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

10-mL Vial Label
(click image for full-size original)

5-mL Syringe Label

5-mL Syringe Label
(click image for full-size original)

AMMONIA N 13
ammonia n-13 injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71162-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIA N-13 (AMMONIA N-13) AMMONIA N-13 37.5 mCi in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71162-001-10 1 VIAL, GLASS in 1 CONTAINER contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CONTAINER (71162-001-10)
2 NDC:71162-001-05 5 mL in 1 SYRINGE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210524 12/21/2018
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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