TECHNESCAN MAG3

Technescan MAG3™ is a kit for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2 •2H 2 O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2 •2H 2 O), 40 milligrams sodium tartrate dihydrate (Na 2 C 4 H 2 O 6 •2H 2 O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas: image description image description

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 (70 kg) 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.

None known.

The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

STORAGE Technescan MAG3 should be stored at controlled room temperature 20° to 25°C (68° to 77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15° to 30°C) and must be used within six hours of preparation. Table 4. Radiation Dose Estimates for Tc 99m Mertiatide *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. **Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200 μCi/kg). 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