TECHNETIUM TC99M MEDRONATE Kit for the preparation Ref.[11056] Active ingredients: Technetium ⁹⁹ᵐTc medronic acid

Source: FDA, National Drug Code (US)  Revision Year: 2020 

3. Indications and Usage

MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.

10. Dosage and Administration

The recommended adult dose, after reconstitution with oxidant-free sodium pertechnetate Tc-99m, is 370 to 740 megabecquerels (10 to 20 millicuries [200 µCi/kg]) by slow intravenous injection over a period of 30 seconds. Optimum scanning time is 1 to 4 hours post-injection.

To minimize the contribution of the bladder content to the image, the patient should void immediately before imaging is started.

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The
solution should not be used if cloudy.

Radiation dosimetry

The estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate are shown in Table 4. The effective half-life was assumed to be the physical half-life for all calculated values.

Table 4. Radiation Doses2:

Tissue Absorbed Radiation Dose
mGy/740 MBq rads/20 mCi
Total Body1.30.13
Total Bone7.00.70
Red Marrow5.60.56
Kidneys8.00.8
Liver0.60.06
Bladder Wall26.02.6
2 hr. void62.06.2
4.8 hr. void2.40.24
Ovaries3.40.34
2 hr. void1.60.16
4.8 hr. void2.20.22
Testes  
2 hr. void  
4.8 hr. void  

2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975

12. Storage and Handling

Store the unreconstituted reaction vials at 25°C (77°F); excursions permitted between 15° and 30°C (59° to 86°F). After labeling with Technetium Tc-99m, the reconstituted product should be stored at 25°C (77°F) in the original vial, and be placed in a suitable lead shield. Excursions permitted between 15° and 30°C (59° to 86°F). Discard the reconstituted solution after 12 hours.

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