Xenon, Xe-133
Xenon
Curium Us Llc
Human Prescription Drug
NDC 69945-098Xenon, Xe-133 also known as Xenon is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Xenon, Xe-133 is 69945-098. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Xenon, Xe-133 drug includes Xenon Xe-133 - 10 mCi/mL . The currest status of Xenon, Xe-133 drug is Active.
Drug Information:
| Drug NDC: | 69945-098 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Xenon, Xe-133 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Xenon |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Curium Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gas |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | XENON XE-133 - 10 mCi/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Mar, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA018327 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Curium US LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175866
N0000000205
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | X3P9A5HNYF
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Radiopharmaceutical Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Inhalation Diagnostic Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Inhalation Diagnostic Agent [EPC]
Radiopharmaceutical Activity [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69945-098-21 | 1 CAN in 1 CONTAINER (69945-098-21) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | 30 Mar, 2016 | N/A | No |
| 69945-098-23 | 3 CAN in 1 CONTAINER (69945-098-23) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | 30 Mar, 2016 | N/A | No |
| 69945-098-25 | 5 CAN in 1 CONTAINER (69945-098-25) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE | 30 Mar, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Xenon, xe-133 xenon xenon xe-133 xenon xe-133 air xenon, xe-133 xenon xenon xe-133 xenon xe-133 air
Indications and 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.
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.
General Precautions:
General xenon xe 133 gas as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management. exhaled xenon xe 133 gas should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of radionuclides. 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.
Dosage and 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.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions adverse reactions specifically attributable to xenon xe 133 gas have not been reported.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with xenon xe 133 gas. it is also not known whether xenon xe 133 gas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. xenon xe 133 gas should be given to a pregnant woman only if clearly needed. ideally, all examinations that use radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Description:
Description xenon xe 133 gas is for diagnostic inhalation use only. it is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of xenon xe 133 gas in 2 milliliters of carrier xenon and atmospheric air. xenon xe 133 gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. xenon xe 133 is produced by fission of uranium u 235. at the time of calibration, it contains no more than 0.3% xenon xe 133m, no more than 1.5% xenon xe 131m, no more than 0.06% krypton kr 85 and no more than 0.01% iodine i 131, with no less than 99.9% total radioactivity as radioxenon. table 1 shows the effect of time on radionuclidic composition. table 1. radionuclidic composition percent of total radioactivity days % xe-133 % xe-133m % xe-131m % kr-85 % i-131 -5 >98.3 <0.6 <1.0 <0.03 <0.01 0 calibration date >98.1 <0.3 <1.5 <0.06 <0.01 7 >97.2 <0.08 <2.5 <0.15 <0.02 14 expiration date >95.7 <0.02 <4.1 <0.37 <0.02
Clinical Pharmacology:
Clinical pharmacology xenon xe 133 is a readily diffusible gas which is neither utilized nor produced by the body. it passes through cell membranes, freely exchanges between blood and tissue, and tends to concentrate more in body fat than in blood, plasma, water or protein solutions. in the concentrations recommended for diagnostic studies, it is physiologically inactive. inhaled xenon xe 133 gas will enter the alveolar wall and the pulmonary venous circulation via capillaries. most of the xenon xe 133 gas that enters the circulation from a single breath is returned to the lungs and exhaled after a single pass through the peripheral circulation.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
How Supplied:
How supplied xenon xe 133 gas is available in 2 milliliter vials with color-coded labels in 370 megabecquerel (10 millicurie; catalog no. 097) and 740 megabecquerel (20 millicurie; catalog no. 098) sizes. both sizes are available in packages of 1, 3 and 5 vials, each with individual lead shielding.
Package Label Principal Display Panel:
Principal display panel - 10 mci xenon xe 133 gas 370 mbq (10 mci)/vial caution radioactive material single dose container -dispose in accordance with regulatory requirements. for use with xenotron⢠i xenon gas dispenser only. rx only curium us llc a097v0 r03/2019 label label
Principal display panel - 20 mci xenon xe 133 gas 740 mbq (20 mci)/vial caution radioactive material single dose container -dispose in accordance with regulatory requirements. for use with xenotron⢠i xenon gas dispenser only. rx only curium us llc a098v0 r03/2019 label label