Knowledge base

Polyoxidonium® studies are conducted in accordance with high international standards

The International Multicenter Clinical Study (IMCS) of the safety and efficacy of Polyoxidonium® for the treatment of COVID-19 is carried out in accordance with the WHO international protocol, which is a high standard of evidence-based medicine.

Polyoxidonium® is registered in Europe (Slovakia) and complies with all EU regulatory requirements. Besides, Polyoxidonium® is also included in the European clinical practice guidelines (Slovakia) for the treatment of coronavirus infection.

Research results

Double-blind, randomized, placebo-controlled clinical studies of efficacy and safety have shown that Polyoxidonium® as part of ARI therapy can2,3,4:

formula
decrease disease severity
decrease duration of clinical symptoms
reduce the risk of relapses
decrease the need in prolonged antibacterial therapy

For the 6-month observation period, no negative changes in the patients' condition were observed, which is indicative of a high safety profile of Polyoxidonium®.

formula
thermometer

A meta-analysis of efficacy and safety clinical studies has shown that in the treatment of infectious and inflammatory diseases of the respiratory tract, Polyoxidonium® can5:

reduce the body temperature normalization period
reduce the muscle and joint ache period

PASS

In 2017 the PASS (Post-Authorisation Safety Study) — a multicenter, prospective, open-label, non-interventional post-authorisation safety study — was completed in Europe (Slovakia)6.

502
patients
in 15
study centers took part in the study
90%
of them noticed improvement in their condition in the course of the study

The safety profile was confirmed in all categories of patients.

Polyoxidonium® is included into guidelines and supported by leading scientific organizations:

  1. Guidelines of the National Medical Association of Otorhinolaryngologists "Acute sinusitis" (approved by N.A. Daikhes and Yu.K. Yanov), 2018.
  2. Guidelines of the National Medical Association of Otorhinolaryngologists "Acute rhinitis" (approved by N.A. Daikhes and Yu.K. Yanov), 2018.
  3. Guidelines for Vaccination and Immunotherapy for ENT pathology (edited by M.P. Kostinov), 2019.
  4. Otorhinolaryngology, Standards of Medical Care, GEOTAR, 2019.
  5. Learn more

WHY POLYOXIDONIUM®?

Polyoxidonium pack
Polyoxidonium® can increase the lowered indicators of the immune system, lower the high ones and have no effect on the normal indicators. No hyperactivation of the immune system occurs7.
No cumulative effect: the drug is completely excreted from the body, mainly by the kidneys. Retreatment is possible in 3–4 months1.
Chemically pure drug, does not contain antigens of animal or plant origin, can be prescribed to patients with allergic pathologies1.
drug pack

Why Polyoxidonium®?

Polyoxidonium® is compatible with many drugs, including antibiotics, antiviral agents, cytostatics and glucocorticosteroids, antihistamines1.
High-tech production facilities operate in full compliance with Russian and international GMP standards. The company uses environmentally friendly technologies.
A positive 20-year experience of Polyoxidonium® application in various therapeutic areas proves that it has no significant side effects1.
drug pack
In case of any drug-associated adverse events or any claims to the product quality, please contact NPO Petrovax Pharm, LLC:
Or use pharmacovigilance feedback page: http://petrovax.ru/medication/safety
  1. Patient information leaflet for Polyoxidonium®.
  2. Kharit, S.M., Galustyan, A.N. (2017). Azoximer bromide is a safe and effective drug for treatment of acute upper respiratory tract infections in children: an overview of the results of double-blind, placebo-controlled, randomized clinical trials of phase II and III. Pediatrics (Appendix to Consilium Medicum), 2.
  3. Garaschenko, T.I., Karneeva, O.V., Tarasova, G.D., et al. (2020). Influence of local application of Polyoxidonium on symptoms and course of acute respiratory viral infection in children: results of multicenter double-blind placebo-controlled study. Consilium Medicum, 22(3), 80–86.
  4. Kharlamova, F.S., Uchaikin, V.F., et al. (2013). Experience of Polyoxidonium immunomodulator for the treatment of acute respiratory infections in children. Effective Pharmacotherapy. Epidemiology and Infections, 1(11), 12–20.
  5. Karaulov, A.V., Gorelov, A.V. (2019). The use of azoximer bromide for treatment of inflammatory infections of respiratory system in children: a meta-analysis of controlled clinical studies. Journal of Infectology, vol. 11, No. 4, 31–41.
  6. Pruzinec, P., Chirun, N., Sveikata, A. (2018). The safety profile of Polyoxidonium in daily practice: results from postmarketing safety study in Slovakia. Immunotherapy, 10(2), 1–7.
  7. Letter of the Russian Association of Allergologists and Clinical Immunologists concerning Polyoxidonium® application.
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