Imaging agents:

Indications for LUMASON:

For use in adults and children with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. For use in ultrasonography of the liver to characterize focal liver lesions in adults and children. For use in ultrasonography of the urinary tract for evaluation of suspected or known vesicoureteral reflux in children.

Adult:

See full labeling. Echocardiography: 2mL via IV bolus inj. Ultrasonography of the liver: 2.4mL via IV inj. Both: may repeat dose once if needed. Follow each inj with 5mL normal saline flush.

Children:

See full labeling. Echocardiography: 0.03mL/kg via IV inj; max 2mL per inj. Ultrasonography of the liver: 0.03mL/kg via IV inj; max 2.4mL per inj. Both: may repeat dose once if needed. Follow each inj with 5mL normal saline flush. Ultrasonography of the urinary tract: 1mL via intravesical bolus inj through the urinary catheter. The bladder may be refilled with normal saline for second cycle of voiding and imaging, without the need of a second Lumason inj.

Boxed Warning:

Serious cardiopulmonary reactions.

Warnings/Precautions:

Do not administer by intra-arterial inj. Risk of serious cardiopulmonary reactions; increased risk in those with unstable conditions (eg, acute MI, coronary artery syndromes, CHF, ventricular arrhythmias). Have resuscitation equipment and trained personnel readily available. Assess patients with cardiac shunts for embolic phenomena post inj. Not recommended for use at mechanical indices >0.8; high index values may lead to ventricular arrhythmias. Pregnancy. Nursing mothers.

Pharmacologic Class:

Contrast media.

Adverse Reactions:

Headache, nausea, dysgeusia, inj site pain, feeling hot; cardiopulmonary reactions, hypersensitivity reactions (monitor).

Generic Availability:

NO

How Supplied:

Kit—1 (one vial + diluent + mini-spike)