Active substanceAzoxime bromideAzoxime bromide
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  • Polyoxidonium®
    lyophilizate locally w / m in / in 
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  • Polyoxidonium®
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  • Dosage form: & nbsplyophilizate for solution for injection and topical application
    Composition:

    Composition per 1 ampoule or vial:

    Active substance: Polyoxidonium (Azoxime bromide) 3 mg or 6 mg

    Excipients: mannitol, povidone, betacarotene - up to 4.5 mg for a dosage of 3 mg or up to 9 mg for a dosage of 6 mg.

    Description:Porous mass from white with a yellowish tinge to yellow. The drug is hygroscopic and photosensitive.
    Pharmacotherapeutic group:Immunomodulating agent
    ATX: & nbsp

    L.03.A.X   Other immunostimulants

    Pharmacodynamics:

    Polyoxidonium® has an immunomodulatory effect, increases the body's resistance to local and generalized infections. The basis of the mechanism of immunomodulatory action of Polyoxidonium ® is a direct effect on phagocytic cells and natural killers, as well as stimulation of antibody formation.

    Polioksidoniy® restores immunity in secondary immunodeficiency, caused by different infection, trauma, burns, autoimmune diseases, malignancies, complications after surgical operations, use of chemotherapeutic agents, cytostatic drugs, steroid hormones.

    Along with immunomodulating action, it has a pronounced Polioksidoniy® detoxification and antioxidant activity, has the ability to excrete toxins, heavy metal salts, inhibits lipid peroxidation. These properties are determined by the structure and high molecular nature Polioksidoniy® preparation. Its inclusion in the complex therapy of cancer patients reduces intoxication on the background of chemotherapy and radiation therapy, in most cases, allows to standard therapy without changing the scheme in connection with the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, etc.).

    Use of the drug in the background Polioksidoniy secondary immunodeficiency states to improve the efficiency and reduce the duration of treatment, significantly reduce the use of antibiotics,bronchodilators, glucocorticosteroids, lengthen the period of remission.

    The drug is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

    Pharmacokinetics:

    With intramuscular introduction, Polyoxidonium® has a high bioavailability (89%); time to reach the maximum concentration in the blood - 40 minutes; quickly distributed to all organs and tissues. Half-distribution in the body

    (fast phase) - 0.44 hours, half-life (slow phase) - 36.2 hours. In the body, the preparation is hydrolyzed to oligomers, which are excreted predominantly kidneys.
    Indications:

    Correction of immunity in adults and children from 6 months.

    In adults in complex therapy:

    - chronic recurrent infectious and inflammatory diseases, which can not be standardized at the stage of exacerbation and remission;

    - acute and chronic viral and bacterial infections (including urogenital infectious-inflammatory diseases);

    - tuberculosis;

    - acute and chronic allergic diseases (including pollinosis, bronchial asthma,atopic dermatitis), complicated by a chronic recurrent bacterial and viral infection;

    - in oncology in the course and after chemotherapy and radiation therapy to reduce immunosuppressive, nephro- and hepatotoxic effects of drugs;

    - for activation of regenerative processes (fractures, burns, trophic ulcers);

    - Rheumatoid arthritis, long-term treated with immunosuppressants; with complicated ARI course of rheumatoid arthritis;

    - for the prevention of postoperative infectious complications;

    - for the prevention of influenza and acute respiratory disease

    In children in complex therapy:

    - acute and chronic inflammatory diseases caused by pathogens of bacterial, viral, fungal infections (including ENT organs - sinusitis, rhinitis, adenoiditis, pharyngeal tonsillitis hypertrophy, ARVI);

    - acute allergic and toxic-allergic conditions;

    - A bronchial asthma complicated by chronic infections of the respiratory tract;

    - atopic dermatitis, complicated by a purulent infection;

    - intestinal dysbiosis (in combination with specific therapy);

    - for rehabilitation often and long-term ill;

    - prevention of influenza and acute respiratory infections.

    Contraindications:

    Increased individual sensitivity.Pregnancy, lactation (clinical experience is not available).

    Carefully:

    Acute renal failure, children under 6 months of age (clinical experience is limited).

    Dosing and Administration:

    Methods of application Polyoxidonium: parenteral, intranasal. The methods of application are chosen by the doctor depending on the severity of the disease and the age of the patient.

    Intramuscularly or intravenously (drip): the drug is prescribed to adults in doses of 6-12 mg once a day, every other day, or 1-2 times a week, depending on the diagnosis and severity of the disease.

    For intramuscular injection, the contents of the ampoule or vial are dissolved in 1.5-2 ml 0.9 % solution of sodium chloride or water for injection. For intravenous (drop), the drug is dissolved, in 2 ml of 0.9% solution of sodium chloride, Hemodesa-H, Reopoliglyukin or 5 % dextrose solution, then sterilely transferred to a vial with the indicated solutions in a volume of 200-400 ml.

    The prepared solution for parenteral administration is not subject to storage. Intranasally: a dose of 6 mg is dissolved in 1 ml (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.

    Recommended treatment regimens for adults

    Parenteral:

    In acute inflammatory diseases: 6 mg daily for 3 days, then every other day with a total course of 5-10 injections.

    When chronic inflammatory diseases: 6 mg every other day 5 injections, then 2 times a week with at least 10 injections.

    With tuberculosis: 6-12 mg twice a week with a course of 10-20 injections.

    In patients with acute and chronic urogenital diseases: 6 mg every other day with a course of 10 injections in combination with chemotherapy.

    With chronic recurrent herpes: 6 mg every other day with a course of 10 injections in combination with antiviral drugs, interferons and / or inducers of interferon synthesis.

