INGARON Prescribing Information (intranasal)

Pharmacological properties
INGARON® is a recombinant human interferon gamma, consists of 144 amino-acid residues, deprived of first three amino-acid residues Cys-Tyr-Cys, replaced with Met. Molecular weight is 16.9 kDa. Obtained by microbiological synthesis in recombinant Escherichia coli strain and purified by column chromatography. Specific anti-viral activity in cells (human fibroblasts) infected with vesicular stomatitis virus is 2∙107 IU per mg of protein. 

Interferon gamma (immune interferon) is an essential proinflammatory cytokine, produced in the human body by natural killer cells, CD4 Th1 cells and CD8 cytotoxic suppressor cells. Receptors for interferon gamma are found in macrophages, neutrophils, natural killer cells and cytotoxic Т-lymphocytes. Activates effector functions of these cells, in particular, their microbicidity, cytotoxicity, production of cytokines, superoxide and nitrooxide radicals (thus causing death of intracellular parasites). Interferon gamma blocks replication of viral DNA and RNA, synthesis of virus proteins and assembly of mature virus particles. It causes cytotoxic effect on virus infected cells. 

Inhibits b-cell-mediated response to interleukin-4, suppresses production of IgE and expression of CD23-antigen. Induces apoptosis of B-cells originating autoreactive clones. Disables suppressive effect of interleukin-4 to interleukin-2 depending proliferation and generation of lymphokine activated killers. Activates production of acute inflammation phase proteins C2 and C4 components of complement system. 

Unlike other interferons, it increases I and II class major histocompatibility complex antigen expression, and induces expression of these molecules even on those cells that don't express them constitutively. Therefore, efficiency of antigen presentation and their ability to be recognized by Т-lymphocytes increases. 

Interferon gamma blocks synthesis of β-TGF responsible for development of pulmonary and hepatic fibrosis.
Indications for use
Prevention and treatment (as part of combined therapy) of influenza. Prevention and treatment (as part of combined therapy) of influenza H5N1 and H1N1.
Individual intolerance of interferon gamma or any other component of the drug. Pregnancy. Children (below 7 years old).
Dosing and Administration

Intranasally. Dissolve the vial content in 5 ml of water for injections. 

In case of first signs of influenza or ARVI, 2 drops into each nasal passage after cleaning nasal passages 5 times a day for 5-7 days.

In order to prevent ARVI and influenza in case of contact with a sick person and/or exposure to cold, 2-3 drops into each nasal passage every second day 30 minutes before breakfast for 10 days. If necessary, preventive course may be repeated. In case of single contact, one dripping is enough.

It is recommended to massage the nose alae with fingers for a few minutes after dripping in order to distribute the drug in nasal cavity evenly. 

Side effects
None known.
Form of issue
Lophilizate for preparation of solution for intranasal application in vials, 100,000 IU in each vial.
Packaging set: 1 vial of drug, 1 vial of water for injection (5 ml) and 1 cap-dropper made of polyethylene in packaging of polyethylene or medical dropper in contour cellular package or in cassette contour package.

1 or 5 of contour package with application instructions are put into cardboard package.
1 or 5 vials of the drug respectively supplied with 1 or 5 cap-droppers made of polyethylene in packaging of polyethylene or medical dropper and with application instructions are put into cardboard package.
Storage conditions and shelf life
Keep in dry dark place out of the reach of children at temperature of +25ºС maximum. Shelf life - 2 years. Keep the drug solution in refrigerator for not longer than 10 days (do not freeze). Do not use after expiry date.

Pharmaklon RPE, LLC, Russia

Legal address:
30/34 Chekhov street, Serpukhov, Moscow region, Russia, 142200

Мanufacturer's address:
Biomed named after Mechnikov, Petrovo-Dalnee, Krasnogorsk district, Moscow region, Russia, 143422

Phone/fax:+7 (4967) 36-07-71, +7 (495) 120-12-47


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