U.S. Spect products | Generator

Ultra-Technekow™ V4

(technetium Tc 99m generator)

This information is intended for U.S. healthcare professionals only.

Product information

  • Curium provides a review of the supply of target material, reactors, processing facilities, generator systems, and radioactive waste in a newly published paper. Access the full review of Mo 99/Tc 99m generator systems.
  • Manufactured using 100% LEU-derived Mo 99.
  • 100% terminally sterilized Ultra-Technekow V4 generator production line uses cutting-edge technology in the production process from start to finish.
  • Multiple shielding options of lead and depleted uranium (DU) help provide reliable radiation protection across all 13 of our generator-size offerings. Learn more about generator shielding options.
  • Calibrated for early AM delivery; our vast logistics network allows for, in most cases, delivery prior to the start of the facility’s first shift.
  • Not made with natural rubber latex
  • Complimentary Generator Return Program
  • Parametric release – this FDA approval demonstrates our control of the sterilization process and confidence in our critical process controls.
  • The entire generator manufacturing process, from start to finish, is digitally recorded. This allows for excellent training opportunities and preventative maintenance planning and scheduling.

Indication & Usage

The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labelling 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

 

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.
  • 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™ V4 generator. Do not use any other generator eluant or saline from any other source.
  • 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.
  • 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.
  • 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

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

Use in specific populations

  • Pregnancy: Sodium Pertechnetate Tc 99m should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
  • Breastfeeding: Technetium Tc 99m is excreted in human milk during lactation, therefore, formula-feedings should be substituted for breast-feedings.

Frequently asked questions

We manufacture generators three days a week: Sunday, Monday and Wednesday.

Generators can be ordered through your local Sales Representative, or our U.S. 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.

Directions for use of the saline vial alignment insert is found in the Elution section of the full prescribing information.  You may also watch a short video demonstration here.

The SVAI is smooth, impervious, free from cracks and crevices, and non-shedding. It can be cleaned and disinfected using hydrogen peroxide (3%), Sporicidin® Disinfectant Spray, Solution, Aerosol (Ready to Use) or Vesphene® IIse (1:128 Dilution).  For additional information on cleaning or generator accessories, refer to the Generator Accessories User Manual.

Sporicidin® is a registered trademark of Contec, Inc.  Vesphene® is a registered trademark of Steris Corporation.

All standing order changes or cancellations are handled by the U.S. 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.

Call Curium Pharmacovigilance / Product Monitoring Department at 866.789.2211

How is this product supplied

Distribution

Direct

Calibration date

6 a.m. CST – Sunday, Monday and Wednesday 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 # NDC
Mo 99 V4 Generator (L) 1 Each 1.0 Ci N9010 69945-010-03
Mo 99 V4 Generator (L) 1 Each 1.5 Ci N9015 69945-015-04
Mo 99 V4 Generator (L) 1 Each 2.0 Ci N9020 69945-020-05
Mo 99 V4 Generator (L) 1 Each 2.5 Ci N9025 69945-025-06
Mo 99 V4 Generator (L) 1 Each 3.0 Ci N9030 69945-030-07
Mo 99 V4 Generator (L) 1 Each 3.5 Ci N9035 69945-035-08
Mo 99 V4 Generator (L/D) 1 Each 5.0 Ci N9051 69945-051-09
Mo 99 V4 Generator (L/D) 1 Each 6.0 Ci N9060 69945-060-10
Mo 99 V4 Generator (L/D) 1 Each 7.5 Ci N9075 69945-075-11
Mo 99 V4 Generator (D) 1 Each 11.0 Ci N9110 69945-110-12
Mo 99 V4 Generator (D) 1 Each 14.0 Ci N9140 69945-140-13
Mo 99 V4 Generator (D) 1 Each 16.0 Ci N9160 69945-160-14
Mo 99 V4 Generator (D) 1 Each 19.0 Ci N9190 69945-190-15

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Product contact information

Maryland Heights

N/A