Petrovax Pharm reports on Polyoxidonium® tablets 12 mg scope extension. This product was approved for children aged 3+ years. The PIL change was approved by the Russian Ministry of Health on 01.06.2017.1
Polyoxidonium® tablets 12 mg scope extension was registered on the back of clinical study data that confirmed the product’s high efficacy in combined treatment of acute and chronic respiratory infections (ARI) as well as it high safety profile.
Clinical studies involved 228 subjects aged 3 to 14 years diagnosed with ARI of the upper respiratory tract and influenza from 7 clinical centers in Russia with relevant experience of ARI treatment in children. The studies were conducted as prospective, multicenter, double-blind, placebo-controlled, comparative, randomized, parallel-arm clinical trials in compliance with the GCP regulations, WMA Declaration of Helsinki ethical principles as well as applicable local requirements and legislation.
The above studies provided for a conclusion that Polyoxidonium® high efficacy proved clinically as well as high safety make it possible recommending the product for inclusion into the range of medications used for treatment of ARI and flu in children aged 3+ years.
Polyoxidonium® background information
Polyoxidonium® is an innovative pharmaceutical product developed by Russian scientists. It produces an immunomodulating, detoxifying, and anti-oxidative effect. Due to its unique formula, the medication is used for combined treatment of acute and chronic respiratory infections of bacterial, viral, or fungal origin as well as for flu and ARVI prevention both in children and adults. In 2016, according to practicing physicians, Polyoxidonium® was recognized as the best immunomodulator to treat ARVI in children, and won the Russian Pharma Awards.
The product has a complex of properties essential for a child in an acute respiratory infection phase, i.e. it removes intoxication and inflammation, and activates interferon production. Symptoms and general state improvement is observed since the first days of treatment. 2Polyoxidonium® restores immune defense in sickly children, and enhances the child’s body resistance. The clinical application experience in ARVI acute phase showed a decrease of the risk of bacterial complications and ARI within a year following a treatment course.3
Polyoxidonium® is manufactured at a state-of-the-art facility to international GMP standards, which guarantees its stability and high quality. The product is exported to the CIS and EU.
- Patient Information Leaflet for Polyoxidonium®, tablets 12 mg, R No. 002935/04-010617 approved by Russian Ministry f Health on 01.06.2017
- Вавилова В.П., Вавилов А.М., Черкаева А.Х. Возможности современной терапии острых респираторных вирусных инфекций у детей. Consilium Medicum. Педиатрия 2015 №3 (Vavilova V.P., Vavilov A.M., Cherkaeva A.Kh. Possibilities of advanced treatment of acute respiratory viral infections in children. Consilium Medicum. Pediatrics 2015, No. 3)
- Харламова Ф.С., Учайкин В.Ф., Кузьменко Л.В., Чирун Н.В. и др. Опыт применения иммуномодулятора Полиоксидоний для лечения ОРИ у детей. Эффективная фармакотерапия 11/2013 (Kharlamova F.S., Uchaykin V.F., Kuzmenko L.V., Chirun N.V., et al. Experience of Polyoxidonium application for ARI treatment in children. Effective Pharmacotherapy 11/2013)