Immunotrezan (Tablets) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

ATC Code

A13A (General tonic preparations)

Active Substance

Oxyethylammonium methylphenoxy acetate (Grouping name)

Dosage Form

Immunotrezan

Tablets 200 mg: 7, 10, 14, or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish or brownish tint, round, flat-cylindrical, with a score on one side and a bevel on two sides, with a slight characteristic odor or odorless. Marbling is allowed.

The score is intended only for breaking to facilitate swallowing, and not for dividing into equal doses.

Excipients: lactose monohydrate, corn starch, povidone K25, calcium stearate.

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Preparation with adaptogenic and restorative action

Pharmacotherapeutic Group

General tonic preparations

Pharmacological Action

Adaptogenic agent. Stimulates the production of alpha and gamma interferons, affects the immune status of the body by activating the cellular and humoral links of immunity, stimulates the phagocytic activity of macrophages.

It strengthens the body’s immune system, increases endurance during physical and mental stress, reduces the effect of various toxins, increases the body’s resistance to hypoxia, low and high temperatures and other adverse environmental factors.

Pharmacokinetics

Oxyethylammonium methylphenoxy acetate has high bioavailability, is rapidly metabolized in the liver, and is excreted by the kidneys mainly in the form of glucuronides. Does not accumulate in the body with long-term use.

Indications

As part of complex therapy: for the prevention and treatment of acute respiratory viral infections; during periods of high intellectual and heavy physical exertion; to increase the body’s resistance to various stressful influences (hypoxia, overheating, hypothermia) and adverse environmental influences (sudden climate change, adaptation to changes in atmospheric pressure).

ICD codes

Dosage Regimen

Administer orally. Adhere strictly to the prescribed individual regimen based on the specific indication for use.

For prevention and complex therapy of acute respiratory viral infections (ARVI), take one 200 mg tablet daily for a duration of 7 to 10 days.

To increase resistance during periods of high intellectual or physical stress, and for adaptation to adverse environmental factors, take one 200 mg tablet daily for 10 to 14 days.

Initiate therapy at the first signs of illness or prior to expected stressful exposure for optimal effect.

Swallow the tablet whole with a sufficient amount of water. The tablet score is intended only to facilitate swallowing and not for dose division.

The maximum single dose is one 200 mg tablet. The maximum daily dose is one 200 mg tablet.

The duration of the course should not exceed 14 days without medical consultation. If symptoms persist or worsen, discontinue use and consult a physician.

The drug is approved for use in elderly patients and in patients with impaired hepatic or renal function. No dosage adjustment is required for these populations.

Contraindicated in children under 12 years of age, during pregnancy, and during breastfeeding.

Adverse Reactions

Rarely allergic reactions – hypersensitivity reactions, anaphylactic shock, anaphylaxis, angioedema.

Contraindications

Hypersensitivity to the active substance; children under 12 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

The drug is approved for use in impaired liver function.

Use in Renal Impairment

The drug is approved for use in impaired renal function.

Pediatric Use

Contraindicated for use in children under 12 years of age (due to the lack of data on efficacy and safety of use).

Geriatric Use

Approved for use in elderly patients.

Special Precautions

If, during the use of the product, patients with acute respiratory viral infections have persistent severe symptoms of the disease or they worsen, the product should be discontinued and a doctor should be consulted.

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.