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Miraluma

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Miraluma

Miraluma®*
Kit for the Preparation of Technetium Tc99m Sestamibi for Injection

DRUG DESCRIPTION

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 (SnCl2•2H20) - 0.025 mg
  • Stannous Chloride, Dihydrate, (SnCl2•2H20) - 0.075 mg
  • Tin Chloride (stannous and stannic) Dihydrate, maximum
  • (as SnCl2•2H20) - 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.

Physical Characteristics

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 below in Table 4.

Table 4.0 - Principal Radiation Emission Data

Radiation Mean %/Disintegration Mean Energy (KeV)
Gamma-2 89.07 140.5
1Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108 (1981).

External Radiation

The specific gamma ray constant for Tc99m is 5.4 micro coulombs/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 radio nuclide that results from interposition of various thicknesses of Pb is shown in Table 5.0. To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radio nuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000.

Table 5.0 - Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm Coefficient of Attenuation
0.017 0.5
0.08 10-1
0.16 10-2
0.25 10-3
0.33 10-4

To correct for physical decay of this radio nuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 6.0.

Table 6.0 - Physical Decay Chart; Tc99m Half-Life 6.02 Hours

Hours Fraction Remaining Hours Fraction Remaining
0* 1.000 8 .398
1 .891 9 .355
2 .794 10 .316
3 .708 11 .282
4 .631 12 .251
5 .562    
6 .501    
7 .447    
* Calibration Time

*Cardiolite® and Miraluma® (technetium tc99m sestamibi) are different names for the same drug.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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