Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/653
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GLOFIL-125 (Injection)
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| dailymed-instance:dosage |
Dosage: The suggested dose range employed in the average patient (70 kg) is as follows:Continuous intravenous infusion: 20 to 100��Ci (0.74-3.7 megabecquerels) (Sigman, et al (1) method).Single intravenous injection: 10 to 30��Ci (0.37-1.11 megabecquerels) (Cohen, et al (2) method).The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.<br/>Technique:<br/>Continuous intravenous infusion: Sigman
(1) method I. Preparation: II. Procedure: III. Clearance Calculations:<br/>Single intravenous injection: Cohen
(2) method: The method of Cohen, et al (2) requires little preparation, few and small blood samples, no bladder catheterization, and no constant intravenous infusion. It is simple to perform, rapid, and
utilizes equipment which is readily available in most modern laboratories. I. Preparation: II. Procedure:
Record actual times for the collection of the blood and urine samples. III. Clearance Calculations: C = UV/P + 1.73/SA where C = glomerular filtration rate in mL/min/1.73 mU = urine radioactivity in counts/min/mLV = urine flow rate in mL/minP= mean plasma radioactivity in counts/min/mLSA= body surface area in m<br/>Radiation Dosimetry: The estimated absorbed radiation doses to an average (70 kg)
patient from an intravenous dose of 100��Ci (3.7 megabecquerels) of
GLOFIL-125 are shown in Table 4. Calculations assume that
there is 1% free iodide in the preparation and that the thyroid uptake of
the iodine is 25%.<br/>Visual Inspection: Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit.
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| dailymed-instance:descripti... |
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��Ci/mL as
of the calibration date. Sodium bicarbonate and hydrochloric acid are present
for pH adjustment.<br/>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. 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. 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.
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| dailymed-instance:clinicalP... |
The renal clearance of sodium iothalamate in man closely
approximates that of inulin. The compound is cleared by glomerular filtration
without tubular secretion or reabsorption. Following infusion administration
of I-125 iothalamate, the effective half-life is about 0.07 days.
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| dailymed-instance:contraind... |
GLOFIL-125 should not be administered via
a central venous line.
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| dailymed-instance:supply |
Identity: 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��Ci/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.<br/>Storage: Refrigerate the product upon receipt at 2��C to 8��C.<br/>Dose Volume Calculation: 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)<br/>REFERENCES:<br/>ADDITIONAL REFERENCES: 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
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| dailymed-instance:precautio... |
General: As in the use of any radioactive material, care should be
taken to minimize radiation exposure to the patient, consistent with proper
patient management, and to insure minimum radiation exposure to occupational
workers. Radiopharmaceuticals should be used only by
physicians who are qualified by training and experience in the safe use and
handling of radionuclides. Rapid or bolus-like injections should be avoided.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed to evaluate
carcinogenic potential, mutagenic potential, or whether this drug affects fertility in males or females.<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
GLOFIL-125. It is also not known whether GLOFIL-125
can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. GLOFIL-125 should be given to a pregnant woman
only if clearly needed.<br/>Nursing Mothers: Radioiodine is excreted in human milk during lactation. It
is not known whether GLOFIL-125 is excreted in human milk.
Therefore, formula feedings should be substituted for breast feedings.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
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| dailymed-instance:genericMe... |
Iothalamate sodium, I-125
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| dailymed-instance:fullName |
GLOFIL-125 (Injection)
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| dailymed-instance:adverseRe... |
None reported.
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| dailymed-instance:warning |
None known.
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| dailymed-instance:indicatio... |
GLOFIL-125 (Sodium Iothalamate I-125 Injection)
is indicated for evaluation of glomerular filtration in the diagnosis or monitoring
of patients with renal disease.
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| dailymed-instance:name |
GLOFIL-125
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