Knowledge base
Knowledge baseAccording to the results of international studies, Polyoxidonium is recognized as safe for all groups of patients and is included in the clinical recommendations not only in Russia, but also in Slovakia.
Randomized, placebo-controlled, double-blind clinical trials to evaluate efficacy and safety have shown that, in the therapy of ARVI, Polyoxidonium contributes to (2, 3, 4):
Within a randomized, placebo-controlled, double-blind trial of Polyoxidonium, patients were monitored for 6 months. The trial included children with acute respiratory infections. During the study, no negative changes in their health condition were observed, which may indicate a high safety profile of the Polyoxidonium drug.
A meta-analysis of efficacy and safety clinical trials showed that, in the therapy of inflammatory infections of the respiratory tract, Polyoxidonium (5):
In 2017, a PASS study (Post Authorisation Safety Study) — a multicenter, prospective, open-label, non-interventional, post-authorization safety study was completed in Europe (Slovakia) (6).
The safety profile was confirmed in all patient categories.
- Guidelines for vaccination and immunotherapy in ENT-pathology //edited by Kostinov, M.P. — 2019.
- SLovak clincial recommendations on the treatment of SARS-CoV-2 in elderly patients.
- Influenza in adults. Clinical recommendations of the Ministry of Health of the Russian Federation. 2022.
- Clinical recommendations of the Ministry of Health of the Russian Federation Salmonella infection in children
- Methodological recommendations Diagnosis, prevention, treatment, and rehabilitation of viral lung damage in the SARS COV-2 infection
- Acute respiratory infections in children: complications and life-threatening conditions. Saint Petersburg State Pediatric Medical University. 2021
- Temporary methodological recommendations Drug therapy of acute respiratory viral infections (ARVI) in outpatient practice during the COVID-19 pandemic.
- Methodological recommendations Influenza and other ARVI during the ongoing COVID-19 pandemic: prevention and treatment. Moscow: Federal Medical-Biological Agency, 2022.
- Instructions for medical use of the drug Polyoxidonium.
- S.M. Kharit, A.N. Galustyan. Azoximer bromide is a safe and effective drug in the treatment of acute upper respiratory tract infections in children: a review of the results of randomized, placebo-controlled, double-blind phase II and III clinical trials // Pediatrics (Consilium Medicum Journal Supplement). — 2017. — 2.
- T.I. Garaschenko, O.V. Karneeva, G.D.Tarasova et al. Influence of local application of Polyoxidonium on symptoms and course of acute respiratory viral infection in children: results of a multicenter, double-blind, placebo-controlled study. // Consilium Medicum. — 2020. — 22 (3). — Pages 80–86.
- V.S. Kharlamova, V.F. Uchaikin et al. Experience of the Polyoxidonium® immunomodulator use in treatment of ARI in children // Effective Pharmacotherapy. Epidemiology and Infections. — 2013. — No. 1(11). — Pages 12–20.
- A.V. Karaulov, A.V. Gorelov. The use of azoximer bromide in the therapy of inflammatory infections of the respiratory system in children: a meta-analysis of controlled clinical trials // Journal of Infectology. — Volume 11. — No. 4. — 2019. — Pages 31–41.
- P. Pruzhinets, N. Chirun, O. Sveikata. Safety profile of Polyoxidonium in daily practice: results of post-authorization safety study in Slovakia // Immunotherapy. — 2018. — 10 (2). — Pages 1–7.
- Letter from the Russian Association of Allergists and Clinical Immunologists on the Polyoxidonium drug use.