Technetium Tc 99m Sulfur Colloid

FDA Drug Profile — Kit for the Prepartion of Technetium Tc99m Sulfur Colloid

Drug Details

Generic Name
Technetium Tc 99m Sulfur Colloid
Brand Names
Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
Application Number
NDA017858
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.