Polyoxidonium lyophilizate for preparation of solution for injection 6mg 5ml vials, 5pcs

Composition

Composition for 1 ampoule or bottle:

Active ingredient:  

Polyoxidonium® (Azoximer bromide) – 6 mg

Auxiliary substances:  

mannitol,

povidone,

betacarotene – up to 9 mg

Pharmacological action

Pharmacotherapeutic group:

immunomodulatory agent

ATX Code: [L0 H]

PHARMACOLOGICAL ACTION

Polyoxidonium® has an immunomodulatory effect, increases the body’s resistance to local and generalized infections. The mechanism of immunomodulatory action of Polyoxidonium® is based on direct action on phagocytic cells and natural killers, as well as stimulation of antibody formation.

Polyoxidonium® restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, burns, autoimmune diseases, malignant neoplasms, complications after surgery, the use of chemotherapeutic agents, cytostatics, and steroid hormones.

Along with the immunomodulatory effect, Polyoxidonium® has a pronounced detoxification and antioxidant activity, has the ability to remove toxins, heavy metal salts from the body, and inhibits lipid peroxidation. These properties are determined by the structure and high-molecular nature of Polyoxidonium®.

Its inclusion in the complex therapy of cancer patients reduces intoxication on the background of chemo and radiation therapy, in most cases allows for standard therapy without changing the scheme due to the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, and others).

The use of Polyoxidonium® against the background of secondary immunodeficiency conditions can increase the effectiveness and shorten the duration of treatment, significantly reduce the use of antibiotics, bronchodilators, glucocorticosteroids, and extend the remission period.

The drug is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergizing, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

PHARMACOKINETICS

When administered intramuscularly, Polyoxidonium® has a high bioavailability (89%); the time to reach the maximum concentration in the blood is 40 minutes; it is quickly distributed to all organs and tissues. The half-life in the body (fast phase) is 0.44 hours, the half-life (slow phase) is 36.2 hours. In the body, the drug is hydrolyzed to oligomers, which are mainly excreted by the kidneys.

Indications

Correction of immunity in adults and children from 6 months.

In adults in complex therapy:

• chronic recurrent infectious and inflammatory diseases that do not respond to standard therapy in the acute and remission stages•

* acute and chronic viral and bacterial infections (including urogenital infectious and inflammatory diseases);

• tuberculosis;

• acute and chronic allergic diseases (including hay fever, asthma, atopic dermatitis), complicated by recurrent bacterial and viral infection;

• in Oncology during and after chemotherapy and radiation therapy to reduce immunosuppressive, nephrotoxicity and hepatotoxicity of drugs;

• to activate regenerative processes (fractures, burns, trophic ulcers);

• for long-term treatment of rheumatoid arthritis with immunosuppressants; for acute respiratory infections complicated by rheumatoid arthritis;

* for the prevention of postoperative infectious complications;

• for the 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 respiratory tract – sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, SARS);

• acute allergic and toxic-allergic conditions;

• bronchial asthma complicated by chronic infections of the respiratory tract;

• atopic dermatitis, complicated by purulent infection;

• intestinal dysbacteriosis (in combination with specific therapy);

• rehabilitation and often chronically ill;

• the prevention of influenza and acute respiratory infections.

Use during pregnancy and lactation

Polyoxidonium is contraindicated in pregnancy, breast-feeding and children under 6 months of age (there is no clinical experience with its use).

Contraindications

Increased individual sensitivity. Pregnancy, lactation (no clinical experience of use).

WITH CAUTION

Acute renal failure, children under 6 months of age (limited clinical experience).

Side effects

Possible soreness at the injection site when administered intramuscularly.

Interaction

Polyoxidonium® is compatible with antibiotics, antiviral, antifungal and antihistamines, bronchodilators, glucocorticosteroids, cytostatics.

How to take, course of use and dosage

DOSAGE AND use FOR ADULTS

Methods of use of Polyoxidonium®: parenteral, intranasal. Methods of application are chosen by the doctor depending on the severity of the disease and the age of the patient.

