Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
AMMONIA N-13 (UNII: 9OQO0E343Z) (AMMONIA N-13 - UNII:9OQO0E343Z)
The University of Texas MD Anderson Cancer Center
AMMONIA N-13
AMMONIA N-13 37.5 mCi in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMMONIA N 13- AMMONIA N-13 INJECTION THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMMONIA N 13 INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N 13 INJECTION. AMMONIA N 13 INJECTION FOR INTRAVENOUS USE. INITIAL U.S. APPROVAL: 2007 INDICATIONS AND USAGE (1) THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMMONIA N 13 INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N 13 INJECTION. AMMONIA N 13 INJECTION FOR INTRAVENOUS USE. INITIAL U.S. APPROVAL: 2007 (1) (1) 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). (1) DOSAGE AND ADMINISTRATION Rest Imaging Study (2.1): (2) 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. (2) Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes. (2) Stress Imaging Study (2.2): (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. (2) Patient Preparation (2.3): (2) To increase renal clearance of radioactivity and to minimize radiat Прочитайте повний документ