Technetium Tc 99m Mertiatide
Generic Name: technetium tc 99m mertiatide
Brand Names:
Technetium Tc 99m Mertiatide
11 DESCRIPTION 11.1 Chemical Characteristics Kit for the Preparation of Technetium Tc 99m Mertiatide Injection is a sterile, multiple-dose kit for the preparation of technetium Tc 99m mertiatide injection, a radioactive diagnostic agent for intravenous use. The active ingredient, betiatide, is N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine and has a molecular weight of 367.38 g/mol.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics Kit for the Preparation of Technetium Tc 99m Mertiatide Injection is a sterile, multiple-dose kit for the preparation of technetium Tc 99m mertiatide injection, a radioactive diagnostic agent for intravenous use. The active ingredient, betiatide, is N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine and has a molecular weight of 367.38 g/mol.
Uses
1 INDICATIONS AND USAGE Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
Dosage
2 DOSAGE AND ADMINISTRATION Instruct patients to drink a sufficient amount of water before administration and continue to drink and to void frequently following administration. ( 2.2 ) Recommended dose in adult patients:185 MBq to 370 MBq (5 mCi to 10 mCi) as an intravenous bolus injection. ( 2.3 ) Recommended dose in pediatric patients aged 30 days and older: 2.6 MBq/kg to 5.2 MBq/kg (0.07 mCi/kg to 0.14 mCi/kg) with a minimum dose of 37 MBq (1 mCi) as an intravenous bolus injection. ( 2.3 ) See Full Prescribing Information for radiation safety, drug preparation, administration, and radiation dosimetry information. ( 2.1 , 2.4 , 2.5 , 2.6 , 2.7 ) 2.1 Radiation Safety – Drug Handling After radiolabeling, the kit produces Technetium Tc 99m Mertiatide Injection.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. General disorders and administration site conditions : shaking chills, fever. Nervous system disorders : seizure. Respiratory, thoracic and mediastinal disorders : wheezing, dyspnea. Skin and subcutaneous tissue disorders : itching, rash. Vascular disorders : elevation in blood pressure.
Warnings
5 WARNINGS AND PRECAUTIONS Radiation risks: Ensure safe handling to minimize radiation exposure to patients and healthcare providers. ( 5.1 ) 5.1 Radiation Risks Technetium Tc 99m Mertiatide Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.2 ) ] . 4 CONTRAINDICATIONS None. None. (4)
Pregnancy
8.1 Pregnancy Risk Summary There are no data with technetium Tc 99m mertiatide use in pregnant women to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproductive studies have been conducted with technetium Tc 99m mertiatide. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m mertiatide is expected to be low (see Data).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Kit for the Preparation of Technetium Tc 99m Mertiatide Injection containing 1 mg betiatide, is supplied as a white lyophilized powder packaged in a sterile, multiple-dose 10 mL vial as a carton of 5 vials (NDC 65174-261-05). The carton also contains: - 5 venting needles with filter. - 5 radioassay information labels for the radiolabeled product.
Frequently Asked Questions
What is Technetium Tc 99m Mertiatide used for?▼
1 INDICATIONS AND USAGE Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
What are the side effects of Technetium Tc 99m Mertiatide?▼
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. General disorders and administration site conditions : shaking chills, fever. Nervous system disorders : seizure. Respiratory, thoracic and mediastinal disorders : wheezing, dyspnea. Skin and subcutaneous tissue disorders : itching, rash. Vascular disorders : elevation in blood pressure.
Can I take Technetium Tc 99m Mertiatide during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data with technetium Tc 99m mertiatide use in pregnant women to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproductive studies have been conducted with technetium Tc 99m mertiatide. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m mertiatide is expected to be low (see Data).
What are the important warnings for Technetium Tc 99m Mertiatide?▼
5 WARNINGS AND PRECAUTIONS Radiation risks: Ensure safe handling to minimize radiation exposure to patients and healthcare providers. ( 5.1 ) 5.1 Radiation Risks Technetium Tc 99m Mertiatide Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.2 ) ] . 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.