LEUKOSCAN Powder for solution for injection Ref.[27586] Active ingredients: Technetium ⁹⁹ᵐTc sulesomab

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Immunomedics GmbH, Otto-Röhm-Straße 69, D-64293 Darmstadt, Germany

Product name and form

LeukoScan 0.31 mg, powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

Qualitative and quantitative composition

Kit for the preparation of 99mTc-labelled LeukoScan.

Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan. The kit does not include the radioisotope.

Excipients: Sucrose (37.8 mg).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc sulesomab

Technetium ⁹⁹ᵐTc sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker. It is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
List of Excipients

Stannous chloride dihydrate
Sodium chloride
Acetic acid, glacial (Trace)
Hydrochloric acid (Trace)
Sodium potassium tartrate, tetrahydrate
Sodium acetate, trihydrate
Sucrose
Nitrogen

Pack sizes and marketing

One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.

The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.

Pack size: one vial per carton container.

Marketing authorization holder

Immunomedics GmbH, Otto-Röhm-Straße 69, D-64293 Darmstadt, Germany

Marketing authorization dates and numbers

EU/1/97/032/001

Date of first authorisation: 14 February 1997
Date of lastest renewal: 20.05.2007

Drugs

Drug Countries
LEUKOSCAN Spain, Lithuania
 
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