Active substanceInterferon alfa-2bInterferon alfa-2b
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  • Dosage form: & nbspLiofilizate for the preparation of solution for injection and topical application.
    Composition:

    In one ampoule or one bottle contains:

    Active substance - interferon alfa-2b human recombinant 0.5 million ME; Excipients: albumin, infusion solution 10% - 4.50 mg, sodium chloride 9.07 mg, sodium hydrogen phosphate dodecahydrate - 2.74 mg, sodium dihydrogen phosphate dihydrate 0.37 mg.

    Active substance - interferon alfa-2b human recombinant 1 million ME; Excipients: albumin, infusion solution 10% - 4.50 mg, sodium chloride - 8.96 mg, sodium hydrogen phosphate dodecahydrate - 2.86 mg, sodium dihydrogen phosphate dihydrate - 0.40 mg.

    Active substance - interferon alfa-2b human recombinant 3 million ME; Excipients: albumin, infusion solution 10% - 4.50 mg, sodium chloride - 8.52 mg, sodium hydrogen phosphate dodecahydrate - 3.34 mg, sodium dihydrogen phosphate dihydrate - 0.49 mg.

    Active substance - interferon alfa-2b human recombinant 5 million ME; Excipients: albumin, solution for infusions 10% - 4.50 mg, sodium chloride - 8.09 mg, sodium hydrogen phosphate dodecahydrate - 3.82 mg, sodium dihydrogen phosphate dihydrate - 0.58 mg.

    Description:Powder or porous mass of white color. Hygroscopic. When diluted, a colorless, transparent or slightly opalescent solution forms.
    Pharmacotherapeutic group:MIBP is a cytokine.
    ATX: & nbsp

    L.03.A.B.05   Interferon alfa-2b

    Pharmacodynamics:
    The drug has antiviral, antitumor, immunomodulating activity.
    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, 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 the phagocytic activity of macrophages, the enhancement of the specific cytotoxic effect 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 production and secretion of intracellular proteins. The antitumor effect of the drug is realized by suppressing the proliferation of tumor cells and the synthesis of some oncogenes, leading to inhibition of tumor growth.
    Pharmacokinetics:The maximum concentration (Cmax) of interferon alfa-2b for parenteral administration of the drug is observed after 2-4 hours. After 20-24 hours after administration, recombinant interferon alpha-2b in serum is not detected. The content of interferon alpha-2b in serum is directly dependent on the dose of the drug administered and the frequency of administration.
    Metabolism is carried out in the liver, partially excreted unchanged, mainly through the kidneys.
    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 terms, the administration of the drug is less effective, the drug is not effective in developing hepatic coma and the cholestatic course of the disease);

    - with acute prolonged hepatitis B and C, chronic active hepatitis B and C, chronic hepatitis B with delta agent, without signs of cirrhosis and with the appearance of signs of cirrhosis;

    - with stage IV kidney, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis, reticulosarcomatosis), Kaposi's sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myeloid leukemia, histiocytosis from Langerhans cells, subleukemic myelosis, essential thrombocythemia;

    - with viral conjunctivitis, keratoconjunctivitis, keratitis, keratoyridocyclitis, keratouveitis;

    - In complex therapy in children from 1 year:

    - with acute lymphoblastic leukemia in remission after the end of induction chemotherapy (at 4-5 months of remission);

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

    Contraindications:
    Hypersensitivity to the components of the drug;
    Severe forms of allergic diseases;
    Severe diseases of the cardiovascular system - heart failure in the stage of decompensation, a recent myocardial infarction, severe cardiac rhythm disturbances;
    Severe renal and / or hepatic insufficiency, including, caused by the presence of metastases, chronic hepatitis with decompensated liver cirrhosis, autoimmune hepatitis;
    Epilepsy and other disorders of the central nervous system, mental illness and disorders in children and adolescents;
    An autoimmune disease in the anamnesis;
    The use of immunosuppressants after transplantation;
    Diseases of the thyroid gland that can not be controlled by conventional therapeutic methods;
    Creatinine clearance below 50 ml / min (when administered in combination with ribavirin), when used in combination with ribavirin, contraindications in the ribavirin application instructions should also be considered;
    Use in men whose partners are pregnant; Pregnancy and the period of breastfeeding.
    Carefully:Renal and / or hepatic insufficiency, expressed myelosuppression. Mental disturbances, especially those expressed by depression, suicidal thoughts and attempts in the anamnesis. Patients with psoriasis, sarcoidosis.
    Pregnancy and lactation:The drug is contraindicated for use during pregnancy and during breastfeeding.
    Dosing and Administration:

    The drug is used intramuscularly, subcutaneously, in the focus or under the lesion, subconjunctivalally and locally. Immediately before use, the contents of the ampoule or vial are dissolved in water for injection or 0.9% solution of sodium chloride (in 1 ml - with intramuscular, subcutaneous injection and in the focus, in 5 ml - with subconjunctival and local administration). The drug solution should be colorless, transparent or with weak opalescence, without sediment and foreign inclusions. The dissolution time should be about 3 minutes.

