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Instructions

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Instruction for use: Polyoxidonium

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Dosage form: Lyophilizate for solution for injection and topical application; Semi-finished products; Solution for preparation of medicinal forms and vaccines; Suppositories, vaginal / rectal; tablets

Active substance: Azoximer bromide

ATX

L03 Immunostimulants

Pharmacological group:

Immunomodulating agent [Other immunomodulators]

The nosological classification (ICD-10)

A16.9 Tuberculosis of respiratory organs of unspecified site without reference to bacteriological or histological confirmation: Hemoptysis in tuberculosis; Cough with tuberculosis; Pleural effusion in tuberculosis

A49 Bacterial infection of unspecified site: Bacterial infection; Infectious diseases

B34 Viral infection of unspecified site: Viral respiratory tract infections; Infections viral; Viral infection; Viral infections

D84.9 Unspecified Immunodeficiency: Pneumonia in immunodeficient states; Autoimmune disease; Autoimmune diseases; Severe immunodeficiency; immune deficiency; Immunodeficiency; immunodeficiency diseases; Immunodeficiency states due to surgery; Immunotherapy for cancer; Immunomodulation; Infections in patients with weakened immune systems; Correction of immune deficiency; Correction of immunodeficiencies; Correction of a weakened immune system; Correction of a weakened immunity in immunodeficient states; Violation of immunity; Violation of the immune status; Immune System Disorders; Primary immunodeficiency; Maintaining immunity; Lowering the body's defenses; Lowering the immunity; Lowering the immunity of colds and infectious diseases; The decrease of the immune status; Lowered resistance to infections; Lowered resistance to infections and colds; Lowered resistance; Immunosuppression; Predisposition to colds; acquired immune deficiencies; Radiation immunodeficiency; The development of immunodeficiency; Immune dysfunction syndrome; immunodeficiency syndrome; primary immunodeficiency syndrome; Reducing the body's defenses; Immunosuppression; Reduced immune defense; Reducing local immunity; Reducing the total body resistance; The decrease in cell-mediated immunity; Reduced resistance to infections in children; Reducing the body's resistance; Reduced resistance; reduced immunity; Status immunodeficiency; Stimulation of the processes of nonspecific immunity; Heavy selective secondary immunodeficiency; immunity Oppression; Primary immunodeficiency

J01 Acute sinusitis: Inflammation of the paranasal sinuses; Inflammatory diseases of the paranasal sinuses; Purulent-inflammatory processes of the paranasal sinuses; Infectious-inflammatory disease of ENT organs; Infection of the paranasal sinuses; Combined sinusitis; Exacerbation of sinusitis; Acute inflammation of the paranasal sinuses; Acute bacterial sinusitis; Acute sinusitis in adults; Subacute sinusitis; Sinusitis acute; Sinusitis

J03.9 Acute tonsillitis, unspecified (angina agranulocytic): Throat infections; Acute tonsillitis; Angina; Follicular tonsillitis; Angina alimentary-hemorrhagic; Secondary sore throat; Sore throat primary; Angina follicular; Angina; Inflammatory diseases of the tonsils; Catarrhal angina; Lacunar angina; Acute Sore Throat; Tonsillitis; Tonsillitis acute; Tonsillar angina; Follicular sore throat; Bacterial tonsillitis

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

J11 Influenza, virus not identified: Influenza; Influenza in the early stages of the disease; Influenza in children; cold in the chest; Begins flu-like condition; Acute disease parainfluenza; parainfluenza; parainfluenza state; influenza epidemics; The pains of the influenza

J30 Vasomotor and allergic rhinitis: Allergic rhinopathy; Allergic rhinosinusopathy; Allergic diseases of the upper respiratory tract; Allergic rhinitis; Allergic rhinitis seasonal; Vasomotor runny nose; Prolonged allergic rhinitis; All-year-round allergic rhinitis; All-year allergic rhinitis; Year-round or seasonal allergic rhinitis; All-the-year-round rhinitis of an allergic nature; Rhinitis vasomotor allergic; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic rhinitis; Edema of the nasal mucosa; Edema of the nasal mucosa; Edema of the mucous membrane of the nasal cavity; Swelling of the nasal mucosa; Swelling of the nasal mucosa; Pollinosis; Permanent allergic rhinitis; Rhinoconjunctivitis; Rhinosinusitis; Rhinosinusopathy; Seasonal allergic rhinitis; Seasonal allergic rhinitis; Hay rhinitis; Chronic allergic rhinitis; Allergic diseases of the respiratory tract

