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 ?mol), equivalent to 6.91 mg of mangafodipir. 50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 ?mol), 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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