Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
AMMONIA N-13 (UNII: 9OQO0E343Z) (AMMONIA N-13 - UNII:9OQO0E343Z)
NCM USA Bronx LLC
AMMONIA N-13
AMMONIA N-13 260 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Ammonia N 13 Injection, USP 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. None Pregnancy Category C Animal reproduction studies have not been conducted with Ammonia N 13 Injection, USP. It is also not known whether Ammonia N 13 Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonia N 13 Injection, USP should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from Ammonia N 13 Injection, USP, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for N 13 isotope) after administration of the drug or avoid
Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 0.139 - 9.620 GBq/mL (3.75 - 260 mCi/mL) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution. The recommended dose of radioactivity (10-20 mCi, 370-740 MBq) is associated with a theoretical mass dose of 0.5-1 picomoles (8.47-16.94 picograms) of Ammonia. NDC Code: 24445-643-30 This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.
Abbreviated New Drug Application
AMMONIA N 13 N 13- AMMONIA N-13 INJECTION NCM USA BRONX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMMONIA N 13 INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N 13 INJECTION, USP. AMMONIA N 13 INJECTION, USP FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005 INDICATIONS AND USAGE Ammonia N 13 Injection, USP 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 AND ADMINISTRATION Rest Imaging Study(2.1): Aseptically withdraw Ammonia N 13 Injection, USP 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, USP from its container and administer 10-20 mCi (0.368 – 0.736 GBq) of Ammonia N 13 Injection, USP 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, USP 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 at least one hour. DOSAGE FORMS AND STRENGTHS Glass vial containing 0.139-9.620 GBq (3.75-260 mCi/mL) of Ammonia N 13 Injection, USP in aque Přečtěte si celý dokument