ALBUMINEX

STN: 125644
Proper Name: Albumin (Human) 5% and 25%
Tradename: ALBUMINEX
Manufacturer: Bio Products Laboratory, USA
Indication:

• Indicated for adults and children  for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass.

Product Information

• Package Insert - Albuminex (5% Clean)
• Package Insert - Albuminex (25 % Clean)

Supporting Documents

• Clinical Reviewer - ALBUMINEX
• June 19, 2018 Approval Letter - ALBUMINEX
• June 19, 2018 Summary Basis of Regulatory Action - ALBUMINEX
• Approval History, Letters, Reviews, and Related Documents - ALBUMINEX