Polyoxydoñas

General characteristics. Structure:

Active agent: полиоксидоний® (Azoksimera bromide) - 3 mg or 6 mg

Excipients: Mannitolum, povidone, бетакаротен – to 4,5 mg for a dosage of 3 mg or to 9 mg for a dosage of 6 mg.

Pharmacological properties:

Полиоксидоний® possesses immunomodulatory action, increases resistance of an organism concerning local and generalized infections. A basis of the mechanism of immunomodulatory effect of the drug Polioksidoniy® is direct influence on the englobing cells and natural killers, and also antibodyformation stimulation.
Полиоксидоний® recovers immunity at the secondary immunodeficiency caused by various infections, injuries, burns, autoimmune diseases, malignant new growths, complications after surgeries, use of chemotherapeutic means, tsitostatik, steroid hormones.
Along with immunomodulatory action, Polioksidoniy® has the expressed detoksikatsionny and antioxidant activity, has ability to bring toxins, salts of heavy metals out of an organism, inhibits peroxide oxidation of lipids. The specified properties are defined by structure and the high-molecular nature of the drug Polioksidoniy®. Inclusion it in complex therapy of oncological patients reduces intoxication against the background of himio-and radiation therapy, in most cases allows to carry out standard therapy without change of the scheme in connection with development of infectious complications and side effects (a miyelosupressiya, vomiting, diarrhea, cystitis, colitis and others).
Use of the drug Polioksidoniy® against the background of secondary immunodeficiency allows to increase efficiency and to reduce treatment duration, to considerably reduce use of antibiotics, bronchial spasmolytics, glucocorticosteroids, to extend remission term.
Drug is well transferred, has no mitogenetic, polyclonal activity, antigenic properties, does not render allergenic, mutagen, embriotoksichesky, teratogenic and cancerogenic action.

PHARMACOKINETICS. At intramuscular introduction of Polioksidoniy® has high bioavailability (89%); time of achievement of the maximum concentration in blood - 40 minutes; it is quickly distributed on all bodies and fabrics. The semi-distribution period in an organism (a bystry phase) – 0,44 hours, an elimination half-life (a slow phase) - 36,2 hours. In an organism drug is hydrolyzed to oligomers which are removed preferential by kidneys.

Indications to use:

Correction of immunity at adults and children of 6 months.
At adults in complex therapy:

• the chronic recurrent infectious and inflammatory diseases which are not giving in to standard therapy in a stage of an aggravation and in a remission stage;
• acute and persistent viral and bacterial infections (including urogenital infectious and inflammatory diseases);
• tuberculosis;
• the acute and chronic allergic diseases (including a pollinosis, bronchial asthma, atopic dermatitis) complicated by a persistent recurrent bacterial and viral infection;
• in oncology in process and after himio-and radiation therapy for decrease immunosuppressive, нефро - and a hepatotoxic action of medicines;
• for activation of regenerator processes (fractures, burns, trophic ulcers);
• a pseudorheumatism, it is long treated immunodepressants; at the current of a pseudorheumatism complicated by ORZ;
• for prevention of postoperative infectious complications;
• for prevention of flu and ORZ
At children in complex therapy:

• the acute and chronic inflammatory diseases caused by causative agents of bacterial, viral, fungal infections (including. ENT organs - sinusitis, rhinitis, an adenoiditis, a hypertrophy of a pharyngeal almond, a SARS);
• acute allergic and toksiko-allergic states;
• the bronchial asthma complicated by persistent infections of a respiratory path;
• the atopic dermatitis complicated by a purulent infection;
• an intestinal dysbiosis (in a combination to specific therapy);
• for rehabilitation it is frequent and long ill;
• prevention of flu and ORZ.

Route of administration and doses:

Drug Polioksidoniy® routes of administration: parenteral, intranasal. Routes of administration are chosen the doctor depending on disease severity and age of the patient.

Intramusculary or intravenously (kapelno): 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.
For intramuscular introduction contents of an ampoule or a bottle dissolve in 1,5-2 ml 0,9% of solution of sodium of chloride or water for injections. For intravenous (drop) administration drug Gemodeza-N, Reopoliglyukina or 5% of solution of a dextrose dissolve in 2 ml 0,9% of solution of sodium of chloride, then sterilely transfer to a bottle with the specified solutions of 200-400 ml.
The prepared solution for parenteral administration is not subject to storage.
Intranazalno: the dose of 6 mg is dissolved in 1 ml (20 drops) of the distilled water, by 0,9% of solution of sodium chloride or boiled water of room temperature.

The recommended schemes of treatment of adults
Parenterally:

• At acute inflammatory diseases: on 6 mg daily within 3 days, further every other day the general course of 5-10 injections.
• At chronic inflammatory diseases: on 6 mg every other day 5 injections, further 2 times a week a course not less than 10 injections.
• At tuberculosis: on 6-12 mg 2 times a week a course of 10-20 injections.
• At patients with acute and chronic urogenital diseases: on 6 mg every other day a course of 10 injections in combination with himiopreparata.
• At chronic recurrent herpes: on 6 mg every other day a course of 10 injections in combination with antiviral drugs, interferona and/or inductors of synthesis of interferon.
• For treatment of the complicated forms of allergic diseases: on 6 mg, a course of 5 injections: two first injections daily, then every other day. At acute allergic and toksiko-allergic states to enter intravenously 6-12 mg in combination with antiallergic drugs.
• At a pseudorheumatism: on 6 mg every other day 5 injections, further 2 times a week a course not less than 10 injections.

