Nh3n13

Generic Name: nh3n13

Radioactive Diagnostic Agent [EPC]Over-the-Counter (OTC)

Brand Names:

Ammonia N 13

11 DESCRIPTION 11.1 Chemical Characteristics Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [ 13 N] ammonia, has the molecular formula of 13 NH 3 with a molecular weight of 16.02, and has the following chemical structure: Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution.

Overview

11 DESCRIPTION 11.1 Chemical Characteristics Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [ 13 N] ammonia, has the molecular formula of 13 NH 3 with a molecular weight of 16.02, and has the following chemical structure: Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution.

Uses

1 INDICATIONS AND USAGE Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease ( 1 ).

Dosage

2 DOSAGE AND ADMINISTRATION Rest Imaging Study ( 2.1 ): Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 – 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein. Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes. Stress Imaging Study ( 2.2 ): If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N13 injection to allow sufficient isotope decay. Administer a pharmacologic stress-inducing drug in accordance with its labeling.

Side Effects

6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system ( 6). To report SUSPECTED ADVERSE REACTIONS, contact UCSF Radiopharmaceutical Facility at 1-415-353-4435 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

7 DRUG INTERACTIONS The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Warnings

5 WARNINGS AND PRECAUTIONS Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5 ). 5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.4)] . 4 CONTRAINDICATIONS None None ( 4 )

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING Ammonia N 13 Injection is packaged in 10 mL multiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [ 13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 10 mL volume.

Frequently Asked Questions

What is Nh3n13 used for?

1 INDICATIONS AND USAGE Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease ( 1 ).

What are the side effects of Nh3n13?

6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system ( 6). To report SUSPECTED ADVERSE REACTIONS, contact UCSF Radiopharmaceutical Facility at 1-415-353-4435 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the important warnings for Nh3n13?

5 WARNINGS AND PRECAUTIONS Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5 ). 5.1 Radiation Risks Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.4)] . 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.