DRUG DESCRIPTION
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.
Pharmaceutical Form
Solution for infusion
A clear bright to dark yellow solution,
TESLASCAN (mangafodipir) has the following physicochemical properties:
| pH | 7.0-8.0. |
| 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 |
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