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Ultra-Technekow™ DTE Technetium Tc 99m Generator

Technetium Tc 99m Generator

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.

How Supplied

Distribution Direct
Calibration Day 6 a.m. CST - Sunday, Monday, Wednesday and Friday each week
Expiration 14 days post manufacture
Storage Conditions Controlled room temperature 20-25°C (68°F-77°F)

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Generator, Mo99 (DU)* 1 each 11.0 Ci N892** n/a
Generator, Mo99 (DU)* 1 each 14.0 Ci N893** n/a
Generator, Mo99 (DU)* 1 each 16.0 Ci N894** n/a
Generator, Mo99 (DU)* 1 each 19.0 Ci N895** n/a
Generator, Mo99 (L)* 1 each 1.0 Ci N883** n/a
Generator, Mo99 (L)* 1 each 1.5 Ci N884** n/a
Generator, Mo99 (L)* 1 each 2.0 Ci N885** n/a
Generator, Mo99 (L)* 1 each 2.5 Ci N886** n/a
Generator, Mo99 (L)* 1 each 3.0 Ci N887** n/a
Generator, Mo99 (L)* 1 each 3.5 Ci N888** n/a
Generator, Mo99 (L/T)* 1 each 5.0 Ci N889** n/a
Generator, Mo99 (L/T)* 1 each 6.0 Ci N890** n/a
Generator, Mo99 (L/T)* 1 each 7.5 Ci N891** n/a

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
How many days a week are generators manufactured?We manufacture generators four days a week: Sunday, Monday, Wednesday and Friday.
How do I place an order for a generator?Generators can be ordered through your local Sales Representative, or our Customer Service Department at 888.744.1414, option 1 then option 2. Up to a four-week order processing time has been established allowing adequate time to verify RAM licensing and to secure the required raw materials.
How do I go about making changes to a current standing order?All standing order changes or cancellations are handled by the Customer Service Department at 888.744.1414, option 1 then option 2. A four-week processing time on standing order changes or cancellations is required.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.