Active substanceInterferon alfa-2bInterferon alfa-2b
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  • Dosage form: & nbspLyophilizate for the preparation of a suspension for oral administration.
    Composition:One bottle contains: active substance - 250 thousand ME, 500 thousand ME or 1 million ME of Interferon alfa-2b human recombinant; Excipients: sodium chloride - 8,01 mg, sodium hydrophosphate dodecahydrate - 4,52 mg, sodium dihydrogen phosphate dihydrate - 0,56 mg, Lipoid C100 (phospholipids [mixture with a percentage of phosphatidylcholine at least 94%]) - 41.18 mg, cholesterol - 4.53 mg, alpha-tocopherol acetate 0.56 mg, lactose monohydrate 91.34 mg.
    Description:Powder or porous mass of white or yellowish color. It is allowed to flake, complete or partial, from the surface of the glass of the vial to form a tabloid-like shape. Hygroscopic.
    Pharmacotherapeutic group:Cytokine.
    ATX: & nbsp

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:
    It has an immunomodulatory and antiviral effect.
    Interferon alfa-2b human recombinant, which is an active ingredient in the preparation, is synthesized by bacterial cells of the strain of Escherichia coli SG-20050 / pIF 16, into the genetic apparatus of which the human interferon alpha-2b gene is built. It is a protein containing 165 amino acids, and is identical in characteristics and properties to human leukocyte interferon alpha-2b.
    The antiviral effect of interferon alfa-2b is manifested during the reproduction of the virus by active incorporation into the metabolic processes of the cells.Interferon alfa-2b, interacting with specific receptors on the surface of cells, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetase and protein kinase), the action of which inhibits the formation of viral protein and viral ribonucleic acid in the cell. The immunomodulatory effect of interferon alfa-2b is manifested in an increase in phagocytic activity of macrophages, enhancement of specific cytotoxic action of lymphocytes on target cells, changes in the quantitative and qualitative composition of secreted cytokines; changes in the functional activity of immunocompetent cells; changes in the production and secretion of intracellular proteins.
    Indications:
    Complex therapy of patients with acute hepatitis B, chronic hepatitis B in active and inactive replicative forms, as well as chronic hepatitis B complicated by glomerulonephritis.
    Treatment of patients with atopic diseases, allergic rhinoconjunctivitis, bronchial asthma during specific immunotherapy.
    Prevention and treatment of influenza and ARVI in adults and children.
    Complex therapy of urogenital chlamydial infection in adults.
    Complex therapy of febrile and meningeal forms of tick-borne encephalitis in adults.
    Emergency prophylaxis of tick-borne encephalitis in combination with anti-malignant immunoglobulin.
    Contraindications:
    - Hypersensitivity to interferon or any other components of the drug;

    - severe forms of allergic diseases;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

    - pregnancy and the period of breastfeeding.
    Carefully:Hepatic and / or renal failure, expressed myelosuppression, thyroid disease.
    Dosing and Administration:

    It is applied orally.

    Immediately before use, 1-2 ml of distilled or cooled boiled water is added to the contents of the vial. When shaken for 1-5 minutes, a homogeneous suspension should form.

    In acute hepatitis B the drug is taken 30 minutes before meals as follows:

    - adults and children of school age - 1 million ME 2 times a day for 10 days;

    - children of preschool age (from 3 to 7 years) - 500 thousand. ME 1 time per day for 10 days or, after control biochemical blood tests, a longer time - until complete clinical recovery.

    With chronic hepatitis B in active and inactive replicative forms, as well as with chronic hepatitis B associated with glomerulonephritis the drug is taken 30 minutes before meals as follows:

    - adults and children of school age - 1 million ME twice a day for 10 days and then for 1 month - every other day, once a day (at night);

    - children of preschool age (from 3 to 7 years) - 500 thousand. ME twice a day for 10 days and then - for 500 thousand. ME within 1 month every other day, once a day (at night).

    When carrying out specific immunotherapy the drug is taken in the morning, 30 minutes after eating, according to the following scheme:

    - with allergic rhinoconjunctivitis adults - 500 thousand. ME daily for 10 days (exchange rate 5 million ME);

    - atopic bronchial asthma adults - 500 thousand each. ME once a day for 10 days, and then for 500 thousand. ME every other day for 20 days. The total duration of treatment is 30 days.

