Technetium Tc 99m Sulfur Colloid Kit
Generic Name: technetium tc 99m sulfur colloid kit
Brand Names:
Kit For The Preparation Of Technetium Tc 99m Sulfur Colloid
11 DESCRIPTION Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration.
Overview
11 DESCRIPTION Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration.
Uses
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.
Dosage
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.
Side Effects
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.
Interactions
7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied.
Warnings
5 WARNINGS AND PRECAUTIONS Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available. (5.1) 5.1 Anaphylactic Reactions Anaphylactic 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. 5.2 Radiation Risks Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. 4 CONTRAINDICATIONS None None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta [see Data] . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits (NDC 65174-179-05). All kit components are sterile and non-pyrogenic.
Frequently Asked Questions
What is Technetium Tc 99m Sulfur Colloid Kit used for?▼
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.
What are the side effects of Technetium Tc 99m Sulfur Colloid Kit?▼
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.
Can I take Technetium Tc 99m Sulfur Colloid Kit during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta [see Data] . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection.
What are the important warnings for Technetium Tc 99m Sulfur Colloid Kit?▼
5 WARNINGS AND PRECAUTIONS Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available. (5.1) 5.1 Anaphylactic Reactions Anaphylactic 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. 5.2 Radiation Risks Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. 4 CONTRAINDICATIONS None None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.