Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
HUMAN SERUM ALBUMIN I-131 (UNII: ACH35131L1) (HUMAN SERUM ALBUMIN I-131 - UNII:ACH35131L1)
Iso-Tex Diagnostics, Inc.
IODINATED I-131 SERUM ALBUMIN
IODINATED I-131 SERUM ALBUMIN 0.025 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
Biologic Licensing Application
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 Læs hele dokumentet