    Intramuscular and subcutaneous administration

    In acute viral hepatitis B the drug is administered to 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 control biochemical blood tests), the treatment course can be continued for 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.

    When. acute lingering and chronic viral hepatitis B with the exception of the delta-agent and without signs of cirrhosis, the drug is administered 1 million ME 2 times a week for 1-2 months. In the absence of the effect, the treatment should be extended to 3-6 months or after the end of the 1-2 month treatment, 2-3 similar courses should be performed at intervals of 1-6 months.

    In chronic viral hepatitis B with delta-agent without signs of liver cirrhosis the drug is injected at 500 thousand to 1 million ME per day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.

    In chronic viral hepatitis B with delta-agent and signs of cirrhosis of the liver drug administered to 250-500 thousand. ME per day 2 times a week for 1 month. When there are signs of decompensation, similar repeated courses are conducted at intervals of not less than 2 months.

    In acute prolonged and chronic active hepatitis C without signs of cirrhosis, the drug is administered 3 million ME 3 times a week for 6-8 months. If there is no effect, prolong the treatment to 12 months. Repeated course of treatment after 3-6 months.

    With kidney cancer the drug 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 the drug is administered daily for 3-6 million ME within 2 months. After normalization of the clinical blood test, 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 420-600 million ME and more.

    In acute lymphoblastic leukemia in children in the remission period after the end of induction chemotherapy (at 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 malignant lymphomas and Kaposi's sarcoma the drug is administered to 3 million ME per day daily for 10 days in combination with cytostatics (propididium chloride, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungal mycosis, primary reticulosis and reticulosarcomatosis, it is advisable to alternate intramuscular injection of the drug to 3 million ME and intrafocal - 2 million ME within 10 days.

    Have patients with erythrodermic stage of fungal mycosis when the temperature rises above 39 ° C and if the process worsens, 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 ME once a week for 6-7 weeks.

    In chronic myelogenous leukemia the drug is administered to 3 million ME daily or 6 million ME in one day. The treatment period is from 10 weeks to 6 months.

    With histiocytosis from Langerhans cells the drug is administered to 3 million ME daily for 1 month. Repeated courses with 1-2-month intervals for 1-3 years.

    With subleukemic myelosis and essential thrombocythemia for the correction of hyperthrombocytosis - 1 million ME daily or after 1 day for 20 days.

    With respiratory papillomatosis of the larynx the drug is administered on 100-150 thousand. ME per kilogram of body weight daily for 45-50 days, then in the same dosage 3 times a week for 1 month. The second and third courses are conducted at intervals of 2-6 months. In persons with a high pyrogenic reaction (39 ° C and above), the simultaneous use of paracetamol or indomethacin is recommended for the administration of the drug.

    PeRandfocal administration

    With basal cell and squamous cell carcinoma, keratoacanthoma the drug is injected under the lesion for 1 million ME 1 time per day every day 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 keratoyridocyclitis prescribe subconjunctival injections of the drug in a dose of 60 thousand. 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 - from 15 to 25 injections.

    Local application

    For topical application, the contents of the drug ampoule are dissolved in 5.0 ml of 0.9% sodium chloride solution 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 ampoule into a sterile vial and store the solution in the refrigerator at 4-10 ° C for no more than 12 hours.

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

    Side effects:

    The frequency of unwanted reactions is given in accordance with the WHO classification: "very frequent" - 1/10, "frequent" - more than 1/100, but less than 1/10, "infrequent" - more than 1/1000, but less than 1/100, "rare" - more than 1/10000, but less than 1/1000 and "very rare" with a occurrence of less than 1/10000, including individual messages.

