DRAXIMAGE DTPA Kit, Powder for solution for injection (2020)
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1. Indications and Usage
DRAXIMAGE DTPA, after radiolabeling with Technetium Tc 99m, is indicated for 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization, assessment ...
2. Dosage and Administration
2.1 Radiation Safety Drug Handling Tc 99m labeled DRAXIMAGE DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and ...
3. Dosage Forms and Strengths
Kit for the preparation of Technetium Tc 99m pentetate injection: multiple-dose 10 mL glass vial contains a non-radioactive (white) lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic ...
4. Contraindications
Hypersensitivity to the active ingredient or to any component of the product <em>[see Warnings and Precautions (5.1)]</em>.
5. Warnings and Precautions
5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for ...
6. Adverse Reactions
The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate ...
8.1. Pregnancy
Risk Summary Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate ...
8.2. Lactation
Risk Summary There are limited data available in scientific literature on the presence of Technetium Tc 99m pentetate in human milk. There are no data available on the effects of Technetium Tc 99m pentetate ...
8.4. Pediatric Use
Technetium Tc 99m pentetate is indicated for lung ventilation and evaluation of pulmonary embolism when paired with perfusion imaging and for renal visualization, assessment of renal perfusion, and estimation ...
8.5. Geriatric Use
No formal studies of Technetium Tc 99m pentetate in the elderly were performed to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified ...
11. Description
11.1 Chemical Characteristics DRAXIMAGE DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose ...
12.1. Mechanism of Action
Intravenous Administration Following intravenous administration for brain and renal imaging, Technetium Tc 99m pentetate is distributed in the vascular compartment. It is cleared by the kidneys, which ...
12.2. Pharmacodynamics
Brain Imaging Technetium Tc 99m pentetate with intravenous administration tends to accumulate in intra-cranial lesions with excessive neovascularity or an altered blood brain barrier. Technetium Tc 99m ...
12.3. Pharmacokinetics
After an intravenous administration, the pharmacokinetics of Technetium Tc 99m pentetate were studied by monitoring radioactivity in serial venous blood samples for 7 hours post-administration. The mean ...
16.1. How Supplied
DRAXIMAGE DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride ...
16.2. Storage and Handling
Store the unreconstituted reaction vials at 25°C (77°F); excursions permitted between 15 and 30°C (59 and 86°F). This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory ...
17. Patient Counseling Information
Administration Instructions Intravenous Use Advise patients to hydrate after administration of Tc 99m labeled DRAXIMAGE DTPA injection and to void frequently to minimize radiation dose <em>[see Dosage ...