Long term animal studies have not been performed to evaluate the carcinogenic potential of Ammonia N 13 Injection. Genotoxicity assays and impairment of male and female fertility studies with Ammonia N 13 Injection have not been performed.
In a descriptive, prospective, blinded image interpretation study2 of adult patients with known or suspected coronary artery disease, myocardial perfusion deficits in stress and rest PET images obtained with Ammonia N 13 (N=111) or Rubidium 82 (N=82) were compared to changes in stenosis flow reserve (SFR) as determined by coronary angiography. The principal outcome of the study was the evaluation of PET defect severity relative to SFR.
PET perfusion defects at rest and stress for seven
apical, anteroseptal, posteroseptal, anterolateral, posterolateral, and
inferior walls) were graded on a 0 to 5 scale defined as normal (0), possible
(1), probable (2), mild (3), moderate (4), and severe (5) defects. Coronary
angiograms were used to measure absolute and relative stenosis dimensions and
to calculate stenosis flow reserve defined as the maximum value of flow at
maximum coronary vasodilatation relative to rest flow under standardized
hemodynamic conditions. SFR scores
ranged from 0 (total occlusion) to 5 (normal).
With increasing impairment of flow reserve, the subjective PET defect severity increased. A PET defect score of 2 or higher was positively correlated with flow reserve impairment (SFR<3).
- Annals of the ICRP. Publication 53. Radiation dose to patients
from radiopharmaceuticals. New York: Pergamon
- Demer, L.L.K.L.Gould, R.A.Goldstein, R.L.Kirkeeide, N.A.Mullani, R.W. Smalling, A.Nishikawa, and M.E.Merhige. Assessment of coronary artery disease severity by PET: Comparison with quantitative arteriography in 193 patients. Circulation 1989; 79: 825-35.
Ammonia N 13 Injection is packaged in 10 mL mulitiple 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 8 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).Use the solution within 35 minutes of the End of Synthesis (EOS) calibration.
Instruct patients to drink plenty of water or other fluids (as tolerated) in the 4 hours before their PET study.
17.2 Post-study Voiding
Instruct patients to void after completion of each image acquisition session and as often as possible for one hour after the PET scan ends.
17.3 Post-study Breastfeeding Avoidance
Instruct nursing patients to substitute stored breast milk or infant formula for breast milk for 2 hours after administration of Ammonia N 13 Injection.
Manufactured and Distributed by:
University of Wisconsin Radiopharmaceutical Production Facility
Madison, Wisconsin 53705
Drug Product Vial Label
Drug Product Shield Label
|AMMONIA N 13 ammonia n 13 injection|
|Labeler — University of Wisconsin System (161202122)|
|Registrant — University of Wisconsin System (161202122)|
|UW Radiopharmaceutical Production Facility||117218915||positron emission tomography drug production (72333-001)|
Revised: 09/2020 University of Wisconsin System
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