Polyoxidonium 5's 6 mg lyophilized powder for injection

The instruction for medical use of POLIOKSIDONIY® medicine the Trade name of Polioksidoniy® the International unlicensed name Azoksimera bromide the Dosage form Lyophilisate for preparation of solution for injections and topical administration, 3 mg and 6 mg Structure One bottle contains active agent - an azoxymeasure bromide of 3 mg or 6 mg, excipients: Mannitolum, povidone. The description the Porous mass of white color with a yellowish shade. Pharmacotherapeutic group Anti-neoplastic and immunomodulatory drugs. Immunostimulators. The ATX L03 code the Pharmacological Azoksimer's Pharmacokinetics properties bromide is characterized by fast absorption and high speed of distribution in an organism. The maximum concentration of drug in blood at intramuscular introduction is reached in 40 minutes. Elimination half-life for different age from 36 to 65 hours. Bioavailability of drug high: more than 90% at parenteral administration. Azoksimera bromide is quickly distributed on all bodies and body tissues, gets through hematoencephalic and hemato-ophthalmic barriers. The cumulative effect is absent. In Azoksimer's organism bromide is exposed to biological degradation to low-molecular oligomers, is removed mainly by kidneys, with excrements – no more than 3%. Azoksimer's pharmacodynamics bromide possesses complex action: immunomodulatory, detoksitsiruyushchy, antioxidant, moderate anti-inflammatory. A basis of the mechanism of immunomodulatory action of Azoksimer of bromide is direct impact on englobing cells and natural killers and also stimulation of antibodyformation, synthesis of interferon alpha and interferon - gamma. Detoksikatsionny and antioxidant Azoksimera properties of bromide in many respects are defined by structure and the high-molecular nature of drug. Azoksimera bromide increases resistance of an organism concerning local and generalized infections of a bacterial, fungal and virus etiology. Restores immunity in the secondary immunodeficiency caused by various infections, injuries, complications after surgeries, burns, autoimmune diseases, malignant new growths, uses of chemotherapeutic means, tsitostatik, steroid hormones. Characteristic of Azoksimer of bromide at local (intranasal, sublingual) use is the ability to activate factors of early protection of an organism against an infection: drug stimulates bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases bactericidal properties of saliva and secretion of mucous upper airways. Azoksimera bromide blocks soluble toxic substances and microparticles, has ability to bring toxins, salts of heavy metals out of an organism, inhibits peroxide oxidation of lipids, both due to interception of free radicals, and by means of elimination catalystically of active ions of Fe2+. Azoksimera bromide reduces inflammatory reaction by means of normalization of synthesis about - and anti-inflammatory cytokines. Azoksimera bromide is well had, has no mitogenetic, polyclonal activity, antigenic properties, does not render allergenic, mutagen, embriotoksichesky, teratogenic and cancerogenic action. Azoksimera bromide has no smell and taste, does not possess local irritant action when drawing on mucous membranes of a nose and a stomatopharynx. Indications it Is applied at adults and children from 6 months to treatment and prevention of infectious and inflammatory diseases (virus, bacterial and fungal etiology), in a stage of aggravation and remission. For treatment of adults (in complex therapy): - chronic recurrent infectious and inflammatory diseases of various localization, a bacterial, virus and fungal etiology in an aggravation stage, - acute viral, bacterial infections of ENT organs, upper and lower airways, gynecologic and urological diseases, - the acute and chronic allergic diseases (including a pollinosis, bronchial asthma, atopic dermatitis) complicated by persistent recurrent bacterial and viral and fungal infection - malignant tumors in process and after khimio- and radiation therapy for decrease immunosuppressive, nefro - and hepatotoxic action of medicines, - generalized forms of surgical injections, for activation of regenerator processes (fractures, burns, trophic ulcers), - the pseudorheumatism complicated by a bacterial, viral and fungal infection against the background of long reception of immunodepressants, - a pulmonary tuberculosis. For treatment of children 6 months are more senior (in complex therapy): - sharp and exacerbations of the chronic inflammatory diseases of any location (including JIOP bodies - sinusitis, rhinitis, an adenoiditis, a hypertrophy of a pharyngeal tonsil, a SARS) caused by causative agents of bacterial, viral, fungal infections - the acute allergic and toksiko-allergic conditions complicated by a bacterial, viral and fungal infection - the bronchial asthma complicated by persistent infections of a respiratory path - the atopic dermatitis complicated by a purulent infection - an intestinal dysbiosis (in combination with specific therapy). For prevention (monotherapy) at children 6 months and adults are more senior: - flu and a SARS, - postoperative infectious complications. Route of administration and doses drug Polioksidoniy® Routes of administration: parenteral, intranasal, sublingual. Routes of administration, the dosing mode, need and frequency rate of carrying out the subsequent courses of therapy are chosen the doctor depending on disease severity and age of the patient. Preparation of solutions for parenteral administration (intramusculary and intravenously): For intramuscular introduction