Active substanceInterferon alfa-2bInterferon alfa-2b
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  • Dosage form: & nbsp
    lyophilizate for solution for injection
    Composition:One ampoule of the drug contains the active substance: interferon alfa-2b (interferon alfa-2b human recombinant) - 1.00 million IU, 3.00 million ME or 5.00 million ME; auxiliary substances: dextran (polyglucin) in terms of dry matter - 1.00 mg, sodium chloride - 8.80 mg, sodium hydrophosphate dodecahydrate - 5.50 mg, sodium dihydrogen phosphate dihydrate - 0.07 mg.
    Description:
    Powder or porous mass of white color, hygroscopic.
    Pharmacotherapeutic group: Interferon alfa
    ATX: & nbsp

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:Interferal ® has antiviral, antitumor, immunomodulating activity. When parenteral administration is disintegrated, partially excreted unchanged, mainly through the kidneys. The active substance of Interferal ® is interferon alpha-2b, a recombinant protein synthesized by Escherichia coli strain BL21 (DE3) [pAYC-ET- (hIFN-α2b) -lacI], which has a human leukocyte interferon alpha-2b gene in its genetic apparatus.
    Indications:

    Complex therapy in adults

    - acute viral hepatitis B in moderate to severe forms at the beginning of icteric period before the 5th day of jaundice (at a later date, the administration of the drug is less effective, Interferal® is not effective in developing hepatic coma and cholestatic course of the disease);

    - acute lingering hepatitis B, chronic active hepatitis B and D without signs of cirrhosis and with the appearance of initial signs of cirrhosis. Treatment of chronic viral hepatitis B can be carried out both in the form of monotherapy and combination therapy;

    - chronic viral hepatitis C, accompanied by the determination of α-antibodies to hepatitis C virus, high viral load according to polymerase chain reaction, increased activity of alanine aminotransferase (ALAT) without signs of hepatic decompensation (Child-Pugh class A). For the treatment of chronic viral hepatitis C, as a rule, combined therapy with ribavirin is recommended in the absence of contraindications;

    - viral (influenza, adenovirus, enterovirus, herpetic, parotitic), viral-bacterial and mycoplasma meningoencephalitis. The use of Interferal ® is most effective in the first 4 days of the disease;

    - viral conjunctivitis, keratoconjunctivitis, keratitis, keratouveitis;

    - stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis), Kaposi's sarcoma, basal cell and squamous cell carcinoma, keratoacanthoma, chronic myelogenous leukemia, hysteocytosis-X,subleukemic myelosis, essential thrombocytopenia;

    - multiple sclerosis.

    Complex therapy in children

    - acute lymphoblastic leukemia during remission after the end of inductive chemotherapy (for 4-5 months of remission);

    - respiratory papillomatosis of the larynx, starting from the next day after removal of papillomas.

    Contraindications:

    - ANDindividual intolerance to any component of the drug;

    - cardiovascular diseases in the stage of decompensation;

    - renal failure of various etiologies;

    - mental illness;

    - hepatic insufficiency of various genesis;

    - Thyroid gland disease if it is not controlled by appropriate therapy;

    - severe forms of allergic diseases;

    - pregnancy and lactation.

    Dosing and Administration:

    Interferal ® is used intramuscularly, in the focus or under the lesion, subconjunctivally. Immediately before use, the contents of the ampoule are dissolved in water for injection. The dissolution time of the contents of the ampoule is no more than 3 minutes. The drug solution should be transparent, without foreign inclusions. The diluted drug is not subject to storage.

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

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

    With chronic active hepatitis without signs of liver cirrhosis, the drug is injected at 500,000 to 1 million ME in a 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 in a 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.

    In chronic viral hepatitis C, monotherapy with Interferal ® is recommended for subcutaneously 3 million ME 1 time per day every other day for 24 weeks or combined therapy with ribavirin.In case of recurrence of the disease after the course of monotherapy with interferon, the repeated course should be performed in combination with ribavirin for at least 6 months. After the control virological studies of blood in patients with HCV of the 1 st genotype and a high content of the virus RNA, which do not detect RNA of hepatitis C virus (RNA) by the end of the first 6 months of therapy in serum HCV), treatment continues for another 6 months.

    In case of cancer of the kidney, Interferal® is used for 3 million ME daily for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total amount of the drug is from 120 million ME up to 300 million ME and more.

    With hairy cell leukemia, Interferal is administered daily 3 to 6 million ME within 2 months. After the normalization of the hemogram, the daily dose of the drug is reduced to 1-2 million ME. Then, supportive therapy for 3 million ME 2 times a week for 6-7 weeks. The total amount of the drug is from 420 to 600 million ME and more.

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

    With chronic myelogenous leukemia for 3 million ME daily or 6 million ME in one day.Term of treatment from 10 weeks to 6 months.

    With histocytosis-X, 3 million ME daily for 1 month. Repeated courses with 1 -2-month intervals for 1 -3 years.

    With subleukemic myelosis and essential thrombocytopenia for correction of hyperthrombocytosis by 1 million ME daily or after 1 day for 20 days.

    With malignant lymphomas and Kaposi's sarcoma, Interferal® is administered 3 million ME in a day 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 Interferal ® preparation to 3 million ME and intrafocal for 2 million ME within 10 days.

    In patients with erythrodermic stage of fungal mycosis, when the temperature rises above 39 ° C and in case of aggravation of the process, the drug administration 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 ME 1 time per week for 6-7 weeks.

    With respiratory papillomatosis of the larynx, the drug is injected at 100-150 thousand ME 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, Interferal® is prescribed 1 million ME: with pyramidal syndrome 3 times a day, with cerebellar syndrome 1-2 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 from 50 to 60 million ME.

    In persons with a high pyrogenic reaction (39 ° C and above), the simultaneous use of non-steroidal anti-inflammatory drugs is recommended for the administration of Interferal®.

    Perifocal administration. In basal cell and squamous cell carcinoma, Interferal ® keratoacanthoma is administered under the lesion of 1 million ME 1 time per day 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 of Interferal® at a dose of 60,000 ME 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.

    Side effects:

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

    With all severe adverse reactions, the drug should be discontinued.

    Overdose:To date, no cases of overdose, accompanied by any clinical symptoms. However, as with an overdose of any drug, symptomatic therapy should be performed with monitoring the functions of vital organs and with regular monitoring of the patient's condition.
    Interaction:Care should be taken when using Interferal ® with drugs that depress the function of the bone marrow, neuroleptics and tranquilizers.
    Effect on the ability to drive transp. cf. and fur:In most patients, Interferal® does not cause drowsiness, weakness.However, with prolonged use (course of therapy 6-12 months), an individual reaction to the drug is possible. In this case, when taking an activity requiring attention and rapid psychomotor reactions (including when driving vehicles or working with mechanisms), care must be taken.
    Form release / dosage:Lyophilizate for solution for injection 1.0 million ME, 3.0 million ME, 5.0 million ME.
    Packaging:In glass ampoules. 5 ampoules in a cassette contour pack. 1 contour pack together with instructions for use in a pack of cardboard.
    Storage conditions:

    The preparation is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 10 ° C. During transportation it is allowed to change the temperature regime (up to 25 ° C), but not more than 5 days.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007454/10
    Date of registration:30.07.2010 / 19.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GosNII OCHB FMBA, FSUE GosNII OCHB FMBA, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.10.2017
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