J31 Chronic rhinitis, nasopharyngitis and pharyngitis: Allergic rhinosinusopathy; Inflammation of the nasal mucosa; Infectious and inflammatory diseases of ENT organs; Catarrh of the nasopharyngeal region; Year-round rhinitis; Ozena; Persecution in the throat or nose; Rhinitis hyperplastic; Rhinitis chronic; Pharyngoesophagitis; Chronic Bacterial Rhinitis

J32 Chronic sinusitis: Allergic rhinosinusopathy; Purulent sinusitis; Catarrh of the nasopharyngeal region; Catarrhal inflammation of the paranasal sinuses; Exacerbation of sinusitis; Sinusitis chronic

J35.0 Chronic tonsillitis: chronic tonsillitis; Inflammatory diseases of the tonsils; Angina chronic; Chronic hypertrophic tonsillitis; Tonsillar angina

J35.1 Hypertrophy of the tonsils: Hypertrophy of the pharyngeal tonsil; Thorvald's Cyst

J45 Asthma: Asthma of physical effort; Asthmatic conditions; Bronchial asthma; Bronchial asthma of light course; Bronchial asthma with difficulty in sputum discharge; Bronchial asthma of severe course; Bronchial asthma physical effort; Hypersecretory asthma; The hormone-dependent form of bronchial asthma; Curbing asthma attacks with bronchial asthma; Non-allergic bronchial asthma; Night Asthma; Exacerbation of bronchial asthma; Attack of bronchial asthma; Endogenous forms of asthma; Night attacks of asthma; Cough with bronchial asthma

K63.8.0 * Dysbacteriosis: Intestinal lymphangiectasia

K71 Toxic liver damage: Toxic liver damage; Hepatitis medication; Hepatitis Toxicum; Liver medication; Medicinal Hepatitis; Liver medications; Medicinal Hepatitis; Medical Hepatitis; Dysfunction of the liver of toxic etiology; Toxic hepatitis; Toxic liver damage; Toxic hepatitis; Hepatotoxic effect of drugs; Toxic liver disease; Effect of drugs on the liver; The effect of toxins on the liver

L20 Atopic dermatitis: Allergic diseases of the skin; Allergic skin disease noninfectious etiology; Allergic skin disease etiology nemikrobnoy; Allergic skin diseases; Allergic skin lesions; Allergic reactions on the skin; atopic dermatitis; Allergic dermatosis; Allergic diathesis; Allergic itching dermatosis; Allergic skin disease; Allergic skin irritation; allergic Dermatitis; atopic Dermatitis; allergic dermatoses; exudative diathesis; Itchy atopic eczema Itchy allergic dermatosis; Allergic skin disease; Cutaneous allergic reaction to drugs and chemicals; Cutaneous reactions to medications; Skin and allergic disease; Acute eczema; common neurodermatitis; Chronic atopic dermatitis; Exudative diathesis

L98.4.2 * Trophic skin ulcer: Varicose ulcer; Varicose ulcers; Cutaneous ulcer; Non-healing ulcers; Trophic ulcer; Trophic ulcer of lower leg; Trophic skin lesions; Trophic after-burn ulcers; Trophic ulcers; Trophic skin ulcers; Ulcer of lower leg; Ulcer of skin; Ulcer of trophic skin; Ulcer on legs; Ulcerative necrosis of the skin; Ulcer of shin; Ulcer of the lower leg; Ulcers of lower extremities; Difficult healing ulcers

M06.9 Rheumatoid arthritis, unspecified: Rheumatoid arthritis; Pain syndrome in rheumatic diseases; Pain in rheumatoid arthritis; Inflammation in rheumatoid arthritis; Degenerative forms of rheumatoid arthritis; Children's rheumatoid arthritis; Exacerbation of rheumatoid arthritis; Acute articular rheumatism; Rheumatic arthritis; Rheumatic polyarthritis; Rheumatoid arthritis; Rheumatic polyarthritis; Rheumatoid arthritis; Rheumatoid arthritis; Rheumatoid arthritis of active course; Rheumatoid periarthritis; Rheumatoid polyarthritis; Acute rheumatoid arthritis; Acute rheumatism

N11 Chronic tubulointerstitial nephritis: Nephritis tubulointerstitial chronic; Pyelonephritis chronic; Chronic Pielite; Chronic pyelonephritis