drug Полиоксидоний® 3 of mg is dissolved in 1 ml (a dose of 6 mg in 2 ml) by waters for injections or 0.9% of solution of sodium of chloride. After solvent introduction, drug is left for 2-3 minutes for swelling, then mixed rotary motions, without stirring up. For intravenous drop administration the drug Polioksidoniy® dissolve sterile 0.9% of solution of sodium of chloride in 2 ml. After solvent introduction, drug is left for 2-3 minutes for swelling, then rotary motions mixed. The dose calculated for the patient is transferred sterilely to a bottle/package from 0.9% chloride sodium solution. The prepared solution for parenteral administration is not subject to storage. Preparation of solution for intranasal and sublingual use: for children the dose of 3 mg is dissolved in 1.0 ml (20 drops), a dose of 6 mg – in 2.0 ml (40 drops) (one drop (0.05 ml) of the prepared solution contains 0.15 mg of drug), for adults the dose of 6 mg is dissolved in 1.0 ml (20 drops) of the distilled water, by 0.9% of solution of sodium chloride or boiled water of room temperature. A route of administration and doses at adults Parenterally (intramusculary or intravenously): drug is appointed the adult in doses of 6-12 mg of 1 times a day daily, every other day, or 1-2 times a week depending on the diagnosis and disease severity. In acute viral and bacterial infections of ENT organs, upper and lower airways, gynecologic and urological diseases: on 6 mg daily within 3 days, further every other day a course of 10 injections. In chronic recurrent infectious and inflammatory diseases of various localization, a bacterial, virus and fungal etiology, in an aggravation stage: on 6 mg every other day 5 injections, further 2 times a week a course of 10 injections. In the acute and chronic allergic diseases (including a pollinosis, bronchial asthma, atopic dermatitis) complicated by a bacterial, viral and fungal infection: on 6-12 mg, a course of 5 injections. In the pseudorheumatism complicated by a bacterial, viral and fungal infection against the background of long reception of immunodepressants: on 6 mg every other day 5 injections, further 2 times a week a course of 10 injections. At generalized forms of surgical infections: on 6 mg daily within 3 days, further every other day a course of 10 injections. For activation of regenerator processes (fractures, burns, trophic ulcers): on 6 mg within 3 days, then every other day, a course of 10 injections. For prevention of postoperative infectious complications: on 6 mg every other day 5 injections. In a pulmonary tuberculosis: on 6 mg 2 times a week a course of 20 injections. At oncological patients: - to and against the background of chemotherapy for decrease immunodepressive, gepato- and nephrotoxic action of chemotherapeutic means on 6 mg every other day a course of 10 injections, further the frequency of introduction is defined by the doctor depending on shipping and duration khimio- and radiation therapy, - for prevention of immunosuppressive influence of a tumor, for correction of an immunodeficiency after khimio- and radiation therapy, after surgical oncotomy the prolonged use of the drug Polioksidoniy® (from 2-3 months to 1 year) on 6 mg 1-2 times a week is shown. When assigning a long course the effect of cumulation, manifestation of toxicity and accustoming is not noted. Intranazalno is appointed on 6 mg a day (on 3 drops in each nasal course 3 times a day – within 10 days): - for treatment sharp and exacerbations of persistent infections of ENT organs, - for strengthening of regenerator processes of mucous membranes, - for prevention of complications and a recurrence of chronic diseases, - for prevention of flu and a SARS. A route of administration and doses for children drug Polioksidoniy® Routes of administration: parenteral, intranasal and sublingual. Routes of administration are chosen the doctor depending on disease severity and age of the patient. Parenterally (intramusculary or intravenously): appoint to children of 6 months in a dose 0.1 - 0.15 mg/kg daily, every other day or 2 times a week a course of 5-10 injections. Intranazalno and it is sublingual: daily in a daily dose of 0.15 mg/kg a course up to 10 days. The drug is administered on 1-3 drops in one nasal course or under language with an interval of not less than 1-2 hours, in 2-3 receptions a day. One drop (0.05 ml) of the prepared solution contains 0.15 mg of drug. Calculation of a daily dose for intranasal and sublingual use is provided in table 1. Table 1. Calculation of a daily dose of the drug Polioksidoniy® for intranasal or sublingual use for children. The weight of the child Kolichestvo of drops in day of 5 kg of 5 drops of 10 kg of 10 drops of 15 kg of 15 drops of 20 kg of 20 drops At the body weight of the child more than 20 kg calculation of a daily dose is made at the rate of 1 drop on 1 kg of body weight, but no more than 40 drops (6 mg of active ingredient). The prepared solution for intranasal and sublingual use can be stored at the room temperature in packing of the producer till 48 o'clock. The recommended schemes of treatment of children Parenterally: At sharp and exacerbations of chronic inflammatory diseases of any localization (including. ENT organs – sinusitis, rhinitis, an adenoiditis, a hypertrophy of a pharyngeal tonsil, a SARS), the bacterial, viral, fungal infections caused by activators: on 0.1 mg/kg 3 days in a row, further every other day a course of 10 injections. At the acute allergic and toksiko-allergic conditions (including bronchial asthma, atopic dermatitis) complicated by a bacterial, viral and