Kit For The Preparation Of Technetium Tc99m Disofenin
Loading...Kit For The Preparation Of Technetium Tc99m Disofenin Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
The possibility of allergic reactions should be considered.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Technetium Tc99m Disofenin is indicated as a hepatobiliary imaging agent. Hepatolite is indicated in the diagnosis of acute cholecystitis as well as to rule out the occurrence of acute cholecystitis in suspected patients with right upper quadrant pain, fever, jaundice, right upper quadrant tenderness and mass or rebound tenderness, but not limited to these signs and symptoms.
In otherwise healthy individuals, non-visualization of the gallbladder 4 hours after administration of Hepatolite following a 2-6 hour fast and in the presence of activity in the small intestine is indicative of a diagnosis of acute cholecystitis. Under the same conditions in an otherwise healthy person, visualization of the gallbladder during a 1 hour scintigraphy is effective in excluding a diagnosis of acute cholecystitis. If the gallbladder is not visualized by 1 hour, scanning must continue for four hours or until the gallbladder is visualized.
When the gall bladder fails to appear within the first 60 minutes of imaging
after the administration of Hepatolite, a single 0.04mg/kg dose of intravenous morphine, diluted in 10mL normal saline may be administered over 3 minutes. (See CLINICAL PHARMACOLOGY section)
History
There is currently no drug history available for this drug.
Other Information
Each vial contains a sterile, non-pyrogenic, lyophilized mixture of
- Disofenin - 20mg
- Stannous Chloride, minimum (SnCL 2•2H 20) - 0.24mg
- Total Tin, maximum (SnCL 2•2H 20) - 0.6 mg
Prior to lyophilization the pH is adjusted to between 4-5 with HCL and/or NaOH. The contents of the vial are lyophilized and stored under nitrogen.
The drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection.
The structure of disofenin is shown below:
The precise structure of stannous technetium-disofenin complex is unknown at this time.
PHYSICAL CHARACTERISTICS
Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours.1 Photons that are useful for detection and imaging studies are listed in Table 1.
| Table 1. Principal Radiation Emission Data |
||
| Radiation |
Mean % per Disintegration |
Mean Energy (keV) |
| Gamma-2 |
89.07 |
140.5 |
1Kocher, David C., Radioactive Decay Data Tables, DOE/TIC-11026, 108 (1981).
External Radiation
The specific gamma ray constant for Tc99m is 5.4 microcoulombs/kg-MBq-hr (0.78R/mCi-hr) at 1cm. The first half value layer is 0.017cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead (Pb) is shown in Table 2. To facilitate control of the radiation exposure from MBq (mCi) amounts of this radionuclide, the use of a 0.25cm thickness of lead (Pb) will attenuate the radiation emitted by a factor of 1,000.
| Table 2. Radiation Attenuation by Lead Shielding |
|
| Shield Thickness (Pb) cm |
Coefficient of Attenuation |
| 0.017 |
0.5 |
| 0.08 |
10-1 |
| 0.16 |
10-2 |
| 0.25 |
10-3 |
| 0.33 |
10-4 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
| Table 3. Physical Decay Chart; Tc 99m Half-Life 6.02 Hours |
|||
| Hours |
Fraction Remaining |
Hours |
Fraction Remaining |
| 0* |
1.000 |
7 |
.447 |
| 1 |
.891 |
8 |
.398 |
| 2 |
.794 |
9 |
.355 |
| 3 |
.708 |
10 |
.316 |
| 4 |
.631 |
11 |
.282 |
| 5 |
.562 |
12 |
.251 |
| 6 |
.501 |
||
*Calibration time
Sources
Kit For The Preparation Of Technetium Tc99m Disofenin Manufacturers
-
Pharmalucence, Inc.
![Kit For The Preparation Of Technetium Tc99m Disofenin (Hepatolite) Injection, Powder, Lyophilized, For Solution [Pharmalucence, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kit For The Preparation Of Technetium Tc99m Disofenin | Pharmalucence, Inc.
The suggested dose range for i.v. administration, to be employed in the average patient (70kg) is:
Non-Jaundiced patient: 37 - 185 MBq (1-5 mCi) Patient with serum bilirubin level
greater than 5 mg/dL: 111-296 MBq (3-8 mCi)The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. (If blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation in situ.) Do not backflush the syringe; slow injection is recommended. Radiochemical purity should be checked prior to patient administration.
Store at controlled room temperature (20-25°C) before and after reconstitution.
The patient should be in a fasting state; 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
This preparation is usually administered to a patient only once. However, should a second dose be required, the interval between doses should not be less than 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Login To Your Free Account