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The following message was posted to: PharmPK
Dear All,
Can anyone tell me what the limit is for PEG-400 parenteral (IV)
administration to humans on a g/kg/d basis? Provided the solution is
iso-osmotic, would a solution of 15% in a 250 mL volume exceed the upper
limits for infusion? Thanks!
Best regards,
Shawna Fleming, Ph.D.
Drug Safety Assessment
Synta Pharmaceuticals Corp.
125 Hartwell Avenue
Lexington, MA 02421
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The following message was posted to: PharmPK
Dear Shawna,
You can find 11.25% PEG 400 potency in an approved IV
infusion formulation on the CDER homepage: Inactive
ingredient for approved drug products,
www.accessdata.fda.gov/scripts/cder/iig/index.cfm
Unfortunately there is no disclosure on the active
ingredient. The dose of it would be helpful for calculation.
Best regards: Maria Vikmon
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