Polyoxidonium [injection] 6mg x 5 vials

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Trade name: Polyoxidonium®

International Nonproprietary Name: Azoximer bromide

Chemical name: copolymer of N-oxide 1,4-ethylene piperazine and (N- carboxymethyl)-1,4- ethylene piperazinium bromide

Drug form: lyophilizate for solution for injections and topical application

Composition per ampoule or flask: Active substance: azoximer bromide – 3 mg or 6 mg

Excipients: mannitol – 0.9 mg, povidone K17– 0.6 mg (for 3 mg dosage); mannitol – 1.8 mg, povidone K17–1.2 mg (for 6 mg dosage).

Description: porous white with a yellowish tint mass

Pharmaco-therapeutic group: immune modulator

PHARMACOLOGICAL PROPERTIES Polyoxidonium® possesses an immune modulating action, increases the organism resistance to local and general infections. Polyoxidonium’ main mechanism of action is the direct effect on the phagocytic cells and natural killers together with antibody production stimulation. Polyoxidonium® recovers the immunity in different secondary deficiencies caused by different infections, traumas, burns, malignant neoplasm, post-surgical complications, chemotherapy, cytostatics, and steroid hormones. Together with the immune modulating properties Polyoxidonium® possesses an expressed detoxicating and antioxidant properties; is able to eliminate toxins, heavy metals ions from the organism, and inhibits the lipid peroxidation. All propertied mentioned are determined by Polyoxidonium structure and high molecular nature. Polyoxidonium® inclusion into the chemotherapy of oncologic patients results in therapy-induced intoxication alleviation, and allows to perform complete standard chemo- or radiotherapy cycle without infection complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis etc.) that are often the reason for therapy preterm termination. Polyoxidonium application for secondary immune deficiencies allows to increase therapy efficacy and to shorten its duration, significantly to reduce the antibiotics, broncholitics, clucocorticoids application, and to lengthen the remission period. The preparation is well tolerated, has no mitogenic, polyclonal activity, free from antigen properties, and has no allergenic, mutagenic, embryo toxic, teratogenic and carcinogenic potential.

PHARMACOKINETICS After intramuscular injection Polyoxidonium has high bioavailability (about 86%). Polyoxidonium maximal blood plasma concentration is achieved 40 minutes after the application. Polyoxidonium is rapidly distributed into all organs and tissues; half-distribution period is 0.44 hours for quick phase, and 36.2 hours for slow (half-elimination) phase. In the organism drug is hydrolyzed to oligomers that are eliminated primarily by kidneys.

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