Kit For The Preparation Of Technetium Tc 99m Medronate
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Questions & Answers
Side Effects & Adverse Reactions
This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis).
Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.
Legal Issues
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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 Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.
History
There is currently no drug history available for this drug.
Other Information
Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection.
Each 10mL multidose vial contains:
- Medronic acid: 20 mg
- Ascorbic acid: 1 mg
- Stannous fluoride, SnF 2: 0.13 mg (minimum)
- Total tin (maximum, as stannous fluoride, SnF 2): 0.38 mg
The pH is adjusted to 6.5 (6.3 to 6.7) with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present in the vial. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The structural formula is:
When a solution of sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection is added to the vial, the diagnostic agent, Technetium Tc 99m Medronate is formed for administration by intravenous injection. The pH of the reconstituted product is 5.4 to 6.8. The precise structure of Technetium Tc 99m Medronate Injection is not known at this time.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours1. The principal photon that is useful for detection and imaging studies is listed in Table 1.
| Radiation |
Mean % per Disintegration |
Mean Energy (keV) |
| Gamma-2 |
89.07 |
140.5 |
1Kocher, DC: Radioactive Decay Data Tables, DOE/TIC-11026, 108, 1981.
EXTERNAL RADIATION:
The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr 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 the 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.
| 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 3.
| 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 |
* Calibration Time
Sources
Kit For The Preparation Of Technetium Tc 99m Medronate Manufacturers
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Pharmalucence, Inc.
![Kit For The Preparation Of Technetium Tc 99m Medronate (Tc 99m Medronate) Injection, Powder, Lyophilized, For Solution [Pharmalucence, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kit For The Preparation Of Technetium Tc 99m Medronate | Pharmalucence, Inc.
Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.
After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is:
370-740 megabecquerels: (10-20 millicuries) given intravenously. Imaging is optimal at 1 to 4 hours post Injection.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Radiation DosimetryThe effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4.
TABLE 4 Estimated Absorbed Radiation Dose2 Technetium Tc 99m MedronateOrgan
(MGy/740 MBq)
(Rads / 20 mCi)
Total Body
1.3
0.13
Bone Total
7.0
0.70
Red Marrow
5.6
0.56
Kidneys
8.0
0.80
Liver
0.6
0.06
Bladder Wall
2 hour void
26
2.60
4.8 hour void
62
6.20
Ovaries
2 hour void
2.4
0.24
4.8 hour void
3.4
0.34
Testes
2 hour void
1.6
0.16
4.8 hour void
2.2
0.22
2Method of calculation: "S" Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)
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