Nazoferon

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAZOFERON® (NAZOFERON)

Composition:

Active substance: interferon alfa-2b;

1 ml of nasal drops contains not less than 100,000 IU of recombinant human interferon alfa-2b;

Excipients: methylparahydroxybenzoate (E 218), lysine hydrochloride, potassium chloride, trometamol hydrochloride, trometamol, hypromellose, disodium edetate, purified water.

Pharmaceutical form. Nasal drops.

Main physicochemical characteristics: clear, colorless liquid.

Pharmacotherapeutic group. Immunostimulants. Interferons. Interferon alfa-2b.

ATC code L03A B05.

Pharmacological properties.

Pharmacodynamics.

NAZOFERON**®** is an antiviral, antimicrobial, anti-inflammatory, immunomodulatory, and antiproliferative agent. The biological activity of interferon is characterized by the following effects:
Antiviral – inhibits viral replication (including adenoviruses, influenza viruses) through inhibitory effects on transcription and translation processes.
Antiproliferative – suppresses cell proliferation (of most DNA- and RNA-containing viruses). Interferon induces the synthesis of a specific enzyme – protein kinase – which prevents translation by phosphorylating one of the initiation factors of this process; it also activates a specific ribonuclease that damages viral mRNA.
Additional effects of interferon include: stimulation of other cytokine production, induction of specific enzymes, inhibition of cell proliferation, and immunomodulation (enhancement of macrophage phagocytic activity and lymphocyte-specific cytotoxicity against target cells). Interferon acts as an immune mediator, exhibits pronounced tissue specificity, and protects the body against infectious disease pathogens.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

NAZOFERON**®** is used for the prevention and treatment of acute respiratory viral infections (ARVI) in children from 1 month of age and adults:

• who suffer from frequent and prolonged upper respiratory tract infections;
• upon contact with individuals infected with ARVI;
• during hypothermia;
• during seasonal increases in morbidity within organized groups (children and adults), among risk groups—healthcare workers, teachers, especially during epidemic periods.

Contraindications.

Hypersensitivity to alpha-2b interferon and other components included in the drug formulation, severe forms of allergic diseases in medical history. Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of intranasal vasoconstrictive agents is not recommended, as they may promote dryness of the nasal mucosa.

Instructions for Use

The medicinal product should be administered into each nasal passage.

Before using the medication, lie down on your back or sit with your head slightly tilted backward, turning it toward the side of the nostril into which the drops will be instilled. Without touching the inner nasal walls with the dropper tip, instill the medication. Immediately after instillation, it is recommended to gently massage the sides of the nose externally with fingers for several minutes to ensure even distribution of the medicinal product over the nasal mucosa.

Administration of drops to children should be carried out under adult supervision.

The medicinal product contains methylparahydroxybenzoate, which may cause allergic reactions, including delayed-type reactions, and in rare cases bronchospasm.

Do not use the medication if the packaging integrity or labeling is compromised, if there are changes in physical properties (color or clarity of the liquid), or after the expiration date.

To prevent the spread of infection, the medication bottle should be used individually.

Avoid contact of the medication with the mucous membranes of the eyes.

Use during pregnancy or breastfeeding.

Use is contraindicated.

Effect on the ability to drive or operate machinery.

No effect.

Method of Administration and Dosage.

At the first signs of acute respiratory viral infection (within 5 days)

Children aged 1 month to 1 year – 1 drop into each nostril 5 times daily (single dose – 8000 IU, daily dose – 40000 IU).

Children aged 1 to 3 years – 2 drops into each nostril 3–4 times daily (single dose – 16000 IU, daily dose – 48000–64000 IU).

Children aged 3 to 14 years – 2 drops into each nostril 4–5 times daily (single dose – 16000 IU, daily dose – 64000–80000 IU).

Children aged 14 to 18 years – 2 drops into each nostril 5–6 times daily (single dose – 16000 IU, daily dose – 80000–96000 IU).

Adults – 3 drops into each nostril 5–6 times daily (single dose – 24000 IU, daily dose – 120000–144000 IU).

For prophylaxis of respiratory viral infections

Upon contact with infected individuals or after chilling – according to age-related dosage, twice daily for 5–7 days. Prophylactic courses may be repeated if necessary. In case of single exposure, a single application is sufficient.

During seasonal increase in infection rates – single application in the morning according to age-related dosage, with intervals of 1–2 days.

Method of administration of nasal drops in a bottle sealed with a dropper (see Fig. 1 and section "Special Instructions"):

1. Remove the protective cap from the bottle.
2. Turn the bottle with the nozzle downward; before first use, perform several test presses.
3. Press the dropper the required number of times according to the prescribed dosage, applying into each nostril.
4. After use, close the bottle with the cap.

Fig. 1

Children.

The medicinal product is intended for use in children aged 1 month and older.

Overdose.

Not studied.

Side effects.

In isolated cases – skin rash.

If any adverse reactions occur, consult a physician.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Shelf life after opening the vial, under storage conditions of 2 °C to 8 °C (in the refrigerator): 10 days.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store at a temperature of 2 °C to 8 °C.

Keep out of reach and sight of children.

Packaging. 5 ml in amber glass bottles with dropper caps.

1 bottle per carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.