Active substanceInterferon alfa-2bInterferon alfa-2b
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  • Dosage form: & nbspLyophilizate for the preparation of solution for intramuscular and subcutaneous injection.
    Composition:

    Interferon alfa-2b human recombinant is isolated from cells Pseudomonas putida, in the genetic apparatus of which the human leukocyte interferon alpha-2 gene is embeddedb. The polypeptide structure of the molecule, the biological activity and pharmacological properties of the recombinant protein and human leukocyte interferon alfa-2b are identical

    Composition

    The vial or ampoule contains

    active substance: interferon alfa-2b human recombinant 1 million ME, 3M ME, 5M ME, 6M ME, 9M ME, 18M ME ; Excipients: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, dextran 60.

    Description:Powder or porous mass of white color.
    Pharmacotherapeutic group:Cytokine and immunomodulator.
    ATX: & nbsp

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:
    Realdiron® renders antiviral, immunomodulating, antiproliferative and antitumor effect.

    Interferon alfa, interacting with related receptors on the cell surface, initiates a complex chain of changes within the cell. It is assumed that these processes are associated with preventing the replication of viruses in the cell, inhibiting the proliferation of cells and immunomodulating action of interferon. Interferon alfa has the ability to stimulate the phagocytic activity of macrophages, as well as the cytotoxic activity of T cells and "natural killers." These properties of interferon alpha and caused the therapeutic effect of Realdirona.

    Indications:Realdiron® is used in patients
    for viral diseases:

    - acute hepatitis B,

    - chronic active hepatitis B,

    - chronic hepatitis C,

    - tick-borne encephalitis;

    at oncological diseases:

    - hairy cell leukemia,

    - chronic myelogenous leukemia,

    - renal cell carcinoma,

    - sarcoma Kaposi against AIDS,

    - cutaneous T-cell lymphoma (mushroom mycosis and Sesari syndrome),

    - malignant melanoma.
    Contraindications:Realdiron® is not prescribed to patients who are allergic to interferon alpha or other components of the drug.
    Pregnancy and lactation:
    Realdiron® should be given to pregnant women and nursing mothers only with the apparent superiority of the expected therapeutic effect in the mother compared to the possible unwanted effects on the fetus (especially in the first 3 months) or the baby.

    Dosing and Administration:

    Realdiron® is used for intramuscular or subcutaneous administration, dissolving immediately before use the contents of the vial or ampoule in 1 ml of water for injection.The drug dissolves quickly, regardless of the dose contained in the vial or ampoule. The drug solution is a colorless, transparent or slightly opalescent liquid. Realdiron® does not contain preservatives, so only freshly prepared solution should be used to avoid bacterial contamination.

    Viral diseases:

    When acute hepatitis B (light, medium-heavy and severe forms) Realdiron® is injected into 1 million ME twice 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 controlling biochemical blood tests to assess the functional state of the liver), treatment can continue for another 2 weeks, during which the drug is administered 1 million ME two times a week.

    Realdiron® is most effective at the beginning of icteric period before the 5th day of jaundice, in later periods, the administration of the drug is less effective. Realdiron® is not effective in developing hepatic coma and cholestatic course of the disease.

    When chronic active hepatitis B the drug is prescribed for 3-6 million ME three times a week for 24 weeks.If after administration of the drug for 12 weeks there is no clinical, biochemical improvement and / or disappearance HBsAg, treatment with Rehldironum is canceled.

    When chronic hepatitis C The drug is prescribed by 3 million ME three times a week for 24 weeks. If after administration of the drug for 4 weeks, there is no 50% reduction in ALT activity in the blood plasma, the dose of the drug is increased to 6 million ME three times per week. Treatment with Rehldironum is terminated if, after 12 weeks of the drug, there is no clinical, biochemical improvement.

    When Tick-borne encephalitis. With meningeal forms of tick-borne encephalitis, the drug is administered for 1-3 million ME twice a day for 10 days. Then appoint supportive treatment - five injections of 1-3 million ME every 2 days.

    Oncological diseases:

    The instructions contain recommended therapeutic doses of Realdirone®. The general principle of the use of interferon in cancer is to prescribe the maximum dose that the patient can tolerate for a sufficiently long period of time (months and years). As interferon alfa has a cytostatic effect that supports treatment with Realdiron should continue after reaching an objective effect - hematological remission, regression of solid tumor sites.

