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词条 Anthrax immune globulin
释义

  1. Preparation

  2. Safety and Efficacy Testing

  3. References

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| tradename = Anthrasil
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| routes_of_administration = Intravenous
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}}Anthrax immune globulin, tradename Anthrasil, is a human immune globulin that is used in combination with antibiotics to treat anthrax. It was developed by Cangene and purchased in 2011 by the Biomedical Advanced Research and Development Authority (BARDA) under Project Bioshield. On 24 March 2015 it was granted approval by the United States Food and Drug Administration for use in treating inhalation anthrax in conjunction with antibiotics.[1][2]

Preparation

Anthrax immune globulin is prepared from the plasma of donors who have been vaccinated against anthrax.

Safety and Efficacy Testing

Due to the ethical and feasibility concerns with testing the efficacy of anthrax immune globulin in humans, it was tested in rabbits and monkeys under the FDA's animal efficacy rule. Following efficacy testing, anthrax immune globulin was tested for safety in human volunteers, where the most common side effects were headache, back pain, nausea and infusion site pain and swelling.

References

1. ^{{Cite web|url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439752.htm|title = FDA approves treatment for inhalation anthrax|date = 25 March 2015|accessdate = |website = |publisher = United States Food and Drug Administration|last = |first = }}
2. ^{{Cite web|url = https://www.drugs.com/history/anthrasil.html|title = Anthrasil Approval History|date = |accessdate = 26 March 2015|website = |publisher = Drugs.com|last = |first = }}
{{Immune sera and immunoglobulins}}

4 : Antibodies|Blood products|Medical treatments|Polyclonal antibodies

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