    In the prevention and treatment of influenza and ARVI the drug is taken 30 minutes before meals:

    - for prevention: adults and children over 15 years - 500 thousand. ME once a day, 2 times a week for 1 month during the rise in morbidity; children from 3 to 15 years

    - on 250 thousand. ME once a day 2 times a week for 1 month during the rise in the incidence.

    - in the treatment of influenza and SARS: adults and children over 15 years - 500 thousand. ME daily 2 times a day for 3 days; children from 3 to 15 years - 250 thousand. ME daily 2 times a day for 3 days.

    With complex therapy of urogenital infections in adults the drug is taken for

    30 minutes before meals for 500 thousand. ME daily 2 times a day for 10 days.

    In the complex therapy of tick-borne encephalitis the drug is taken 30 minutes before meals:

    - at a feverish form: on 500 thousand. ME 2 times a day (morning and evening) for 7 days;

    - at a meningeal form: on 500 thousand. ME 2 times a day (morning and evening) for 10 days;

    In case of emergency prophylaxis of tick-borne encephalitis the drug is taken 30 minutes before meals for 500 thousand. ME 2 times a day (morning and evening) for 5 days. Anti-fungal immunoglobulin is administered intramuscularly once, no later than the 4th day after the tick bite at a dose of 0.1 ml / kg.

    Side effects:

    When using the drug Reaferon-EU-Lipint in clinical studies, adverse reactions to the drug were not observed. Given that the active ingredient is recombinant interferon alpha-2b, with the use of the drug Reaferon-EU-Lipint side effects characteristic of this group of drugs are possible: chills, fever, asthenic symptoms (apathy, fatigue, lethargy) headaches, myalgia, arthralgia. These side effects are partially stopped by indomethacin / paracetamol. Perhaps the development of allergic reactions.

    From the digestive system: nausea, dry mouth, dyspepsia, decreased appetite.

    From the nervous system: with prolonged use may be irritability, anxiety, insomnia, apathy, depression.

    From the endocrine system: changes are possible on the part of the thyroid gland.

    From the laboratory indicators: with prolonged use may be leukopenia, lymphopenia, thrombocytopenia.

    Overdose:Cases of overdose were not observed. It is possible to increase dose-dependent side effects. Treatment is symptomatic.
    Interaction:
    Interferon alfa-2b is able to reduce the activity of cytochrome P450 isoenzymes and, consequently, interfere with the metabolism of cimetidine, phenytoin, dipyridamole, theophylline, diazepam, propranolol, warfarin, and some cytostatics.May enhance neurotoxic, myelotoxic or cardiotoxic effects of drugs administered earlier or simultaneously with it. It should avoid joint use with drugs that depress the central nervous system, immunosuppressive drugs (including oral and parenteral forms of glucocorticosteroids).

    Drinking alcohol during treatment is not recommended.
    Special instructions:With thyroid diseases, the drug should be administered under the supervision of an endocrinologist. When there are signs of dysfunction of the thyroid gland against the background of therapy, it is recommended to control the concentration of thyroid-stimulating hormone (TSH).
    Effect on the ability to drive transp. cf. and fur:The period of application of the drug to patients experiencing fatigue, drowsiness or disorientation, should refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
    Form release / dosage:
    Liofilizate for the preparation of a suspension for oral administration, 250,000 ME or 500,000 ME, or 1 million ME.
    Packaging:
    Lyophilizate for the preparation of a suspension for oral administration.
    For 250 thousand ME or 500 thousand.ME, or 1 million ME active substance in glass vials. The vials are hermetically sealed with rubber stoppers and crimped with aluminum caps.
    1 bottle with instructions for use in a cardboard pack.
    By 3, 5 or 6 bottles in a cell box of PVC film; 1 or 2 cell packs together with the Instruction for use in a cardboard pack.
    Storage conditions:Store in a dark place at a temperature not exceeding 8 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.
    Not applicable after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000821 / 01
    Date of registration:19.03.2007
    The owner of the registration certificate:VECTOR-MEDICA, CJSC VECTOR-MEDICA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.12.2015
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