N14 Tubulo-interstitial and tubular lesions caused by drugs and heavy metals

N30 Cystitis: Urethrocystitis; Recurrent cystitis; Fibrous cystitis; Cystopyelitis; Exacerbation of chronic cystitis; Acute bacterial cystitis

N34 Urethritis and urethral syndrome: Urethral buzhirovanie; Gonococcal urethritis; Urethrocystitis; Gonorrheic urethritis; Urethritis; Non-gonococcal urethritis; Negative urethritis; Lesion of the urethra; Acute gonococcal urethritis; Acute gonorrhea urethritis; Acute urethritis; Infection of the urethra; Bacterial nonspecific urethritis; Bacterial urethritis

N39.0 Urinary tract infection without established localization: Fungal infections of the urinary tract; Asymptomatic bacteriuria; Bacterial infections of the urinary tract; Bacterial infections of the urinary tract; Bacterial infections of the genitourinary system; Bacteriuria; Bacteriuria asymptomatic; Bacteriuria chronic latent; Asymptomatic bacteriuria; Asymptomatic massive bacteriuria; Inflammatory urinary tract disease; Inflammatory urinary tract disease; Inflammatory diseases of the bladder and urinary tract; Inflammatory diseases of the urinary system; Inflammatory diseases of the urinary tract; Inflammatory diseases of the urogenital system; Fungal diseases of the urogenital tract; Urinary Tract Infections; Urinary Tract Infections; Infections of the urinary system; Urinary tract infections; Urinary Tract Infections; Urinary tract infections caused by enterococci or mixed flora; Urinary tract infections uncomplicated; Urinary tract infections complicated; Infections of the urogenital system; Infections urogenital; Infectious diseases of the urinary tract; Urinary Tract Infection; Urinary tract infection; Urinary system infection; Urinary tract infection; Urinary tract infection; Infection of the urogenital tract; Uncomplicated urinary tract infections; Uncomplicated urinary tract infections; Uncomplicated urinary tract infections; Uncomplicated infections of the genitourinary system; Exacerbation of chronic urinary tract infection; Retrograde kidney infection; Recurrent urinary tract infections; Recurrent urinary tract infections; Recurrent infectious diseases of the urinary tract; Mixed urethral infections; Urogenital infection; Urogenital Infectious-Inflammatory Disease; Urogenital mycoplasmosis; Urologic disease of infectious etiology; Chronic urinary tract infection; Chronic inflammatory diseases of the pelvic organs; Chronic urinary tract infections; Chronic infectious diseases of the urinary system

N41 Inflammatory diseases of the prostate: Prostatitis; Disease of the prostate; Infection of the genitals; Chronic non-specific prostatitis

N70 Salpingitis and oophoritis: Adnexitis; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Infection of the genitals; Oophoritis; Acute adnexitis; Salpingitis; Salpingo-oophoritis; Chronic inflammatory diseases of the ovaries; Inflammation of the ovaries

N71 Inflammatory diseases of the uterus other than the cervix: Intrauterine infections; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Infection of the genitals; Chronic endometriometritis; Chronic inflammatory disease of the uterus; Endometritis; Endometriometry

N73 Other inflammatory diseases of female pelvic organs

N76 Other inflammatory diseases of the vagina and vulva: Vulvovaginitis atrophic; Vulvovaginitis bacterial; Vulvovaginitis estrogen-deficient; Bacterial vaginosis; Vaginitis; Vaginitis bacterial; Inflammatory diseases of the vagina and vulva; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Vulvit; Vulvovaginitis; Vulvovaginitis; Gardnerella; Fungal vulvovaginitis in girls and virgins; Infection of the vagina; Infection of the genitals; Colpitis; Violation of purity of the vaginal secretion; Nonspecific cervicovaginitis; Nonspecific vulvitis; Nonspecific vulvovaginitis; Nonspecific colpitis; Recurrent nonspecific bacterial vaginosis; Senylic coverings; Mixed Colpus; Chronic vaginitis; Vulvovaginal infections; Bacterial vaginitis; Bacterial vaginosis; Bacterial vaginitis; Mixed vaginal infections

