Polyoxidonium lyophilisate for preparation for injection 3 mg 5 ml vials 5 pcs. (Azoksymera bromide)

Latin name

Polyoxidonium

Release form

lyophilisate for injection and topical solution.

Packaging

5 vials of 5 ml.

Indications

It is used in adults and children from 6 months for the treatment and prevention of infectious and bacterial infections of the bacterial and bacterial infections , in the stage of exacerbation and remission.

For the treatment of adults (in complex therapy):

of chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology in the acute stage of

acute viral, bacterial infections of the ENT organs, 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 infections of

malignant tumors during and after chemo- and radiation therapy to reduce the immunosuppressive, nephro- and hepatotoxic effects of

drugs of generalized forms of surgical infections to activate regenerative processes (fractures, burns , trophic ulcers)

rheumatoid arthritis, complicated by bacterial, viral and fungal infections, against the background of long-term administration of immunosuppressants

tube rkuleza lungs.

For the treatment of children older than 6 months (in complex therapy):

of acute and exacerbation of chronic inflammatory diseases of any localization (including ENT organs - sinusitis, rhinitis, adenoiditis, pharyngeal tonsil hypertrophy, acute respiratory viral infections) caused by bacterial pathogens, viral, fungal infections

acute allergic and toxic-allergic conditions, complicated by bacterial, viral and fungal infections

bronchial asthma, complicated by chronic infections of the respiratory tract

atopic dermatitis, complicated by purulent infection

dysbacteriosis with intestinal therapy (in combination.

For prevention (monotherapy) in children over 6 months of age and adults:

influenza and SARS

postoperative infectious complications.

Contraindications

Increased individual sensitivity

Pregnancy, lactation

Children under 6 months of age

Acute renal failure.

Precautions

- chronic renal failure (used no more than 2 times a week).

Use during pregnancy and lactation

The use of the drug PolyoxidoniumВ® is contraindicated for pregnant women and women during breastfeeding (there is no clinical experience with the use).

In an experimental study of the drug PolyoxidoniumВ® in animals, there was no effect on the generative function (fertility) of males and females, embryotoxic and teratogenic effects, effects on the development of the fetus, both during administration of the drug throughout pregnancy and during lactation.

Composition

Composition per 1 vial:

Active ingredient:

Azoximer bromide - 3 mg

Excipients:

mannitol - 0.9 mg,

povidone K 17 - 0.6 mg.

Dosing and Administration

Dosing and Administration Polyoxidonium®: parenteral, intranasal, sublingual.

Dosage, dosage, necessity and frequency of subsequent courses of therapy are selected by the doctor depending on the severity of the disease and the age of the patient.

Preparation of solutions for parenteral administration (intramuscularly and intravenously):

For intramuscular administration, Polyoxidonium® 3 mg is dissolved in 1 ml

(dose 6 mg in 2 ml) of water for injection or 0.9% sodium chloride solution. After introducing the solvent, the drug is left for 2-3 minutes to swell, then mixed with rotational movements, without shaking.

For intravenous drip, Polyoxidonium® is dissolved in 2 ml of a sterile 0.9% sodium chloride solution. After introducing the solvent, the drug is left for 2-3 minutes to swell, then mix with rotational movements. The dose calculated for the patient is sterilely transferred to the vial /

vial with 0.9% sodium chloride solution.

The prepared solution for parenteral administration is not subject to storage.

Preparation of a solution for intranasal and sublingual administration:

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) the prepared solution contains 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 adults

Parenteral (intramuscular or intravenous): the drug is prescribed to adults in doses of 6-12 mg 1 time per day, every other day or 1-2 times a week, depending on the diagnosis and severity of the disease.

In acute viral and bacterial infections of the ENT organs, upper and lower respiratory tract, gynecological and urological diseases: 6 mg daily for 3 days, then every other day with a course of 10 injections.

In chronic recurrent infectious and inflammatory diseases of various 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 hay fever, asthma, atopic dermatitis), complicated by bacterial, viral and fungal infections: 6-12 mg, 5 injections.

For rheumatoid arthritis complicated by bacterial, viral and fungal infections, against the background of prolonged use of immunosuppressants: 6 mg every other day

5 injections, then 2 times a week with a course of 10 injections.

For 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, with a course of 10 injections.

For the prevention of postoperative infectious complications: 6 mg every other day 5 injections.

