Ammonia N 13 Injection

INDICATIONS AND USAGE

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.

IMPORTANT SAFETY INFORMATION

Radiation Risks
Ammonia N 13 Injection may increase the risk of cancer. Use t he smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

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.

DOSAGE FORMS AND STRENGTHS

Glass vial (30 mL) containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (the total volume in the vial will vary) that is suitable for intravenous administration.

Full Prescribing Information Ammonia N 13 Injection