TECHNETIUM TC99M MERTIATIDE Kit for the preparation Ref.[10977] Active ingredients: Technetium ⁹⁹ᵐTc mertiatide

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

3. Indications and Usage

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.

10. Dosage and Administration

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.

Radiation dosimetry

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 Old1-year Old* 5-year Old* 10-year Old* 15-year OldAdult
Assumed Weight (kg) 3.49.819325770
Tc 99m Mertiatide Dose37 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.

12. Storage and Handling

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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