MIBI TECHNESCAN Kit for radiopharmaceutical preparation Ref.[27644] Active ingredients: Technetium ⁹⁹ᵐTc sestamibi

Source: Health Products Regulatory Authority (IE) Revision Year: 2014 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands

Product name and form

Technescan MIBI 1 mg Kit for radiopharmaceutical preparation.

Pharmaceutical Form
Kit for radiopharmaceutical preparation. White to almost white pellets or powder. To be reconstituted with sodium pertechnetate (^99mTc) solution for injection.

Qualitative and quantitative composition

Each vial contains 1 mg [Tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)copper(I)] tetrafluoroborate.

The radionuclide is not part of the kit.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Technetium ⁹⁹ᵐTc sestamibi	Technetium ^99mTc sestamibi is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands, hence the name sesta (6) MIBI. Following intravenous injection of the drug, Technetium ^99mTc sestamibi is taken up by the myocardium, parathyroid, and/or breast tissue.

List of Excipients
Stannous chloride dihydrate Cysteine hydrochloride monohydrate Sodium citrate Mannitol Hydrochloric acid (for pH-adjustment) Sodium hydroxide(for pH-adjustment)

Pack sizes and marketing

10 ml multi-dose glass vials, type 1 borosilicate glass (Ph. Eur.) sealed with a chlorobutyl rubber stopper.

Pack size: 5 vials.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA690/020/001

Date of first authorisation: 21^st November 2008
Date of last renewal: 8^th May 2013

Drugs

Drug	Countries
MIBI TECHNESCAN	Spain, Ireland, Malta, United Kingdom

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