LUMASON- sulfur hexafluoride kit LUMASON- sulfur hexafluoride injection, powder, lyophilized, for suspension

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

SULFUR HEXAFLUORIDE (UNII: WS7LR3I1D6) (SULFUR HEXAFLUORIDE - UNII:WS7LR3I1D6), DISTEAROYLPHOSPHATIDYLCHOLINE, DL- (UNII: EAG959U971) (DISTEAROYLPHOSPHATIDYLCHOLINE, DL- - UNII:EAG959U971), SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) (UNII: 841B886EJ7) (SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) - UNII:841B886EJ7)

Verfügbar ab:

BRACCO DIAGNOSTICS INC

INN (Internationale Bezeichnung):

SULFUR HEXAFLUORIDE

Zusammensetzung:

SULFUR HEXAFLUORIDE 60.7 mg in 1 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Echocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux. Lumason is contraindicated in patients with known or suspected: - Hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG) [see Warnings and Precautions (5.2) and Description (11)] . Risk Summary There are no data with Lumason use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with administration of sulfur he

Produktbesonderheiten:

Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension is supplied as a single patient use kit and as a 20-vial pack as follows: Store the kit at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

New Drug Application

Fachinformation

LUMASON- SULFUR HEXAFLUORIDE
LUMASON- SULFUR HEXAFLUORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SUSPENSION
BRACCO DIAGNOSTICS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUMASON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUMASON.
LUMASON (SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES) FOR INJECTABLE
SUSPENSION, FOR
INTRAVENOUS USE OR INTRAVESICAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
SERIOUS CARDIOPULMONARY REACTIONS, INCLUDING FATALITIES, HAVE OCCURRED
UNCOMMONLY
DURING OR FOLLOWING THE INJECTION OF ULTRASOUND CONTRAST AGENTS,
INCLUDING SULFUR
HEXAFLUORIDE LIPID MICROSPHERES (5.1). MOST SERIOUS REACTIONS OCCUR
WITHIN 30 MINUTES
OF ADMINISTRATION (5.1).
ASSESS ALL PATIENTS FOR THE PRESENCE OF ANY CONDITION THAT PRECLUDES
ADMINISTRATION
(4).
ALWAYS HAVE RESUSCITATION EQUIPMENT AND TRAINED PERSONNEL READILY
AVAILABLE (5.1).
RECENT MAJOR CHANGES
Contraindications (4)
4/2021
Warnings and Precautions, Hypersensitivity Reactions (5.2)
4/2021
INDICATIONS AND USAGE
Lumason is an ultrasound contrast agent indicated for use
in echocardiography to opacify the left ventricular chamber and to
improve the delineation of the left
ventricular endocardial border in adult and pediatric patients with
suboptimal echocardiograms (1)
in ultrasonography of the liver for characterization of focal liver
lesions in adult and pediatric patients (1)
in ultrasonography of the urinary tract for the evaluation of
suspected or known vesicoureteral reflux in
pediatric patients (1)
DOSAGE AND ADMINISTRATION
Avoid intra-arterial injection (2.1, 5.3)
See Full Prescribing Information for reconstitution instructions (2.3)
For intravenous injection:
Echocardiography in adults: After reconstitution, administer 2 mL as
an intravenous injection (2.2, 2.4)
Echocardiography in pediatric patients: After reconstitution,
administer 0.03 mL per kg as an
intravenous injectio