Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 30 January 2017
PRECAUTIONS General As in the use of any radioactive material,
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the
Pregnancy Category C Animal reproduction studies have not been conducted with GLOFIL-125.
It is also not known whether GLOFIL-125 can cause fetal
GLOFIL-125 should be given to a pregnant woman only if clearly needed.
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.
Dosage The suggested dose range employed in the
Continuous intravenous infusion: 20 to 100?Ci (0.74-3.7 megabecquerels) (Sigman, et al (1) method).
The patient dose should be measured by a
Technique Continuous intravenous infusion Sigman1 method I. Preparation: 1.
It is not necessary to
After the establishment of
An intravenous infusion of Lactated Ringers (Hartmanns) solution is started in each arm, one to maintain a site for injection of the GLOFIL-125, the other to serve as a site for serial withdrawal of
A two-way stopcock connects the needle and intravenous tubing of each arm.
The dose is equally divided into (1) an intravenous priming dose to be injected as is and (2) a sustaining dose to be diluted in 30 to 60 mL of isotonic sodium chloride, depending on how many collection periods are anticipated.
This is immediately followed by infusion of the sustaining solution through the same site, usually at the rate of 0.5 mL/min., by means of an automatic pump.
During this infusion,
After attaining equilibrium, consecutive 15
From the arm opposite the injection site, 5 mL of
This 30 mL contains the contents of the tubing, including infusion fluid, and must be
During each collection period,
Clearance Calculations: 1.
Aliquots (1 mL each) of plasma and
Glomerular filtration rate is calculated by the formula C=UV/P, in which: C = glomerular filtration rate in mL/min U= urinary concentration of radioactivity in net counts/min/mL V= urinary flow rate in mL/min P = plasma concentration of radioactivity in net counts/min/mL 4.
GFR can be expressed in terms of body weight (mL/min/ kg) or body surface area (mL/min/ m2).
Unilateral glomerular filtration rates can be determined by the same technique by utilizing ureteral catheterization.
I. Preparation: 1.
Lugol 's solution, 3 drops orally, three times a day, is administered for one or two days prior to the test.
Oral water load is begun one hour before starting the test.
Start with 20 mL/kg and force any
Procedure: Record actual times for the collection of the
Empty the bladder and label the
Inject 10-30 µCi GLOFIL-125 intravenously; wait 30 to 60 minutes.
Collect the entire
Draw 4 to 5 mL of
Label Plasma #1.
After another 30 to 60 minutes, collect the entire
Immediately draw another
Label Plasma #2.
After final 30 to 60 minute wait, collect the
Label Urine #2.
Draw the last
Label Plasma #3.
Clearance Calculations: 1.
Radioactivity of one mL aliquots of both
Calculations of the clearance rates are made by using the formula: (1) C = C = UV/P + 1.73/SA where C = glomerular filtration rate in mL/min/1.73 m2 U =
Calculations assume that there is 1 %
|Date Last Revised||22-04-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage Refrigerate the product upon receipt at 2°C to 8°C.|
|Marketing authorisation holder||Iso-Tex Diagnostics, Inc.|