Showing posts with label iv. Show all posts
Showing posts with label iv. Show all posts

Friday, November 6, 2009

FDA FAQ On IV Peramivir To Treat H1N1 Flu

Updated October 24, 2023

The original links broke.

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Recently, the FDA Says Yes to IV Peramivir To Treat Flu. Now here's the FDA followup with Peramivir IV Questions and Answers for Health Care Providers. It's a pretty comprehensive collection of over 20 questions and answers, and concludes with a set of related links. 

Friday, October 30, 2009

FDA Says Yes to IV Peramivir To Treat Flu

The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

  • the patient is not responding to either oral or inhaled antiviral therapy, or
  • when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
  • for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic. Additional Related Information From The FDA: EUA Letter of Authorization EUA Fact Sheet for Health Care Providers EUA Fact Sheet for Patients and Parents/Caregivers Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA 


From SkillsPlus International Inc.