SCINTIMUN Kit for radiopharmaceutical preparation Ref.[27572] Active ingredients: Technetium ⁹⁹ᵐTc antigranulocyte antibody

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: CIS bio international, B.P.32, F-91192 Gif-sur-Yvette Cedex, France

Product name and form

Scintimun 1 mg kit for radiopharmaceutical preparation.

Pharmaceutical Form

Kit for radiopharmaceutical preparation.

Scintimun: white powder.

Solvent for Scintimun: white powder.

Qualitative and quantitative composition

Each vial of Scintimun contains 1 mg of besilesomab.

Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.

The radionuclide is not part of the kit.

Excipients with known effect: Each vial of Scintimun contains 2 mg of sorbitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc antigranulocyte antibody
List of Excipients

Scintimun vial:

Sodium dihydrogen phosphate, anhydrous
Disodium monohydrogen phosphate, anhydrous
Sorbitol E420
Under nitrogen atmosphere

Solvent for Scintimun vial:

1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP)
Stannous chloride dihydrate
Sodium hydroxide / Hydrochloric acid (for pH adjustment)
Nitrogen

Pack sizes and marketing

Scintimun vial: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped capsule (green) containing 5.02 mg of powder.

Solvent for Scintimun: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium capsule (yellow) containing 2.82 mg of powder.

Pack sizes:

Kit of one multidose vial of Scintimun and one vial of solvent.
Kit of two multidose vials of Scintimun and two vials of solvent.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/09/602/001
EU/1/09/602/002

Date of first authorisation: 11 January 2010
Date of latest renewal: 26 August 2014

Drugs

Drug Countries
SCINTIMUN Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom

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