Ultra-technekow V4 Recall
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Questions & Answers
Side Effects & Adverse Reactions
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m are greater in pediatric patients than in adults and, in general, the younger the patient the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit risk assessments involving pediatric patients.
Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Only use generator eluant specified for use with the Ultra-Technekow™ V4 Generator. Do not use any other generator eluant or saline from any other source.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.
Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for detection of vesico-ureteral reflux
Nasolacrimal Drainage System Imaging (dacryoscintigraphy)
Sodium Pertechnetate Tc 99m is used IN PEDIATRIC PATIENTS as an agent for:
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux
There is currently no drug history available for this drug.
The Ultra-Technekow™ V4 Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina in a column shielded by lead, tungsten, or depleted uranium. The column assembly and shielding are encased in a plastic container that is covered with a plastic elution hood. The elution hood has an opening for the column assembly double inlet needles and an opening for the single outlet needle. The needles accommodate the sterile eluant vials and sterile evacuated collection vials. A sterile vial containing a bacteriostat is supplied with the generator for the customer to aseptically seal the outlet needle after each elution.
This terminally sterilized generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. Incorporated between the column outlet and the collection vial is a sterile 0.22 micrometer filter. Sterile, non-pyrogenic isotonic solutions of Sodium Pertechnetate Tc 99m can be obtained conveniently by periodic aseptic elution of the generator. These solutions should be clear, colorless, and free from any particulate matter. The Sodium Pertechnetate
Tc 99m Injection is suitable for intravenous injection and direct instillation.
The carrier-free solution may be used as is, or diluted to the proper concentration. Over the life of the generator, an elution will contain an amount of technetium Tc-99m in direct proportion to the quantity of Mo-99 decay since the previous elution of the generator. The quantity of Tc-99m in the eluate is determined by quantity of Mo-99 on the column, and the elapsed time between elutions.
Each eluate of the generator should not contain more than the USP limit of 0.15 kilobecquerel molybdenum Mo-99 per megabecquerel technetium Tc-99m (0.15 microcurie Mo-99 per millicurie Tc-99m) per administered dose at the time of administration and an aluminum ion concentration of not more than 10 micrograms per milliliter of the generator eluate, both of which must be determined by the user before administration.
Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of generator elution.
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 1.
Table 1. Principal Radiation Emission Data
The specific gamma ray constant for technetium Tc-99m is 0.795 R/hr-mCi at 1 cm. The first half-value layer is 0.023 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.27 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1000.
Table 2. Radiation Attenuation by Lead Shielding
Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 2.75 days, or 66 hours (see Table 3). The physical decay characteristics of molybdenum Mo-99 are such that only 88.6% of the decaying molybdenum Mo-99 atoms form technetium Tc-99m. Generator elutions may be made at any time, but the amount of technetium Tc-99m available will depend on the interval measured from the last elution. Approximately 47% of the maximum available technetium Tc-99m is reached after 6 hours and 95% after 23 hours. To correct for physical decay of molybdenum Mo-99 and technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Tables 3 and 4.
Table 3. Physical Decay Chart; Molybdenum Mo-99, Half-Life 66 Hours
Table 4. Physical Decay Chart; Technetium Tc-99m, Half-Life 6 Hours