Polioksidonija

Active material: Azoksimera bromide
When ATH: L03AX
CCF: Immunostimulatory drug
ICD-10 codes (testimony): A15, A18, B00, B02, I83.2, J00, J01, J03, J04, J06.9, J10, J30.1, J31, J32, J35.0, J37, J45, K63, L20.8, L30.3, M05, N10, N11, N30, N34, N41, N70, N71, N72, T14, T30, Z29.8
When CSF: 14.01.06
Manufacturer: NGOs Petrovax Pharm Ltd. (Russia)

Pharmaceutical form, composition and packaging

Lyophilisate for solution for injection and topical a porous mass of white with a yellowish tint to yellow.

Excipients: mannitol, povidone, betakaroten.

The ampules (5) – packs cardboard.
The ampules (5) – packings Valium planimetric (1) – packs cardboard.
The ampules (5) together with the solvent (water d / and – amp.) – packs cardboard.

Lyophilisate for solution for injection and topical a porous mass of white with a yellowish tint to yellow.

Excipients: mannitol, povidone, betakaroten.

Bottles (5) – packs cardboard.
Bottles (5) – packings Valium planimetric (1) – packs cardboard.
Bottles (5) together with the solvent (0.9% rr sodium chloride – amp.) – packs cardboard.
Bottles (5) together with the solvent (water d / and – amp.) – packs cardboard.

Lyophilisate for solution for injection and topical a porous mass of white with a yellowish tint to yellow.

Excipients: mannitol, povidone, betakaroten.

The ampules (5) – packs cardboard.
The ampules (5) – packings Valium planimetric (1) – packs cardboard.
The ampules (5) together with the solvent (water d / and – amp.) – packs cardboard.

Lyophilisate for solution for injection and topical a porous mass of white with a yellowish tint to yellow.

Excipients: mannitol, povidone, betakaroten.
Bottles (5) – packs cardboard.
Bottles (5) – packings Valium planimetric (1) – packs cardboard.
Bottles (5) together with the solvent (water d / and – amp.) – packs cardboard.
Bottles (5) together with the solvent (0.9% rr sodium chloride – amp.) – packs cardboard.

Pharmacological action

Immunomodulatory drugs. It increases the body's resistance against local and generalized infections. The basis of the mechanism of immunomodulatory effects Polyoxidonium^® It is a direct effect on the phagocytic cells and natural killer cells, as well as the stimulation of antibody production.

It restores immune responses in secondary immunodeficiency, caused by various infections, injuries, burns, malignant neoplasms, complications after surgery, the use of chemotherapeutic agents (in t. no. cytostatics, steroid hormone).

Along with immunomodulatory effects Polyoxidony^® It has expressed detoxification activity, which is determined by the structure and nature of the preparation of high molecular. It improves the stability of cell membranes to the cytotoxic effects of drugs and chemicals, reduces their toxicity.

Application Polyoxidonium^® in combination therapy can improve efficiency and reduce the duration of treatment, significantly reduce the use of antibiotics, bronchospasmolytics, GCS, increase the period of remission.

The drug does not have mitogenic, polyclonal activity, antigenic properties, It has no allergenic, mutagenic, embriotoksicski, teratogenic and carcinogenic effects.

Pharmacokinetics

Absorption

The bioavailability of the drug in the / m introduction of 89%. After the / m of the time to reach C_max in plasma is 40 m.

Distribution

Rapidly distributed in all organs and tissues. Period poluraspredeleniya in the body with a / in the introduction of 25 m.

Metabolism and excretion

In the body, the drug is hydrolyzed to oligomers, which are derived mainly kidneys. T_1/2 (b-фаза) with a / in the introduction of 25.4 no, when i / m administration – 36.2 no.

Testimony

Adult (6 mg)

In the combined therapy:

- Chronic recurrent inflammatory diseases of different etiologies, not amenable to standard therapy, both in the acute stage, and in remission;

- Rheumatoid arthritis in long-term immunosuppressive treatment;

- Rheumatoid arthritis, complicated by acute respiratory infections or ARI;

- Acute and chronic viral and bacterial infections (incl. urogenital infectious and inflammatory diseases);

- Tuberculosis;

- Acute and chronic allergic diseases (incl. pollen disease, bronchial asthma, atopic dermatitis), complications of chronic recurrent bacterial and viral infections;

- During and after chemo- and radiotherapy of tumors;

- To reduce nephrotoxicity- and hepatotoxic drugs;

- To activate regenerative processes (fractures, burns, sores).

In monotherapy:

- For the prevention of postoperative infectious complications;

- For the correction of secondary immunodeficiency, arising as a result of aging or exposure to adverse factors;

- For the prevention of influenza and acute respiratory infections.

Children 6 months and older (3 mg)

In the combined therapy:

- Acute and chronic infectious and inflammatory diseases, caused by bacterial pathogens, Viral, fungal infections (incl. ENT – sinusitis, rhinitis, adenoiditis, hypertrophy of pharyngeal tonsil, SARS);

- Acute allergic and toxic-allergic states;

- Bronchial asthma, complications of chronic infections of the respiratory system;

- Atopic dermatitis, complicated by purulent infection;

- Intestinal dysbiosis (in combination with specific therapy);

- Rehabilitation and often chronically ill children;

- Prevention of influenza and acute respiratory infections.

Dosage regimen

Doses and route of administration sets physician according to the diagnosis, severity of the disease, the patient's age.

