Ultra-TechneKow DTE

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 ensure 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.

No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Sodium Pertechnetate Tc 99m may affect fertility in males or females.

Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m. It is also not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Pertechnetate Tc 99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.

Ideally, examinations using radiopharmaceutical drug products - especially those elective in   nature - of women of childbearing capability should be performed during the first ten days following the onset of menses.

Technetium Tc-99m is excreted in human milk during lactation, therefore, formula-feedings should be substituted for breast-feedings.

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risk under WARNINGS.

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 weight

The 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.

If the vacuum in the collecting vial is lost, do not attempt to re-evacuate the vial, but discard and use a new collecting vial.

Ultra-TechneKow™ DTE

A880CO
R10/2015

CAUTION
RADIOACTIVE MATERIAL

Ultra-TechneKow™ DTE

A880CO
R10/2015

CAUTION
RADIOACTIVE MATERIAL