Salt solution for peritoneal dialysis with dextrose (Solution) Instructions for Use

Marketing Authorization Holder

Sphere-Pharm, LLC (Russia)

ATC Code

B05D (Peritoneal dialysis solutions)

Dosage Forms

	Salt solution for peritoneal dialysis with dextrose	Solution for peritoneal dialysis 1.5%: 2000 ml containers
		Solution for peritoneal dialysis 2.3%: 2000 ml containers
		Solution for peritoneal dialysis 4.25%: 2000 ml containers

Dosage Form, Packaging, and Composition

Solution for peritoneal dialysis is a transparent liquid ranging from light yellow to yellow in color.

Excipients: water for injections – up to 1 L.

Ionic composition: sodium ion – 134 mmol/L, calcium ion – 1.75 mmol/L, magnesium ion – 0.5 mmol/L, chloride ion – 103.5 mmol/L, lactate ion – 35 mmol/L, anhydrous glucose – 83.3 mmol/L.
Theoretical osmolarity: 358 mOsm/L.

2000 ml – containers (1) – systems (4) – cardboard boxes.

Solution for peritoneal dialysis is a transparent liquid ranging from light yellow to yellow in color.

Excipients: water for injections – up to 1 L.

Ionic composition: sodium ion – 134 mmol/L, calcium ion – 1.75 mmol/L, magnesium ion – 0.5 mmol/L, chloride ion – 103.5 mmol/L, lactate ion – 35 mmol/L, anhydrous glucose – 126.1 mmol/L.
Theoretical osmolarity: 401 mOsm/L.

2000 ml – containers (1) – systems (4) – cardboard boxes.

Solution for peritoneal dialysis is a transparent liquid ranging from light yellow to yellow in color.

Excipients: water for injections – up to 1 L.

Ionic composition: sodium ion – 134 mmol/L, calcium ion – 1.75 mmol/L, magnesium ion – 0.5 mmol/L, chloride ion – 103.5 mmol/L, lactate ion – 35 mmol/L, anhydrous glucose – 235.8 mmol/L.
Theoretical osmolarity: 511 mOsm/L.

2000 ml – containers (1) – systems (4) – cardboard boxes.

Clinical-Pharmacological Group

Solution for peritoneal dialysis

Pharmacotherapeutic Group

Peritoneal dialysis solution

Pharmacological Action

Peritoneal dialysis is a long-term therapy involving the continuous use of peritoneal dialysis solutions.

The basic principle underlying any peritoneal dialysis technique is the use of the peritoneum as a semi-permeable membrane through which the exchange of solutes and water between the blood and the dialysis solution occurs via diffusion and convection, in accordance with their physicochemical properties.

The electrolyte composition of the solution is largely similar to the physiological composition of blood serum, although it is adapted (particularly in terms of potassium content) for use in patients with uremia to enable renal replacement therapy via intraperitoneal exchange of substances and fluid.

Substances normally excreted in urine, such as nitrogenous waste products (urea, creatinine, inorganic phosphates, uric acid, other solutes, and water), are removed from the body with the dialysate solution. Water balance can be maintained by using solutions with different glucose concentrations, which provide fluid removal (ultrafiltration).

The metabolic acidosis characteristic of end-stage renal failure is compensated for by the presence of lactate in the solution. Complete metabolism of lactate leads to the formation of bicarbonate.

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Indications

End-stage (decompensated) chronic renal failure of various origins that can be treated with peritoneal dialysis.

ICD codes

Dosage Regimen

For intraperitoneal use only.

Select the dextrose concentration based on the required ultrafiltration volume: use 1.5% for minimal fluid removal, 2.3% for moderate removal, and 4.25% for maximum fluid removal.

Determine the exchange volume individually, typically starting at 1500-2000 ml for adults. Reduce the volume for pediatric patients based on body surface area and age.

Perform exchanges following an aseptic technique. Warm the solution to body temperature before infusion.

Establish the dwell time according to the prescribed dialysis regimen, typically ranging from 4 to 8 hours.

Adjust the frequency of exchanges and the total number per day based on the patient’s residual renal function, urea clearance, and clinical status.

Monitor inflow and outflow times. Record the volume and clarity of the drained dialysate after each exchange.

Regularly assess serum electrolytes, acid-base balance, and fluid status. Adjust the regimen to correct imbalances.

Immediately discontinue the procedure and consult a physician if the drained fluid is cloudy or if the patient experiences abdominal pain, which may indicate peritonitis.

