Active substanceInterferon alfa-2b human recombinantInterferon alfa-2b human recombinant
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  • Dosage form: & nbsp
    lyophilizate for solution for injection and topical application
    Composition:

    Active substances:

    Interferon alfa-2b human recombinant - 500 ltd. ME, 1M ME, 3M ME, 5M ME.

    Excipients: polyglucin, sodium chloride, sodium phosphate monosubstituted 2-water, sodium phosphate disubstituted.

    Description:The preparation is a lyophilized powder or a porous mass of white or almost white color, hygroscopic.
    Pharmacotherapeutic group:Antiviral, antitumor agent
    ATX: & nbsp

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:It has antiviral, antitumor, immunomodulating activity. ALPHARON with parenteral administration undergoes disintegration, is partially excreted unchanged, mainly through the kidneys. The drug, like all interferons, can lead to the appearance of antibodies to interferon and, as a consequence, to a decrease in the therapeutic effect of the drug.
    Indications:
    In complex therapy in adults:
    - with acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period before the 5th day of jaundice (in later periods, the administration of the drug is less effective,is not effective in developing hepatic coma and cholestatic course of the disease);
    - with acute prolonged hepatitis B, chronic active hepatitis B and D without signs of cirrhosis and with the appearance of signs of cirrhosis;
    - with chronic viral hepatitis C;
    - in viral (influenza, adenovirus, enterovirus, herpetic, parotitic), viral-bacterial and mycoplasma meningoencephalitis. The drug is most effective in the first 4 days of the disease;
    - with viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;
    - with stage IV kidney, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis), Kaposi's sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myeloid leukemia, histiocytosis-X, subleukemic myelosis, essential thrombocytopenia;
    - with multiple sclerosis.
    In complex therapy in children:
    - with acute lymphoblastic leukemia in the remission period after the end of inductive chemotherapy (for 4-5 months of remission);
    - with respiratory papillomatosis of the larynx, starting from the next day after removal of papillomas.
    Contraindications:Severe forms of allergic diseases; pregnancy.
    Dosing and Administration:

    Intramuscularly, subcutaneously, into the focus or under the lesion, subconjunctival or local. Immediately before use, the contents of the vial are diluted with water for injection (1 ml with intramuscular injection and introduction into the focus, 5 ml with subconjunctival and local administration). The drug solution should be transparent, without foreign inclusions. The dissolution time should not exceed 4 minutes. The diluted drug is not subject to storage.

    Intramuscular and subcutaneous injection. In acute hepatitis B injected 1 million ME 2 times a day for 5-6 days, then the dose is reduced to 1 million ME per day and injected for another 5 days. If necessary (after the control biochemical blood tests) the treatment course can be continued 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.

    In acute prolonged and chronic active hepatitis B, with the exception of delta infection and without signs of liver cirrhosis, 1 million IU administered 2 times a week for 1-2 months. If there is no effect, the treatment is prolonged to 3-6 months or after 2-3 months of treatment, 2-3 similar courses are performed at intervals of 1-6 months.

    In chronic active hepatitis D without signs of liver cirrhosis, the drug is administered 500,000 to 1 million IU per day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.

    With chronic active hepatitis B and D with signs of cirrhosis of the liver for 250-500 thousand ME per day 2 times a week for 1 month. When there are signs of decompensation, similar repeated courses are conducted with an interval of at least 2 months. With chronic viral hepatitis C; adults - 3 million IU IM or n / c 3 times a week for 9 months. Children - 3 million IU / square meter (maximum dose - 3 million ME) 3 times a week for 9 months.

    In kidney cancer, 3 million IU are administered daily for 10 days. Repeated courses of treatment (3-9 and more) are carried out with an interval of 3 weeks. The total amount of the drug is from 120 million ME to 300 million ME or more.

    With hairy cell leukemia, the drug is administered daily for 3-6 million ME for 2 months. After the normalization of the hemogram, the daily dose is reduced to 1-2 million ME. Then support maintenance is prescribed for 3 million ME 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million ME or more.

    In acute lymphoblastic leukemia in children in the remission period after the end of inductive chemotherapy (for 4-5 months of remission) for 1 million ME once a week for 6 months,then once in 2 weeks for 24 months. Simultaneously, supportive chemotherapy is performed.

