Genferon Lite nasal drops 10 thousandsIU/ml+0.8mg/ml vial, 10ml

Composition

>

1 ml of the solution contains:

operating materials: interferon Alfa-2b human recombinant* 10 000 IU, taurine 0,80 mg;

excipients: intrumpetigent – 0.02 mg, glycerol – 7,00 mg, dextran-35-45 thousand – 2.4 mg, Polysorbate-80 – 1.0 mg, sodium chloride – 0.8 mg, potassium chloride 0.02 mg, sodium hydrogen phosphate – 0,115 mg, potassium dihydrogen phosphate – 0.02 mg, water for injection up to 1 ml.

* The composition of the substance “Interferon alfa-2b human recombinant(rfIFN-a2b)” includes excipients: sodium chloride, sodium acetate trihydrate, ice acetic acid, water for injection.

Pharmacological action

Pharmacotherapy group

An immunomodulatory agent.

ATX code: L03A

Pharmacological properties

Pharmacodynamics . The drug Genferon®Light, nasal drops, has an antiviral, immunomodulatory, anti-inflammatory, antiproliferative, antibacterial effect, has local regenerating, membrane-stabilizing and antioxidant properties.

Interferon alpha blocks the reproduction of viruses at the stage of synthesis of specific proteins and prevents infection of uninfected cells of the nasal mucosa, which is the site of invasion of pathogens and the primary focus of inflammation in respiratory infections.

The immunomodulatory effect is manifested by an increase in cell-mediated responses of the immune system, which increases the effectiveness of the immune response against foreign agents. This is achieved by activating CD8+ killer T cells, NK cells (natural killers), and enhancing differentiation.

B-lymphocytes and their production of antibodies, activation of the monocyte-macrophage system and phagocytosis, as well as an increase in the expression of molecules of the main histocompatibility complex type I, which increases the probability of recognition of infected cells by immune system cells.

Activation of white blood cells contained in all layers of the mucous membrane under the influence of interferon ensures their active participation in the elimination of pathological foci; in addition, due to the influence of interferon, the production of secretory immunoglobulin A is restored. The antibacterial effect is mediated by immune system reactions enhanced under the influence of interferon.

Taurine, which is part of the drug, normalizes metabolic processes in tissues, promotes regeneration and faster recovery of the nasal mucosa damaged by the pathological process.

Pharmacokinetics. For intranasal use of Genferon®Light, nasal drops, creates a high concentration of interferon in the focus of infection and has a pronounced local antiviral and immunostimulating effect. Systemic absorption of the drug is insignificant; with intranasal use, human recombinant Interferon alfa-2b is detected in small amounts in the lung tissue and blood. In the body, biotransformation occurs mainly in the kidneys with a half-life (_half-life) of 5.1 hours. A small amount of the drug entering the systemic circulation has a systemic immunomodulatory effect.

Indications

Treatment of influenza and other acute respiratory viral infections in children aged 29 days to 14 years.

Use during pregnancy and lactation

It is not used because the drug is indicated for use in children aged 29 days to 14 years.

Contraindications

• Hypersensitivity to Interferon alfa-2b or other components of the drug.

• Newborns from 0 to 28 days (due to the lack of clinical data).

Side effects

Local allergic reactions (burning sensation, itching) are possible. These phenomena are reversible and disappear independently within 72 hours after discontinuation of the drug. Continuation of treatment is possible only after consulting a doctor.

Interaction

Concomitant use of intranasal vasoconstrictors is not recommended, as this causes additional dryness of the nasal mucosa.

How to take, course of use and dosage

At the first signs of the disease, Genferon ® light is instilled in the nose for 5 days.

Children from 29 days to 11 months 29 days – 1 drop in each nasal passage 5 times a day (a single dose of 1 000 IU, a daily dose of 5 000 IU).

Children from 1 to 3 years – 2 drops in each nasal passage 3-4 times a day (a single dose of 2 000 IU, daily dose 6 000 – 8 000 IU).

Children from 3 to 14 years – 2 drops in each nasal passage 4-5 times a day (a single dose of 2 000 IU, daily dose 8 000 – 10 000 ME).

Overdose

Cases of overdose of the drug Genferon Light have not yet been reported.

Special instructions

After instillation, it is recommended to massage the wings of the nose with your fingers for several minutes to evenly distribute the drug in the nasal cavity. The effect of the drug Genferon Light on the ability to drive vehicles and control mechanisms on the performance of potentially dangerous activities that require special attention and rapid reactions (driving vehicles, machinery, etc. ) has not been studied.

Storage conditions

Store in a dry place protected from light at a temperature of 2 to 8°C. Within the specified shelf life, patients can store the drug after opening for 7 weeks at a temperature of 2 to 8°C.

Shelf life

2 years

Active ingredient

Interferon alfa-2b, Taurine

Dosage form

nasal spray

Description

Children as prescribed by a doctor, Children older than 1 month

Indications

Respiratory Tract Infections, Flu