GLUSCAN Solution for injection Ref.[50604] Active ingredients: Fludeoxyglucose ¹⁸F

Source: Web Search Revision Year: 2022 Publisher: Advanced Accelerator Applications SA (AAA), 20 rue Diesel, 01630 Saint Genis Pouilly, France

Product name and form

GLUSCAN 500, 500 MBq/mL solution for injection.

Pharmaceutical Form
Solution for injection. Clear, colourless or slightly yellow solution.

Qualitative and quantitative composition

1 mL contains 500 MBq of fludeoxyglucose (¹⁸F) at the date and time of calibration.

The activity per vial ranges from 250 MBq to 5000 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.

Excipients with known effects: Each mL of fludeoxyglucose (¹⁸F) contains 9 mg of sodium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Fludeoxyglucose ¹⁸F	Fludeoxyglucose F18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F18 is used to assess glucose metabolism. It is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.

List of Excipients
Sodium chloride 9 mg/mL Water for injections Sodium citrate for pH adjustment Hydrochloric acid for pH adjustment Sodium hydroxide for pH adjustment Ethanol

Pack sizes and marketing

15 mL glass vial, colourless Type I of the European Pharmacopoeia, closed by a rubber stopper and sealed by an aluminium capsule.

One vial contains 0.5 to 10 mL of solution, corresponding to 250 to 5000 MBq at calibration time.

Multidose vial.

Marketing authorization holder

Advanced Accelerator Applications SA (AAA), 20 rue Diesel, 01630 Saint Genis Pouilly, France

Marketing authorization dates and numbers

France: 34009 575 496 2 6
Spain: 71880
Germany: 72415.00.00
Portugal: 5218664
Poland: 17446

Date of first authorisation:

France: 10/08/2009
Spain: 09/02/2010
Germany: 26/08/2009
Portugal: 31/07/2009
Poland: 16/11/2010

Drugs

Drug	Countries
GLUSCAN	Spain, France, Poland, South Africa

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