ADREVIEW Solution for injection Ref.[10310] Active ingredients: Iobenguane ยนยฒยณI

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

Product description

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:

11.1 Physical Characteristics

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

11.2 External Radiation

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

Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).

How Supplied

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

Drugs

Drug Countries
ADREVIEW Estonia, Spain, France, United Kingdom, United States

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