Adverse Reactions

Procedure-related peritoneal infection, water-electrolyte imbalance, metabolic acidosis, hyperazotemia.

Contraindications

Recent abdominal surgery or wound, abdominal surgery with a history of fibrous adhesions, severe abdominal burns, intestinal perforation; extensive inflammatory skin lesions of the abdomen (dermatitis); inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, diverticulitis); peritonitis; internal or external abdominal fistulas; abdominal wall hernias (umbilical, inguinal, or other locations); intra-abdominal tumors; intestinal obstruction; respiratory diseases (especially pneumonia); sepsis; severe hyperlipidemia; rare cases of uremia that are not amenable to peritoneal dialysis therapy; cachexia and significant weight loss, especially if adequate protein replenishment is not guaranteed; in patients who are physically or mentally unable to perform the peritoneal dialysis procedure according to the doctor’s instructions.

Contraindications depending on the drug used: lactic acidosis, severe hypokalemia, severe hypocalcemia, severe hypercalcemia, hypovolemia, arterial hypotension.

If any of the above disorders develop during the peritoneal dialysis procedure, the decision on how to continue treatment should be made by the attending physician.

Use in Pregnancy and Lactation

When considering the possibility of performing peritoneal dialysis during pregnancy, it is necessary to weigh the benefit of treatment against the potential risks and complications for the mother and child.

Given the benefit of peritoneal dialysis for the mother and the possible risk to the child, temporary discontinuation of breastfeeding should be considered.

Pediatric Use

For children, the volume of the solution should be prescribed according to age and body surface area.

Geriatric Use

There are no special recommendations for the dosage regimen in elderly patients. The increased frequency of hernia development in elderly patients should be considered before initiating peritoneal dialysis therapy.

Special Precautions

Before starting use, the benefits and risks of peritoneal dialysis should be carefully assessed, depending on the drug used: secondary hyperparathyroidism (therapy should include the intake of phosphate-binding agents containing calcium and/or vitamin D to ensure adequate calcium intake); hypocalcemia (a temporary or permanent switch to a peritoneal solution with a higher calcium content may be required if adequate calcium intake is not possible with oral calcium-containing phosphate-binding drugs and/or vitamin D preparations); hypercalcemia resulting from the use of calcium-containing phosphate-binding drugs and/or vitamin D preparations (a temporary or permanent switch to a peritoneal dialysis solution with a lower calcium content may be required); loss of electrolytes due to vomiting and/or diarrhea (a temporary switch to a peritoneal dialysis solution containing potassium may be required); if the patient is receiving therapy with cardiac glycosides (serum potassium levels should be monitored regularly; in case of severe hypokalemia, the need to switch the patient to a potassium-containing peritoneal dialysis solution and provide the patient with dietary recommendations should be considered); polycystic kidney disease in which the kidneys are enlarged in size.

During peritoneal dialysis, the loss of proteins, amino acids, and vitamins, especially water-soluble ones, is inevitable. To avoid deficiency, the patient should be provided with a complete diet or dietary supplements.

During long-term peritoneal dialysis, the transport characteristics of the peritoneal membrane may change, primarily indicated by the loss of ultrafiltration. In severe cases, peritoneal dialysis should be discontinued and hemodialysis initiated.

Regular monitoring of the following parameters is recommended: body weight for early recognition of overhydration and dehydration; serum concentrations of sodium, potassium, calcium, magnesium, phosphate, acid-base balance, blood gases, and blood proteins; serum creatinine and urea; parathyroid hormone and other bone metabolism indicators; blood glucose; residual renal function to adapt peritoneal dialysis treatment.

The dialysate after the procedure should be checked for clarity and volume. Cloudy dialysate and/or abdominal pain are indicators of peritonitis.

Encapsulating peritoneal sclerosis is considered a known rare complication of peritoneal dialysis, which in rare cases can be fatal.

Drug Interactions

The use of peritoneal dialysis solutions with dextrose may lead to a loss of effectiveness of other medicines if they are excreted during peritoneal dialysis. Dose adjustment may be necessary.

With concomitant therapy with cardiac glycosides, careful monitoring of potassium concentration is necessary. A pronounced decrease in serum potassium levels may lead to an increased frequency of adverse reactions associated with the use of cardiac glycosides.

The use of diuretics may help preserve residual renal function but can also lead to water-electrolyte imbalance.

In patients with diabetes mellitus, the daily dose of insulin or oral hypoglycemic drugs should be adjusted to account for the increased glucose load.

Concomitant use of medicines containing calcium or vitamin D may lead to hypercalcemia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.