fungal infection: intravenously by drop infusion in a dose of 0.1 mg/kg, 3 days daily, then every other day, a course of 10 injections in combination with basic therapy. Intranazalno: daily on 1-2 drops in each nasal course 3 times a day a course up to 10 days (watch calculation of a daily dose of drug for intranasal and sublingual introduction in table 1): In acute and chronic rhinitises, rinosinusita, an adenoiditis (treatment and prevention of aggravations), For preoperative training of patients at surgeries in LOR-pathology and also in the postoperative period for the purpose of prevention of infectious complications or a recurrence of a disease, Treatment and prevention of flu and other SARS (within 1 month to expected epidemic), in any terms after the beginning of a disease and in the period of a convalescence), Sublingual, to children of early, preschool and younger school age: daily in a daily dose of 0.15 mg/kg in 2 receptions within 10 days: In adenoidites, a hypertrophy of tonsils: (as a component of conservative treatment), For preoperative preparation and postoperative rehabilitation, For seasonal prevention of aggravations of the chronic centers of infections of a stomatopharynx, upper airways, an inner and middle ear, For treatment of an intestinal dysbiosis (in combination with basic therapy) within 10 days. Side effects At use of the drug Polioksidoniy® met the following general and local reactions: Not often (³1/1,000 to & lt, 1/100): - in the injection site – morbidity, reddening and consolidation of skin. Very seldom (³1/10,000): - fervescence up to 37.3 °C, slight concern, a fever within the first hour after an injection, allergic reactions. Contraindications - individual hypersensitivity - pregnancy and the period of a lactation (clinical experience of use is absent) - an acute renal failure - children's age up to 6 months (clinical experience of use is limited). With care: - chronic kidney disease (apply not more often than 2 times a week). Medicinal interactions of Azoksimer bromide does not inhibit isoenzymes of CYP1A2, CYP2S9, CYP2S19, CYP2D6, R-450 cytochrome therefore drug is compatible to many medicines, including antibiotics, antiviral, antifungal and antihistaminic drugs, glucocorticosteroids and cytostatics. Special instructions At development of allergic reaction it is necessary to stop use of the drug Polioksidoniy® and to see a doctor. In need of the termination of administration of drug of Polioksidoniy® the cancellation can be carried out at once, without gradual reduction of a dose. In case of the admission of introduction of the next dose of drug the subsequent its use should be carried out in the usual mode as it is specified in this instruction or it is recommended the doctor. The patient should not enter the doubled dose for the purpose of compensation of the passed doses. Do not use drug with visual signs of its unfitness (defect of packing, powder discoloration). At morbidity in the place of an injection drug dissolve in 1 ml 0.5% of solution of Procainum (novocaine) on condition of absence at the patient of the increased individual sensitivity on Procainum (novocaine). At intravenous (drop) administration it is not necessary to dissolve in protein-bearing infusion solutions. Pregnancy and a lactation drug Polioksidoniy® use is contraindicated to pregnant women and women during breastfeeding (clinical experience of use is absent). At experimental studying the drug Polioksidoniy® at animals the influence on generative function (fertility) of males and females, embriotoksichesky and teratogenic action, influence on fetation, as is not revealed at administration of drug during all pregnancy, and in the period of a lactation. Features of influence of medicine on ability to run vehicles or potentially dangerous mechanisms. Use of the drug Polioksidoniy® does not affect ability to performance of potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions (including control of vehicles, work with moving mechanisms). Overdose Cases of overdose are not registered. A form of release and packing Lyophilisate for preparation of solution for injections and topical administration on 4.5 mg of drug (for a dosage of 3 mg) or on 9 mg of drug (for a dosage of 6 mg) in the bottles from glass of 1 hydrolytic class which are hermetically corked by rubber bungs and pressed out by aluminum caps. On 5 bottles in blister strip packaging from a film polyvinylchloride. On one blister strip packaging together with the instruction for medical use in the state and Russian languages in a pack from cardboard or on 5 bottles together with the instruction for medical use in the state and Russian languages in a pack from cardboard with an insert from cardboard. On 50 bottles (for hospitals) together with 50 iinstruktion on medical use in the state and Russian languages in a box with partitions from cardboard. Period of storage 2 years. Not to apply year
of an awn after term. To Store storage conditions at a temperature from 2 °C to 8 °C. To store out of children's reach! Prescription status According to the prescription. LLC NPO Petrovax Pharm producer Russian Federation, 142143, Moscow region, city of Podolsk, page. Cover, Sosnovaya St., 1, ph./fax: +7 (495) 926-21-07, e-mail: info@petrovax.ru the Holder of the registration certificate of LLC NPO Petrovax Pharm, the Russian Federation the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: KFK Medservice Plus LLP, Republic of Kazakhstan, Almaty, Mametova St., 54. Phone number: +7 (727) 279 86 02. Fax: +7 (727) 279 98 21
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