Ammonia N 13 37.5 mCi/mL
NH3N13 · INJECTION · The Johns Hopkins University
Ammonia N 13 is a injection containing nh3n13 at 37.5 mCi/mL, taken intravenous. Manufactured by The Johns Hopkins University.
Key Facts
- Brand Name
- Ammonia N 13
- Generic Name
- NH3N13
- NDC Code (Product)
40089-113- Manufacturer
- The Johns Hopkins University
- Strength
- 37.5 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA204514
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 03/21/2012
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 NH3N13. 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 NH3N13. There are no other listed brand versions of NH3N13.
What is the NDC code for Ammonia N 13 37.5 mCi/mL?
The NDC (National Drug Code) for Ammonia N 13 37.5 mCi/mL is 40089-113, listed by The Johns Hopkins University.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)