TECHNESCAN LYOMAA Powder for suspension for injection Ref.[11090] Active ingredients: Technetium ⁹⁹ᵐTc macrosalb

Revision Year: 2016  Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands

Product name and form

Technescan LyoMAA, Powder for suspension for injection / kit for radiopharmaceutical preparation.

Pharmaceutical Form

White powder for reconstitution.

Powder for suspension for injection. Kit for radiopharmaceutical preparation.

Qualitative and quantitative composition

Each vial contains 2.0 mg macrosalb (macroaggregates from human serum albumin).

The radioisotope is not part of the kit.

The number of particles per vial is 4.5 × 106.

Excipients: For a full list of excipients, see section 6.1.

Active Ingredient Description
Technetium ⁹⁹ᵐTc macrosalb

Technetium ⁹⁹ᵐTc macrosalb is for diagnostic use only. It is used for pulmonary perfusion scintigraphy and radionuclide venography. When administered in usual doses, technetium [99mTc] macrosalb injection shows no pharmacodynamic effects detectable clinically or/and analytically.

List of Excipients

Sodium chloride
Sodium acetate
Stannous chloride dihydrate
Human serum albumin
Hydrochloric acid

Pack sizes and marketing

10 ml Type I (Ph. Eur.) glass vial closed with a bromobutyl rubber stopper.

Technescan LyoMAA is supplied as five vials in one carton.

Marketing authorization holder

Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands

Marketing authorization dates and numbers

PA690/12/1

First date of authorisation: 05 April 2002
Last date of authorisation: 05 April 2007

Drugs

Drug Countries
TECHNESCAN LYOMAA Estonia, Spain, France, Singapore

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