Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
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)
BRACCO DIAGNOSTICS INC
SULFUR HEXAFLUORIDE
SULFUR HEXAFLUORIDE 60.7 mg in 1 mg
PRESCRIPTION DRUG
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
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].
New Drug Application
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 Lire le document complet