XENOVIEW- xenon xe 129 hyperpolarized gas

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

XENON XE-129, HYPERPOLARIZED (UNII: 726Q6M95ZA) (XENON XE-129, HYPERPOLARIZED - UNII:726Q6M95ZA)

Tilgængelig fra:

Polarean, Inc.

Indgivelsesvej:

RESPIRATORY (INHALATION)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. None. Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature. Animal reproduction studies were conducted in rats by administering an 80% Xe/20% O2 gas mixture for 2 hours twice a week for 2 and 10 weeks, with no observed effects on fertility or pregnancy. Gas mixtures containing 70% to 75% Xe gas and 25% to 30%

Produkt oversigt:

How Supplied XENOVIEW (xenon Xe 129 hyperpolarized) is provided in a 1,000 mL XENOVIEW Dose Delivery Bag (NDC 80534-1000-1). XENOVIEW Dose Delivery Bags are supplied in a carton of 50 with attachable mouthpieces and affixable dose labels. Xenon Xe 129 Gas Blend for preparation of XENOVIEW is supplied as a compressed gas under high pressure (2,105 pounds per square inch gauge [psig]) in size 302 aluminum cylinders (NDC 80534-6350-1) with a volume of 6,350 liters. Storage and Handling Store XENOVIEW at 20° to 25°C (68° to 77°F) for no more than 5 minutes after final DE measurement. Do not use and discard XENOVIEW 60 minutes after filling of Dose Delivery Bag. Store Xenon Xe 129 Gas Blend at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Manufactured for: Polarean, Inc. 2500 Meridian Parkway, Suite 175 Durham, NC 27713 Tel: [phone] XENOVIEW™ is a trademark of Polarean, Inc. Doc #: 34660B

Autorisation status:

New Drug Application

Produktets egenskaber

XENOVIEW- XENON XE 129 HYPERPOLARIZED GAS
XENOVIEW- XENON XE 129 HYPERPOLARIZED GAS
POLAREAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XENOVIEW SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XENOVIEW.
XENOVIEW (XENON XE 129 HYPERPOLARIZED), FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 2022
INDICATIONS AND USAGE
XENOVIEW , prepared from the Xenon Xe 129 Gas Blend, is a
hyperpolarized contrast agent indicated for
use with magnetic resonance imaging (MRI) for evaluation of lung
ventilation in adults and
pediatric patients aged 12 years and older.
Limitations of Use
XENOVIEW has not been evaluated for use with lung perfusion imaging.
(1)
DOSAGE AND ADMINISTRATION
The recommended target dose of XENOVIEW for adult and pediatric
patients aged 12 years and older is
75 mL to 100 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 by
oral inhalation of the entire
contents of one XENOVIEW Dose Delivery Bag. (2.1)
Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129
with a recommended target DE
range of 75 mL to 100 mL measured within 5 minutes of administration,
in a volume of 250 mL to 750
mL total xenon with additional nitrogen, NF (99.999% purity) added to
reach a total volume of 1,000
mL. (2.1)
Administer dose within 5 minutes of DE measurement. (2.2)
Initiate imaging immediately after inhalation. (2.2)
See Full Prescribing Information for detailed information regarding
preparation, administration, image
acquisition, and image interpretation. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
XENOVIEW is a clear, colorless, odorless gas contained in a 1,000 mL
XENOVIEW Dose Delivery Bag. The
bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 in a
volume of 250 mL to 750 mL total
xenon.
The strength is DE per 1,000 mL administered. The minimum DE for a
dose of XENOVIEW is 75 mL with
a recommended DE target range of 75 to 100 mL. DE of greater than 100
mL is acceptable. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRE