YTRACIS Radiopharmaceutical precursor, solution Ref.[27721] Active ingredients: Yttrium ⁹⁰Y chloride

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE CEDEX, FRANCE

Product name and form

YTRACIS radiopharmaceutical precursor, solution.

Pharmaceutical Form

Radiopharmaceutical precursor, solution.

Clear, colourless solution, free of particulate matter.

Qualitative and quantitative composition

1 ml of sterile solution contains 1.850 GBq Yttrium (90Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium.

One vial contains 0.925 to 3.700 GBq (see section 6.5).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Yttrium ⁹⁰Y chloride

Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable zirconium (90Zr). 90Y-yttrium has a half-life of 2.67 days (64.1 hours).

List of Excipients

Hydrochloric acid 30%
Water for injections

Pack sizes and marketing

Colourless Type I glass 2-ml vial, closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.

1 vial contains 0.5 to 2 ml (corresponding to 0.925 to 3.700 GBq calibrated three or four days after the manufacturing date) depending on the ordered radioactivity.

The vial is supplied in a lead pot of appropriate thickness.

Marketing authorization holder

CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE CEDEX, FRANCE

Marketing authorization dates and numbers

EU/1/03/250/001

Date of the first authorisation: 24/03/2003
Date of the last renewal: 24/03/2008

Drugs

Drug Countries
YTRACIS Austria, Estonia, Spain, France, Israel, Lithuania, Poland, Singapore, United Kingdom

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