R54 Age-related disease: External signs of aging; Age-related eye disease; Age-related visual impairment; Age-related vascular disease; Age constipation; Age-related changes in visual acuity; Age-related changes in the brain involutional; Age-related disorders; Age-related hearing loss; gerontological practice; senile dementia; Deficiency of calcium and vitamin D3 in the elderly; cerebral vascular disease and age-related; involutionary depression; involutional depression; Correction of metabolism in middle and old age; Malnutrition in elderly and senile age.; senile dementia; senile dementia; senile depression; senile colpites; senile psychosis; Syndrome of age involution; Hearing loss age; Aging; Brain Aging; The aging of the organism; senile dementia; senium; Senile involutional psychosis; senile psychosis; Memory impairment in elderly patients; Conduct disorders in the elderly

T30 Thermal and chemical burns of unspecified site: Pain syndrome with burns; Pain in burns; Pain with burns; Sluggishly healing post-burn wounds; Deep burns with a wet scab; Deep burns with abundant compartments; Deep burn; Laser burn; Burn; Burn of rectum and perineum; Burn with mild exudation; Burn disease; Burn injury; Superficial burn; Superficial burn of I and II degree; Superficial skin burns; After-burn trophic ulcer and wound; Post-burn complication; Loss of fluid in burns; Sepsis burn; Thermal burns; Thermal skin lesions; Thermal burn; Trophic after-burn ulcers; Chemical burn; Surgical burn

T78.4 Unspecified Allergy: Allergic reactions to insulin; Allergic reactions to insect stings; Allergic reactions similar to systemic lupus erythematosus; Allergic diseases; Allergic diseases of mucous membranes; Allergic diseases and conditions resulting from increased release of histamine; Allergic diseases of mucous membranes; Allergic symptoms; Allergic symptoms in the mucous membranes; Allergic reactions; Allergic reactions caused by insect bites; Allergic reactions; Allergic conditions; Allergic laryngeal edema; allergopathy; allergic conditions; Allergy; House dust allergy; Anaphylaxis; Cutaneous reactions to medications; Skin reaction to insect stings; Cosmetic allergy; Drug allergy; Acute allergic reaction; Laryngeal edema allergic genesis and background radiation; Food and drug allergy

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

Z29.1 Prophylactic immunotherapy: Vaccination against viral infections; donor Vaccination; Vaccination and revaccination; Vaccination of newborns; Vaccination against hepatitis B; Immunization; Correction of the immune status; Therapeutic and prophylactic immunization; Preventive immunization; Specific immunoprophylaxis; Stimulation of the processes of nonspecific immunit

Z51.0 Radiotherapy course: Supplement to external radiation therapy; Local X-Ray Irradiation; Radiation therapy; Brain edema associated with radiation therapy; Lesion in radiation therapy; Radiotherapy

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Z54 recovery period: The recovery period; The recovery period after illness; Recovery; The recovery from the flu and colds; Recovery after illness; The lack of mineral salts in the period of convalescence; The period of recovery after illness; The period of recovery after illness and surgery; The period of recovery after a serious illness; The period of convalescence after illness; rehabilitation period; rekovalestsentsii period after infectious diseases; decubation; The period of convalescence after surgery and infectious diseases; The period of convalescence after prolonged infections; The period of convalescence after serious diseases; The period of convalescence after severe infections; Rehabilitation period; convalescent state; Convalescence after illness; Convalescence after infectious diseases; Convalescence after debilitating diseases; Convalescence after infectious diseases; Convalescence at an elevated blood loss; Status of convalescence after illness

Z58 Problems related to physical environmental factors: Atmospheric pollution; Meteopathy; Hypotensive reactions when weather changes; Impact of harmful environmental factors; Impact of unfavorable environmental factors; The impact of physical factors; Unfavorable action of the environment; Stay in adverse environmental conditions; Adverse effects on the body of environmental factors; Living in ecologically unfavorable areas; Work in environmentally unfavorable areas; Sharp change of climatic conditions; Hypersensitivity to weather changes

Composition

Tablets - 1 table.

active substance: Azoxime bromide 12 mg

In a mixture with auxiliaries: mannitol, povidone, betacarotene - to obtain a mixture of 18 mg

Auxiliary substances: lactose monohydrate 185 mg; Potato starch - 45 mg; Stearic acid - 2 mg

Lyophilizate for solution for injection and topical application 1 amp. or fl.

active substance: Azoxime bromide 3 mg; 6 mg

Auxiliary substances: mannitol; Povidone; Betakaroten - up to 4.5 (for a dose of 3 mg) or 9 (for a dose of 6 mg) mg

Suppositories for vaginal or rectal administration 1 supp.

active substance: Azoxime bromide 6 mg; 12 mg

Auxiliary substances: mannitol; Povidone; Betakaroten - up to 9 (for a dose of 6 mg) or 18 (for a dose of 12 mg) mg

Base: cocoa butter beans - until a suppository of 1.3 g

Description of dosage form

Tablets: from white with a yellowish tinge to a yellow color with an orange tinge, flat-cylindrical, with a facet, a risk - on the one hand and the inscription "PO" on the other. It is possible to have hardly noticeable impregnations of a more intense color.

