Instruction for use: Oftalmoferon

Dosage form: Eye drops

Active substance: Interferon alfa-2b human recombinant + Diphenhydramine*

ATX

S01AD05 Interferon

Pharmacological groups:

Anti-viral agent combined (cytokine + H1-histamine receptor blocker) [Ophthalmic agents in combination]

Anti-viral agent combined (cytokine + H1-histamine receptor blocker) [Interferon in combination]

The nosological classification (ICD-10)

B00.5 Herpetic eye disease: Recurrent ophthalmoherpes; Herpetic keratitis; Ophthalmoherpes; Herpetic conjunctivitis; Herpetic uveitis; Herpetic keratitis; Herpetic stromal keratitis without ulceration of the cornea; Herpetic stromal keratitis with ulceration of the cornea;Eye shape Herpes zoster; Herpetic keratoconjunctivitis; Conjunctivitis herpeticum; Herpetic conjunctivitis; Deep forms of ophthalmoherpes; Superficial herpetic keratitis

B30.0 Adenovirus-induced keratoconjunctivitis (H19.2 *): Adenoviral keratoconjunctivitis; Epidemic keratoconjunctivitis adenovirus

B30.1 Adenovirus-induced conjunctivitis (H13.1 *): Adenoviral eye damage; Adenoviral Conjunctivitis; Epidemic Adenoviral Conjunctivitis; Pharyngo-conjunctival fever acute

B30.3 Acute epidemic hemorrhagic conjunctivitis (enterovirus) (H13.1 *): Hemorrhagic conjunctivitis; Enterovirus conjunctivitis; Conjunctivitis Enterovirus

H04.1 Other diseases of the lacrimal gland: Dry eye syndrome; Lacrimation inadequate; Reduced secretion of tear fluid

H16 Keratitis: Adenoviral keratitis; Bacterial keratitis; Spring keratitis; Deep keratitis without epithelial lesion; Deep keratitis without epithelial damage; discoid keratitis; Outline keratitis; keratitis rosacea; Keratitis with corneal destruction; Superficial keratitis; punctate keratitis; Traumatic keratitis; Superficial punctate keratitis

H16.0 Corneal ulcer: Allergic corneal ulcer; Allergic corneal ulcer; Erosion of the cornea; Regional ulcer; Purulent corneal ulcer; Corneal ulcer; Trophic ulcers of the cornea; Traumatic erosion of the cornea; Ulceration of the cornea; Keratitis with corneal ulceration; Ulcerative keratitis; Purulent corneal ulcers; Epithelial point keratitis; Ulceration of superficial corneal layers; Keratomalacia; Corneal ulcer; Recurrent erosions of the cornea; Recurrent ulcers of the cornea; Bacterial corneal ulcer; Septic ulcer of the cornea; Corneal edge ulcer

H16.2 Keratoconjunctivitis: Chronic allergic keratoconjunctivitis; Bacterial keratoconjunctivitis; Deep forms of adenovirus keratoconjunctivitis; Infectious conjunctivitis and keratoconjunctivitis caused by Chlamydia trachomatis; Acute allergic keratoconjunctivitis; Spring keratoconjunctivitis; Phlyctenular keratoconjunctivitis

H19.1 Keratitis due to herpes simplex virus, and keratoconjunctivitis (B00.5 +): Recurrent ophthalmoherpes; Ophthalmoherpes; Herpetic keratoconjunctivitis; Herpetic conjunctivitis

H19.2 Keratitis and keratoconjunctivitis in other infectious and parasitic diseases classified elsewhere: Enterovirus conjunctivitis; Parenchymal keratitis

H20 Iridocyclitis: Recurrent Irritis; Sympathetic iridocyclitis; Sluggish posterior uveitis; Sluggish posterior uveitis; Posterior uveitis; Iridocyclitis of posterior segment of eye; Iridocyclitis and other uveitis; Irit; Keratoididocyclitis; Sharp Irritus; Uveitis; Cyclitis; Acute Iridocyclitis; Acute non-infectious uveitis

H59 Lesions of the eye and its adnexa after medical procedures: Condition after surgery on the eyeball; Condition after plastic surgery on the eyelids; Condition after surgery on the cornea; Condition after surgical eye surgery; Dilation of the pupil after instillation of the mydriatic

