Kit For The Preparation Of Technetium Tc 99m Mebrofenin
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Questions & Answers
Side Effects & Adverse Reactions
The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
History
There is currently no drug history available for this drug.
Other Information
Each multidose 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:
Molecular Weight = 387.23
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.
PHYSICAL CHARACTERISTICS
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.
| Principal Radiation Emission Data |
||
| Radiation |
Mean % per Disintegration |
Mean Energy (keV) |
| Gamma-2 |
89.07 |
140.5 |
1Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108.
External Radiation
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.
| 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.
| 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
Sources
Kit For The Preparation Of Technetium Tc 99m Mebrofenin Manufacturers
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Pharmalucence, Inc.
![Kit For The Preparation Of Technetium Tc 99m Mebrofenin Injection, Powder, Lyophilized, For Solution [Pharmalucence, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kit For The Preparation Of Technetium Tc 99m Mebrofenin | Pharmalucence, Inc.
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:
Nonjaundiced patient: 74 - 185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi)The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
An interval of at least 24 hours should be allowed before repeat examination.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
RADIATION DOSIMETRY
The estimated absorbed radiation doses1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.
TABLE 4Estimated Absorbed Radiation Doses†
Normal Subjects*
Severely Jaundiced
Patients**
Tissue
mGy/
370 MBq
rads/
10 mCi
mGy/
370 MBq
rads/
10 mCi
Total Body
2.0
0.2
1.7
0.17
Liver
4.7
0.47
8.1
0.81
Gallbladder Wall
13.7
1.37
12.5
1.25
Small Intestine
29.9
2.99
16.0
1.60
Upper Large
Intestine Wall
47.4
4.74
24.8
2.48
Lower Large
Intestine Wall
36.4
3.64
19.7
1.97
Kidney
2.2
0.22
1.9
0.19
Urinary Bladder Wall
2.9
0.29
24.2
2.42
Ovaries
10.1
1.01
6.4
0.64
Testes
0.5
0.05
1.1
0.11
Red Marrow
3.4
0.34
2.5
0.25
†Method of Calculation:
(1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332.
(2) Values for S: "S", Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).
* Bilirubin <1.5 mg/dL
Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.
** Bilirubin >10 mg/dL (mean 21.8 mg/dL)
Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.
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