Liofilizate for the preparation of solution for injection and topical application: porous mass from white with a yellowish tinge to yellow. The drug is hygroscopic and photosensitive.

Suppositories: torpedo-shaped, light yellow with a weak specific odor of cocoa butter.

Pharmachologic effect

Mode of action - immunomodulating, antioxidant, detoxifying.

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.

The use of Polyoxidonium® on the background of secondary immunodeficiency states allows to increase the efficiency and shorten the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, GCS, and prolong 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.

For tablets additionally

Polyoxidonium ® activates phagocytes of peripheral blood and tissue macrophages, which facilitates faster elimination of the pathogen from the body in the presence of a foci of infection. In addition, Polyoxidonium® activates lymphoid cells located in regional lymph nodes, namely B cells that produce secretory IgA.

With sublingual application activates lymphoid cells located in the nasal cavity, eustachian tubes, oropharynx, bronchi. In addition, it activates the bactericidal properties of saliva.

When administered orally, it also activates lymphoid cells located in the lymph nodes of the intestine. The consequence of this is an increase in the resistance of the respiratory tract, GIT and ENT organs to infectious agents.

For lyophilizate for solution for injection and topical application and suppositories additionally

Recovers immune responses in secondary immunodeficiency states caused by various infections, traumas, burns, autoimmune diseases, malignant neoplasms, complications after surgical operations, the use of chemotherapeutic agents, cytostatics, steroid hormones.

Along with the immunomodulating effect it has pronounced detoxification and antioxidant activity, it has the ability to excrete toxins from the body, salts of heavy metals, inhibits lipid peroxidation. These properties are determined by the structure and high molecular weight nature of Polyoxidonium®.

Increases the stability of cell membranes to the cytotoxic effect of drugs and chemicals, reduces their toxicity.

The inclusion of Polyoxidonium® in the complex therapy of cancer patients reduces the intoxication on the background of chemo- and radiotherapy, in most cases allows treatment without changes in the standard therapy scheme due to the development of infectious complications and side effects (including myelosuppression, vomiting, diarrhea, Cystitis, colitis).

Pharmacokinetics

Tablets: after oral administration, it is rapidly absorbed from the digestive tract, bioavailability is approximately 50%. Cmax in the blood plasma is reached after 3 hours after ingestion. Pharmacokinetics is linear (concentration in the blood plasma is proportional to the dose taken). Polyoxidonium® is a hydrophilic compound. The apparent Vd is about 0.5 l / kg, which indicates that the drug is distributed mainly in the intercellular fluid. The period of half-absorption is 35 minutes, T1 / 2 is 18 hours.

Liofilizate for solution for injection and topical application: with the / m introduction Polyoxidonium ® has a high bioavailability (89%); Tmax in the blood - 40 min; Quickly distributed to all organs and tissues. The half-distribution in the body (fast phase) is 0.44 h, T1 / 2 (slow phase) - 36.2 h. In the body, the preparation is hydrolyzed to oligomers, which are excreted mainly by the kidneys.

Suppositories: when rectal administration has a high bioavailability (at least 70%), reaching Cmax in the blood 1 h after the administration. The half-distribution period is about 0.5 h, the half-elimination period is 36.2 h.

In the body, it is hydrolyzed to oligomers, which are excreted mainly by the kidneys. There is no cumulative effect.

Indication of the Polyoxidonium

Tablets

In adults and adolescents over 12 years of age - the treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology), which cannot be standardized at the stage of exacerbation and remission:

In complex therapy:

Acute and chronic recurrent infectious and inflammatory diseases of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;

Allergic diseases complicated by recurrent bacterial, fungal and viral infections (including pollinosis, bronchial asthma);

Rehabilitation often and for a long time (more than 4-5 times a year) of ill persons.

In the form of monotherapy:

Prevention of recurrent herpetic infection;

Seasonal prophylaxis of exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle ear;

In immunocompromised individuals - prevention of influenza and other acute respiratory infections in the pre-epidemic period;

Correction of secondary immunodeficiencies due to aging or exposure to adverse factors.

