Kit For The Prepartion Of Technetium Tc99m Sulfur Colloid
(Technetium Tc 99m Sulfur Colloid)Kit For The Prepartion Of Technetium Tc99m Sulfur Colloid Prescribing Information
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 emits radiation. Use procedures to minimize radiation exposure. Measure patient dose by a suitable radioactivity calibration system immediately before administration.
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All components of a kit are sterile and non-pyrogenic. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Included in each 5-kit package are one package insert and 10 radiation labels.
Lactation: Advise a lactating woman to pump and discard breast milk for 24 hours and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection (
8.2 LactationTechnetium Tc 99m is excreted in human milk during lactation. Exposure of Technetium Tc 99m Sulfur Colloid Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection. Following higher dose procedures [greater than 370 MBq (10 mCi)], patients should minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection.
None
Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available (
5.1 Anaphylactic ReactionsAnaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid Injection. Have emergency resuscitation equipment and personnel immediately available.