TELESCAN Solution for infusion Ref.[9492] Active ingredients: Mangafodipir

Source: European Medicines Agency (EU) Revision Year: 2012 Publisher: GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, NO-0401, OSLO, Norway

Product name and form

TESLASCAN 0.01 mmol/ml solution for infusion.

Pharmaceutical Form
Solution for infusion. A clear bright to dark yellow solution. TESLASCAN 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

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 section 6.1.

Active Ingredient	Description
Mangafodipir	Mangafodipir is a chelate containing the metal manganese – which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI – and the ligand fodipir (dipyridoxyl diphosphate). Manganese is preferentially taken up by normal liver parenchyma and also in the pancreas so that contrast enhancement between abnormal and normal tissue can be expected.

List of Excipients
Ascorbic acid Sodium chloride Sodium hydroxide and/or hydrochloric acid (pH adjustment) Water for injections

Pack sizes and marketing

50 ml clear, colourless vials (type 1 glass). The containers are closed with rubber stoppers and sealed with aluminium caps with polypropylene lids.

TESLASCAN is supplied in packs of 1 × 50 ml and 10 × 50 ml vials.

Not all pack sizes may be marketed.

Marketing authorization holder

GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, NO-0401, OSLO, Norway

Marketing authorization dates and numbers

EU/1/97/040/001
EU/1/97/040/002

Date of first authorisation: 22.05.1997
Date of latest renewal: 22.05.2007

Drugs

Drug	Countries
TESLASCAN	Turkey

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