Liofilizate for solution for injection and topical application

Correction of immunity in adults and children from 6 months.

In adults in complex therapy:

Chronic recurrent infectious-inflammatory diseases, not amenable to standard therapy in the stage of exacerbation and remission;

Acute and chronic viral and bacterial infections (including urogenital infectious and 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 chemo-and radiotherapy - a decrease in immunosuppressive, nephro- and hepatotoxic effects of drugs;

Activation of regenerative processes (fractures, burns, trophic ulcers);

Rheumatoid arthritis, long-term treated with immunosuppressants;

Rheumatoid arthritis complicated by acute respiratory illness or acute respiratory viral infection;

Prevention of postoperative infectious complications;

Prevention of influenza and acute respiratory infections.

In children in complex therapy:

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

Acute allergic and toxic-allergic conditions;

Bronchial asthma, complicated by chronic infections of the respiratory tract;

Atopic dermatitis complicated by a purulent infection;

Dysbacteriosis of the intestine (in combination with specific therapy);

Rehabilitation often and long-term sick;

Prevention of influenza and acute respiratory infections.

Suppositories

In adults and children older than 6 years.

In complex therapy for the correction of immune deficiency:

Chronic recurrent infectious-inflammatory diseases, which cannot be standardized both in the acute stage and in the stage of remission;

Acute viral, bacterial and fungal infections;

Inflammatory diseases of the urogenital tract, incl. Urethritis, cystitis, pyelonephritis, prostatitis, salpingoophoritis, endomyometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis (including viral etiology);

Various forms of tuberculosis;

Allergic diseases complicated by recurrent bacterial, fungal and viral infections (including pollinosis, bronchial asthma, atopic dermatitis);

Rheumatoid arthritis, long-term treated with immunosuppressants;

Rheumatoid arthritis complicated by acute respiratory illness or acute respiratory viral infection;

Activation of regenerative processes (fractures, burns, trophic ulcers);

Rehabilitation often and for a long time (more than 4-5 times a year) of ill persons;

In the process and after chemo-and radiation therapy of tumors;

Reduction of nephro- and hepatotoxic effects of drugs.

In the form of monotherapy:

Prevention of recurrent herpetic infection;

Seasonal prevention of exacerbations of chronic foci of infections, prevention of influenza and acute respiratory infections in the pre-epidemic period;

Correction of secondary immunodeficiencies due to aging or exposure to adverse factors.

Contraindications

Common for all dosage forms

Increased individual sensitivity;

Pregnancy (no clinical experience);

Lactation period.

For tablets additionally

Children up to 12 years.

For suppositories additionally

Children under 6 years.

Carefully

Common for all dosage forms - acute renal failure.

For tablets additionally - lactose intolerance, lactase deficiency, glucosogalactose malabsorption.

For lyophilizate for the preparation of solution for injection and topical application (optional) - children under 6 months (clinical experience is limited).

Application in pregnancy and breastfeeding

Application in pregnancy and lactation is contraindicated (clinical experience is not available). Excretion Polyoxidonium® with breast milk has not been studied.

Side effects

Tablets: no side effects reported.

Liofilizate for the preparation of solution for injection and topical application: it may be painful at the injection site with the IM introduction.

Suppositories: not revealed.

Interaction

Tablets, lyophilizate for solution for injection and topical application, suppositories: drug interaction not established. It is possible to use Polyoxidonium® with many drugs, incl. Compatible with antibiotics, antiviral, antifungal and antihistamine drugs, bronchodilators, GCS, cytostatics and β-adrenomimetics.

Dosing and Administration

Tablets.

Orally and sublingually, for 20-30 minutes before meals, daily 1, 2 or 3 times a day.

Adults - in doses of 12 or 24 mg, adolescents - in a dose of 12 mg. The method and dosage regimen is determined by the doctor, depending on the diagnosis, severity and severity of the process.

