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Radiogenix System
  • Professionals
  • FDA PI

Radiogenix System

Generic name:technetium tc 99m generator
Dosage form: injection
Drug class:Diagnostic radiopharmaceuticals

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

INDICATIONS & USAGE SECTION for Radiogenix System 1.2

The Radiogenix System is a technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection. Sodium Pertechnetate Tc 99m Injection is indicated for use in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in:

Adults for:

  • Thyroid Imaging
  • Salivary Gland Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteral reflux
  • Nasolacrimal Drainage System Imaging (dacryoscintigraphy)

Pediatric Patients for:

  • Thyroid Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteral reflux.

DOSAGE & ADMINISTRATION SECTION for Radiogenix System 1.2

2.1 Radiation Safety Drug Handling

  • The potassium molybdate Mo-99 source solution and Sodium Pertechnetate Tc 99m Injection are radioactive and should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers. Use waterproof gloves and effective shielding, including syringe shields, throughout the entire preparation and handling for the Radiogenix System and technetium Tc-99m injection [see Warnings and Precautions (5.1)].

2.2 Important Administration Instructions

  • Use aseptic technique in eluting generator and in all drug preparation and handling.
  • Inspect the Sodium Pertechnetate Tc 99m Injection for particulate matter and discoloration prior to administration. Do not administer Sodium Pertechnetate Tc 99m Injection if there is any evidence of particulate matter and discoloration.
  • Measure patient dose with a suitable radioactivity calibration system immediately prior to administration.
  • Instruct patients to hydrate after intravenous or intravesicular administration. Encourage the patient to void as soon as the imaging study is completed and frequently for the next 12 hours to minimize th...