Ammonia N 13 (Page 3 of 3)
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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.
14 CLINICAL STUDIES
In a descriptive, prospective, blinded image interpretation study 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 cardiac regions(anterior, 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).
15 REFERENCES
Annals of the ICRP. Publication 53. Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1988.
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.
16 HOW SUPPLIED/STORAGE AND HANDLING
Ammonia N 13 Injection is a clear and colorless solution packaged in 10 mL single dose glass vial containing between 0.8325 GBq to 8.325 GBq (22.5 mCi to 225 mCi) or in a 5 mL single dose syringe containing between 0.555 GBq to 5.55 GBq (15 mCi to 150 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 4 or 6 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.
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Use the solution within 45 minutes of the End of Synthesis (EOS) calibration.
17 PATIENT COUNSELING INFORMATION
17.1 Pre-study Hydration
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:
IONETIX CORPORATION
San Francisco, CA 94105
PRINCIPAL DISPLAY PANEL — 3.75-37.5 mCi/mL Vial Container Label
5-mL Syringe Label
AMMONIA N 13
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Labeler — Ionetix Corporation (967706008) |
Registrant — Ionetix Corporation (967706008) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 080610313 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 081548036 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 117025964 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 117380405 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 117380973 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 117622347 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 118778025 | positron emission tomography drug production (71162-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ionetix Corporation | 118310980 | positron emission tomography drug production (71162-001) |
Revised: 03/2024 Ionetix Corporation
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