Ingaron lyophilisate for the solution for the i/m administration 500000me bottle №5

International non-proprietary name: Interferon gamma human recombinant.

Dosage Form:

lyophilisate for preparation of solution for intramuscular and subcutaneous administration.

Composition:

Active substance:
interferon gamma -500000 IU,

Excipients:
mannitol.

Description:

The drug is a loose or porous mass of white, hygroscopic.

Pharmacotherapeutic group:

Antiviral and immunomodulating agent.

Pharmacological properties

INGARON®, a recombinant human interferon gamma, consists of 144 amino acid residues (a. O.), Is devoid of the first three a. about. 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. The specific antiviral activity on cells (human fibroblasts) infected with vesicular stomatitis virus is 2 · 10⁷ Units per mg protein.
Interferon gamma (immune interferon) is the most important pro-inflammatory cytokine, produced in the human body by natural killer cells, CD4 Th1 cells and CD8 cytotoxic suppressor cells.
Interferon gamma receptors have macrophages, neutrophils, natural killer cells, cytotoxic T-lymphocytes.
Interferon Gamma:

• Activates the effector functions of these cells, in particular their microbicidal activity, cytotoxicity, production of cytokines, superoxide and nitrooxide radicals, thereby causing the death of intracellular parasites.
• Inhibits the B-cell response, interleukin-4, inhibits the production of IgE and the expression of the CD23 antigen.
• It is an inducer of apoptosis of differentiated B cells, giving rise to autoreactive clones.
• Cancels the suppressive effect of interleukin-4 on interleukin-2-dependent proliferation and generation of activated killer lymphokine.
• Activates the production of proteins of the acute phase of inflammation, enhances the expression of genes C2 and C4 components of the complement system.
• Unlike other interferons, it increases the expression of GCGS antigens of both I and II classes on different cells, and induces the expression of these molecules even on those cells that do not express them constitutively. This increases the efficiency of the presentation of antigens and the ability of their recognition by T-lymphocytes.
• It blocks the replication of viral DNA and RNA, the synthesis of viral proteins and the assembly of mature viral particles.
• It has a cytotoxic effect on virus-infected cells.
• Blocks the synthesis of β -TGF responsible for the development of pulmonary fibrosis and liver.

Indications for use

Treatment of chronic viral hepatitis C, chronic viral hepatitis B, HIV / AIDS infection and pulmonary tuberculosis in complex therapy.
Prevention of infectious complications in patients with chronic granulomatous disease.
Treatment of cancer in complex therapy as an immunomodulator, including in combination with Chemotherapy.
Treatment of genital herpes virus infection and shingles (herpes zoster) in monotherapy.
Treatment of urogenital chlamydia in complex therapy.
Treatment of chronic prostatitis in complex therapy.
Treatment of anogenital warts (human papillomavirus) and prevention of disease recurrence.

Contraindications

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

Dosage and administration

The introduction of the drug intramuscularly or subcutaneously.
The contents of the vial are dissolved in 2 ml of water for injection.
The dose of the drug is set individually.
For the treatment of patients with chronic viral hepatitis B, chronic viral hepatitis C, as well as HIV / AIDS infection and pulmonary tuberculosis, the average daily dose for adults is 500,000 IU. It is entered once a day, every day or every other day. The course of treatment is from 1 to 3 months, if necessary, after 1-2 months, the treatment is repeated.
For the prevention of infectious complications in patients with chronic granulomatous disease, the average daily dose for adults is usually 500,000 IU. It is entered once a day, every day or every other day. In the course of 5-15 injections, if necessary, the course is extended or repeated after 10-14 days.
For the treatment of cancer, the average daily intake for adults is 500,000 IU. Introduced 1 time per day every other day.
For the treatment of genital herpes virus infection, shingles (herpes zoster) and urogenital chlamydia, the average daily dose for adults is 500,000 IU. It is administered 1 time per day subcutaneously, every other day. The course of treatment is 5 injections.
For the treatment of chronic prostatitis, the daily dose is 100,000 IU. It is administered 1 time per day subcutaneously, every other day. The course of treatment is 10 injections.
For the treatment of anogenital warts, the daily dose is 100,000 IU.
It is administered 1 time per day subcutaneously, after the conducted cryodestruction, every other day.
The course of treatment is 5 injections.

Side effect

Local soreness at the injection site in the form of a weak pain of a breaking nature (like overtrained muscle) and hyperemia.
The use of high doses of more than 1,000,000 IU may be accompanied by the development of flu-like syndrome: headache, weakness, fever, joint pain. Mild symptoms do not require pharmacological correction. When expressed phenomena - moped with Paracetamol.

Release form:

Lyophilisate for preparation of a solution for intramuscular and subcutaneous administration in vials of 100,000 IU, 500,000 IU, 1,000,000 IU or 2,000,000 IU of active substance per 1 bottle. 1, 5, 10 or 20 bottles of the drug with instructions for use are placed in a pack of cardboard, or 1, 5, 10 or 20 bottles of the drug in a contour cell packaging or in a cassette contour package with instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, dark place and out of reach of children, at a temperature of 2-10 ° C. Do not freeze.

Shelf life:

2 years. Do not use after the expiration date printed on the package.