Polyoxidonium powder for injection 3mg N5
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Description
Porous mass of white color with a yellowish tinge.
Active ingredients
Release form
Composition
Active ingredient: Azoxymere bromide - 3 mg or 6 mg; Excipients: mannitol - 0.9 mg, povidone K 17 - 0.6 mg (for a dosage of 3 mg); mannitol - 1.8 mg, Povidone K 17 - 1.2 mg (for a dosage of 6 mg).
Pharmacological effect
Azoxymere bromide has a complex effect: immunomodulatory, detoxifying, antioxidant, mild anti-inflammatory. The basis of the mechanism of the immunomodulating action of Azoxymere bromide is a direct effect on phagocytic cells and natural killers, as well as the stimulation of antibody production, the synthesis of interferon-alpha and interferon-gamma. Detoxification and antioxidant properties of Azoxymere bromide are largely determined by the structure and high molecular nature of the drug. Azoximera bromide increases the body's resistance to local and generalized infections of bacterial, fungal and viral etiology. Restores immunity in secondary immunodeficiency states caused by various infections, injuries, complications after surgery, burns, autoimmune diseases, malignant tumors, the use of chemotherapeutic agents, cytostatics, steroid hormones. A characteristic feature of Azoxymere bromide in local (intranasal, sublingual) use is the ability to activate the body’s early defense factors against infection: the drug stimulates the bactericidal properties of neutrophils and macrophages, enhances their ability to absorb bacteria, and increases the bactericidal properties of saliva and secretions of the mucous upper respiratory tract. Azoxymer bromide blocks soluble toxic microparticles, has the ability to excrete toxins from the body, heavy metal salts, inhibits lipid peroxidation, both by intercepting free radicals and by eliminating the catalytically active Fe2 + ions. Azoximera bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.Azoximer bromide is well tolerated, does not possess mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects. Azoxymere bromide is odorless and tasteless; it does not have a local irritant effect when applied to the mucous membranes of the nose and oropharynx.
Pharmacokinetics
Azoxymere bromide is characterized by rapid absorption and a high rate of distribution in the body. The maximum concentration of the drug in the blood after intramuscular injection is achieved after 40 minutes. The half-life for different ages is from 36 to 65 hours. The bioavailability of the drug is high: more than 90% when administered parenterally. Azoxymere bromide is rapidly distributed to all organs and tissues of the body, it penetrates through the blood-brain and blood-brain barriers. No cumulative effect. In the body of Azoximer, bromide is biodegradable to low molecular weight oligomers, excreted primarily by the kidneys, with feces no more than 3%.
Indications
It is used in adults and children from 6 months for the treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology), in the stage of exacerbation and remission. For the treatment of adults (in complex therapy):
• chronic
recurrent
infectious and inflammatory diseases
different localization, bacterial, viral and fungal etiology in the stage
aggravations;
• acute viral, bacterial infections of upper respiratory tract, upper and lower
respiratory tract, gynecological and urological diseases;
• acute and chronic allergic diseases (including hay fever,
bronchial asthma, atopic dermatitis), complicated by bacterial,
viral and fungal infection;
• malignant tumors during and after chemotherapy and radiation therapy for
reduction of immunosuppressive, nephrotoxic and hepatotoxic effects
drugs;
• generalized forms of surgical infections; to activate regenerative
processes (fractures, burns, trophic ulcers);
• rheumatoid arthritis complicated by bacterial, viral and fungal
infection, on the background of long-term use of immunosuppressants;
• pulmonary tuberculosis.
For the treatment of children older than 6 months (in combination therapy):
• acute and exacerbation of chronic inflammatory diseases of any
localization (including ENT organs - sinusitis, rhinitis, adenoiditis, hypertrophy
pharyngeal tonsil, ARVI), caused by pathogens of bacterial,
viral, fungal infections;
• acute allergic and toxic-allergic conditions complicated by
bacterial, viral and fungal infection;
• bronchial asthma complicated by chronic respiratory infections
tract;
• atopic dermatitis, complicated by purulent infection;
• intestinal dysbiosis (in combination with specific therapy).
For prophylaxis (monotherapy) in children older than 6 months and adults:
• flu and ARVI;
• postoperative infectious complications.
Contraindications
• Increased individual sensitivity;
• Pregnancy, breastfeeding period;
• Children's age up to 6 months;
• Acute renal failure.
Precautionary measures
- chronic renal failure (not used more often than 2 times a week).
Use during pregnancy and lactation
The use of the drug Polyoxidonium® is contraindicated for pregnant women and women in
breastfeeding period (no clinical experience).
