PENTACIS Powder for solution for injection Ref.[49884] Active ingredients: Technetium ⁹⁹ᵐTc pentetic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: CIS Bio International, Route National 306, BP 32, 91192 Gif-Sur-Yvette Cedex, France

Product name and form

PENTACIS.

Kit for the preparation of technetium (99mTc) pentetate injection.

Pharmaceutical Form

Powder for solution for injection.

Kit for radiopharmaceutical preparation.

White freeze-dried product.

Qualitative and quantitative composition

Calcium trisodium pentetate 9.10 mg/vial.

The product contains no antimicrobial preservative.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc pentetic acid
List of Excipients

Stannous chloride dihydrate
Sodium chloride
Under a nitrogen atmosphere

Pack sizes and marketing

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

Pack size: Kit of 5 multidose vials.

Marketing authorization holder

CIS Bio International, Route National 306, BP 32, 91192 Gif-Sur-Yvette Cedex, France

Marketing authorization dates and numbers

PA 0677/002/001

Date of first authorisation: 04 March 1999
Date of last renewal: 04 March 2009

Drugs

Drug Countries
PENTACIS Spain, France, Hong Kong, Ireland
 
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