Sublingually:

- with inflammatory processes of the oropharynx (bacterial, viral and fungal nature): 1 tab. 2 times a day after 12 hours, for 10-14 days. In severe forms of herpetic and fungal infection of the oral cavity - 1 tab. 3 times a day after 8 hours for 15 days;

- with chronic diseases of the paranasal sinuses and chronic otitis: 1 tab. 2 times a day after 12 hours, for 5-10 days;

- with chronic tonsillitis: 1 table. 3 times a day after 8 hours for 10-15 days;

- with chronic diseases of the upper respiratory tract: adults - 2 tablets. (24 mg) 2 times a day, adolescents - 1 table. (12 mg) 2 times a day, after 12 hours, for 10-14 days;

- for the prevention of influenza and acute respiratory infections: immunocompromised persons suffering from ARI more than 4 times a year, in the pre-epidemic period, adults - 2 tablets. (24 mg), adolescents - 1 table. (12 mg) 2 times a day after 12 hours, for 10-15 days.

Oral:

- with chronic diseases of the upper respiratory tract: adults - 2 tablets. (24 mg) 2 times a day after 12 hours, adolescents - 1 table. (12 mg) 2 times a day, after 12 hours, for 10-14 days.

Liofilizate for solution for injection and topical application

Adults

Parenterally, intranasally. Methods of application are chosen by the doctor depending on the severity of the disease and the age of the patient.

IM or IV (drop): the drug is prescribed to adults at 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 the IM introduction, the contents of the ampoule or vial are dissolved in 1.5-2 ml of a 0.9% solution of sodium chloride or water for injection. For intravenous (drop) administration, the drug is dissolved in 2 ml of 0.9% solution of sodium chloride, Hemodeza-H, Reopoliglyukin or 5% dextrose solution, then sterilely transferred to a bottle 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 a day later with a total course of 5-10 injections;

- for chronic inflammatory diseases: 6 mg every other day 5 injections, then 2 times a week for 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 each, a course of 5 injections - 2 first injections daily, then every other day. In case of acute allergic and toxic-allergic conditions, administer iv 6-12 mg in combination with other 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 - 6-12 mg every other day with a course of at least 10 injections, then the frequency of administration is determined by the doctor depending on the tolerability and duration of chemotherapy and radiation therapy;

- for the prophylaxis of the immunosuppressive effect of the tumor, for the correction of immunodeficiency after chemotherapy and radiotherapy, after a surgical removal of the tumor, prolonged use of the preparation Polyoxidonium® (2-3 months to 1 year) - 6-12 mg 1-2 times a week.

In patients with acute renal failure: appoint no more than 2 times a week.

Intranasal prescribe at 6 mg / 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 the disease, for the prevention of influenza and acute respiratory infections. 3 drops in each nasal passage through 2-3 hours (3 times a day) for 5-10 days.

Children

Parenteral, intranasal, sublingual. Methods of application are chosen by the doctor depending on the diagnosis, severity of the disease, age and body weight of the patient.

Parenterally, the drug is prescribed for children from 6 months at a dose of 3 mg (IM or IV drop 0.1-0.15 mg / kg) daily, every other day or twice a week with a course of 5-10 injections (the dose is indicated in Table).

For the IM introduction, the drug is dissolved in 1 ml of water for injection or 0.9% solution of sodium chloride.

For IV injection, the drug is dissolved in 1.5-2 ml sterile 0.9% solution of sodium chloride, Reopoliglyukin, Hemodesa-H or 5% dextrose solution, sterilely transferred into a bottle 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. To prepare a solution for intranasal and sublingual use, a dose of 3 mg is dissolved in 1 ml (20 drops), a dose of 6 mg in 2 ml of distilled water, 0.9% solution of sodium chloride or boiled water at room temperature. One drop of the prepared solution (50 μl) contains 0.15 mg of the Polyoxidonium® preparation, which is prescribed for 1 kg of the child's body weight.

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 ° C).

Recommended treatment regimens for children:

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

- for chronic inflammatory diseases: 0.15 mg / kg 2 times a week for up to 10 injections;

- for acute allergic and toxic-allergic conditions: intravenous 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: IM / 0.1 mg / kg by a course of 5 injections with an interval of 1-2 days.

Intranasal injection of 1-3 drops in one nasal passage through 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.

Baby body weight, kg Number of drops per day Volume of injected solution, ml
5 5 0,25
10 10 0,5
15 15 0,75
20 20 1,0

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.

Suppositories

Rectal or vaginal by 1 supp. (6 and 12 mg) once a day. The method and dosage regimen is determined by the doctor depending on the diagnosis, severity and severity of the process. Polyoxidonium® can be applied rectally or vaginally daily, every other day, or twice a week.

Polyoxidonium®, suppositories 12 mg is used in adults rectally or vaginally.

Rectal: 1 time per day for 1 supp. (After cleansing the intestine).