In an experimental study of the drug Polyoxidonium® in animals not identified
effects on the generative function (fertility) of males and females, embryotoxic and
teratogenic effects on the development of the fetus, as with the introduction of the drug in the period
throughout pregnancy and during lactation.
Dosage and administration
Methods of use of the drug Polyoxidonium®: parenteral, intranasal, sublingual.
Methods of use, dosing regimen, the need and frequency of the subsequent courses of therapy are chosen by the doctor depending on the severity of the disease and the age of the patient.
Preparation of solutions for parenteral administration (intramuscularly intravenously):
For intramuscular administration, Polyoxidonium® 3 mg is dissolved in 1 ml (6 mg dose in 2 ml) of water for injection or 0.9% sodium chloride solution. After making the solvent, the drug is left for 2–3 minutes to swell, then stirred by stirring movements, without shaking.
For intravenous drip, Polyoxidonium® is dissolved in 2 ml sterile 0.9% sodium chloride solution.After the solvent is added, the preparation is left for 2-3 minutes to swell, then it is stirred by rotational movements. The dose calculated for the patient is sterilely transferred into a vial / packet of 0.9% sodium chloride solution. The prepared solution for parenteral administration cannot be stored.
Preparation of the solution for intranasal and sublingual use: for children, a dose of 3 mg is dissolved in 1.0 ml (20 drops), a dose of 6 mg - in 2.0 ml (40 drops) (in one drop (0.05 ml) of the prepared solution is contained 0.15 mg of the drug); for adults, a dose of 6 mg is dissolved in 1.0 ml (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.
Dosage and administration
in adultsParenteral (intramuscular or intravenous): 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 acute viral and bacterial infections of upper respiratory tract, upper and lower respiratory tract, gynecological and urological diseases: 6 daily every 3 days, then every other day with a course of 10 injections.
With chronic recurrent infectious and inflammatory diseases of different localization, bacterial, viral and fungal etiology, in the acute stage: 6 mg every other day, 5 injections, then 2 times a week with a course of 10 injections.
In acute and chronic allergic diseases (including pollinosis, bronchial asthma, atopic dermatitis), complicated by a bacterial, viral igribkovoy infection: 6-12 mg each, course of 5 injections.
In rheumatoid arthritis, complicated by bacterial, viral and fungal infections, on the background of long-term immunosuppressants: 6 mg every other day5 injections, then 2 times a week with a course of 10 injections.
With generalized forms of surgical infections:
6 mg daily for 3 days, then every other day with a course of 10 injections.
To activate regenerative processes (fractures, burns, trophic ulcers):
6 mg for 3 days, then every other day, a course of 10 injections. To prevent postoperative infectious complications: 6 mg every day after 5 injections. In pulmonary tuberculosis: 6 mg 2 times a week in a course of 20 injections. In cancer patients: - before and during chemotherapy to reduce immunosuppressive,Hepato-nefrotoksicheskogo effects of chemotherapeutic agents for 6 mg every day after a course of 10 injections; further, the frequency of administration is determined by the doctor depending on the tolerance and duration of chemotherapy and radiation therapy; long-term use of the drug Polyoxidonium® (from 2-3 months to 1 year) to 6 mg 1-2 times a week. When prescribing a long course, there is no effect of cumulation, manifestation of toxicity and addiction. Intranasal prescribe 6 mg per day (3 drops in each nasal passage 3 times per day - for 10 days):
- for the treatment of acute and exacerbations of chronic infections of the upper respiratory tract;
- to enhance the regenerative processes of the mucous membranes;
- for the prevention of complications and recurrence of chronic diseases;
- for the prevention of influenza and SARS.
Methods of use and doses in children
Methods of use of the drug Polyoxidonium®: parenteral, intranasal and
sublingual.
Methods of use are chosen by the doctor depending on the severity of the disease and the age of the patient.
Parenteral (intramuscular or intravenous):
prescribed to children from 6 months at a dose of 0.1-0.15 mg / kg daily, every other day or 2 times a week with a course of 5-10 injections.
Intranasal and sublingual: daily in a daily dose of 0.15 mg / kg course up to 10 days.
The drug is administered in 1-3 drops in one nasal passage or under the tongue with an interval of at least 1-2 hours, in 2-3 doses per day.
In one drop (0.05 ml) of the prepared solution contains 0.15 mg of the drug.
The calculation of the daily dose for intranasal and sublingual use is presented in
table 1
Table 1 Calculation of the daily dose of the drug Polyoxidonium® for intranasal or sublingual use in children.