Source: FDA, National Drug Code (US) Revision Year: 2017
MYOVIEW 30 mL is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each multiple-dose 30 mL glass vial contains a sterile, non-pyrogenic, lyophilized powder of 1.38 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.09 mg stannous chloride dihydrate, (minimum stannous tin 0.015 mg; total stannous and stannic tin 0.0522 mg) 1.92 mg disodium sulphosalicylate, 3 mg sodium D-gluconate, and 11 mg sodium hydrogen carbonate, and 3 mg ascorbic acid. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.
The chemical formula of tetrofosmin is C18H40O4P2with the following structural formula:
When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed. The reconstituted product is a clear solution and the pH is in the range of 7.5-9.0.
Technetium Tc99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2.
Table 2. Principal radiation emission data – technetium Tc99m:
| Radiation | Mean % disintegration | Mean energy (keV) |
|---|---|---|
| Gamma 2 | 88.5 | 140.5 |
The air-kerma-rate (exposure-rate) constant for technetium Tc99m is 5.23 m²∙pGy∙(MBq)–1∙s–1 [0.795 cm²∙R∙(mCi)–1∙h–1].
A range of values for the relative radiation attenuation by various thicknesses of Pb shielding is shown in Table 3. For example, the use of 3mm thick Pb will decrease the external radiation exposure by a factor of approximately 1000.
Table 3. Radiation attenuation by lead shielding:
| Shield thickness (Pb) mm | Factor of attenuation |
|---|---|
| 0.25 | 0.5 |
| 1 | 10-1 |
| 2 | 10-2 |
| 3 | 10-3 |
| 4 | 10-4 |
| 5 | 10-5 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4.
Table 4. Physical decay chart – Tc99m half-life 6 hours:
| Hours | Fraction Remaining | Hours | Fraction Remaining |
|---|---|---|---|
| 0* | 1.000 | 7 | 0.446 |
| 1 | 0.891 | 8 | 0.397 |
| 2 | 0.794 | 9 | 0.354 |
| 3 | 0.707 | 10 | 0.315 |
| 4 | 0.630 | 11 | 0.281 |
| 5 | 0.562 | 12 | 0.250 |
| 6 | 0.500 | 24 | 0.063 |
* Calibration time (time of preparation)
| Dosage Forms and Strengths |
|---|
|
Kit for the preparation of technetium Tc99m tetrofosmin injection: 30 mL multiple-dose, clear, glass vial with a white sterile, non-pyrogenic, lyophilized powder of 1.38 mg tetrofosmin, 0.09 mg stannous chloride dihydrate, 1.92 mg disodium sulphosalicylate, 3 mg sodium D-gluconate, 11 mg sodium hydrogen carbonate, and 3 mg ascorbic acid. Following reconstitution with the Tc99m eluate, MYOVIEW is a clear solution not exceeding 2960 MBq/mL (80 mCi/mL) of Tc99m. |
| How Supplied |
|---|
|
Five (5) multiple-dose kits, each containing a 30 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 1.38 mg tetrofosmin, 0.09 stannous chloride dihydrate, 1.92 mg disodium sulphosalicylate, 3 mg sodium D-gluconate, 11 mg sodium hydrogen carbonate and 3 mg ascorbic acid. NDC 17156-026-30 The radionuclide is not part of the kit. Before reconstitution and radiolabeling with Tc99m, the contents of the kit are not radioactive. |
| Drug | Countries | |
|---|---|---|
| MYOVIEW | Austria, Cyprus, Estonia, Spain, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Singapore, United Kingdom, United States |
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