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

For intramuscular use, the contents of the ampoule or vial are dissolved in 1.5-2 ml of 0.9% sodium chloride solution or water for injection. For intravenous (drip) use, the drug is dissolved in 2 ml of 0.9% sodium chloride solution, Hemodesis-H,

RheoPolyglukine or 5% dextrose solution, then sterile transferred to a bottle with these solutions of 200-400 ml.

The prepared solution for parenteral use 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 adult treatment regimens

Parenterally:

For acute inflammatory diseases: 6 mg daily for 3 days, then every other day with a general course of 5-10 injections.

For chronic inflammatory diseases: 6 mg every other day for 5 injections, then 2 times a week with a course of at least 10 injections.

For tuberculosis: 6-12 mg 2 times 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 drugs.

For 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, a course of 5 injections: the first two injections daily, then every other day. In acute allergic and toxic-allergic conditions, enter intravenously 6-12 mg in combination with anti-allergic drugs.

For rheumatoid arthritis: 6 mg every other day for 5 injections, then 2 times a week with a course of at least 10 injections.

In cancer patients:

before and during chemotherapy to reduce immunosuppressive, hepato – and nephrotoxic action of chemotherapeutic agents for 6-12 mg a day rate of at least 10 injections; further, the frequency of use is determined by the doctor depending on tolerability and duration of chemotherapy and radiation therapy;

– to prevent the immunosuppressive effects of the tumor, for the correction of immunodeficiency after chemotherapy and radiotherapy after surgical removal of the tumor is shown prolonged use of the drug Polyoxidonium® (from 2-3 months to 1 year) 6-12 mg 1-2 times a week.

In patients with acute renal failure, it is prescribed no more than 2 times a week.

Intranasally prescribed 6 mg per day for the treatment of acute and chronic infections of ENT organs, to enhance the regenerative processes of the mucous membranes, for the prevention of complications and relapses of diseases, for the prevention of influenza and acute respiratory infections. 3 drops in each nasal passage after 2-3 hours (3 times a day) for 5-10 days.

DOSAGE AND use FOR CHILDREN

Methods of use of Polyoxidonium®: 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 to children from 6 months in a dose of 3 mg (intramuscularly or intravenously drip 0.1-0.15 mg / kg) daily, every other day or 2 times a week with a course of 5-10 injections (the dose calculation is indicated in the table).

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

For intravenous drip use, the drug is dissolved in 1.5-2 ml of a sterile 0.9% solution of sodium chloride, RheoPolyglukin, Hemodez-H or 5% dextrose solution, and sterically transferred to a vial with these solutions of 150-250 ml.

Intranasally and sublingually: 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% sodium chloride solution or boiled water at room temperature. One drop of the prepared solution (50 µl) contains 0.15 mg of Polyoxidonium®, which is prescribed for 1 kg of the child’s body weight.

Solution for sublingual and intranasal use should be stored in the refrigerator for no 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

• In 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 a course of up to 10 injections.

* For acute allergic and toxic-allergic conditions: intravenous drip at a dose of 0.15 mg / kg in combination with anti-allergic drugs.

• For the treatment of complicated forms of allergic diseases in combination with basic therapy: intramuscularly at 0.1 mg/kg in a course of 5 injections with an interval of 1-2 days.

Intranasally,1-3 drops are administered in one nasal passage after 2-3 hours (2-4 times a day). For intranasal and sublingual use, the calculation of the daily dose for children is presented in the table.

5 kg-5 drops 0.25 ml

10 kg – 10 drops 0.5 ml

15 kg – 15 drops 0.75 ml

20 kg – 20 drops 1.00 ml

Sublingual: 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 after 2-3 hours.

Overdose

Not described.

Special instructions

If there is pain at the injection site, the drug is dissolved in 1 ml of 0.25% procaine solution if the patient does not have an increased individual sensitivity to procaine. When administered intravenously (drip), it should not be dissolved in protein-containing infusion solutions.

Form of production

Lyophilizate for solution preparation for injection and topical application

Storage conditions

Store in a dry place at a temperature of 2 to 8 °C.

Keep out of the reach of children.

Shelf life

2 years

Active ingredient

Azoximer bromide

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children as prescribed by a doctor, Children over 6 months of age, Adults as prescribed by a doctor

Indications

Bronchial asthma, Immunodeficiency states, Chronic infections