JEANATOPE- iodinated i-125 albumin injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

HUMAN SERUM ALBUMIN I-125 (UNII: 68WQQ3N9TI) (HUMAN SERUM ALBUMIN I-125 - UNII:68WQQ3N9TI)

Dostupno od:

Iso-Tex Diagnostics, Inc.

INN (International ime):

IODINATED I-125 SERUM ALBUMIN

Sastav:

IODINATED I-125 SERUM ALBUMIN 0.01 mCi in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume. At present there are no known contraindications to the use of this preparation.

Proizvod sažetak:

Jeanotope (Iodinated I-125 Albumin Injection USP) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 3.7  megabequerels /10.0 ml (100 microcuries/10.0 ml), 18.5 megabequerels/0.5 ml  (500 microcuries/0.5 ml) and 37.0 megabequerels/1.0 ml (1.0 millicuries/1.0  ml). Complete assay data for each vial is provided on the container. The maximum concentration of Iodinated I-125 Injection does not exceed one millicurie per milliliter at time of calibration.

Status autorizacije:

Biologic Licensing Application

Svojstava lijeka

JEANATOPE- IODINATED I-125 ALBUMIN INJECTION, SOLUTION
ISO-TEX DIAGNOSTICS, INC.
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JEANATOPE
R
DESCRIPTION
Jeanatope 1-125 (Iodinated 1-125 Albumin Injection) is a sterile,
nonpyrogenic, aqueous solution for
intravenous use. Each milliliter provides approximately 10 mg protein
(normal human serum albumin),
1.6 mg sodium phosphate, 16 mg sodium biphosphate, not more than 0.4
mg guanidine hydrochloride,
sodium chloride for isotonicity, and 9 mg benzyl alcohol as a
preservative. The stabilizer
aceryltryptophanate and sodium caprylate have a concentration of less
than 0.0089M. The pH has been
adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid.
Jeanotope I-125 was prepared from the blood that was non-reactive when
tested for hepatitis B surface
antigen (HBsAg) and HIV antibody.
PHYSICAL CHARACTERISTICS
Iodine 125 decays by electron capture with a physical half-life of
60.14 days.
Photons that are useful for detection and imaging studies are listed
in Table 1.
EXTERNAL RADIATION
The specific gamma ray constant for I-125 is 1.5 R/millicurie-hour at
1 cm. The first half-value
thickness of Pb for I-125 is .002 mm. A range of values for the
relative attenuation of the radiation
emitted by this radionuclide that results from interposition of
various thicknesses of Pb is shown in
Table 2. For example, the use of .02 min of Pb will decrease the
external radiation exposure by a factor
of 1,000.
x Only
1
CLINICAL PHARMACOLOGY
Following intravenous injection, radioiodinated serum albumin is
uniformly distributed throughout the
intravascular pool within 10 minutes; extravascular distribution takes
place more slowly. Labeled
albumin also can be detected in the lymph and in certain body tissues
within 10 minutes after injection,
but maximum distribution of radioactivity throughout the extravascular
space does not occur until two to
four days after administration. The time at which extravascular
activity is maximal has been designated
as the "equilibrium time." When this point has been reached, the
radioactivity