Ammonia N 13 260 mCi/mL
AMMONIA N-13 · INJECTION · SOFIE Co. dba SOFIE
Ammonia N 13 is a injection containing ammonia n-13 at 260 mCi/mL, taken intravenous. Manufactured by SOFIE Co. dba SOFIE.
Key Facts
- Brand Name
- Ammonia N 13
- Generic Name
- AMMONIA N-13
- NDC Code (Product)
49609-003- Manufacturer
- SOFIE Co. dba SOFIE
- Strength
- 260 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203543
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 08/04/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Rest Imaging Study ( 2.1 ): Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 – 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein. Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes. Stress Imaging Study ( 2.2 ): If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N13 injection to allow sufficient isotope decay. Administer a pharmacologic stress-inducing drug in accordance with its labeling. Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 – 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10-20 minutes. Patient Preparation ( 2.3 ): To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, hydrate the patient before the procedure and encourage voiding as soon as each image acquisition is completed and as often as possible thereafter for…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The possibility of interactions of Ammonia N 13 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
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 UCSF Radiopharmaceutical Facility at 1-415-353-4435 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Ammonia N 13 used for?
Ammonia N 13 contains AMMONIA N-13. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Ammonia N 13 a controlled substance?
Ammonia N 13 is not classified as a controlled substance by the DEA.
What is the generic name for Ammonia N 13?
The generic name for Ammonia N 13 is AMMONIA N-13. There are 4 other brand versions of AMMONIA N-13.
What is the NDC code for Ammonia N 13 260 mCi/mL?
The NDC (National Drug Code) for Ammonia N 13 260 mCi/mL is 49609-003, listed by SOFIE Co. dba SOFIE.