View Drug - Ammonia N-13
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Ammonia N-13

Generic: AMMONIA N-13

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Basic Information
Manufacturer
The Methodist Hospital Research Institute
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c79222b1-7dd8-f1fe-e053-2a95a90a3639
Indications & Usage
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.

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Adverse Reactions
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 The Houston Methodist Research Institute at 713-363-9155 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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