MAGNEVIST (brand of gadopentetate dimeglumine) Injection FOR INTRAVENOUS ADMINISTRATION Rx only WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
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Gadolinium contrast agents: Over exposure?
Background MRI has dramatically changed the way we diagnose disease. With the introduction of contrast agents specifically for MRI, we were now able to see that which was ‘invisible’. Gadopentetate dimeglumine (Magnevist) was introduced over 20 years ago, since then many more agents with variable features have been introduced. Several newer agents have improved ‘relaxivity’ and some designated ...
متن کاملRisk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis.
BACKGROUND AND OBJECTIVES Recent studies strongly link nephrogenic systemic fibrosis to gadolinium administration for magnetic resonance imaging. In a recent advisory, the Food and Drug Administration stated that all gadolinium-containing chelates are potentially associated with nephrogenic systemic fibrosis; however, most reported cases are linked to gadodiamide (Omniscan) and gadopentetate di...
متن کاملMAGNEVIST (brand of gadopentetate dimeglumine) Injection FOR INTRAVENOUS ADMINISTRATION
Do not administer MAGNEVIST to patients with: o chronic, severe kidney disease (GFR < 30 mL/min/1.73m), or o acute kidney injury (see CONTRAINDICATIONS). Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtra...
متن کاملMechanism of NSF: New evidence challenging the prevailing theory.
Nephrogenic systemic fibrosis (NSF) has been associated with the administration of gadolinium-based contrast agents in patients with severely impaired renal function (SIRF), endstage renal disease (ESRD), or acute renal failure (ARF). Since the vast majority of these patients do not get NSF, it is highly likely that patient factors play a role in its development. Although "free" or dechelated g...
متن کاملCritical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents.
For magnetic resonance, the established class of intravenous contrast media is the gadolinium-based contrast agents. In the 3 decades since initial approval, these have proven in general to be very safe for human administration. However, in 2006, a devastating late adverse reaction to administration of the less stable gadolinium-based contrast agents was identified, nephrogenic systemic fibrosi...
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تاریخ انتشار 2013