    In chronic myelogenous leukemia, 3 million ME daily or 6 million ME every other day. The duration of treatment is from 10 weeks to 6 months.

    With histiocytosis, X is 3 million IU daily for 1 month. Repeated courses with 1 -2 monthly intervals for 1-3 years.

    With subleukemic myelosis and essential thrombocytopenia to correct hyperthrombocytosis by 1 million ME daily or after 1 day for 20 days. With malignant lymphomas and Kaposi's sarcoma, 3 million IU per day are administered daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate intramuscular injection of the drug to 3 million ME and intraocular injection of 2 million ME for 10 days.

    In patients with erythrodemic stage of fungal mycosis with a temperature rise above 39 C and in case of aggravation of the process, the drug should be discontinued. In case of insufficient therapeutic effect, after 10-14 days a second course of treatment is prescribed. After achieving a clinical effect, a maintenance therapy of 3 million IU is prescribed once a week for 6-7 weeks.With respiratory papillomatosis of the larynx, the drug is administered for 100-150 thousand IU per 1 kg of body weight daily for 45-50 days, then at the same dosage 3 times a week for 1 month. The second and third courses are conducted at intervals of 2-6 months. With multiple sclerosis appoint 1 million ME: with pyramidal syndrome 3 times a day, with cerebellar syndrome 1-3 times a day for 10 days, followed by the introduction of 1 million ME once a week for 5-6 months. The total amount of the drug is 50-60 million ME.

    In persons with a high pyrogenic reaction (39 ° C and above) simultaneous use of indomethacin is recommended for the administration of the drug.

    Perifocal administration. With basal cell and squamous cell carcinoma, keratoacanthoma is injected under the lesion to 1 million IU once daily for 10 days. In the case of pronounced local inflammatory reactions, the injection under the lesion is carried out after 1-2 days. At the end of the course, if necessary, conduct a cryodestruction.

    Subconjunctival administration. With stromal keratitis and keratoiridocyclitis, subconjunctival injections are administered at a dose of 60,000 IU in a volume of 0.5 ml daily or every other day, depending on the severity of the process.Injections are performed under local anesthesia with a 0.5% solution of dicain. The course of treatment for 15 to 25 injections.

    Local application. For topical application, the contents of the vial are dissolved in 5 ml of a 0.9% solution of sodium chloride for injection. In case of storage of the drug solution, it is necessary, in accordance with the rules of aseptic and antiseptic, to transfer the contents of the vial into a sterile vial and store the solution in a refrigerator at a temperature of 4-10 ° C for no more than 12 hours.

    With conjunctivitis and superficial keratitis, the conjunctiva of the affected eye is applied 2 drops 6-8 times a day. As the inflammatory phenomena disappear, the number of instillations is reduced to 3-4. The course of treatment is 2 weeks.

    Side effects:

    With parenteral administration, chills, fever, fatigue, skin rashes and itching, as well as leuko- and thrombocytopenia, in the case of the latter, a blood test 2-3 times a week is necessary. When the lesion is cut off, a local inflammatory reaction occurs. These side effects are usually not an obstacle to continued use of the drug.

    With topical application on the mucous membrane of the eye, conjunctival infection, hyperemia of the eye mucosa, single follicles, and edema of the conjunctiva of the lower arch are possible.With severe local and general adverse reactions, the drug should be discontinued.

    Form release / dosage:Liofilizate for the preparation of solution for injection and topical application.
    Packaging:In vials of 500 000 ME, 1 000 000 ME, 3 000 000 ME, 5 000 000 ME of active substance per 1 bottle. For 1, 5, 10 or 20 bottles of the drug with the instructions for use are placed in a pack of cardboard or 1, 5, 10 or 20 vials of the drug in a contour acheikova package or in a cassette contour pack with instruction for use placed in a pack of cardboard.
    Storage conditions:In a dry place, protected from light and out of reach of children, at a temperature not exceeding 10 ° C.
    Shelf life:2 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001040
    Date of registration:27.08.2010
    The owner of the registration certificate:NPP FARMAKLON, LLC NPP FARMAKLON, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.07.2017
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