Ultra-technekow Dte
Loading...Ultra-technekow Dte Recall
Get an alert when a recall is issued.
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™ DTE Generator. Do not use any other generator eluant or saline from any other source.
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
The Ultra-TechneKow™ DTE 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:
Thyroid Imaging
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:
Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux
History
There is currently no drug history available for this drug.
Other Information
The Ultra-TechneKow™ DTE Generator is prepared with fission-produced molybdenum Mo-99 adsorbed onto alumina column shielded by lead, tungsten, or depleted uranium. This generator provides a closed system for the production of sterile metastable technetium Tc-99m, which is produced by the decay of molybdenum Mo-99. 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 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.
Sources
Ultra-technekow Dte Manufacturers
-
Mallinckrodt Inc.
![Ultra-technekow Dte (Technetium Tc-99m Generator) Injection, Solution [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ultra-technekow Dte | Mallinckrodt Inc.
Sodium Pertechnetate Tc 99m is administered by intravenous injection. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.
For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder.
The suggested dose ranges employed for various diagnostic indications in the average ADULT PATIENT (70 kg) are as follows:
Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi)
Thyroid gland imaging: 37 to 370 MBq (1 to 10 mCi)
Salivary gland imaging: 37 to 185 MBq (1 to 5 mCi)
Nasolacrimal drainage system: Maximum dose of 3.7 MBq (100 µCi)The recommended dosages in PEDIATRIC PATIENTS are:
Vesico-ureteral imaging: 18.5 to 37 MBq (0.5 to 1 mCi)
Thyroid gland imaging: 2.22 to 2.96 MBq (60 to 80 µCi) per kg body weightThe patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution to be administered as the patient dose should be clear, colorless, and contain no particulate matter.
Login To Your Free Account