Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE CEDEX, FRANCE
YTRACIS radiopharmaceutical precursor, solution.
| Pharmaceutical Form |
|---|
|
Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter. |
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% |
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.
CIS bio international, Boîte Postale 32, F-91192 GIF-SUR-YVETTE CEDEX, FRANCE
EU/1/03/250/001
Date of the first authorisation: 24/03/2003
Date of the last renewal: 24/03/2008
| Drug | Countries | |
|---|---|---|
| YTRACIS | Austria, Estonia, Spain, France, Israel, Lithuania, Poland, Singapore, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