For pulmonary tuberculosis: 6 mg 2 times a week with a course of 20 injections.

In cancer patients:

- before and during chemotherapy to reduce immunosuppressive, the hepato- and nephrotoxic effects of chemotherapeutic agents of 6 mg every other day with a

course of 10 injections, then the frequency of administration is determined by the doctor depending on the tolerance and duration of

chemotherapy and radiation therapy - to prevent the immunosuppressive effect of the tumor, to correct immunodeficiency after chemotherapy and radiation therapy, after surgical removal of the tumor, the long-term use of the drug Polyoxidonium® (from 2-3 months to 1 year) is shown at 6 mg 1-2 times a week. When prescribing a long course, the effect of cumulation, toxicity and addiction are not observed.

Intranasal administration of 6 mg per day (3 drops in each nasal passage 3 times a day - for 10 days):

- for the treatment of acute and exacerbations of chronic infections of the ENT organs

- to enhance the regenerative processes of the mucous membranes of

- for the prevention of complications and relapses 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 application are chosen by the doctor depending on the severity of the disease and the age of the patient.

Parenteral (intramuscular or intravenous): prescribed for children from 6 months old at a dose of 0.1-1.15 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 in a course of up to 10 days.

The drug is administered 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.

Calculation of the daily dose for intranasal and sublingual administration is presented in Table 1.

Table 1. Calculation of the daily dose of Polyoxidonium® for intranasal or sublingual administration in children.

Weight of a child

Number of drops per day

5 kg

5 drops

10 kg

15 drops

15 drops

20 kg

20 drops

For a child’s body weight of more than 20 kg, the daily dose per 1 calculation is made from 1 drop from 1 kg body weight, but not more than 40 drops (6 mg of active substance).

The prepared solution for intranasal and sublingual administration can be stored at room temperature in the manufacturer's packaging for up to 48 hours.

Recommended treatment regimens for children:

Parenteral:

For acute and exacerbation of chronic inflammatory diseases of any localization (including ENT organs - sinusitis, rhinitis, adenoiditis, pharyngeal tonsil hypertrophy, SARS) caused by bacterial, viral, fungal pathogens infections: 0.1 mg / kg 3 days in a row, then every other day with a course of 10 injections.

In acute allergic and toxic-allergic conditions (including bronchial asthma, atopic dermatitis) complicated by bacterial, viral and fungal infections: intravenous drip at a dose of 0.1 mg / kg, 3 days daily, then every other day, with a course of 10 injections in combination with basic therapy.

Intranasal: 1-2 drops daily in each nasal passage 3 times a day for up to 10 days (see calculation of the daily dose for intranasal and sublingual administration in table 1):

For acute and chronic rhinitis, rhinosinusitis, adenoiditis (treatment and exacerbation prevention)

For preoperative preparation of patients with surgical interventions for ENT pathology, as well as in the postoperative period with the aim of preventing infectious complications or relapses of the

disease Treatment and prevention of influenza and other acute respiratory viral infections ( within 1 month before the expected epidemic), at any time after the onset of the disease and during convalescence)

Sublingual, for children of early, preschool and primary school age: daily in a daily dose of 0.15 mg / kg in 2 divided doses for 10 days:

With adenoiditis, tonsil hypertrophy: (as a component of conservative treatment)

For preoperative preparation and postoperative rehabilitation of

For seasonal prevention of exacerbations of chronic foci of infections of the oropharynx, upper respiratory tract, inner and middle ear

For the treatment of intestinal dysbiosis (in combination with basic therapy) for 10 days .

Side effects of

When using the drug Polyoxidonium®, the following general and local reactions were found:

Not often: at the injection site - soreness, redness and tightening of the skin.

Very rare: fever up to 37.3 ° C, slight anxiety, chills during the first hour after injection, allergic reactions.

Drug Interaction

Azoximer bromide does not inhibit isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, cytochrome P-450, so the drug is compatible with many medicines, including antibiotic, antimicrobials, antibiotics

Overdose

Not described.

Storage conditions

In a dry place at a temperature of 2 to 8 ° C. Keep out of the reach of children.

Expiration

2 years. Do not use after the expiry date stated on the packaging.

Deystvuyuschee substances

Azoksymera bromide

Terms of delivery from

pharmacies Prescription

dosage form

dosage form

p injection solution

NPO Petrovaks Pharm, Russia



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