CARDIOLITE Powder for solution, lyophilized Ref.[49661] Active ingredients: Technetium ⁹⁹ᵐTc sestamibi

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product 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∙2H2O) - 0.025 mg
  • Stannous Chloride, Dihydrate, (SnCl2∙2H2O) - 0.075 mg
  • Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl2∙2H2O) - 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.

11.1 Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours2. Photons that are useful for detection and imaging studies are listed below in Table 3.0.

Table 3.0. Principal Radiation Emission Data:

Radiation Mean %/Disintegration Mean Energy (KeV)
Gamma-2 89.07 140.5

2 Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981).

11.2 External Radiation

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 4.0. 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.

Table 4.0. 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 radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 5.0.

Table 5.0 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

Dosage Forms and Strengths

CARDIOLITE Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.
How Supplied

CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC #11994-001-55) and twenty (20) vials (NDC #11994-001-20), sterile and non-pyrogenic.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Prior to lyophilization the pH is between 5.3-5.9.

Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each twenty (20) vial kit is one (1) package insert, twenty four (24) vial shield labels and twenty four (24) radiation warning labels.

This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.

Drugs

Drug Countries
CARDIOLITE Hong Kong, Israel, Japan, United States, South Africa
 
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