STAMICIS Kit for radiopharmaceutical preparation Ref.[10992] Active ingredients: Technetium ⁹⁹ᵐTc sestamibi

Source: European Medicines Agency (EU)  Revision Year: 2016  Publisher: CIS bio international, B.P.32, F-91192 Gif sur-Yvette Cedex

Product name and form

STAMICIS 1 mg kit for radiopharmaceutical preparation.

Pharmaceutical Form

Kit for radiopharmaceutical preparation.

White powder.

Qualitative and quantitative composition

Each vial contains 1 mg [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate.

The radionuclide is not part of the kit.

Excipients with known effect: One ml of solution contains 4.5 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc sestamibi

Technetium 99mTc sestamibi is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands, hence the name sesta (6) MIBI. Following intravenous injection of the drug, Technetium 99mTc sestamibi is taken up by the myocardium, parathyroid, and/or breast tissue.

List of Excipients

Stannous chloride dihydrate
Cysteine hydrochloride monohydrate
Sodium citrate
Mannitol

Pack sizes and marketing

15 mL multidose glass vial, type I borosilicate glass sealed with a bromobutyl rubber stopper and an aluminium caps.

Pack size: 5 vials.

Marketing authorization holder

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

Drugs

Drug Countries
STAMICIS Austria, Estonia, Spain, France, Hong Kong, Ireland, Malta, 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.