Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: CIS bio International, BP 32, 91192 Gif-Sur-Yvette Cedex, France
OSTEOCIS 3mg kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
|
Kit for radiopharmaceutical preparation. White pellet. |
Each vial contains 3mg of sodium oxidronate (or hydroxymethylene diphosphonate, HMDP).
The radionuclide is not part of the kit.
Excipient with known effect: Each vial contains 4.5 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Technetium ⁹⁹ᵐTc oxidronic acid |
Technetium ⁹⁹ᵐTc oxidronic acid is a radiopharmaceutical agent. A radiopharmaceutical is defined as a medicinal formulation containing radioisotopes that are used in major clinical areas for diagnosis and/or therapy. Technetium ⁹⁹ᵐTc oxidronic acid is indicated as a skeletal imaging agent in adults and children to delineate areas of abnormal osteogenesis, such as those that occur with metastatic bone disease, Paget’s disease, arthritic disease, osteomyelitis, and fractures. |
| List of Excipients |
|---|
|
Stannous chloride dihydrate |
15ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium caps.
Pack sizes: Kit of 5 multidose vials.
CIS bio International, BP 32, 91192 Gif-Sur-Yvette Cedex, France
PA0677/007/001
Date of first Authorization: 26th May 2000
Date of next renewal: 26th May 2010
| Drug | Countries | |
|---|---|---|
| OSTEOCIS | Spain, France, Hong Kong, Ireland, Malta, 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.
