"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
TESLASCAN 0.01 mmol/ml Solution for infusion (mangafodipir)
SPC approved in Renewal in the Centralized procedure in EU
Name Of The Medicinal Product
TESLASCAN 0.01 mmol/ml solution for infusion (mangafodipir) .
Qualitative And Quantitative Composition
Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μmol), equivalent to 6.91 mg of mangafodipir. 50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 μmol), equivalent to 345.5 mg of mangafodipir.
Excipient: Sodium 0.16 mmol (3.6 mg)/ml equivalent to 126 mg per normal dose of 35 ml.
For a full list of excipients, see the HOW SUPPLIED section.
Solution for infusion
A clear bright to dark yellow solution,
TESLASCAN (mangafodipir) has the following physicochemical properties:
|Osmolality (mosmol/kg H2O) at 37 °C||290|
|Viscosity (mPa.s) at 20 °C||1.0|
|Viscosity (mPa.s) at 37 °C||0.7|
|Density (g/ml) at 20 °C||1.01|
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Teslascan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.