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  • ULTRA-TECHNEKOW™ DTE GENERATOR

    (technetium Tc 99m generator)

     

    We focus on delivering quality products.

    Full US prescribing information

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    QUALITY

    • Only qualified and regulatory registered suppliers of molybdenum-99 (Mo-99) raw material, are utilized in the Ultra-Technekow DTE (technetium Tc 99m generator) product, requiring significant testing and audit oversight.
    • Manufacturing and analytical processes are performed and documented in accordance with site controlled procedures as approved by the U.S. FDA.

    • Dispensing equipment, ion chambers, and other manufacturing instruments are maintained with regular Quality Control testing and calibration including use of National Institute of Standards and Technology (NIST) Mo-99 standards.

    • 100% of all generators are test eluted during the manufacturing process to help ensure final product specifications are met including Tc-99m assay, radionuclide impurity testing and verification of Mo-99:Tc-99m ratio.

  • INDICATIONS AND USAGE

    Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for:

    • Brain Imaging (including cerebral radionuclide angiography)
    • Thyroid Imaging
    • Salivary Gland Imaging
    • Placenta Localization
    • Blood Pool Imaging (including radionuclide angiography)
    • 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:

    • Brain Imaging (including cerebral radionuclide angiography)
    • Thyroid Imaging
    • Blood Pool Imaging (including radionuclide angiography)
    • Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux


    IMPORTANT RISK INFORMATION

    WARNINGS AND PRECAUTIONS

    • 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.
    • 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.
    • 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 and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
    • After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.
    • Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from time of generator elution.

    ADVERSE REACTIONS

    • Serious adverse reactions may include anaphylaxis.

    USE IN SPECIFIC POPULATIONS

    •  Breastfeeding: should be discontinued because Technetium Tc 99m is excreted in human milk.