|
1 Indications And Usage Regranex Is Indicated For The Treatment Of Lower Extremity Diabetic Neuropathic Ulcers That Extend Into The Subcutaneous Tissue Or Beyond And Have An Adequate Blood Supply, When Used As An Adjunct To, And Not A Substitute For, Good Ulcer Care Practices Including Initial Sharp Debridement, Pressure Relief And Infection Control. Limitations Of Use : The Efficacy Of Regranex Has Not Been Established For The Treatment Of Pressure Ulcers And Venous Stasis Ulcers [ See Clinical Studies (14.2) ] And Has Not Been Evaluated For The Treatment Of Diabetic Neuropathic Ulcers That Do Not Extend Through The Dermis Into Subcutaneous Tissue [Stage I Or Ii, International Association Of Enterostomal Therapy (Iaet) Staging Classification] Or Ischemic Diabetic Ulcers. The Effects Of Becaplermin On Exposed Joints, Tendons, Ligaments, And Bone Have Not Been Established In Humans [ See Nonclinical Toxicology (13.2) ] . Regranex Is Not Intended To Be Used In Wounds That Close By Primary Intention. Regranex Is A Human Platelet-Derived Growth Factor Indicated For The Treatment Of Lower Extremity Diabetic Neuropathic Ulcers That Extend Into The Subcutaneous Tissue Or Beyond And Have An Adequate Blood Supply. Regranex Is Indicated As An Adjunct To, And Not A Substitute For, Good Ulcer Care Practices. ( 1 ) Limitations Of Use : The Efficacy Of Regranex Has Not Been Established For The Treatment Of Pressure Ulcers And Venous Stasis Ulcers. ( 1 ) The Effects Of Regranex On Exposed Joints, Tendons, Ligaments, And Bone Have Not Been Established In Humans. ( 1 ) Regranex Is Not Intended To Be Used In Wounds That Close By Primary Intention. ( 1 )
|