MYOVIEW SUMMARY
MYOVIEW™
Kit for the Preparation of Technetium Tc99m
Tetrofosmin for Injection
The MYOVIEW kit is supplied as a pack of five vials for use in the preparation of a technetium Tc99m tetrofosmin intravenous injection to be used for the scintigraphic delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium and for the evaluation of ventricular function. Each vial contains a predispensed, sterile, non-pyrogenic, lyophilized mixture of 0.23 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate (minimum stannous tin 0.005 mg; maximum total stannous and stannic tin 0.0158 mg), 0.32 mg disodium sulphosalicylate and 1.0 mg sodium D-gluconate, and 1.8 mg sodium hydrogen carbonate. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.
MYOVIEW is indicated for scintigraphic imaging of the myocardium following separate administrations under exercise and/or resting conditions. It is useful in the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium.
MYOVIEW is also indicated for scintigraphic imaging of the myocardium to identify changes in perfusion induced by pharmacologic stress in patients with known or suspected coronary artery disease.
MYOVIEW is also indicated for the assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients being evaluated for heart disease.
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