RENOCIS Kit for radiopharmaceutical preparation Ref.[27899] Active ingredients: Technetium ⁹⁹ᵐTc succimer

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: CIS bio International, Route Nationale 306 Saclay, BP 32, 91192 Gif-Sur-Yvette Cedex, France

Product name and form

RENOCIS 1 mg kit for radiopharmaceutical preparation.

Pharmaceutical Form

Kit for radiopharmaceutical preparation.

White lyophilisate.

Qualitative and quantitative composition

Each vial contains 1 mg of succimer (dimercaptosuccinic acid).

The radionuclide is not part of the kit.

Excipient with known effect: The product contains sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc succimer
List of Excipients

Stannous chloride dihydrate (E512)
Inositol
Ascorbic acid (E300)
Sodium hydroxide (E524) (for pH adjustment)
Nitrogen atmosphere (E941)

Pack sizes and marketing

15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium capsules.

Pack size: 5 multidose vials

Marketing authorization holder

CIS bio International, Route Nationale 306 – Saclay, BP 32, 91192 Gif-Sur-Yvette Cedex, France

Marketing authorization dates and numbers

PA0677/005/001

Date of first authorisation: 19 March 1999
Date of last renewal: 19 March 2009

Drugs

Drug Countries
RENOCIS Spain, France, Ireland, 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.