At oncological patients:
• to and against the background of chemotherapy for decrease immunodepressive, gepato-and nephrotoxic action of chemotherapeutic means on 6-12 mg every other day a course not less than 10 injections; further the frequency of introduction is defined by the doctor depending on portability and duration himio-and radiation therapy;
• for prevention of immunodepressive influence of a tumor, for correction of an immunodeficiency after himio-and radiation therapy, after a surgical oncotomy prolonged use of the drug Polioksidoniy® (from 2-3 months to 1 year) on 6-12 mg 1-2 times a week is shown.
At patients with an acute renal failure appoint not more often 2 weekly.

Intranazalno is appointed on 6 mg a day for treatment of acute and persistent infections of ENT organs, for strengthening of regenerator processes of mucous membranes, for prevention of complications and a recurrence of diseases, for prevention of flu and ORZ. On 3 drops in each nasal course in 2-3 hours (3 times a day) within 5-10 days.

ROUTES OF ADMINISTRATION AND DOSES FOR CHILDREN
Drug Polioksidoniy® routes of administration: parenterally, intranazalno, sublingual. Routes of administration are chosen the doctor depending on the diagnosis, disease severity, age and the body weight of the patient.

Parenterally drug appoint to children of 6 months in a dose of 3 mg (intramusculary or intravenously kapelno 0,1-0,15 mg/kg) daily, every other day or 2 times a week a course of 5-10 injections (calculation of a dose is specified in the table).
For intramuscular introduction drug is dissolved in 1 ml of water for injections or 0,9% chloride sodium solution.
For intravenous drop administration drug is dissolved in 1,5-2 ml sterile 0,9% of solution of sodium of chloride, Reopoliglyukin, by Gemodeza-N or 5% of solution of a dextrose, sterilely transfer to a bottle with the specified solutions of 150-250 ml.
Intranazalno and it is sublingual: daily in a daily dose of 0,15 mg/kg within 5-10 days. The drug is administered on 1-3 drops in one nasal course or under language in 2-3 hours.
For preparation of solution for intranasal and sublingual use the dose of 3 mg is dissolved in 1 ml (20 drops), a dose of 6 mg - in 2 ml of the distilled water, 0,9% of solution of sodium chloride or boiled water of room temperature. One drop of the prepared solution (50 мкл) contains 0,15 mg of Polioksidoniy® who appoint to 1 kg of body weight of the child.
To store solution for sublingual and intranasal use in the refrigerator no more than 7 days. Before use the pipette with solution has to be heated to room temperature (20-25 about C).

The recommended schemes of treatment of children
• At acute inflammatory diseases: on 0,1 mg/kg every other day a course of 5-7 injections.
• At chronic inflammatory diseases: on 0,15 mg/kg 2 times a week a course to 10 injections.
• At acute allergic and toksiko-allergic states: intravenously kapelno in a dose of 0,15 mg/kg in combination with antiallergic drugs.
• For treatment of the complicated forms of allergic diseases in combination with basic therapy: intramusculary on 0,1 mg/kg a course of 5 injections with an interval of 1-2 days.

Intranazalno is entered on 1-3 drops into one nasal course in 2-3 hours (2-4 times a day). For intranasal and sublingual introduction calculation of a daily dose for children is presented in the table.

Child's weight	Quantity of drops in days	The volume of the entered solution in ml
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: according to all indications - daily in a daily dose of 0,15 mg/kg within 10 days, for treatment of an intestinal dysbiosis within 10-20 days. 1-3 drops under language in 2-3 hours drip.

Features of use:

At morbidity in the place of an injection drug dissolve in 1 ml 0,25% of solution of Procainum in case of absence at the patient of the increased individual sensitivity on Procainum. At intravenous (drop) administration it is not necessary to dissolve in protein-bearing infusion solutions.

Side effects:

Morbidity in the place of an injection at intramuscular introduction is possible.

Interaction with other medicines:

Полиоксидоний® it is compatible to antibiotics, antiviral, antifungal and antihistaminic drugs, bronchial spasmolytics, glucocorticosteroids, cytostatics.

Contraindications:

The increased individual sensitivity. Pregnancy, a lactation (clinical experience of use is absent).

WITH CARE
Acute renal failure, children's age up to 6 months (clinical experience of use is limited).

Overdose:

It is not described.

Storage conditions:

List B.
In dry, protected from light, the place, unavailable to children, at a temperature from 4 to 8 °C.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for injections and topical administration on 4,5 mg (for a dosage of 3 mg), on 9 mg (for a dosage of 6 mg) in ampoules or bottles from glass of 1 hydrolytic class. On 5 ampoules or bottles in a blister strip packaging.

On one blister strip packaging together with the application instruction in a pack from a cardboard bandbox or on 5 ampoules or bottles together with the application instruction in a pack from a cardboard bandbox with an insert from a cardboard bandbox.

On 50 ampoules or bottles together with 10 application instructions in a box with partitions from a cardboard (for hospitals).