glofil-125- Iothalamate sodium, I-125 injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Iothalamate sodium, I-125 (UNII: 31J5U3Q9ZN) (Iothalamate sodium, I-125 - UNII:31J5U3Q9ZN)

Dostupno od:

QOL Medical

INN (International ime):

Iothalamate sodium, I-125

Farmaceutski oblik:

INJECTION

Sastav:

1 mg

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

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 [phone] Revised April 2006 No. 1000 NDC 67871-772-92

Svojstava lijeka

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