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Side Effects & Adverse Reactions
None.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Technetium Tc 99m Pentetate Injection may be used to perform kidney imaging, brain imaging, to assess renal perfusion, and to estimate glomerular filtration rate.
History
There is currently no drug history available for this drug.
Other Information
Each kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pentetate Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg total tin expressed as stannous chloride dihydrate in lyophilized form under an atmosphere of nitrogen. The pH is adjusted with HCl and / or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5. Addition of sterile, non-pyrogenic, and oxidant-free sodium pertechnetate Tc-99m solution produces a rapid labeling which is essentially quantitative and which remains stable in vitro throughout the 12-hour life of the preparation. No bacteriostatic preservative is present.
The structure of the technetium labeled form is:
Its chemical name is:
Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-,sodium.
®Registered Trademark of Jubilant DraxImage Inc.
Technetium-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 |
EXTERNAL RADIATION
The specific gamma ray constant for technetium Tc-99m is 5.44 µC•kg-1•MBq-1•hr-1 (0.78 R/mCi-hr) at 1 cm. The first half-value layer is 0.017 cm of lead. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1000. A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 2.
Table 2
Radiation Attenuation by Lead Shielding
Shield Thickness |
Coefficient of Attenuation |
0.017 0.08 0.16 0.25 0.33 |
0.5 10-1 10-2 10-3 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 3.
Table 3
Physical Decay Chart of Technetium Tc-99m, Half Life: 6.02 Hours
*Calibration Time 1 Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026, 108(1981). |
|||
Hours |
Fraction |
Hours |
Fraction |
0* 1 2 3 4 |
1.000 0.891 0.794 0.708 0.631 |
5 6 8 10 12 |
0.562 0.501 0.398 0.316 0.251 |
Sources
Pentetic Acid Manufacturers
-
Jubilant Draximage Inc.
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