Vaginal: with gynecological diseases 1 soup. Once a day (at night) is inserted into the vagina in a prone position.

Polyoxidonium ®, suppositories 6 mg are applied: in children over 6 years of age rectally - 1 supp. 1 time per day (after cleansing of the intestine), in adults - rectally (after cleansing the intestine) or vaginally (in the vagina in the prone position) as a maintenance dose - 1 soup. 1 time per day (at night).

The standard scheme of application of Polyoxidonium® is 1 soup. (6 or 12 mg) once a day, daily for 3 days, then - through the day, with a course of 10-20 suppositories. If necessary, the course of treatment is repeated after 3-4 months.

For patients who have been receiving immunosuppressive therapy for a long time, cancer patients with acquired immune system defect - HIV, exposed to radiation, sustained from 2-3 months to 1 year maintenance therapy Polyoxidonium ® (adults - 12 mg, children 6 years and older - 6 mg 1-2 times a week).

Recommended application regimens in complex therapy:

- for chronic infectious and inflammatory diseases: in the stage of exacerbation - according to the standard scheme, in the remission stage - 1 soup. In 1-2 days, the general course - 10-15 supp .;

- with acute infectious processes and for the activation of regenerative processes (fractures, burns, trophic ulcers): daily for 1 supp., Treatment course - 10-15 supp .;

- for tuberculosis: according to the standard scheme, treatment course - not less than 15 supp., Then it is possible to use maintenance therapy - 2 soups. A week course of 2-3 months;

- on the background of chemo-and radiation therapy of tumors: 1 supp. Daily 2-3 days before the start of the course of therapy, further the frequency of administration of suppositories is determined by the doctor depending on the tolerability and duration of chemo- and radiotherapy;

- for rehabilitation often (more than 4-5 times a year) and long-term ill persons and with rheumatoid arthritis: 1 supp. In a day, the course of treatment is 10-15 supp.

- for correction of secondary immunodeficiencies, incl. Arising from aging: 1 soup. (12 mg) 2 times a week, the course - not less than 10 soups. 2-3 times a year.

In the form of monotherapy:

- for seasonal prevention of exacerbations of chronic foci of infection, prevention of recurrent herpetic infection: in a day adults - 6-12 mg, children - 6 mg. The course is 10 soup.

- for correction of secondary immunodeficiencies, prevention of influenza and acute respiratory infections: according to the standard scheme.

- with gynecological diseases (rectally or vaginally): according to the standard scheme.

Overdose

Cases of an overdose of Polyoxidonium® are not known.

Special instructions

For lyophilizate for the preparation of solution for injection and topical application: when painful at the injection site, the drug is dissolved in 1 ml of 0.25% solution of procaine if the patient has no increased individual sensitivity to procaine. When IV injection (drip) should not be dissolved in infusion solutions containing protein.

For tablets and suppositories: Do not exceed the indicated doses and duration of treatment without consulting your doctor.

Does not affect the ability to drive and control vehicles.

Release Form

Tablets containing 12 mg of Polyoxidonium®. In the outline of the cell packaging of PVC film and aluminum foil. 10 pieces. In a pack of 1 or 2 packs.

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 vials of glass. At 5 amp. Or vials in a planar cell package; 1 contour cell package is placed in a cardboard box or 5 amp. Or bottles placed in a cardboard box with an insert.

50 amp. Or bottles placed in a cardboard box with an insert (for hospitals).

Vaginal or rectal suppositories 6 mg or 12 mg. In the planar cell pack 5 pcs. 2 cell packs in a cardboard bundle.

Manufacturer

OOO NPO Petrovax Pharm.

Conditions of supply of pharmacies

Lyof. And local. Approx. - on prescription.

Table., Supp. Vag./Rect. - without recipe.

Storage conditions of the drug Polyoxidonium

In dry, the dark place at a temperature of 4-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Polyoxidonium

Suppositories vaginal / rectal 6 mg - 2 years. Do not use the drug after the expiration date indicated on the package

Suppositories vaginal / rectal 12 mg - 2 years. Do not use the drug after the expiration date indicated on the package

Lyophilizate for solution for injection and topical application 3 mg - 2 years. Do not use the drug after the expiration date indicated on the package

Lyophilizate for solution for injection and topical application 6 mg - 2 years. Do not use the drug after the expiration date indicated on the package

Tablets 12 mg - 2 years. Do not use the drug after the expiry date printed on the package.

Do not use after the expiry date printed on the package.

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