Active Ingredient: Mangafodipir
Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
5 - 5 umol per kg of body weight
From 5 To 5 umol per kg of body weight once every day
The medicinal product is for single intravenous use only as repeated dosing has not been studied. It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas.
Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.
At the clinical dose the contrast agent has no T2effect, and pre and post- T2-weighted images are equivalent. The clinical use of mangafodipir has been investigated at field strengths from 0.5 to 2.0 Tesla.
The recommended dose is 0.5 ml/kg bodyweight (5 μmol/kg bodyweight). This corresponds to a dose of 35 ml for a 70 kg person. Above 100 kg body weight, 50 ml is usually sufficient to provide a diagnostically adequate contrast effect.
It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas.
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