TechneLite Technetium Tc99m Generator

 

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INDICATIONS AND USAGE:

The TechneLite® 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 Injection is used IN ADULTS as an agent for:
Thyroid Imaging
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
Nasolacrimal Drainage System Imaging
Sodium Pertechnetate Tc-99m Injection is used IN CHILDREN as an agent for:
Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

CONTRAINDICATIONS:

None Known

IMPORTANT SAFETY INFORMATION:

Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc-99m Injection.

WARNINGS:

Radiation risks associated with the use of Sodium Pertechnetate Tc-99m Injection are greater in children than in adults and, in general, the younger the child, 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 children.  Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

PRECAUTIONS:

Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite®, Technetium Tc-99m Generator, elution. 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. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please see full Prescribing Information

 

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