Dosing and Administration
Jubi-R™ supplied as a vial for intravenous injection use only.
Remdesivir for injection, 100 mg, is supplied as a single-dose vial containing a sterile, preservative-free white to off-white to yellow lyophilized powder that is to be reconstituted with 19 mL of Sterile Water for Injection and diluted into 0.9% saline prior to administration by intravenous infusion.
Essential Information
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The Secretary of the Department of Health and Human Services, USA has declared a public health emergency that justifies the emergency use of Remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection
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In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, Remdesivir, for the treatment of COVID-19
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The distribution of Remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens
Emergency Use Authorization (EUA)
Remdesivir has been approved/authorized for emergency use for the treatment of COVID-19 by several other regulatory agencies such as the EMA (European Medicines Agency), MHLW (Ministry of Health, Labour and Welfare), Japan, etc. CDSCO (Central Drugs Standard Control Organisation), India has also approved the restricted emergency use of Remdesivir for the treatment of suspected or laboratory confirmed COVID-19 cases.
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