Overview
Technetium Tc-99m pertechnetate is a radiopharmaceutical diagnostic agent composed of an oxoanion with the chemical formula TcO4-. Pertechnetate has a wide variety of uses within nuclear medicine as it distributes within the body to a similar extent as iodine. It also concentrates in the thyroid gland, salivary glands, gastric mucosa, and choroid plexus. However, in contrast to the iodide ion, the pertechnetate ion is released unchanged from the thyroid gland. Currently marketed as the product Drytec, technetium-99m pertechnetate is indicated for imaging of the following tissues: thyroid, salivary gland, urinary bladder (for detection of vesico-ureteral reflux), and the nasolacrimal drainage system. Technetium-99m's short half life (6 hours) makes storage impossible, therefore it is supplied as its parent nuclide molybdenum-99, which spontaneously decays to technetium-99 through beta decay. This is normally supplied in a hospital setting through the use of a technetium-99m generator, whereby technetium exits the generator in the form of the pertechnetate ion, TcO4−, which can be extracted and promptly used for clinical diagnostics. Following intravenous injection, single photon emission computed tomography (SPECT) is performed to detect the gamma ray emmitted by the decay of Technetium-99m to Technetium-99.
Indication
Sodium Pertechnetate Tc99m Injection is indicated for use in adults for imaging in the following tissues: thyroid, salivary gland, urinary bladder (for detection of vesico-ureteral reflux), and nasolacrimal drainage system (dacryoscintigraphy). It is indicated for use in children for imaging the following tissues: thyroid and urinary bladder.
Associated Conditions
- Vesicoureteral Reflux (VUR)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/04/19 | Phase 1 | Active, not recruiting | |||
2011/09/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Curium US LLC | 69945-035 | INTRAVENOUS | 3.5 Ci in 1 1 | 6/9/2022 | |
Lantheus Medical Imaging, Inc. | 11994-090 | INTRAVENOUS | 250 mCi in 1 mL | 1/31/2023 | |
Lantheus Medical Imaging, Inc. | 11994-091 | INTRAVENOUS | 250 mCi in 1 mL | 1/31/2023 | |
Curium US LLC | 69945-025 | INTRAVENOUS | 2.5 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-010 | INTRAVENOUS | 1 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-110 | INTRAVENOUS | 11 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-015 | INTRAVENOUS | 1.5 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-030 | INTRAVENOUS | 3 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-160 | INTRAVENOUS | 16 Ci in 1 1 | 6/9/2022 | |
Curium US LLC | 69945-140 | INTRAVENOUS | 14 Ci in 1 1 | 6/9/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
GENTECH MOLYBDENUM (99Mo) / TECHNETIUM (99mTc) STERILE GENERATOR | SIN16108P | INJECTION, SOLUTION (RADIOPHARMACEUTICAL) | 15.92/ 23.88/31.84/39.80/47.76/63.68/79.61/95.53 GBq | 2/24/2021 | |
TEKCIS RADIONUCLIDE GENERATOR 2-50 GBQ | SIN15741P | GENERATOR | 2/4/6/8/10/12/16/20/25/50 GBq | 7/10/2019 | |
UltraTechneKow FM Generator | SIN14082P | SOLUTION | 2.08,4.16,6.24,8.32,10.4,12.47,16.63,20.79,24.95,29.11,33.26,41.58 (Gbq) | 1/19/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Sodium Pertechnetate[99mTc] Injection | 国药准字H10960232 | 化学药品 | 注射剂(小容量注射剂) | 9/1/2020 | |
Sodium Pertechnetate[99mTc] Injection | 中国工程物理研究院核物理与化学研究所 | 国药准字H20244390 | 化学药品 | 注射剂 | 7/9/2024 |
Sodium Pertechnetate[99mTc] Injection | 国药准字H19994108 | 化学药品 | 注射剂 | 2/5/2020 | |
Sodium Pertechnetate[99mTc] Injection | 国药准字H10960230 | 化学药品 | 注射剂(小容量注射剂) | 9/3/2020 | |
Sodium Pertechnetate[99mTc] Injection | 国药准字H10973020 | 化学药品 | 注射剂 | 7/28/2020 | |
Sodium Pertechnetate[99mTc] Injection | 国药准字H10960231 | 化学药品 | 注射剂(小容量注射剂) | 9/3/2020 | |
Sodium Pertechnetate[99mTc] Injection | 国药准字H10973062 | 化学药品 | 注射剂 | 2/23/2023 | |
Sodium Pertechnetate[99mTc] Injection | 国药准字H10973010 | 化学药品 | 注射剂 | 7/1/2022 | |
Sodium Pertechnetate [99mTc] Injection(99mTcO4) | 国药准字H10960089 | 化学药品 | 注射剂(注射液) | 6/17/2020 | |
Sodium Pertechnetate [99mTc] Injection(99mTcO4) | 国药准字H10960091 | 化学药品 | 注射剂(注射液) | 6/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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