Z94.7 Presence of transplanted cornea: Consequence of keratoplasty

Composition

Eye drops 1 ml

Active substances: Interferon alpha-2b human recombinant at least 10,000 IU

Diphenhydramine hydrochloride (dimedrol) 1 mg

Auxiliary substances: boric acid - 3.1 mg; Disodium edetate 0.4 mg; Sodium chloride - 2.2 mg; Sodium acetate - 7 mg; Hypromellose - 3 mg; Povidone 8000 - 5 mg; Macrogol 4000 - 50 mg; Purified water - up to 1 ml

Description of dosage form

Drops: clear, colorless or with a slight yellowish tinge solution.

Pharmachologic effect

Mode of action - antiviral, immunomodulating, anti-allergic, antihistamine, antipruritic, antiproliferative, decongestant local.

Pharmacodynamics

Oftalmoferon® is a combined drug that contains the antiviral and immunomodulating agent interferon alfa-2b human recombinant and antihistaminic drug diphenhydramine.

Interferon human recombinant alpha-2b has a broad spectrum of antiviral activity, immunomodulating, antiproliferative action. Diphenhydramine - blocker of H1-histamine receptors - has anti-allergic effect, reduces edema and itching of the conjunctiva.

Pharmacokinetics

With topical application, the drug is not subject to systemic absorption. The concentration of active substances reached in the blood is well below the detection limit (the limit of determination of interferon alpha-2b is 1-2 IU / ml) and has no clinical significance. Information on the degree of penetration of diphenhydramine into various tissues of the eye after topical application is not present.

Indication of the Oftalmoferon

Adenoviral, hemorrhagic (enterovirus), herpetic conjunctivitis;

Adenoviral, herpetic (vesicular, dotted, tree-like, kartose) keratitis;

Herpetic stromal keratitis with ulceration of the cornea and without ulceration;

Adenoviral and herpetic keratoconjunctivitis;

Herpetic uveitis and herpetic keratouveitis (with and without ulceration);

Dry eye syndrome;

Prevention of graft disease and prevention of relapse of herpetic keratitis after keratoplasty;

Prevention and treatment of complications after excimer laser refractive surgery of the cornea.

Contraindications

Individual intolerance to the components of the drug.

Application in pregnancy and breastfeeding

The use of the drug during pregnancy and lactation is possible only according to the prescription of the attending physician if the expected effect exceeds the risk of complications in the fetus and the newborn.

Side effects

Not marked.

Interaction

The drug is compatible and well combined with anti-inflammatory, antibacterial, corticosteroid, reparative ophthalmic forms of drugs and drugs of tear-replacement therapy.

Dosing and Administration

Conjunctival.

With viral eye lesions in adults and children in acute stages of the disease, the drug is instilled into the conjunctival sac by 1-2 drops up to 6-8 times a day. As the inflammation slows down, the number of instillations is reduced to 2-3 times a day, until the symptoms disappear.

With the "dry" eye syndrome, the drug is used daily, digging into the sick eye 1-2 drops 2 times a day for 25-30 days, until the symptoms disappear.

For the prevention and treatment of complications after excimer laser refractive surgery of the cornea, the drug is used daily, starting from the day of operation, by instilling 1-2 drops into the eye 2 times a day for 10 days.

To prevent graft disease and prevent the recurrence of herpetic keratitis after keratoplasty, the drug is used daily by digesting 1-2 drops into the operated eye 3-4 times a day for the first 2 weeks after the operation.

Overdose

Cases of drug overdose have not been identified.

Special instructions

Patients using contact lenses should instill the drug only with the lenses removed and can wear them 15-20 minutes after instillation of the drug.

Influence on the ability to drive vehicles and work with machinery. Immediately after instillation, blurring of visual perception is possible, therefore it is advisable to start driving vehicles or working with mechanisms a few minutes after instillation of the drug.

Release Form

Eye drops. In plastic bottles with a dispenser-dropper for 5 and 10 ml. On 1 ôë. In a pack of cardboard.

Manufacturer

ZAO "Firn M". Moscow

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Oftalmoferon

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Oftalmoferon

2 years. The opened vial should not be stored for more than 30 days.

Do not use after the expiry date printed on the package.