Source: FDA, National Drug Code (US) Revision Year: 2020
AdreView (Iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0–6.5.
Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:
Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.
Table 3. Principal Radiation Emission Data – Iodine 123:
Radiation | Energy Level (keV) | Abundance (%) |
---|---|---|
Gamma | 159 | 83 |
The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).
Table 4. Reduction in In-air Collision Kerma Caused by Lead Shielding*:
Shield Thickness cm of lead (Pb) | Reduction in In-air Collision Kerma |
---|---|
0.04 | 0.5 |
0.13 | 10-1 |
0.77 | 10-2 |
2.16 | 10-3 |
3.67 | 10-4 |
* Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632.
Dosage Forms and Strengths |
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Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time). |
How Supplied |
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AdreView is supplied in 10 mL glass vials containing a total volume of 5 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of appropriate thickness. NDC 17156-235-01 |
Drug | Countries | |
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ADREVIEW | Estonia, Spain, France, United Kingdom, United States |
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