Source: FDA, National Drug Code (US) Revision Year: 2020
Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi).
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.
Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.
Table 4. Radiation Dose Estimates for Tc 99m Mertiatide:
8-day Old | 1-year Old* | 5-year Old* | 10-year Old* | 15-year Old | Adult | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Assumed Weight (kg) | 3.4 | 9.8 | 19 | 32 | 57 | 70 | ||||||
Tc 99m Mertiatide Dose | 37 MBq (1 mCi) | 72.52 MBq (1.96 mCi) | 140.6 MBq (3.8 mCi) | 236.8 MBq (6.4 mCi) | 370 MBq (10 mCi) | 370 MBq (10 mCi) | ||||||
Organ | mSv | rem | mSv | rem | mSv | rem | mSv | rem | mSv | rem | mSv | rem |
Gallbladder Wall | 2.701 | 0.27 | 2.466 | 0.235 | 1.547 | 0.160 | 1.658 | 0.166 | 1.961 | 0.200 | 1.628 | 0.160 |
Lower Large Intestine Wall | 1.739 | 0.17 | 1.595 | 0.161 | 2.250 | 0.220 | 2.368 | 0.237 | 4.070 | 0.400 | 3.256 | 0.330 |
Small Intestine | 0.518 | 0.052 | 0.5439 | 0.055 | 1.195 | 0.122 | 1.397 | 0.141 | 2.035 | 0.200 | 1.628 | 0.160 |
Upper Large Intestine Wall | 0.962 | 0.096 | 0.943 | 0.096 | 1.828 | 0.186 | 2.0365 | 0.205 | 2.442 | 0.250 | 1.887 | 0.190 |
Kidneys | 1.406 | 0.14 | 1.088 | 0.112 | 1.308 | 0.129 | 1.5155 | 0.154 | 1.739 | 0.180 | 1.443 | 0.140 |
Liver | 0.3219 | 0.032 | 0.3046 | 0.031 | 0.394 | 0.038 | 0.4262 | 0.0435 | 0.481 | 0.048 | 0.3626 | 0.036 |
Ovaries | 0.592 | 0.058 | 0.6164 | 0.061 | 1.322 | 0.133 | 1.5392 | 0.154 | 3.330 | 0.330 | 2.5900 | 0.260 |
Red Marrow | 0.1628 | 0.016 | 0.1595 | 0.0161 | 0.281 | 0.0277 | 0.3552 | 0.0352 | 0.629 | 0.063 | 0.4810 | 0.050 |
Testes | 0.518 | 0.051 | 0.5294 | 0.053 | 1.0826 | 0.110 | 1.1840 | 0.122 | 2.368 | 0.240 | 1.628 | 0.160 |
Urinary Bladder Wall | 11.470 | 1.1 | 9.428 | 0.921 | 21.090 | 2.090 | 23.680 | 2.368 | 59.20 | 6.00 | 48.1000 | 4.80 |
Total Body | 0.2405 | 0.024 | 0.2176 | 0.022 | 0.3656 | 0.0365 | 0.4026 | 0.0410 | 0.814 | 0.081 | 0.6660 | 0.065 |
* Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories. The adult radiation absorbed doses were calculated based on data from ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema.
Kit for the Preparation of Technetium Tc 99m Mertiatide should be stored at controlled room temperature 20°C to 25°C (68-77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15°C to 30°C) and must be used within six hours of preparation.
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