Source: FDA, National Drug Code (US) Revision Year: 2020
Each reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture.
The pH of the reconstituted product is 4.2 to 5.7.
The structure of mebrofenin (2,2'[[2[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below:
When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.
Table 1. Principal Radiation Emission Data:
| Radiation | Mean % per Disintegration | Mean Energy (keV) |
|---|---|---|
| Gamma-2 | 89.07 | 140.5 |
1 Kocher, David C., “Radioactive Decay Data Tables”, DOE/ TIC-11026, (1981) p.108.
The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (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 millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.
Table 2. 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 technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart: Tc 99m half-life 6.02 hours:
| Hours | Fraction Remaining | Hours | Fraction Remaining |
|---|---|---|---|
| 0* | 1.000 | 7 | 0.447 |
| 1 | 0.891 | 8 | 0.398 |
| 2 | 0.794 | 9 | 0.355 |
| 3 | 0.708 | 10 | 0.316 |
| 4 | 0.631 | 11 | 0.282 |
| 5 | 0.562 | 12 | 0.251 |
| 6 | 0.501 | 18 | 0.126 |
* Calibration time
| How Supplied |
|---|
|
Choletec (Kit for the Preparation of Technetium Tc 99m Mebrofenin) is supplied in kits of 10 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Kit Contents10 sterile multidose reaction vials. PreparationPreparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure. Manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Jubilant HollisterStier LLC, Spokane, WA 99207 USA |
| Drug | Countries | |
|---|---|---|
| CHOLETEC | United States |
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