TECHNETIUM Tc 99m MERTIATIDE 1 mg/1
Technetium Tc 99m Mertiatide · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Jubilant DraxImage Inc., dba Jubilant Radiopharma
TECHNETIUM Tc 99m MERTIATIDE is a injection, powder, lyophilized, for solution containing technetium tc 99m mertiatide at 1 mg/1, taken intravenous. Manufactured by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Key Facts
- Brand Name
- TECHNETIUM Tc 99m MERTIATIDE
- Generic Name
- Technetium Tc 99m Mertiatide
- NDC Code (Product)
65174-261- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Strength
- 1 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216820
- Marketing Start
- 03/31/2023
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
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 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. Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is a radioactive diagnostic agent 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. ( 1 )
Dosage & Administration
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. Handle Technetium Tc 99m Mertiatide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Mertiatide Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific trai…
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse Reactions
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. Reported adverse reactions are: tachycardia, nausea, vomiting, shaking chills, fever, seizure, wheezing, dyspnea, itching, rash, and elevation in blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is TECHNETIUM Tc 99m MERTIATIDE used for?
TECHNETIUM Tc 99m MERTIATIDE contains Technetium Tc 99m Mertiatide. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is TECHNETIUM Tc 99m MERTIATIDE a controlled substance?
TECHNETIUM Tc 99m MERTIATIDE is not classified as a controlled substance by the DEA.
What is the generic name for TECHNETIUM Tc 99m MERTIATIDE?
The generic name for TECHNETIUM Tc 99m MERTIATIDE is Technetium Tc 99m Mertiatide. There are no other listed brand versions of Technetium Tc 99m Mertiatide.
What is the NDC code for TECHNETIUM Tc 99m MERTIATIDE 1 mg/1?
The NDC (National Drug Code) for TECHNETIUM Tc 99m MERTIATIDE 1 mg/1 is 65174-261, 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)