Diavitex pd 2.5 %

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAVITEC® PD 1.5 % DIAVITEC® PD 2.5 % DIAVITEC® PD 4.25 % (DIAVITEC® PD 1.5 %) (DIAVITEC® PD 2.5 %) (DIAVITEC® PD 4.25 %)

Composition:

Active substances: sodium chloride, sodium lactate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate;

1 liter of DIAVITEC® PD 1.5 % solution contains sodium chloride 5.669 g; sodium lactate 3.922 g; calcium chloride dihydrate 0.257 g; magnesium chloride hexahydrate 0.102 g; glucose monohydrate 15 g – 1.5% (equivalent to anhydrous glucose 13.6 g – 1.36 %);

1 liter of DIAVITEC® PD 2.5 % solution contains sodium chloride 5.669 g; sodium lactate 3.922 g; calcium chloride dihydrate 0.257 g; magnesium chloride hexahydrate 0.102 g; glucose monohydrate 25 g – 2.5 % (equivalent to anhydrous glucose 22.7 g – 2.27 %);

1 liter of DIAVITEC® PD 4.25 % solution contains sodium chloride 5.669 g; sodium lactate 3.922 g; calcium chloride dihydrate 0.257 g; magnesium chloride hexahydrate 0.102 g; glucose monohydrate 42.5 g – 4.25 % (equivalent to anhydrous glucose 38.6 g – 3.86 %);

Excipient: water for injections.

Pharmaceutical form. Solution for peritoneal dialysis.

Main physicochemical properties: clear, colorless or slightly yellowish liquid. Theoretical osmolarity of DIAVITEC® PD 1.5 % solution – 353 mOsmol/l;

DIAVITEC® PD 2.5 % – 403 mOsmol/l; DIAVITEC® PD 4.25 % – 492 mOsmol/l.

Pharmacotherapeutic group. Solutions for peritoneal dialysis. ATC code B05D.

Pharmacological properties.

Pharmacodynamics.

Peritoneal dialysis for patients with renal insufficiency is a procedure for removing toxic substances produced during nitrogen metabolism and normally excreted by the kidneys, as well as for maintaining regulation of fluid, electrolyte, and acid-base balance.

This procedure is performed by instilling a peritoneal dialysis solution through a catheter into the peritoneal cavity. The movement of substances between the dialysis fluid and the patient's peritoneal capillaries occurs across the peritoneal membrane according to the principles of osmosis and diffusion. After residing in the peritoneal cavity for several hours, the solution becomes saturated with toxic substances and must be replaced.

Except for lactate, provided as a bicarbonate precursor, the electrolyte concentrations in the solution are adjusted to match the standardized electrolyte concentrations in plasma. Nitrogenous waste products present in blood at high concentrations pass through the peritoneal membrane into the dialysis solution. Glucose creates a solution hyperosmolar to plasma, generating an osmotic gradient that promotes fluid removal from plasma into the dialysate, necessary to compensate for the fluid overload observed in patients with chronic renal failure.

Pharmacokinetics.

When administered intraperitoneally, glucose is absorbed into the bloodstream and metabolized via normal pathways.

Clinical characteristics.

Indications.

• Acute renal failure;
• chronic renal failure;
• pronounced water retention in the body;
• electrolyte imbalance;
• drug intoxication when other therapies are ineffective.

The Diavitex PD preparation is particularly useful for controlling serum calcium and phosphate levels in patients with renal failure who are taking phosphate-binding agents containing calcium and magnesium.

Contraindications.

• Hypersensitivity to the active substances;
• presence of severe lactic acidosis;
• irreversible mechanical defects interfering with effective peritoneal dialysis (hereinafter – PD) or increasing the risk of infection;
• documented loss of peritoneal function or significant adhesions negatively affecting peritoneal function.

Interaction with other medicinal products and other forms of interaction.

No studies have been conducted on the interaction of Diavitex PD with other medicinal products. During peritoneal dialysis, plasma concentrations of other dialyzable medicinal products may decrease.

Serum levels of potassium, calcium, and magnesium should be carefully monitored in patients receiving cardiac glycosides due to the risk of digitalis intoxication. Potassium-containing preparations may need to be administered.

Special precautions for use.

