Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
Technetium Tc 99m Sulfur Colloid · KIT · Sun Pharmaceutical Industries, Inc.
Technetium Tc 99M Sulfur Colloid is a radioactive imaging agent used in nuclear medicine scans to help doctors visualize certain organs and tissues, particularly the liver, spleen, and bone marrow. This prescription medication comes as a kit that must be prepared before use for diagnostic imaging procedures.
Key Facts
- Brand Name
- Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
- Generic Name
- Technetium Tc 99m Sulfur Colloid
- NDC Code (Product)
45567-0030- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA017858
- Marketing Start
- 04/19/1978
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. Minimize Tc99m Sulfur Colloid radiation exposure and measure patient doses immediately before administration. Breast cancer or malignant melanoma setting: by subcutaneous injection, 3.7 to 37 MBq (0.1 to 1 mCi in volumes ranging from 0.1 to 1 mL) ( 2.1 ). Peritoneo-venous (LeVeen) shunt setting in adults: ( 2.1 ) by intraperitoneal injection: 37 to 111 MBq (1 to 3 mCi); by percutaneous transtubal injection: 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL. Imaging areas of functioning reticuloendothelial cells by intravenous injection ( 2.1 ): In adults: Liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi); Bone marrow imaging: 111 to 444 MBq (3 to 12 mCi); In pediatric patients: Liver/spleen imaging in newborns: 7.4 to 18.5 MBq (0.2 to 0.5 mCi); Liver/spleen imaging in children: 0.56 to 2.78 MBq (0.015 to 0.075 mCi) per kg of body weight (BW); Bone marrow imaging: 1.11 to 5.55 MBq (0.03 to 0.15 mCi) per kg of BW. Gastroesophageal and pulmo…
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied.
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported adverse reactions, across all categories of use and routes of administration, include rash, allergic reaction, urticaria, anaphylaxis/anaphylactic shock, and hypotension. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported. The most frequently reported adverse reactions include rash, urticaria, anaphylactic shock, and hypotension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-221-7554 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Frequently Asked Questions
What is Kit for the Prepartion of Technetium Tc99m Sulfur Colloid used for?
Technetium Tc 99M Sulfur Colloid is a radioactive imaging agent used in nuclear medicine scans to help doctors visualize certain organs and tissues, particularly the liver, spleen, and bone marrow. This prescription medication comes as a kit that must be prepared before use for diagnostic imaging procedures.
Is Kit for the Prepartion of Technetium Tc99m Sulfur Colloid a controlled substance?
Kit for the Prepartion of Technetium Tc99m Sulfur Colloid is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the Prepartion of Technetium Tc99m Sulfur Colloid?
The generic name for Kit for the Prepartion of Technetium Tc99m Sulfur Colloid is Technetium Tc 99m Sulfur Colloid. There are 1 other brand versions of Technetium Tc 99m Sulfur Colloid.
What is the NDC code for Kit for the Prepartion of Technetium Tc99m Sulfur Colloid ?
The NDC (National Drug Code) for Kit for the Prepartion of Technetium Tc99m Sulfur Colloid is 45567-0030, listed by Sun Pharmaceutical Industries, Inc..