VOLUMEX- iodinated i-131 albumin injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

HUMAN SERUM ALBUMIN I-131 (UNII: ACH35131L1) (HUMAN SERUM ALBUMIN I-131 - UNII:ACH35131L1)

Saatavilla:

Iso-Tex Diagnostics, Inc.

INN (Kansainvälinen yleisnimi):

IODINATED I-131 SERUM ALBUMIN

Koostumus:

IODINATED I-131 SERUM ALBUMIN 0.025 mCi in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies None known.

Tuoteyhteenveto:

Volumex (Iodinated I 131 Albumin Injection USP) is available in single unit dose syringes containing 25 microcuries of activity in one milliliter per syringe on the date of calibration. Each single unit dose syringe is supplied with reference solution. Complete assay data for each single unit dose syringe and reference solution are provided on their respective containers. The maximum concentration of a single unit dose syringe of Volumex does not exceed 26.3 microcuries per milliliter at time of calibration

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

VOLUMEX- IODINATED I-131 ALBUMIN INJECTION, SOLUTION
ISO-TEX DIAGNOSTICS, INC.
----------
VOLUMEX
R Only
DESCRIPTION
Volumex (Iodinated I 131 Albumin Injection) is a diagnostic
radiopharmaceutical
containing iodinated I 131 albumin for intravenous use. Each mL of
sterile,
nonpyrogenic, aqueous, colorless to very pale yellow solution provides
approximately 10
mg protein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg
monobasic
sodium phosphate, not more, than 0.4 mg guanidine hydrochloride,
sodium chloride for
isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer
acetyltryptophanate
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.
Volumex was prepared from blood that was nonreactive when tested for
hepatitis B
surface antigen (HB Ag). The structure of the complex is unknown.
PHYSICAL CHARACTERISTICS
Iodine 131 decays by beta and gamma emissions with a physical
half-life of 8.08 days.
Photons that are useful for detection and imaging studies are listed
in Table 1.
EXTERNAL RADIATION
The specific gamma ray constant for iodine 131 is 2.2R/hour-millicurie
at 1 cm. The first
half-value layer is 0.24 cm lead (Pb). A range of values for the
relative attenuation of the
radiation emitted by this radionuclide that result from interposition
of various
thicknesses of Pb is shown in Table 2. To facilitate control of the
radiation exposure
from this radionuclide, the use of a 2.55 cm thickness of Pb will
attenuate the radiation
emitted by a factor of about 1,000.
x
s
1
CLINICAL PHARMACOLOGY
Following intravenous injection, radioiodinated albumin human is
uniformly distributed
throughout the intravascular pool within 10 minutes; extravascular
distribution takes
place more slowly. Iodinated I 131 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