Peritoneal dialysis should be performed with caution in patients with:

• abdominal cavity disorders, including rupture of the peritoneal membrane and diaphragm due to surgical intervention, developmental anomalies, or trauma (until recovery); with tumors in the abdominal cavity, infections of the abdominal wall, hernia, fecal fistula, history of colostomy or ileostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intraperitoneal cavity;
• other conditions, including recently implanted aortic grafts and severe pulmonary disease.

Encapsulating peritoneal sclerosis (EPS) is considered a known rare complication of peritoneal dialysis. Cases of EPS have also been observed in patients receiving other solutions as part of peritoneal dialysis therapy.

In case of peritonitis, the choice and dosage of antibiotics should be based on microbiological identification and susceptibility testing, whenever possible. Broad-spectrum antibiotics may be indicated prior to identification of causative microorganisms. Glucose-containing solutions should be used with caution in patients with diagnosed allergy to corn or corn-derived products. Hypersensitivity reactions due to allergy to cornstarch may occur, including anaphylactic/anaphylactoid reactions. If any symptoms of hypersensitivity reaction develop, the infusion of the solution should be stopped immediately and the solution drained from the peritoneal cavity. Appropriate therapeutic measures should be initiated according to clinical indications.

Peritoneal dialysis solutions based on lactate should not be administered to patients with severe lactic acidosis (see section "Contraindications"). Patients at risk of lactic acidosis (e.g., severe hypotension or sepsis, which may be associated with acute renal failure, inherited metabolic disorders, treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors) should be monitored before and during treatment with lactate-based peritoneal dialysis solutions.

Before initiating therapy, potential interactions between the solution and medications used to treat pre-existing conditions should be evaluated for each individual patient. Serum levels of potassium, calcium, and magnesium should be carefully monitored in patients receiving cardiac glycosides.

Accurate records of fluid balance should be maintained, and patient body weight should be closely monitored to avoid hyper- or hypovolemia with serious consequences, including congestive heart failure, reduced extracellular fluid volume, and shock.

Significant losses of protein, amino acids, and water-soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be administered as needed.

In patients receiving low-calcium dialysis solutions, calcium concentration should be monitored to prevent hypocalcemia or worsening of hypercalcemia. In such cases, the physician should adjust doses of phosphate binders and/or vitamin D analogs and/or calcimimetics.

The use of 5 or 6 liters of solution per single exchange cycle is not recommended in continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) due to the risk of overfilling.

Overfilling with Diavitek PD solution into the peritoneal cavity may manifest as abdominal distension/abdominal pain and/or dyspnea.

To treat overfilling with Diavitek PD solution in the peritoneal cavity, the solution should be drained from the abdominal cavity.

Incorrect sequence of clamp application or solution administration may lead to air infusion into the peritoneal cavity, which may cause abdominal pain and/or peritonitis.

Excessive use of Diavitek PD solution with high glucose content during peritoneal dialysis may lead to significant dehydration. Potassium is excluded from the composition of Diavitek PD due to the risk of hyperkalemia. In cases of normal serum potassium levels or hypokalemia, addition of potassium chloride (up to 4 mEq/L) may be indicated to prevent severe hypokalemia. This should only be done under medical supervision after careful assessment of serum potassium levels and overall body potassium status.

Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium, and phosphate), blood chemistry (including parathyroid hormone and lipid levels), and hematological parameters should be monitored periodically.

In diabetic patients, blood glucose levels should be monitored regularly during and after dialysis with glucose-containing solutions, and insulin dosage or other hyperglycemia treatment should be adjusted accordingly.

The product should be used immediately after removal from the secondary polymer packaging.

Use during pregnancy or breastfeeding.

Pregnancy

There are no data on the use of Diavitek PD solution during pregnancy or breastfeeding.

Reproductive toxicity studies in animals are insufficient.

Diavitek PD is not recommended for use in pregnant women or women of childbearing potential who are not using contraception.

Breastfeeding

It is unknown whether metabolites of the active substances in Diavitek PD are excreted in human milk. A risk to newborns/infants cannot be excluded.

The decision whether to discontinue breastfeeding or to discontinue/abstain from treatment with Diavitek PD should be made, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Fertility

Clinical data on fertility are lacking.

Ability to affect reaction speed when driving or operating machinery.

Should be used with caution, considering adverse effects that may impair the ability to drive or operate machinery. Such adverse effects (e.g., discomfort, hypovolemia) may occur in patients with end-stage renal disease undergoing peritoneal dialysis.

