Diasolusion PD (Solution) Instructions for Use

Marketing Authorization Holder

IST-Pharm, LLC (Russia)

ATC Code

B05DB (Hypertonic solutions)

Dosage Forms

	Diasolusion PD	Peritoneal dialysis solution 2.3%: containers 2000 ml, 2500 ml or 5000 ml
		Peritoneal dialysis solution 4.25%: containers 2000 ml, 2500 ml or 5000 ml

Dosage Form, Packaging, and Composition

Peritoneal dialysis solution clear, colorless or slightly yellowish.

Excipients : 1M hydrochloric acid solution or 1M sodium hydroxide solution, water for injections up to 1 L.

* 1 M hydrochloric acid solution is obtained from concentrated hydrochloric acid and water for injections; 1 M sodium hydroxide solution is obtained from sodium hydroxide and water for injections.

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

2000 ml – containers (5) – cardboard boxes.
2500 ml – containers (4) – cardboard boxes.
5000 ml – containers (2) – cardboard boxes.

Peritoneal dialysis solution clear, colorless or slightly yellowish.

Excipients : 1M hydrochloric acid solution or 1M sodium hydroxide solution, water for injections up to 1 L.

* 1 M hydrochloric acid solution is obtained from concentrated hydrochloric acid and water for injections; 1 M sodium hydroxide solution is obtained from sodium hydroxide and water for injections.

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

2000 ml – containers (5) – cardboard boxes.
2500 ml – containers (4) – cardboard boxes.
5000 ml – containers (2) – 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 semipermeable membrane through which the exchange of dissolved substances and water between the blood and the dialysis solution occurs by 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 metabolites (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 balanced by the presence of lactate in the solution. Complete metabolism of lactate leads to the formation of bicarbonate.

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 glucose concentration (2.3% or 4.25%) based on the patient’s clinical need for ultrafiltration and fluid removal.

Determine the exchange volume according to the patient’s body size and tolerance; typical volumes range from 1500 ml to 2500 ml for adults.

Warm the solution to body temperature (approximately 37°C) before infusion.

Perform the infusion using strict aseptic technique to prevent peritonitis.

Allow the dialysate to dwell in the peritoneal cavity for the prescribed duration, typically 4 to 6 hours.

Drain the spent dialysate completely after the dwell period.

Adjust the dialysis regimen—including the number of exchanges per day, dwell time, and solution concentration—based on the patient’s residual renal function, uremic control, and fluid status.

For automated peritoneal dialysis (APD), program the cycler according to the prescribed nightly exchange volumes and dwell times.

Monitor the effluent dialysate for volume and clarity; cloudy effluent indicates possible peritonitis.

Regularly assess serum electrolytes, acid-base status, and blood glucose to guide therapy adjustments.

Adverse Reactions

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

Contraindications

Recent abdominal surgery or wound, history of abdominal surgery with 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, the benefit of treatment must be weighed 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 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); electrolyte loss due to vomiting and/or diarrhea (a temporary switch to a peritoneal dialysis solution containing potassium may be required); if the patient is receiving cardiac glycoside therapy (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 dietary advice to the patient should be considered); polycystic kidney disease in which the kidneys are enlarged.

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 parameters; 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 loss of effectiveness of other medicines if they are excreted during peritoneal dialysis. Dose adjustment may be necessary.

With concomitant cardiac glycoside therapy, 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 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.