Triaseptin (Solution) Instructions for Use

Marketing Authorization Holder

Euromed, LLC (Russia)

Manufactured By

Peoples' Friendship University of Russia (Russia)

ATC Code

D08AX07 (Sodium hypochlorite)

Active Substance

Sodium hypochlorite (Grouping name)

Dosage Form

Triaseptin

Solution for topical and external use 0.06%: fl. 50 ml, 100 ml, or 250 ml.

Dosage Form, Packaging, and Composition

Solution for topical and external use transparent, colorless, with a slight odor of chlorine.

Excipients : sodium chloride – 900 mg, sodium carbonate solution 10% – to pH 9.0±1.0, purified water – to 100 ml.

50 ml – dark glass bottles (1) with first opening control, with a spray nozzle insert – cardboard packs.
100 ml – dark glass bottles (1) with first opening control, with a spray nozzle insert – cardboard packs.
250 ml – dark glass bottles (1) with first opening control, with a spray nozzle insert – cardboard packs.

* Sodium hypochlorite, obtained by electrolysis

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic and disinfectant

Pharmacological Action

An inorganic compound, a salt of hypochlorous acid. It has a pronounced bactericidal, fungicidal, virucidal effect. Effectiveness is reduced in the presence of protein, serum, and whole blood.

Pharmacokinetics

Sodium hypochlorite is destroyed almost instantly upon contact with blood and blood components, therefore it is not expected to be detected in the blood.

Indications

As an antiseptic and disinfectant: treatment of wounds, ulcers, burns; disinfection of the skin and mucous membranes (including the oral cavity and pharynx), including disinfection of the external genitalia.

ICD codes

Dosage Regimen

Apply externally for antiseptic treatment of skin, mucous membranes, and wounds.

Use via irrigations, application of wet dressings, compresses, tampons, or turundas.

Change dressings once daily.

For purulent wounds with copious discharge, change dressings more frequently, every 2-3 hours.

Limit the duration of compress application; do not exceed 2 hours per application.

Thoroughly cleanse the wound of pus and necrotic tissue before application.

Apply the solution to the entire affected surface, ensuring complete coverage.

For irrigation, apply a sufficient volume to thoroughly rinse the cavity or wound bed.

For mucous membrane treatment, use a lower pressure during irrigation to avoid tissue trauma.

Discontinue use and consult a physician if signs of irritation or hypersensitivity occur.

Adverse Reactions

Possible allergic reactions, burning sensation at the application site.

Contraindications

Hypersensitivity to sodium hypochlorite, to chlorine-containing compounds, children under 12 years of age.

Use in Pregnancy and Lactation

If it is necessary to use during pregnancy and breastfeeding, the expected benefit of therapy for the mother and the possible risk to the fetus and infant should be carefully assessed.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

Use with caution on large skin surfaces, under occlusive dressings.

Avoid getting this product into the eyes.

This product is not used for processing medical-surgical instruments.

Drug Interactions

Avoid simultaneous or sequential use of other antiseptic agents or soap without prior thorough rinsing of the treated area (a decrease in the effectiveness of this agent is possible).

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

Over-the-Counter

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.