Active substanceSodium NucroseospermateSodium Nucroseospermate
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  • Sodium Nucroseospermate
    solution w / m PC 
    APOLLON, CJSC     Russia
  • Dosage form: & nbspsolution for intramuscular and subcutaneous administration
    Composition:

    Composition per ml:

    Active substance: sodium nucleospermate - 15 mg.

    Excipients: sodium chloride - 1 mg, water for injection - up to 1 ml.
    Description:colorless, clear or slightly opalescent solution
    Pharmacotherapeutic group:leukopoiesis stimulant, immunomodulating agent.
    ATX: & nbsp

    L.03.A   Cytokines and immunomodulators

    Pharmacodynamics:Sodium Nucroseospermate - is a highly purified standardized mixture of nucleic acids derived from milk from sturgeon. Leukopoiesis stimulant. Accelerates granulocytopoiesis in the stage of promyelocytes and myelocytes, increases the neutrophil maturation index. Influences the processes of proliferation, migration and differentiation of other colony-forming units, acting on all levels of hematopoiesis. It has an immunomodulatory effect on the cellular and humoral levels (activates killer cells, stimulates antibody formation). Activates antiviral, antifungal and antimicrobial immunity.
    Pharmacokinetics:

    With intramuscular and subcutaneous administration of the recommended dose a drug Sodium Nucroseospermate quickly enters the bloodstream.Its concentration in the blood rises in a direct linear relationship. The time to achieve Cmax with a single administration is 0.5 hours. T1 / 2 - about 60 hours. After 24 hours a rapid decrease in the concentration of the drug in the blood, associated with its distribution in organs and tissues, begins. Redistribution of the drug between the plasma and the formed elements of the blood occurs in parallel with its metabolism and excretion. Graduallye removal of the drug from the blood occurs in the time interval from 2 to 8 days from the moment of administration.

    With repeated administration of the drug every 24 hours for 5 days there is a process of its accumulation in the blood and bone marrow from only the first four doses. In other proliferating tissues, the total drug concentration Sodium Nucroseospermate increases after the fifth dose administered. 8 days after the 5th administration of the drug the concentration is significantly reduced in all organs and tissues, but it exceeds the concentration achieved with a single administration and sufficient for the therapeutic effect of the drug.

    The main route of drug transport Sodium Nucroseospermate is the endolymphatic pathway. The greatest tropicity to the drug is bone marrow, lymph nodes, spleen, thymus, kidneys. The drug passes hemato-encephalic barrier. It is excreted, including in the form of metabolites, mainly with urine and, in part, with feces. The half-elimination time for subcutaneous and intramuscular administration is 63 to 69 hours.

    When administered intramuscularly during the first day, about 50% of the drug is excreted in the urine and 12.5% ​​- with feces, with subcutaneous injection 37% and 3%.
    Indications:Treatment and prevention of neutropenia during radiation and polychemotherapy in adults and children older than 3 years.
    Contraindications:

    - hypersensitivity to all components of the drug;

    - pregnancy and lactation;

    hypersensitivity to all components of the drug; .

    - pregnancy and lactation;

    - Children's age up to 3 years;

    - acute diseases of the liver, kidneys, pancreas, gastrointestinal tract;

    - severe heart failure;

    - impaired cerebral circulation.

    Carefully:

    Any myeloid precancerous illness.

    If you have a listed disease, before taking the drug always consult a doctor.
    Pregnancy and lactation:During pregnancy and during breastfeeding, the use of the drug is contraindicated.
    Dosing and Administration:Treatment and prevention of neutropenia. Before administration, heat the ampoule to body temperature. It is recommended a slow injection - 5 ml in 1.5-2 minutes.
    Dosing regimen for prevention of neutropenia:
    - at of adults once a day in a dose of 5 ml for 3-5 days, the first injection of the drug 24 hours before the start of the course of chemotherapy.
    - the children older than 3 years once a day in a dose of 5 ml for 1-2 days, the first injection of the drug 24 hours before the start of the course of chemotherapy.
    Dosing regimen for the treatment of neutropenia:
    - at of adults once a day in a dose of 5-10 ml for 5-10 days.
    - at children older than 3 years once a day in a dose of 5 ml during the 1-4 days.
    Maximum single dose for of adults - 150 mg (10 ml of a solution of 15 mg / ml), for children 75 mg.
    To reduce pain at the injection site, joint intramuscular injection of 0.5 ml of 0.5% or 2% lidocaine solution is permissible.
    Side effects:

    General disorders and disorders at the site of administration: short-term increased body temperature (up to 38 ° C), hyperemia and tenderness at the injection site, which do not require special medication.

    If you notice side effects not listed in the instructions, inform the doctor about it.

    Overdose:Effects of drug overdose Sodium Nucroseospermate not described.
    Interaction:

    It can be used simultaneously with cytostatics and lidocaine; enhances the effect of anticoagulants.

    Special instructions:

    Solutions for injection do not contain preservatives, so after

    Opening the ampoule for injection solutions should be used immediately.

    The effectiveness of the drug with leukopenia below 2000 / μl is not is proved.

    Effect on the ability to drive transp. cf. and fur:

    Data on the adverse effect of the drug Sodium Nucroseospermate there is no ability to control vehicles and mechanisms.

    Form release / dosage:

    Solution for intramuscular and subcutaneous administration 15 mg / ml.

    Packaging:By 5 or 10 ml into ampoules of neutral glass.

    1 or 5 ampoules per contour cell pack of polyvinyl chloride films.

    1 circuit cell pack together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    In dry the dark place at a temperature of + 4 ° C

    up to + 8 ° С.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002093
    Date of registration:07.02.2012
    The owner of the registration certificate:APOLLON, CJSCAPOLLON, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.08.2015
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