DOPACIS Solution for injection Ref.[51143] Active ingredients: Fluorodopa ¹⁸F

Source: Medicines Authority (MT) Revision Year: 2019 Publisher: CIS bio international, RN 306-Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex

Product name and form

Dopacis 90 MBq/mL solution for injection.

Pharmaceutical Form
Solution for injection. Clear and colourless solution, with a pH between 4.0 and 5.5.

Qualitative and quantitative composition

1 mL contains 90 MBq of fluorodopa (¹⁸F) at calibration time.

The total activity per vial ranges from 90 MBq to 900 MBq at the date and time of calibration.

Fluorine (¹⁸F) decays to stable oxygen (¹⁸O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.

Excipient with known effect: One mL of Dopacis contains 2.6 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Fluorodopa ¹⁸F	Fluorodopa F18 is a radioactive diagnostic agent used in PET imaging. In dopaminergic nerve terminals in the brain, fluorodopa (FDOPA) F18 is decarboxylated by amino acid decarboxylase to fluorodopamine (FDA) F18 and stored in presynaptic vesicles in the brain. The accumulation of F18 FDA in the striatum is visually detected in the PET scan.

List of Excipients
Acetic acid Sodium acetate Ascorbic acid Disodium edetate Water for injections

Pack sizes and marketing

15 mL colorless type I multidose glass vial, closed with a teflon-coated rubber stopper and sealed with an aluminium cap.

Packaging: One multidose vial containing 1 to 10 mL of solution, corresponding to 90 to 900 MBq at calibration time.

Marketing authorization holder

CIS bio international, RN 306-Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex

Marketing authorization dates and numbers

MA826/00101

Date of first authorisation: 12^th July 2011
Date of latest renewal: 27^th January 2017

Drugs

Drug	Countries
DOPACIS	Spain, France, Malta

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