Xenon, Xe-133 5 mCi/mL
Xenon · GAS · Curium US LLC
Xenon, Xe-133 is a gas containing xenon at 5 mCi/mL, taken respiratory (inhalation). Manufactured by Curium US LLC.
Key Facts
- Brand Name
- Xenon, Xe-133
- Generic Name
- Xenon
- NDC Code (Product)
69945-097- Manufacturer
- Curium US LLC
- Strength
- 5 mCi/mL
- Dosage Form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA018327
- Drug Class
- Inhalation Diagnostic Agent [EPC]
- Marketing Start
- 03/30/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.
Dosage & Administration
DOSAGE AND ADMINISTRATION Xenon Xe 133 Gas is administered by inhalation from a closed respirator system or spirometer. The final patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The recommended activity range employed for inhalation by the average patient (70 kg) is: Pulmonary function including imaging: 74 to 1110 megabecquerels (2 to 30 millicuries) Cerebral blood flow: 370 to 1110 megabecquerels (10 to 30 millicuries) This may be administered as a bolus into the tubing near the patient's mouthpiece or mask after the completion of a tidal exhalation, or by rebreathing for a period of approximately 5 minutes of the Xenon Xe 133 gas in equilibrium with the air contained in the closed system at concentrations of the radionuclide that may vary from 37 to 222 megabecquerels (1.0 to 6.0 millicuries) per liter.
Warnings
WARNINGS Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the laboratory environs not specifically protected by exhaust systems. Xenon Xe 133 Gas adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. Loss of radioactivity due to such adherence may render the study nondiagnostic.
Contraindications
CONTRAINDICATIONS None known.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions specifically attributable to Xenon Xe 133 Gas have not been reported.
Frequently Asked Questions
What is Xenon, Xe-133 used for?
Xenon, Xe-133 contains Xenon. It is a gas taken respiratory (inhalation). Consult your doctor for specific uses.
Is Xenon, Xe-133 a controlled substance?
Xenon, Xe-133 is not classified as a controlled substance by the DEA.
What is the generic name for Xenon, Xe-133?
The generic name for Xenon, Xe-133 is Xenon. There are 7 other brand versions of Xenon.
What is the NDC code for Xenon, Xe-133 5 mCi/mL?
The NDC (National Drug Code) for Xenon, Xe-133 5 mCi/mL is 69945-097, listed by Curium US LLC.