FOR DIAGNOSTIC USE

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:

Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg Sodium Citrate Dihydrate - 2.6 mg L-Cysteine Hydrochloride Monohydrate - 1.0 mg Mannitol - 20 mg Stannous Chloride, Dihydrate, minimum (SnCl₂2H₂O) - 0.025 mg Stannous Chloride, Dihydrate, (SnCl22H2O) - 0.075 mg

Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl₂2H₂O) - 0.086 mg

Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 - 6.0). No bacteriostatic preservative is present.

The precise structure of the technetium complex is Tc99m[MIBI]₆+ where MIBI is 2-methoxy isobutyl isonitrile.

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours¹. Photons that are useful for detection and imaging studies are listed in Table 1.

The specific gamma ray constant for Tc99m is 5.4 microcoulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000.

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

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