Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Iothalamate sodium, I-125 (UNII: 31J5U3Q9ZN) (Iothalamate sodium, I-125 - UNII:31J5U3Q9ZN)
QOL Medical
Iothalamate sodium, I-125
INJECTION
1 mg
INTRAVENOUS
PRESCRIPTION DRUG
GLOFIL® -125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. GLOFIL® -125 should not be administered via a central venous line.
No. 1000, GLOFIL® -125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label. Refrigerate the product upon receipt at 2°C to 8°C. Table 3 provides the required factors for the determination of activity per mL post calibration date for GLOFIL® -125 sterile solution. To determine the dose volume, locate the decay factor (fraction remaining) which corresponds to the day that the dose is to be administered. The following equation is then utilized to determine the dose volume: (activity of desired dose) /[(decay factor) x (amount of activity/mL on calibration day)] = dose volume (mL) (information on label) Manufactured by Iso-Tex Diagnostics, Inc. for QOL Medical QOL Medical Kirkland, WA 98033 Phone 1-866-469-3773 Revised April 2006 No. 1000 NDC 67871-772-92
GLOFIL-125- IOTHALAMATE SODIUM, I-125 INJECTION QOL MEDICAL ---------- GLOFIL -125 SODIUM IOTHALAMATE I-125 INJECTION, USP DESCRIPTION GENERAL GLOFIL -125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 μCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment. PHYSICAL CHARACTERISTICS Iodine-125 decays by electron capture with a physical half-life of 60.14 days. Photons that are useful for detection are listed in Table 1. TABLE 1. PRINCIPAL RADIATION EMISSION DATA * Radiation Mean Number Per Disintegration Mean Energy (keV) Gamma-1 0.067 35.5 Kα X-ray 0.741 27.5 Kα X-ray 0.398 27.2 Kß X-ray 0.140 31.0 Kß X-ray 0.043 31.7 Kß X-ray 0.072 30.9 The specific gamma ray constant for I-125 is 1.43 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I-125 is 0.017 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide resulting from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.28 mm of Pb will decrease the external radiation exposure by a factor of 10,000. TABLE 2. RADIATION ATTENUATION BY LEAD SHIELDING * Shield Thickness (Pb), mm Coefficient of Attenuation 0.017 0.5 0.058 0.1 0.12 0.01 0.2 0.001 0.28 0.0001 To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the date of calibration are shown in Table 3. ® ® * ICRP Publication 38: _Radionuclide Transformations - Energy and Intensity of Emissions._ Published for the International Commission on Radiological Protection by Pergamon Press, New York, 1983, p. 4 4 6. 1 2 1 2 3 * Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, Oak Ridge, TN 1989. TABLE 3. PHYSICAL DECAY CHART; I-125, HALF-LIFE 60.14 DAYS * Days Fra Prečítajte si celý dokument