    In the application of Reaferon-EU (in clinical studies and outside clinical studies), the following adverse events were observed:

    Often with parenteral administration of the drug, there is a flu-like syndrome (chills, fever, asthenia, fatigue, fatigue, myalgia, arthralgia, headaches), partially docked with paracetamol, indomethacin. As a rule, the flu-like syndrome manifests itself at the beginning of treatment and decreases with the continuation.

    From the cardiovascular system: rarely - arrhythmias, transient reversible cardiomyopathy, very rarely - arterial hypotension, myocardial infarction.

    From the digestive system: rarely - dry mouth, nausea, abdominal pain, dyspepsia, eating disorders, weight loss, vomiting, diarrhea, very rarely - pancreatitis, hepatotoxicity.

    From the central nervous system: rarely - irritability, nervousness, depression, asthenia, insomnia, anxiety, impaired ability to concentrate, suicidal thoughts, aggressiveness, very rarely - neuropathies, psychosis.

    From the skin: rarely - skin rashes and itching, increased sweating, hair loss. When injected into the focus or under the lesion, a local inflammatory reaction is rare. These side effects are usually not an obstacle to continued use of the drug.

    From the endocrine system: on the background of long-term use of the drug, there may be changes in the thyroid gland. Very rarely - diabetes mellitus.

    From the laboratory indicators: when the drug is used, there may be deviations from the norm of laboratory indicators, manifested by leukopenia, lymphopenia, thrombocytopenia, anemia, increased activity of alanine aminotransferase, alkaline phosphatase, creatinine concentration, urea. Typically, these changes are usually minor, asymptomatic and reversible.

    From the musculoskeletal system: rarely - rhabdomyolysis, leg cramps, back pain, myositis, myalgia.

    From the respiratory system: rarely - pharyngitis, cough, dyspnea, pneumonia.

    From the urinary system: very rarely - kidney failure.

    From the immune system: rarely - autoimmune pathology (vasculitis, rheumatoid arthritis,lupus-like syndrome), very rarely - sarcoidosis, angioedema, allergic edema, anaphylaxis, facial edema.

    On the part of the organs of vision: with topical application of the drug on the mucous membrane of the eye, there may be hyperemia, single follicles, edema of the conjunctiva of the lower arch. Rarely - hemorrhages in the retina, focal changes in the fundus, thrombosis of the arteries and veins of the retina, decreased visual acuity, optic neuritis, edema of the optic nerve.

    From the organs of hearing: rarely - hearing impairment.

    With severe local and general adverse reactions, the drug should be discontinued.

    Overdose:
    Cases of overdose were not observed. Given that the active substance is interferon alpha-2b, then overdose may increase the severity of dose-related side effects.

    Treated: drug cancellation; if necessary, conduct symptomatic therapy.
    Interaction:
    Interferon alfa-2b is able to reduce the activity of cytochrome P-450 isoenzymes and, consequently, affect the metabolism of cimetidine, phenytoin, curantyl, theophylline, diazepam, propranolol, warfarin, and some cytostatics.May enhance neurotoxic, myelotoxic or cardiotoxic effects of drugs administered earlier or simultaneously with it. Joint use with drugs, depressing central nervous system, immunosuppressive drugs (including oral and parenteral forms of glucocorticosteroids) should be avoided.
    Interferons can affect oxidative metabolic processes. This should be taken into account when used simultaneously with drugs metabolized by oxidation (including with xanthine-aminophylline and theophylline derivatives). With the simultaneous use of Reaferon-EU with theophylline, it is necessary to monitor the concentration of theophylline in the serum and, if necessary, adjust the dosage regimen.
    With the combined use of Reaferon-EU and hydroxyurea, the incidence of skin vasculitis may increase.
    Drinking alcohol during treatment is not recommended.
    Special instructions:

    For the timely detection of abnormalities in laboratory parameters that may occur during therapy, general clinical blood tests should be repeated every 2 weeks, and biochemical - every 4 weeks.

    With a decrease in the number of platelets to less than 50-109/ l, an absolute number of neutrophils less than 0.75-10%, a temporary dose reduction of 2 times is recommended and a repeat of the analysis after 1-2 weeks. If the changes persist, treatment is recommended to be discontinued.

    With a decrease in the number of platelets to less than 25-109/ l, the absolute number of neutrophils less than 0.50-10% treatment is recommended to be discontinued.

    In the case of development of immediate-type hypersensitivity reactions (urticaria, angioedema, bronchospasm, anaphylaxis), the drug is canceled and immediate appropriate medication is prescribed. Transient skin rash does not require discontinuation of therapy.

