INGARON Prescribing Information (injectable)

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.

Interferon gamma: 

• Activates effector functions of these cells, in particular, their microbicidity, cytotoxicity, production of cytokines, superoxide and nitrooxide radicals (thus causing death of intracellular parasites). 
  
• 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 proteins acute phase of inflammation, increases the expression of genes 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 replication of viral DNA and RNA, synthesis of virus proteins and assembly of mature virus particles.
• Causes cytotoxic effect on virus infected cells. 
• Interferon gamma blocks synthesis of β-TGF responsible for development of pulmonary and hepatic fibrosis. 

Treatment in combined therapy:

·         chronic viral hepatitis C;

·         chronic viral hepatitis В;

·         HIV/AIDS infection;

·         pulmonary tuberculosis;

·         oncologic diseases as immunomodulator, including in combination with chemotherapy;

·         urogenital clamidiosis;

·         chronic prostatitis.

Treatment in monotherapy:

·         human papilloma virus (HPV);

·         herpes virus infection;

·         genital herpes virus infection;

·         herpes zoster;

·         anogenital warts (human papilloma virus) and prevention of disease recurrence.

Prevention:

·         infectious complications in patients with chronic granulomatous disease.

Individual intolerance of interferon gamma or any other component of the drug. Pregnancy. Autoimmune diseases. Diabetes mellitus.

Intramuscular or subcutaneous administration. 
Dissolve the contents of vial in 1-2 ml of water for injections.
Drug dose is to be determined individually.

For treatment of chronic viral hepatitis B, chronic viral hepatitis C, HIV/AIDS infection and pulmonary tuberculosis, daily dose for adults is 500,000 IU. Administered once a day, every day or every other day. Course of treatment lasts from 1 to 6 months, if necessary, the course of treatment may be repeated 1 or 2 months later.

For the prevention of infectious complications in patients with chronic granulomatous disease, usually, average daily dose for adults is 500,000 IU. Administered once a day, every day or every other day. The course includes 5 to 15 injections, if necessary, the course may be repeated 10-14 days later.

For treatment of oncology diseases, average daily dose for adults is 500,000 IU. Administered once a day, every other day. 

For treatment of genital herpes virus infection, herpes zoster and urogenital clamidiosis, average daily dose for adults is 500,000 IU. Administered once a day subcutaneously, every other day. Course of treatment is 5 injections.

For treatment of chronic prostatitis, daily dose is 100,000 IU or 500,000 IU. Administered once a day subcutaneously, every other day. Course of treatment is 10 injections.

For treatment of anogenital warts, daily dose is 100,000 IU.
Administered once a day subcutaneously after cryolysis, every other day.
Course of treatment is 5 injections.

Localized pain at the injection site in the form of slight aching (like overtrained muscle) and hyperemia.
Use of high doses over 1,000,000 IU may be accompanied by development of flu-like syndrome: headaches, weakness, temperature rise, joint pain. Mild symptoms do not require pharmacological correction. Marked symptoms are treated with nonsteroidal anti-inflammatory drugs.

Lyophilizate for preparation of solution for intramuscular and subcutaneous administration, 100,000 IU, 500,000 IU, 1,000,000 IU or 2,000,000 IU of active ingredient per 1 vial. 1, 5,10 or 20 vials of the drug with application instructions are put into cardboard package or 1, 5,10 or 20 vials of the drug in contour cellular package or in cassette contour package with application instructions are put into cardboard package.

Keep in dry place away from direct sunlight at 2-10°С.
Shelf life - 2 years. Do not use after expiry date indicated on the package.

Manufacturer / organization accepting complaints of purchasers:
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

E-mail: info@pharmaclon.ru
www.pharmaclon.ru