Viruter^® (Solution) Instructions for Use

Marketing Authorization Holder

Nucleopharm, LLC (Russia)

Manufactured By

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

ATC Code

L03A (Immunostimulants)

Active Substance

Sodium nucleospermate (Grouping name)

Dosage Form

Viruter®

Solution for rectal administration 10 mg/1 ml: bottle 25 ml or 50 ml

Dosage Form, Packaging, and Composition

Solution for rectal administration colorless, transparent or slightly opalescent.

Excipients: sodium chloride – 1 mg, water for injections – up to 1 ml.

25 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
25 ml – bottle (1) – cardboard pack.
50 ml – bottle (1) – cardboard pack.

Clinical-Pharmacological Group

Leukopoiesis stimulant

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Leukopoiesis stimulator. It is a highly purified standardized mixture of nucleic acids obtained from the milt of sturgeon fish. It accelerates granulocytopoiesis at the promyelocyte and myelocyte stages, increases the neutrophil maturation index.

It affects the processes of proliferation, migration, and differentiation of other colony-forming units, acting at all levels of hematopoiesis. It has an immunomodulatory effect at the cellular and humoral levels (activates killer cells, stimulates antibody formation).

It activates antiviral, antifungal, and antimicrobial immunity. It suppresses HIV reproduction and effectively reduces viral load in HIV-infected patients.

Pharmacokinetics

When administered rectally, Sodium nucleospermate quickly enters the bloodstream. The concentration in the blood increases in a direct linear dependence. The time to reach C_max after a single rectal administration is 5 hours.

After 24 hours, a rapid decrease in the concentration of sodium nucleospermate in the blood begins, associated with its distribution in organs and tissues. The redistribution of sodium nucleospermate between plasma and blood cells occurs in parallel with its metabolism and excretion.

The main transport route for sodium nucleospermate is the endolymphatic pathway. The greatest tropism to sodium nucleospermate is shown by the bone marrow, lymph nodes, spleen, thymus, and kidneys. Sodium nucleospermate penetrates the blood-brain barrier.

With repeated administration of sodium nucleospermate every 24 hours for 5 days, its accumulation in the blood and bone marrow is observed only from the first four doses. In other proliferating tissues, the total concentration of sodium nucleospermate increases even after the fifth administered dose.

Eight days after the 5th administration of sodium nucleospermate, its concentration significantly decreases in all organs and tissues, but still exceeds the concentration achieved with a single administration and is sufficient for the therapeutic action of sodium nucleospermate.

The gradual elimination of sodium nucleospermate from the blood occurs in the time interval from the 2nd to the 8th day from the moment of administration. T_1/2 is about 60 hours. When administered rectally, during the first 24 hours, 2.5% of sodium nucleospermate is excreted in the urine, 61.5% in the feces.

Indications

Treatment of HIV infection in adults at different stages of the disease (as part of combination therapy).

ICD codes

Dosage Regimen

Administer rectally.

Prescribe twice a week.

Use 25 ml of the 1% solution ( 250 mg) per administration.

Administer two times per day with an interval between doses.

Continue this regimen for a duration of 8 weeks.

The maximum daily dose is 50 ml of the 1% solution ( 500 mg).

Do not exceed the maximum daily dose.

Adverse Reactions

Possible short-term increase in body temperature up to 38°C (100.4°F), hyperemia.

Contraindications

Hypersensitivity to sodium nucleospermate; acute diseases of the liver, kidneys, pancreas, gastrointestinal tract; severe heart failure; cerebrovascular accident; pregnancy, breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

The use of sodium nucleospermate is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in acute liver diseases.

Use in Renal Impairment

Contraindicated in acute kidney diseases.

Pediatric Use

Contraindicated for use under 18 years of age.

Special Precautions

Sodium nucleospermate should be prescribed with caution in malignant and pre-tumor diseases of the lymphoid tissue.

Drug Interactions

Can be used simultaneously with cytostatics and lidocaine.

Sodium nucleospermate enhances the effect of anticoagulants.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.