Ophtalmoferon^® (Drops) Instructions for Use

Marketing Authorization Holder

Firn M, LLC (Russia)

ATC Code

S01AD05 (Interferon)

Active Substances

Diphenhydramine (Rec.INN registered by WHO)

Interferon alfa-2b (USAN adopted for use in the USA)

Dosage Form

Ophtalmoferon®

Eye drops 10000 IU+1 mg/1 ml: 10 ml bottle

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or slightly yellowish solution.

Excipients: boric acid – 3.1 mg, disodium edetate – 0.4 mg, sodium chloride – 2.2 mg, sodium acetate – 7 mg, hypromellose – 3 mg, povidone – 5 mg, macrogol 4000 – 50 mg, purified water – up to 1 ml.

10 ml – plastic bottles (1) with a dropper dispenser – cardboard packs.
10 ml – polymer bottles (1) with dispenser nozzles – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug for topical use in ophthalmology

Pharmacotherapeutic Group

Combined antiviral agent (cytokine + H1-histamine receptor blocker)

Pharmacological Action

It has antiviral, anti-inflammatory, immunomodulatory, antimicrobial, local anesthetic, and regenerative effects.

Indications

• Adenoviral, enteroviral (hemorrhagic), and herpetic conjunctivitis.
• Adenoviral and herpetic keratitis, including vesicular, punctate, dendritic, geographic, stromal, and ulcerative forms.
• Adenoviral and herpetic keratoconjunctivitis.
• Herpetic uveitis and keratouveitis, including cases with corneal ulceration.

ICD codes

Dosage Regimen

Instill 1-2 drops into the affected eye. During the acute phase of the disease, administer up to 6-8 times per day.

As the inflammatory process subsides, reduce the frequency of instillation to 2-3 times per day. Continue the course of treatment until the clinical symptoms of the disease have completely resolved.

Adverse Reactions

Adverse reactions are generally not noted with the use of this medication. Transient local burning sensation immediately after instillation may occur in some patients, which usually resolves spontaneously without requiring discontinuation of therapy.

Discontinue use and consult a physician if any severe or unexpected local reactions develop, such as persistent irritation, redness, itching, or swelling.

Contraindications

• Hypersensitivity to interferon alfa-2b, diphenhydramine, or any of the excipients in the formulation.
• Known allergic reactions to other interferon preparations or antihistamines.

Special Precautions

If there is no improvement within 5 days of treatment and if side effects occur, consultation with an ophthalmologist is necessary.

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

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.