Hyaferon (Suppositories) Instructions for Use

Marketing Authorization Holder

Firma Vitafarma, JSC (Russia)

ATC Code

L03AB (Interferons)

Active Substances

Hyaluronate sodium (USAN)

Interferon alfa-2b (USAN)

Dosage Form

Hyaferon

Vaginal and rectal suppositories 500000 IU+12 mg: 10 units.

Dosage Form, Packaging, and Composition

Vaginal and rectal suppositories white or white with a creamy tint, cylindrical or cone-shaped, of uniform consistency, with the odor of confectionery fat.

Excipients: confectionery fat, paraffin, emulsifier T-2.

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Interferon. An immunomodulatory drug with antiviral action

Pharmacotherapeutic Group

Cytokine

Pharmacological Action

Interferon alfa-2b human recombinant is a protein obtained by recombinant DNA. The polypeptide structure of the molecule, biological activity, and pharmacological properties are identical to leukocyte interferon alfa-2b.

Interferon alfa-2b human recombinant inhibits the intracellular stages of development of herpes simplex virus types I and II, chlamydia, gardnerella, mycoplasma, and ureaplasma, and has antiviral, immunomodulatory, and antibacterial effects.

Pharmacokinetics

When administered rectally, Interferon alfa-2b human recombinant is absorbed through the mucous membrane, enters the surrounding tissues and the lymphatic system, providing a systemic immunomodulatory effect. Due to partial fixation on the cells of the mucous membrane, it also has a local effect. When used intravaginally, due to the high concentration at the site of infection, it has a pronounced local antiviral and antibacterial effect. The maximum concentration of interferon in the blood serum is reached 5 hours after administration of the drug.

Due to its pronounced hydrophilicity, Sodium hyaluronate forms a dispersion matrix, promotes enhanced activity and proliferation of cellular elements, accelerates tissue regeneration, and stimulates angiogenesis. Being the main structural element of human connective tissue, Sodium hyaluronate ensures uniform prolonged penetration of interferon into the bloodstream.

The decrease in the level of serum interferon 12 hours after administration necessitates its repeated administration.

Indications

• Acute and chronic recurrent herpetic infection; including genital and generalized forms;
• Complex therapy of diseases of the genital area: chlamydia, gardnerellosis, mycoplasmosis, and ureaplasmosis.

ICD codes

Dosage Regimen

Before administration, remove the suppository from its waxed paper wrapper or cut the cell packaging.

For treatment of herpetic infection, administer one suppository either rectally or vaginallytwice daily. Continue this regimen daily for 10 days.

For complex therapy of chlamydia, gardnerellosis, mycoplasmosis, and ureaplasmosis, administer one suppository vaginally twice daily. The treatment course is 20 to 30 days and must be completed daily.

Adhere strictly to the prescribed administration route and duration of therapy. Do not discontinue use prematurely.

If a dose is missed, administer it as soon as remembered. If it is nearly time for the next dose, skip the missed one and resume the regular schedule. Do not double the dose.

Store suppositories under recommended conditions to maintain stability and efficacy. Discard any suppository with altered physical properties, such as a change in color or the appearance of a rancid odor.

Adverse Reactions

The drug is well tolerated and does not cause pronounced side effects. When the daily dose of interferon alfa-2b exceeds 10,000,000 IU, phenomena such as chills, fatigue, loss of appetite, and sweating may be observed. In these cases, it is recommended to consult the attending physician to reduce the dose of the drug.

Contraindications

• Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation has not been studied.

Special Precautions

Hyaferon does not affect the performance of activities requiring special attention and rapid reactions (driving vehicles, operating machinery, etc.).

The drug is not suitable for use

• If the integrity of the packaging is compromised;
• Without labeling;
• With altered physical properties (change in color, appearance of a rancid fat odor);
• With an expired shelf life.

Overdose

Cases of Hyaferon overdose have not been reported.

Drug Interactions

Hyaferon is effective as a component of complex therapy. In combination with antibacterial and antiviral drugs, it allows achieving a high therapeutic effect.

Storage Conditions

In accordance with SP 3.3.2.1248-03. At a temperature of 2 to 8°C (46.4°F).

Shelf Life

Shelf life – 1 year.

Dispensing Status

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.