sodium iodide- Sodium Iodide, I-123 capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Sodium Iodide, I-123 (UNII: 29UKX3A616) (Sodium Iodide, I-123 - UNII:29UKX3A616)

Tilgængelig fra:

GE Healthcare, Medi-Physics, Inc.

INN (International Name):

Sodium Iodide, I-123

Lægemiddelform:

CAPSULE

Sammensætning:

100 uCi

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Sodium Iodide I-123 is indicated for use in the evaluation of thyroid function and/or morphology. None known.

Produkt oversigt:

Sodium Iodide I-123 capsules for oral administration are supplied as follows: Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05 Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05 At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6. This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State. The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield. One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.

Produktets egenskaber

SODIUM IODIDE- SODIUM IODIDE, I-123 CAPSULE
GE HEALTHCARE, MEDI-PHYSICS, INC.
----------
SODIUM IODIDE
I-123 CAPSULES
FOR ORAL ADMINISTRATION
R ONLY
DESCRIPTION
GE Healthcare (Medi-Physics, Inc.) Sodium Iodide I-123 for diagnostic
use is supplied as capsules for
oral administration. At calibration time, each capsule has an activity
of 3.7 MBq (100 µCi) or 7.4 MBq
(200 µCi). Each gelatin capsule contains not more than 20 µg of
sodium hydroxide and not more than 1 g
of sucrose. Each capsule also contains FD&C Yellow No. 6.
Sodium Iodide I-123 is an odorless compound, freely soluble in water.
The I-123 is produced in an
accelerator by bombardment of enriched Xe-124 with protons [Xe-124
(p,2n) Cs-123
Xe-123
I-123].
The radionuclidic composition at calibration time is not less than
99.5% I-123 and not more than 0.5%
all other nuclides (Te-121, I-125, I-131, I-126, I-124, I-130, I-121
and Na-24). The radionuclidic
composition at expiration time is not less than 98.28% I-123 and not
more than 1.72% all other nuclides
(Te-121, I-125, I-131, I-126, I-124, I-130, I-121 and Na-24).
Molecular formula: Na
I
Molecular Weight: 145.99
PHYSICAL CHARACTERISTICS
Iodine-123 decays by electron capture with a physical half-life of
13.2 hours. The photon that is useful
for detection and imaging studies is listed in Table 1.
TABLE 1. PRINCIPAL RADIATION EMISSION DATA
RADIATION
MEAN %/DISINTEGRATION
MEAN ENERGY (KEV)
*
Gamma-2
83.4
159
EXTERNAL RADIATION
The specific gamma ray constant for I-123 is 11.2 µC/Kg-MBq-hr (1.6
R/hr-mCi) at 1 cm. The first half
value thickness of lead (Pb) for I-123 is 0.005 cm. A range of
coefficients of attenuation of the
radiation emitted by this radionuclide can be achieved by the
interposition of various thicknesses of Pb
and is shown in Table 2. For example, the use of 1.63 cm of lead will
decrease the external radiation
exposure by a factor of about 1,000.
TABLE 2. RADIATION ATTENUATION BY LEAD SHIELDING
SHIELD THICKNESS (PB) CM
COEFFICIENT OF ATTENUATION
0.005
0.5
0.10
10
X
123
*
Kocher, David C., R