.01%).

Respiratory, thoracic, mediastinal:

Dispno because of high standing diaphragm, pain in the shoulder.

Gastrointestinal:

Diarrhea, constipation, hernia (very often (> 10%)); sensation of bloating and stretching.

Are common:

General malaise, redness, swelling, exudation, formation of the scab and pain in the place of exit of the catheter.

Violations associated with the procedure of peritoneal dialysis:

Cloudiness of the effluent; dumping / draining of the dialysis solution.

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

Interaction:Not registered.
It should be remembered that the medications taken can enter dialysate and, together with it, be excreted from the body, which may require correction of their dose.
When appointing drugs containing calcium or vitamin D, one should take into account the possibility of hypercalcemia, if a "balance" with a calcium content of 1.75 mmol / l is used.
Simultaneous use of diuretics can be useful for maintaining residual excretion by the kidneys, but at the same time, it can cause disturbances in the water electrolyte balance. The concentration of potassium in the blood plasma should be monitored especially carefully with concomitant therapy with cardiac glycosides, as the sensitivity to these drugs increases with hypokalemia.

Special instructions:The solution should be administered only after a thorough assessment of the risk / benefit ratio for:
- Loss of electrolytes as a result of vomiting and / or diarrhea (temporary potassium content in the PD solution may become necessary).
- Balance 1.5% / 2.3% / 4.25% glucose, 1.25 mmol / l Calcium:
patients with hyperparathyroidism: therapy should include calcium-containing phosphorous binders and / or vitamin D to ensure adequate calcium intake in the intestine. Hypocalcemia: a PD solution with a higher calcium concentration may be required if calcium is not adequately supplied with calcium-containing phosphorous binders and / or vitamin D.
- Balance 1.5% / 2.3% / 4.25% glucose, 1.75 mmol / l calcium: hypercalcemia: for example, due to the appointment of calcium-containing phosphorus binders and / or vitamin D (temporarily or continuously use PD solution with a lower concentration of calcium).
- in patients receiving digitalis: regular monitoring of potassium concentration in the serum is necessary. In case of severe hypokalemia, you may need to use potassium-containing PD solution, as well as dietary recommendations.
- in patients with large polycystic kidneys.
It is necessary to control the degree of turbidity and volume of the effluent.
Turbidity of the solution with abdominal pain, or only abdominal pain, can be indicators of peritonitis. Fever and general malaise or, in very rare cases, sepsis may be associated. The patient should seek medical help immediately. The reservoir with turbid effluent should be closed with a sterile cap and evaluate the microbiological contamination and estimate the number of leukocytes. In case of skin and tunnel infections, you should consult with your doctor as soon as possible.
In the process of peritoneal dialysis, the loss of proteins, amino acids, and water-soluble vitamins is inevitable. To avoid a deficit, you should ensure a complete diet or food supplements.
The transport characteristics of the peritoneal membrane can change during long-term peritoneal dialysis, primarily marked by loss of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.
It is necessary to constantly monitor the balance of fluid and body weight in order to prevent dehydration or hyper hydration.
Mandatory regular monitoring of indicators: sodium, potassium, calcium, magnesium and serum phosphate; acid-base state; blood gases; total plasma protein; serum creatinine and urea; blood glucose; concentrations of electrolytes; the level of parathyroid hormone and other indicators of bone metabolism, residual renal function, to adapt the treatment with peritoneal dialysis.
In elderly patients, a high incidence of hernias in elderly patients should be anticipated even before PD therapy is initiated.
After preparation, the drug should be used immediately, maximum for 24 hours after mixing.
Plastic containers can sometimes be damaged during transportation and storage. This leads to contamination with the growth of bacteria in the dialysis solution. All containers should be carefully checked for damage before attaching the bag to the solution and using the solution. Never use even minimally damaged packets or packages with opaque content. Use a solution for peritoneal dialysis only if the package is not damaged. The outer packaging should only be removed before use.
Do not use two solutions before mixing.
To reduce the risk of infection, aseptic conditions should be maintained during the replacement of the solution. The solutions are packed in plastic bags, which are a protective bag and a two-chamber system inside. One of the two inner chambers contains an alkaline lactate solution, the other is an acidic solution of glucose and electrolytes. After releasing the two-chamber system from the outer protective bag, the ready-to-use solution is obtained by twisting one of the upper corners of either of the two chambers, while the intercamera seam diverges and the contents of the two chambers are mixed.
A single dose in children is calculated according to age, body weight and height.
In patients with diabetes it is necessary to monitor the concentration of glucose in the blood and, if necessary, to correct 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.
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.
A solution for peritoneal dialysis should not be used for intravenous infusion.

Form release / dosage:Solution for peritoneal dialysis, glucose 1.5% and calcium 1.25 mmol / L, glucose 1.5% and calcium 1.75 mmol / L, glucose 2.3% and calcium 1.25 mmol / L, glucose 2, 3% and calcium 1.75 mmol / l, glucose 4.25% and calcium 1.25 mmol / l, glucose 4.25% and calcium 1.75 mmol / l.

Packaging:Plastic bags "Biofine®" -two-chamber plastic systems "safe" with "Lambda" - seam, "slip safe", "safe lock". By 2000 and 2500 ml in two-chamber plastic systems "safe", 5000 ml in two-chamber plastic systems "slip safe", 5000 ml in two-chamber plastic systems "safe lock".
Two-chamber plastic systems are placed with instructions for use in cardboard boxes containing:
1. 4 pcs plastic systems "safety safe" for 2000 or 2500 ml, or
2. 2 pcs plastic system "slip safe" by 5000 ml, or
3. 2 pieces plastic system "safe lock" on 5000 ml.

Storage conditions:Store at a temperature of at least 4 ° C.
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-000040

Date of registration:17.11.2010 / 24.12.2015

Expiration Date:Unlimited

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 JV, CJSCFresenius JV, CJSCRussia

Information update date: & nbsp15.01.17

Illustrated instructions

Instructions

Balance (Balance)