Adult

V / m or / (drop)

At acute inflammatory diseases the drug is prescribed in a dose 6 mg daily for 3 days, further – in one day, general course – 5-10 injection.

At chronic inflammatory diseases administered at a dose of 6 mg a day, conduct 5 injection, further – 2 times a week, course – no less 10 injection.

At tuberculosis administered at a dose of 6 mg 2 times a week, course – 10-20 injection.

At revmatoidnom ARTHRO administered at a dose of 6 mg a day, conduct 5 injection, further – 2 times a week, course – no less 10 injection.

At acute and chronic diseases of the urogenital administered at a dose of 6 mg a day, course – 10 injection in combination with chemotherapy.

At chronic recurrent herpes – dose 6 mg a day, course – 10 injection in combination with antiviral drugs, interferon and inducers of interferon synthesis.

To treatment of complicated forms of allergic diseases administered at a dose of 6 mg, course – 5 injection (The first two injections daily, then – in one day).

At acute allergic and toxic-allergic states the drug is administered in / on 6-12 mg in combination with anti-allergic drugs (incl. with clemastine).

Before and during chemotherapy to reduce the immunosuppressive, scarp- and nephrotoxic action of chemotherapeutic agents the drug is prescribed in a dose 6-12 mg a day, course – no less 10 injection.

To reduce the possible immunosuppressive effect, caused tumor process, and for the correction of immunodeficiency after chemo- and radiation therapy, after surgical removal of the tumor the drug is prescribed in a dose 6 mg 1-2 times a week, It shows long-term use (from 2-3 Months before 1 year).

Patients with acute renal failure drug appoint no more 2 once a week.

Terms of solution for injection

To prepare the solution for the / m of the contents of the vial or ampoule 6 mg dissolved in 1.5-2 ml 0.9% sodium chloride solution or water for injection.

To prepare the solution for I / (Drip) the introduction of the contents of the vial or ampoule 6 mg dissolved in 3 ml 0.9% sodium chloride solution, gemodeza, reopoliglyukina or 5% dextrose, then aseptically transferred to a vial containing said solution volume 200-400 ml.

A solution for parenteral administration must not be stored.

Intranasal

To treatment of acute and chronic infectious diseases of upper respiratory tract, enhance the regenerative processes of the mucous membranes, prevention of complications and recurrence of disease, prevention of influenza and acute respiratory infections appoint 1-3 drop. in each nostril at intervals 2-3 no (no less 3-4 time / day) during 5-10 d.

Terms of a solution for topical use

To prepare the solution for local (intranasal) applications 6 mg of lyophilisate was dissolved in 1 ml distilled water, 0.9% sodium chloride solution or boiled water at room temperature (20 drop.) and used within one day.

Children 6 months and older

V / m or / (drop)

At acute inflammatory diseases the drug is prescribed in a dose 100 mg / kg every other day, course – 5-7 injection.

At chronic inflammatory diseases the drug is prescribed in a dose 150 mg / kg 2 times a week, course – to 10 injection.

At acute allergic and toxic-allergic states the drug is introduced into / in the drip in the dose 150 mg / kg in combination with anti-allergic drugs (incl. with clemastine).

To treatment of complicated forms of allergic diseases combined with basic therapy drug is introduced into / m at a dose 100 ug / kg every 1-2 day, course – 5 injection.

Terms of solution for injection

To prepare the solution for the / m of the contents of the vial or ampoule 3 mg dissolved in 1 ml water for injection or 0.9% sodium chloride solution.

To prepare the solution for the on / in the contents of the vial or bottle 3 mg dissolved in 1.5-2 ml sterile 0.9% sodium chloride solution, polyglucin, gemodeza or 5% dextrose, aseptically transferred to a vial containing said solution volume 150-250 ml.

Intranasal

Polyoxidony^® administered daily at a daily dose of 150 ug / kg body weight for 5-10 days. The solution is instilled by 1-3 drop. in each nostril at intervals 2-3 no (no less 3-4 time / day).

Terms of a solution for topical use

To prepare the solution for local (intranasal) the use of dose 3 mg dissolved in 1 ml (20 drop.), dose 6 mg – in 2 ml distilled water, 0.9% sodium chloride solution or boiled water at room temperature. One drop of this solution (50 l) contains 150 g azoksimera bromide.

Solution for local application should be stored in the refrigerator 7 days. Before using the pipette solution must be heated to room temperature (20-25° C).

Calculation of daily doses for children:

Side effect

Local reactions: tenderness at the injection site when the / m introduction.

Contraindications

- Pregnancy (there is no clinical experience with);

- Individual hypersensitivity to the drug.

FROM caution should be prescribed for acute renal failure, as well as children under the age of 6 Months (clinical experience is limited).

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (clinical experience is limited).

Cautions

When the pain at the injection site with the / m introduction of the drug is dissolved in 1 ml 0.25% procaine solution in the absence of the patient increased individual sensitivity to procaine.

The patient should be informed, that do not exceed the recommended dose and duration of treatment without consulting your doctor.

Overdose

Currently, cases of drug overdose Polyoxidony^® not reported.

Drug Interactions

Polyoxidony^® compatible with antibiotics, antiviral, antifungal and antihistamines, bronholitikami, GCS, cytostatics.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. Lyophilisate for solution for injection and topical application should be stored in a dry, protected from light, reach of children, at a temperature of 4 ° to 8 ° C.. Shelf life – 2 year.