    For the treatment of complicated forms of allergic diseases: 6 mg, 5 injections: two first injections daily, then every other day. In acute allergic and toxic-allergic conditions, administer intravenously for 6-12 mg in combination with antiallergic drugs.

    With rheumatoid arthritis: 6 mg every other day 5 injections, then 2 times a week with at least 10 injections.

    In cancer patients:

    - before and against the background of chemotherapy to reduce immunosuppressive,hepato- and nephrotoxic action of chemotherapeutic agents for 6-12 mg every other day with a course of at least 10 injections; further the frequency of administration is determined by the doctor, depending on the tolerability and duration of chemotherapy and radiation therapy;

    - for the prevention of immunosuppressive effects of the tumor, for the correction of immunodeficiency after chemotherapy and radiotherapy, after a surgical removal of the tumor, a long-term use of the preparation Polyoxidonium® (2-3 months to 1 year) for 6-12 mg 1-2 times a week is shown.

    In patients with acute kidney failure is prescribed not more than 2 times a week.

    Intranasal prescribe at 6 mg per day for the treatment of acute and chronic infections of the ENT organs, to strengthen the regenerative processes of the mucous membranes, to prevent complications and relapses of diseases, for the prevention of influenza and acute respiratory infections.

    3 drops in each nasal passage in 2-3 hours (3 times a day) for 5-10 days.

    METHODS OF USE AND DOSES FOR CHILDREN

    Methods of using the preparation Polyoxidonium®: parenterally, intranasally, sublingually. The methods of application are chosen by the doctor depending on the diagnosis, severity of the disease, age and body weight of the patient.

    Parenteral drug prescribed for children from 6 months in a dose of 3 mg (intramuscular or intravenously drip 0,1-0,15 mg / kg) daily, every other day or twice a week with a course of 5-10 injections (the dose calculation is indicated in the table).

    For intramuscular The drug is dissolved in 1 ml of water for injection or 0.9% solution of sodium chloride.

    For intravenous drip the drug is dissolved in. 1.5-2 ml sterile 0.9 % solution of sodium chloride, rheopolyglucin, Hemodesa-H or 5 % solution of dextrose, sterilely transferred into a vial with the indicated solutions in a volume of 150-250 ml.

    Intranasal and sublingual: daily at a daily dose of 0.15 mg / kg for 5-10 days. The drug is administered 1-3 drops in one nasal passage or under the tongue after 2-3 hours.

    For solution preparation for intranasal and sublingual The dose of 3 mg is dissolved in 1 ml (20 drops), a dose of 6 mg in 2 ml of distilled water, 0.9% sodium chloride solution or boiled water at room temperature. In one drop of the prepared solution (50 μl) contains 0.15 mg of Polyoxidonium®, which is prescribed for 1 kg of the body weight of the child.

    The solution for sublingual and intranasal use should not be stored in the refrigerator for more than 7 days.Before use, the pipette with the solution should be heated to room temperature (20-25 0 FROM).

    Recommended treatment regimens for children

    - In acute inflammatory diseases: 0.1 mg / kg every other day with a course of 5-7 injections.

    - In chronic inflammatory diseases: 0.15 mg / kg 2 times a week, with up to 10 injections.

    - In acute allergic and toxic-allergic conditions: intravenously drip in a dose of 0.15 mg / kg in combination with antiallergic drugs.

    - For the treatment of complicated forms of allergic diseases in combination with basic therapy: intramuscularly at 0.1 mg / kg with a course of 5 injections with an interval of 1-2 days.

    Intranasal injection of 1-3 drops in one nasal passage in 2-3 hours (2-4 times a day). For intranasal and sublingual administration, the calculation of the daily dose for children is presented in the table.

    Weight of child

    Number of drops per day

    Volume of injected solution in ml

    5 kg

    5 drops

    0.25 ml

    10 kg

    10 drops

    0.5 ml

    15 kg

    15 drops

    0.75 ml

    20 kg

    20 drops

    1.00 ml

    Sublingually: for all indications - daily at a daily dose of 0.15 mg / kg for 10 days, for the treatment of intestinal dysbiosis for 10-20 days. Drip 1-3 drops under the tongue in 2-3 hours.

    Side effects:

    There may be pain at the injection site with intramuscular injection.

    Overdose:

    Not described.

    Interaction:Polyoxidonium® is compatible with antibiotics, antiviral, antifungal and antihistamine drugs, bronchodilators, glucocorticosteroids, cytostatics.
    Special instructions:

    When painful at the injection site, the drug is dissolved in 1 ml of 0.25 % solution of procaine in the case of a patient's lack of increased individual sensitivity to procaine. When intravenous (drip) administration should not be dissolved in protein-containing infusion solutions.

    Form release / dosage:Liofilizate for the preparation of solution for injection and topical application of 4.5 mg (for a dosage of 3 mg), 9 mg (for a dosage of 6 mg).
    Packaging:

    Liofilizate for the preparation of solution for injection and topical application of 4.5 mg (for a dosage of 3 mg), 9 mg (for a dosage of 6 mg) in ampoules or bottles of glass 1 hydrolytic class. 5 ampoules or bottles per circuit cell packaging. One contour pack together with the instructions for use in a pack of cardboard box or 5 ampoules or bottles, along with instructions for use in a pack of cardboard box with an insert of cardboard box.

    For 50 ampoules or vials, together with 10 instructions for use in a box with cardboard partitions (for hospitals).

    Storage conditions:

    List B.

    In dry, protected from light, out of reach of children, at a temperature of 4 to 8 ° C.

    Shelf life:

    2 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002935 / 02
    Date of registration:10.10.2008
    The owner of the registration certificate:NPO PETROVAKS PHARM, LLC NPO PETROVAKS PHARM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.08.2015
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