"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
CARDIOLITE (prep kit for technetium tc99 sestamibi for injection) ®
Kit for the Preparation of Technetium Tc99m Sestamibi for Injection
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
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 below in Table 4.
Table 4.0 - Principal Radiation Emission Data
|Radiation||Mean %/Disintegration||Mean Energy (KeV)|
|1Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108 (1981).|
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|
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|
|* Calibration Time|
Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cardiolite Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.