MEGATOPE- 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 1 mCi in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes. None Known.

Tuoteyhteenveto:

MEGATOPE (iodinated I 131 albumin) injection is a colorless to very pale yellow solution available in multiple-dose vials containing the following amounts of radioactivity on the date of calibration: Complete radioassay data for each vial are provided on the MEGATOPE vial label.

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

MEGATOPE- IODINATED I-131 ALBUMIN INJECTION, SOLUTION
ISO-TEX DIAGNOSTICS, INC.
----------
MEGATOPE
RX ONLY.
DESCRIPTION
CHEMICAL CHARACTERISTICS
MEGATOPE (iodinated I 131 albumin) injection is a sterile,
nonpyrogenic, radioactive
diagnostic agent for intravenous use. Each mL contains albumin human
(approximately
10 mg), dibasic sodium phosphate (16 mg), guanidine hydrochloride (not
more than 0.4
mg), monobasic sodium phosphate (1.6 mg), sodium chloride for
isotonicity, and benzyl
alcohol (9 mg) as a preservative. The stabilizers acetyltryptophanate
and sodium
caprylate have a concentration of less than 0.89 mM. The pH has been
adjusted to 7.2
to 7.8 with sodium hydroxide or hydrochloric acid. Each vial contains
37 MBq/mL (1,000
microCi/mL) of radioactivity as iodinated I 131 albumin at time of
calibration (see HOW
SUPPLIED).
PHYSICAL CHARACTERISTICS Iodine-131 decays by beta and gamma emissions
with a
physical half-life of 8.02 days. Photons that are useful for detection
and imaging studies
are listed in Table 1.
Evaluated Nuclear Structure Data File of the Oak Ridge Nuclear Data
Project DOE
(1985).
EXTERNAL RADIATION
The specific gamma ray constant for iodine-131 is 2.2
R/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.
To correct for physical decay of iodine-131, the fractions that remain
at selected
1
intervals after the time of calibration are shown in Table 3.
* Calibration time
CLINICAL PHARMACOLOGY
Following intravenous injection, iodinated I 131 albumin is
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
cer