Expiration date: 05/2025
The composition and form of issue:
Lyophilisate for preparation of solution for intramuscular and subcutaneous injection 1 vial contains active substance:
interferon gamma 100 thousand ME
500 thousand IU
1 million IU
2 million IU
excipients: mannitol
vials in cartons of 1, 5, 10 or 20 vials or in the contour or contour cassette packaging 1, 5, 10 or 20 bottles in cardboard pack 1 pack.
Description pharmaceutical form:
Both dosage forms: loose or porous mass of white color, hygroscopic.
Description pharmacological action:
Ingaron — recombinant interferon gamma human, consists of 144 amino acid residues (a.on.), deprived of the first three.about. — Cys-Tyr-Cys replaced by Met. Molecular mass of 16.9 kDa. Obtained by microbiological synthesis in a recombinant strain of Escherichia coli and purified column chromatography. The specific antiviral activity on the cells (human fibroblasts) infected with vesicular stomatitis virus is 2·10 7 U/mg of protein. Interferon-gamma (immune interferon) is a key proinflammatory cytokine, the producers of which in the human body are natural killer cells, CD4 Th1 cells and CD8 cytotoxic suppressor cells. The receptors for interferon gamma have macrophages, neutrophils, natural killer cells, cytotoxic T-lymphocytes. Interferon gamma activates the effector functions of these cells, in particular their microsociety, cytotoxicity, production of cytokines, superoxide radicals and nitroxide, thereby causing the death of intracellular parasites. Interferon gamma inhibits the b-cell response, IL-4, inhibits the production of IgE and expression of CD23 antigen. Is an inductor of apoptosis of differentiated b-cells that give rise to autoreactive clones. Cancels the suppressive effect of IL-4 on IL-2-dependent proliferation and generation lymphokin-activated killer cells. Activates the production of acute phase proteins of inflammation, increases the expression of genes C2 and C4 components of the complement system.
Unlike other interferon, increases the expression of antigens of major histocompatibility complex (HCGS) as the 1st and 2nd classes on different cells, and induces the expression of these molecules, even on cells that do not Express them constitutively. This increases the efficiency of presentation of antigens and their recognition by T-lymphocytes.
Interferon gamma inhibits the replication of viral DNA and RNA, synthesis of viral proteins and Assembly of Mature viral particles. Interferon-gamma exerts cytotoxic effects on virus-infected cells.
Interferon gamma inhibits the synthesis of &beta-TGF, responsible for the development of fibrosis of the lungs and liver.
Indications:
Lyophilisate for preparation of solution for intramuscular and subcutaneous injection
Integrated therapy:
- chronic viral hepatitis C
- chronic viral hepatitis b
- HIV/AIDS infection
- pulmonary tuberculosis
- cancer (as an immunomodulator — including in combination with chemotherapy)
- urogenital chlamydia
- chronic prostatitis
- genital herpes is a viral infection and shingles (Herpes zoster) — monotherapy
- anogenital warts (human papillomavirus) — treatment and prevention of disease recurrence.
Prevention of infectious complications in patients with chronic granulomatous disease.
Lyophilisate for preparation of solution for intranasal administration
Comprehensive therapy for the prevention and treatment of influenza and influenza of avian origin (H5N1 and H1N1).
Contraindications:
Common to both dosage forms:
- individual intolerance to interferon gamma or any other component of the drug
- pregnancy.
Lyophilisate for preparation of solution for intramuscular and subcutaneous injection:
- autoimmune diseases
- diabetes.
Lyophilisate for preparation of solution for intranasal administration: children under 7 years of age.
Application of pregnancy and breast-feeding:
Contraindicated in pregnancy.
Side effects:
Lyophilisate for preparation of solution for intramuscular and subcutaneous injection: local soreness at the site of the p/to the introduction in the form of weak pain bursting character (like perekreditovanija muscle), and flushing.
The use of doses in excess of 1 million ME may be accompanied by the development of influenza-like syndrome: headache, weakness, increased body temperature, pain in the joints. Mild symptoms do not require pharmacological correction. When expressed phenomena — relief with paracetamol.
Lyophilisate for preparation of solution for intranasal administration have not been identified.
Method of application and dose:
V/m, p/K. the Contents of the vial are dissolved in 2 ml of water for injection. Dose set individually.
For the treatment of patients with chronic viral hepatitis b, chronic hepatitis C, and HIV/AIDS and TB the average daily dose for adults is 500 thousand ME. Is introduced 1 time a day, daily or every other day. The course of treatment is from 1 to 3 months, if necessary, after 1-2 months, repeat the treatment.
To prevent infectious complications in patients with chronic granulomatous disease usually the average daily dose for adults is 500 thousand ME. Is introduced 1 time a day, daily or every other day. The course consists of 5-15 injections, if necessary, extend or repeat in 10-14 days.
For cancer treatment the average daily dose for adults is 500 thousand ME. Enter 1 time per day, every other day.
For the treatment of genital herpes viral infection, shingles (Herpes zoster) and genital chlamydia average daily dose for adults is 500 thousand IU. Enter 1 time per day, n/a, through the day. The course of treatment is 5 injections.
For the treatment of chronic prostatitis daily dose 100 thousand IU. Enter 1 time per day n/a every other day. The course of treatment is 10 injections.
For the treatment of anogenital warts daily dose 100 thousand IU. Enter 1 time per day n/a, after cryodestruction. The course of treatment is 5 injections.
The intranasal route. The contents of a bottle dissolve in 5 ml of water for injection.
At the first sign of influenza, SARS — 2 drops in each nasal passage, after the toilet of the nasal passages, 5 times a day for 5-7 days.
To prevent colds and flu in contact with the patient and/or hypothermia — 2-3 drops in each nostril a day 30 minutes before Breakfast for 10 days. If necessary, preventive courses should be repeated. A single contact a single instillation.
After instillation is recommended to massage the fingers, the wings of the nose for several minutes to distribute the drug in the nasal cavity.
Storage conditions:
Do not freeze.
