Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
Technetium Tc 99m Sulfur Colloid Kit · KIT · Jubilant DraxImage Inc., dba Jubilant Radiopharma
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid is a kit containing technetium tc 99m sulfur colloid kit. Manufactured by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Key Facts
- Brand Name
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
- Generic Name
- Technetium Tc 99m Sulfur Colloid Kit
- NDC Code (Product)
65174-179- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA213516
- Marketing Start
- 12/04/2023
Recall History
Jubilant Draximage Inc., dba Jubilant Radiopharma
Failed Stability Specifications
Side 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 Tc 99m 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 pulmonary…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
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 Jubilant DraxImage Inc., dba Jubilant Radiopharma TM at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Kit for the Preparation of Technetium Tc 99m Sulfur Colloid used for?
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid contains Technetium Tc 99m Sulfur Colloid Kit. It is a kit taken as directed. Consult your doctor for specific uses.
Is Kit for the Preparation of Technetium Tc 99m Sulfur Colloid a controlled substance?
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid?
The generic name for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid is Technetium Tc 99m Sulfur Colloid Kit. There are no other listed brand versions of Technetium Tc 99m Sulfur Colloid Kit.
What is the NDC code for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid ?
The NDC (National Drug Code) for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid is 65174-179, listed by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)