516414 - Bracco Diagnostics, Multihance Injection 529mg SDV 15mL 5/Package

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: • chronic, severe kidney disease (GFR <30 mL/min/1.73m2 ), or • acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for eliminatio