    When hairy cell leukemia Realdiron® is administered for 3 million ME daily. After achieving hematologic remission, support therapy is transferred to 3 million ME three times a week for two months and further treatment can not continue. When relapse treatment is repeated.

    When chronic myelogenous leukemia Realdiron® is administered for 9 million ME daily. After achieving hematologic remission, supportive treatment for 9 million ME three times per week. The duration of treatment is determined by the attending physician and depends on the nature of the course of the disease.

    When renal cell carcinoma Realdiron® is injected into 18 million ME three times per week. Objective effect (complete or partial regression of metastases) occurs after 8-12 weeks of treatment with Rehlildiron or at a later date. When the therapeutic effect or stabilization of the disease is achieved, maintenance therapy of 18 million ME three times per week.The duration of treatment is determined by the attending physician and depends on the nature of the course of the disease. With the progression of the process, treatment with the drug can be replaced by the attending physician for antitumor therapy.

    When sarcoma Kaposi against AIDS the drug is administered daily for 36 million ME. The drug is used for a long time, except for cases of rapid progression of the disease or severe intolerance. After the manifestation of the effect, a maintenance therapy of 18 million ME three times per week.

    When cutaneous T-cell lymphoma (mushroom mycosis and Cesari syndrome)

    prescribe Realdiron® for 18 million ME daily. The duration of treatment is determined by the attending physician and depends on the nature of the course of the disease.

    When malignant melanoma Realdiron® is injected into 18 million ME daily. After achieving an objective effect (complete or partial regression of metastases), supportive therapy for 18 million ME three times per week. Adjuvant therapy Realdiron for 18 million ME three times a week, prescribed after surgical removal of the primary tumor of melanoma I-II stage or metastases to the regional lymph nodes, contributes to an increase in the duration of remission and the survival of patients.

    Side effects:With the introduction of REALDIRON® flu-like symptoms are possible: most often, chills, fever, fatigue, lethargy, headache, myalgia, joint pain, loss of appetite. These symptoms are partially suppressed by acetaminophen / paracetamol. In the treatment with realdiron, minor leukocytopenia, thrombocytopenia, deviations in liver function parameters are possible. These adverse reactions disappear when Rehildiron is discontinued or its dose is reduced.
    Depending on the individual sensitivity to the drug and the prescribed dose of treatment, patients may experience drowsiness, weakness, increased fatigue.
    Interaction:
    If you are taking other medicines, inform your doctor.

    The drug interaction between realdiron and other drugs is not well understood.

    Caution should be applied to Realdiron simultaneously with opioid analgesics, hypnotics and sedatives, with drugs that have a myelosuppressive effect. With the simultaneous use of realdiron with theophylline it is necessary to monitor the concentration of the latter in the blood serum and, if necessary, adjust the dosage regimen.

    Interferons can affect oxidative metabolic processes. This should be taken into account when used with drugs metabolized by oxidation.
    Special instructions:
    Patients with severe heart disease REALDIRON® is administered with caution. Patients who had previously suffered from cardiovascular disease may experience arrhythmia as an adverse reaction.

    If the side effect of the drug is not weakened or aggravated, the dose is reduced by 50% or treated with Realdironum.

    When treating Realdiron, alcohol should be avoided.
    Effect on the ability to drive transp. cf. and fur:Depending on the individual sensitivity and the prescribed dose of treatment, the psychomotor reactions may be slowed down due to side effects of Realdirone® - drowsiness, weakness, increased fatigue. In such cases it is recommended to abandon the driving of vehicles and the management of any mechanisms.
    Form release / dosage:
    Liofilizate for the preparation of solution for intramuscular and subcutaneous administration 1 million ME, 3 million ME, 5 million ME, 6 million ME, 9 million ME, 18 million ME.

    Packaging:
    For 1.3, 5, 6, 9 or 18 million ME in a glass vial (type I glass) sealed with a stopper (type I elastomer) and an aluminum cap with a polypropylene cover, or in a sealed ampoule (type I glass).

    Five vials or ampoules with the drug in a contour squamous PVC packaging together with instructions for medical use are placed in a cardboard box.
    Storage conditions:
    At a temperature of 2 ° C to 8 ° C in a dark place. Keep out of the reach of children.
    The preparation is transported under conditions ensuring the maintenance of the temperature from 2 ° C to 8 ° C.
    Shelf life:
    3 years.
    The expiration date is indicated on the package. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:П N012808 / 01
    Date of registration:21.01.2008
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp10.12.2015
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