    In case of signs of a violation of liver function, the patient must be carefully monitored. With the progression of symptoms, the drug should be discontinued.

    With mild and moderate impairment of kidney function, their functional status should be carefully monitored.

    Caution is prescribed for patients with severe chronic diseases, such as chronic obstructive pulmonary disease, diabetes mellitus with a tendency to ketoacidosis, in patients with bleeding disorders expressed by myelosupression.In patients receiving long-term Reaferon-EU, in rare cases, pneumonitis and pneumonia are observed. Timely withdrawal of interferon alfa and the appointment of glucocorticosteroid therapy contribute to the relief of pulmonary syndromes.

    In patients with thyroid disease before the start of treatment, it is necessary to determine the concentration of thyroid-stimulating hormone, it is recommended to monitor its level at least once every 6 months. If there are violations of the thyroid gland function or worsening of the course of existing diseases, which can not be adequately medicated, it is necessary to cancel the drug.

    In the event of changes in the psychic sphere and / or the central nervous system, including the development of depression, it is recommended that the psychiatrist be observed during the treatment period, and also within 6 months after the end. These disorders are usually rapidly reversible after discontinuation of therapy, however, in some cases, up to 3 weeks are necessary for their complete reverse development. If the symptoms of a mental disorder do not regress or worsen, suicidal thoughts or aggressive behavior directed at other people appear, it is recommended to stop Reaferon-EU treatment and provide psychiatrist advice.Suicidal thoughts and attempts are more often observed in children, especially adolescents (2.4%) than in adults (1%). If therapy with interferon alfa-2b it is recognized necessary in adult patients with serious mental disorders (including history), it should be started only if appropriate individual screening and therapy of mental disorder is carried out. Use of interferon alfa-2b in children and adolescents with serious mental disorders (including in the history) is contraindicated.

    With prolonged use, usually after several months of treatment, there may be abnormalities on the part of the organ of vision. Before the start of therapy, an ophthalmic examination is recommended. When complaining about any ophthalmic disorders, immediate consultation of the oculist is necessary. Patients with diseases in which changes in the retina may occur, for example, diabetes mellitus or hypertension, it is necessary to undergo ophthalmic examination at least once every 6 months. When there is or worsening of vision disorders, consideration should be given to discontinuing Reaferon-EU therapy.

    In elderly patients receiving the drug in high doses, there may be impairment of consciousness, coma, convulsions, encephalopathy. If such disorders develop and the dose reduction is ineffective, treatment should be discontinued.

    Patients with diseases of the cardiovascular system and / or progressive oncological diseases require careful monitoring and monitoring of the ECG. When developing arterial hypotension, it is recommended to provide adequate hydration and appropriate therapy.

    In patients after transplantation (eg, kidney or bone marrow), drug-induced immunosuppression may be less effective, since interferon has a stimulating effect on the immune system.

    With prolonged use, the interferon alfa preparation can induce the appearance of antibodies to interferon in individuals. As a rule, antibody titers are low, their appearance does not lead to a decrease in the effectiveness of treatment.

    With caution appoint patients with a predisposition to autoimmune diseases. When symptoms of an autoimmune disease appear, a thorough examination should be conducted and the possibility of continued therapy with interferon should be assessed.Rarely, interferon alpha therapy is associated with the onset or exacerbation of psoriasis, sarcoidosis.

    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 solution for injection and topical application for 0.5 million ME or 1 million ME, or 3 million ME, or 5 million ME.
    Packaging:
    Liofilizate for the preparation of solution for injection and topical application. In glass ampoules of 0.5 million ME or 1 million ME, or 3 million ME, or 5 million ME; 5 ampoules in a cell pack of a PVC film (PVC); 1 or 2 cell packs, together with the Instruction for use and the ampoule scarifier, in a cardboard bundle. If the ampoules have a break ring or break point, the scarifier is not put into the package.
    In glass bottles of 0.5 million ME or 1 million ME, or 3 million ME, or 5 million ME. The bottles are sealed with rubber stoppers and rolled up with aluminum caps; 5 bottles in a PVC packaging; 1 pack with instructions for use in a cardboard box.
    Storage conditions:Store in a dark place at a temperature not exceeding 8 ° C. Keep out of the reach of children.
    Shelf life:
    3 years.
    The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000642 / 01
    Date of registration:22.07.2008
    The owner of the registration certificate:VECTOR-MEDICA, CJSC VECTOR-MEDICA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.12.2015
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