Method of Administration and Dosage

Dosing

The treatment regimen, frequency, exchange volume, dwell time of the solution in the peritoneal cavity, and duration of dialysis are determined by the physician.

Adults

For CAPD, patients usually undergo 4 cycles per day (24 hours). For APD, 4–5 cycles are typically performed overnight and up to 2 cycles during the day. The instilled volume of the preparation depends on body size and is generally between 2 and 2.5 liters.

Children (from birth to 18 years of age)

The recommended dose is 800–1400 mL/m² per cycle. Do not exceed the maximum dose of 2000 mL. For children under 2 years of age, the recommended instilled volume is 500–1000 mL/m².

As the patient's body weight approaches the ideal "dry" body weight, it is recommended to reduce the glucose concentration in Diavitex PD preparation.

Diavitex PD, 3.86% glucose solution, is a highly osmotic fluid; its independent use may lead to body dehydration (see section "Special Warnings and Precautions for Use").

To prevent the risk of severe dehydration and hypovolemia, and to minimize protein loss, it is recommended to select a peritoneal dialysis solution with the lowest sufficient osmolarity required to remove the necessary amount of fluid during each session.

Method of Administration

The peritoneal dialysis solution is intended solely for intraperitoneal administration. Not for intravenous use.

Warming the solution to 37°C reduces patient discomfort.

However, this procedure should only be performed using dry heat (e.g., heating pad or heating plate).

Solutions should not be heated in water due to the increased risk of contamination. To avoid potential damage to the bag and patient injury or discomfort, solutions must not be heated in a microwave oven.

The entire procedure must be performed under strict aseptic conditions. Do not administer if the solution has changed color, become cloudy, contains particles, or if the packaging shows signs of leakage or compromised integrity.

The drained fluid should be examined for the presence of fibrin or cloudiness, which may indicate peritonitis.

For single use only.

Potassium Addition

Potassium is excluded from the composition of Diavitex PD because dialysis may be performed to correct hyperkalemia. In cases of normal serum potassium levels or hypokalemia, addition of potassium chloride (at concentrations up to 4 mEq/L) may be indicated to prevent severe hypokalemia. This should only be done under medical supervision following careful assessment of plasma potassium levels.

Children: Can be used in children from birth.

Overdose

Overdose is possible and may manifest as hypervolemia, hypovolemia, electrolyte imbalance, or (in diabetic patients) hyperglycemia. Excessive use of Diavitex PD, 3.86% glucose solution, during peritoneal dialysis may cause significant patient dehydration.

Treatment of Overdose

Hypervolemia can be treated by using hypertonic peritoneal dialysis solutions and fluid restriction.

Hypovolemia can be managed by restoring fluid losses orally or intravenously, depending on the degree of dehydration.

Electrolyte imbalances should be treated according to the specific type identified by blood analysis. The most likely imbalance, hypokalemia, can be treated by oral potassium supplementation or by adding potassium chloride to the peritoneal dialysis solution as prescribed by the physician.

Hyperglycemia (in diabetic patients) should be managed by adjusting insulin dosage or oral antidiabetic medications according to the physician's prescribed treatment regimen.

Adverse reactions.

The adverse reactions listed below were reported during the post-marketing period.

Adverse drug reactions are listed according to the following frequency categories: very common – > 10 %, common – > 1 % and < 10 %, uncommon – > 0.1 % and < 1 %, very rare – < 0.01 %, frequency not known (cannot be estimated from available data).

Other adverse effects associated with peritoneal dialysis procedure: fungal peritonitis, bacterial peritonitis, catheter-related infection, catheter-related complications.

Shelf life. 2 years.

Storage conditions.

Store in a dry place, out of reach of children, at a temperature not exceeding 25 °C.

Do not freeze.

Incompatibilities.

Compatibility should be checked when using additives.

Addition of heparin to the peritoneal dialysis solution may be indicated for prevention of catheter blockage in patients with peritonitis or when the effluent from the peritoneal cavity contains fibrin or proteinaceous material. The recommended dose of heparin for adults is 1000 to 2000 IU per 1 L of solution. For children, the recommended dose is 50 IU of heparin per 100 mL of solution.

Packaging. 2000 mL or 2500 mL in polymer containers.

Prescription status. Prescription only.

Manufacturer/Marketing Authorization Holder.

TOV "Yuria-Pharm".

Manufacturer's address and place of business.

108, Kozbartska Street, Cherkasy, 18030, Ukraine. Tel.: (044) 281-01-01