Orvis^® Immuno (Tablets) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

J05AX19 (Tilorone)

Active Substance

Tilorone (Rec.INN registered by WHO)

Dosage Form

Orvis® Immuno

Film-coated tablets, 125 mg: 6 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange in color, round, biconvex; on the cross-section, the core is orange with inclusions of white and orange.

Excipients: calcium hydrogen phosphate (anhydrous dibasic calcium phosphate), microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate, stearic acid.

Shell composition: hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 4000 (polyethylene glycol 4000), polysorbate 80, sunset yellow FCF dye.

6 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug. Interferon synthesis inducer

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; other antiviral agents

Pharmacological Action

A low-molecular-weight synthetic interferon inducer that stimulates the production of all types of interferons (alpha, beta, gamma, and lambda) in the body.

The main producers of interferon in response to tilorone administration are intestinal epithelial cells, hepatocytes, T-lymphocytes, neutrophils, and granulocytes.

After oral administration, the peak of interferon production is detected in the sequence intestine – liver – blood within 4-24 hours.

Tilorone has an immunomodulatory and antiviral effect.

In human leukocytes, it induces interferon synthesis.

It stimulates bone marrow stem cells, enhances antibody production in a dose-dependent manner, reduces the degree of immunosuppression, and restores the ratio of T-suppressors and T-helpers.

It is effective against various viral infections, including influenza viruses, other acute respiratory viral infections, hepatitis viruses, and herpesviruses.

The mechanism of antiviral action is associated with the inhibition of the translation of virus-specific proteins in infected cells, resulting in the suppression of virus reproduction.

Pharmacokinetics

Absorption

After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60%.

Distribution

About 80% of the drug is bound to plasma proteins.

Metabolism

The drug does not undergo biotransformation and does not accumulate in the body.

Excretion

The drug is excreted almost unchanged through the intestine (70%) and through the kidneys (9%). T_1/2 is 48 hours.

Indications

For adults as part of complex therapy for the treatment of

• Influenza and other acute respiratory viral infections (ARVI);
• Herpetic infection.

Prevention of influenza and other ARVI in adults.

ICD codes

Dosage Regimen

The drug is taken orally, after meals.

For the treatment of influenza and other ARVI – 125 mg/day for the first 2 days of treatment, then 125 mg every 48 hours. The course dose is 750 mg (6 tablets).

For the prevention of influenza and other ARVI – 125 mg once a week for 6 weeks. The course dose is 750 mg (6 tablets).

For the treatment of herpetic infection – 125 mg for the first two days, then 125 mg every 48 hours. The course dose is 1.25-2.5 g (10-20 tablets).

The drug Orvis^® Immuno should not be used in children aged 0 to 18 years due to the inability to ensure the dosing regimen.

Adverse Reactions

Possible allergic reactions, dyspeptic symptoms, short-term chills.

If any of the side effects mentioned in the instructions get worse, or the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Hypersensitivity to tilorone or any of the excipients included in the drug;
• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age.

Use in Pregnancy and Lactation

Pregnancy

The use of the drug during pregnancy is contraindicated.

Breastfeeding period

If it is necessary to use the drug during lactation, breastfeeding should be discontinued (see section “Contraindications”).

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

Excipients

The drug contains sunset yellow FCF dye, which may cause allergic reactions.

Effect on the ability to drive vehicles and machinery

The drug Orvis^® Immuno does not have a negative effect on the ability to perform potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving machinery, work of a dispatcher, operator, etc.).

Overdose

Cases of drug overdose are unknown.

Drug Interactions

It is compatible with antibiotics and traditional medicines for the treatment of viral and bacterial diseases. Clinically significant interaction of tilorone with antibiotics, traditional medicines for the treatment of viral and bacterial diseases, and alcohol has not been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.