NAZOFERRON

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NАZOFERON® (NAZOFERON)

Composition:

Active substance: alpha-2b interferon;

1 ml of nasal spray contains not less than 100,000 IU of recombinant human alpha-2b interfer0n;

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

Pharmaceutical form. Nasal spray.

Main physicochemical characteristics: clear, colorless liquid.

Pharmacotherapeutic group. Immunostimulants. Interferons. Alpha-2b interferon.

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 replication of viruses (adenoviruses, influenza viruses) by suppressing 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 interferes with 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 production of other cytokines, induction of specific enzymes, inhibition of cell proliferation, and immunomodulation (enhancement of macrophage phagocytic activity and specific lymphocyte 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.

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

• who frequently suffer from prolonged upper respiratory tract infections;
• upon contact with individuals suffering from ARVI;
• in cases of hypothermia;
• during seasonal increases in morbidity within organized groups (children and adults), among risk groups – healthcare workers, teachers, especially during an epidemic.

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

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

Special precautions for use.

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

The product should not be used if the packaging is damaged, if there are changes in physical properties (such as color or clarity of the solution), or after the expiry date.

To prevent the spread of infection, individual use is recommended.

Use during pregnancy or breastfeeding.

Use is contraindicated.

Ability to influence reaction speed when driving or operating machinery.

Has no effect.

Method of Administration and Dosage

1 spray-dose = 1 short press on the dispenser.

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

Children aged 1 to 3 years – 2 spray-doses into each nostril 3–4 times daily (single dose – 20,000 IU, daily dose – 60,000–80,000 IU).

Children aged 3 to 14 years – 2 spray-doses into each nostril 4–5 times daily (single dose – 20,000 IU, daily dose – 80,000–100,000 IU).

Children aged 14 to 18 years – 2 spray-doses into each nostril 5–6 times daily (single dose – 20,000 IU, daily dose – 100,000–120,000 IU).

Adults – 3 spray-doses into each nostril 5–6 times daily (single dose – 30,000 IU, daily dose – 150,000–180,000 IU).

For prevention of respiratory viral infections

In case of contact with an infected person or exposure to cold – according to age-dependent dosage, twice daily for 5–7 days. Preventive courses should be repeated as necessary. For single contact, one spray administration is sufficient.

During seasonal increase in infection rates – single morning administration according to age-dependent dosage, with an interval of 1–2 days.

Method of nasal spray administration:

1. Remove the protective cap from the bottle.
2. Prime the spray pump by pressing (test spray).

While standing upright, insert the nozzle tip into each nostril alternately and press the pump dispenser.

3. After use, replace the cap on the bottle.

Children.

To be used in children aged 1 year and older.

Overdose.

Not studied.

Side effects.

In isolated cases – skin rash.

If any adverse reactions occur, consult a doctor.

Reporting suspected side effects

Reporting suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all 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, when stored at 2 °C to 8 °C (in the refrigerator): 10 days.

Storage conditions. Store at 2 °C to 8 °C.

Keep out of reach of children.

Packaging.

5 ml in a flacon made of light-protective glass, closed with a pump dispenser with a nasal spray applicator. 1 flacon 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.