Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
AMMONIA N-13 (UNII: 9OQO0E343Z) (AMMONIA N-13 - UNII:9OQO0E343Z)
Shertech Laboratories, 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. It is also not known whether Ammonia N 13 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonia N 13 Injection 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, 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 use of the drug, takin
Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 1.11 GBq to 48.1 GBq (30 mCi to 1300 mCi) of [ 13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 5 mL volume. The recommended dose of radioactivity (10 mCi - 20 mCi, 370 MBq - 740 MBq) is associated with a theoretical mass dose of 0.5 picomoles - 1.0 picomoles of Ammonia. NDC Code: 30 mL Vial: NDC 16129-003-30 This radiopharmaceutical is licensed by the Nuclear Regulatory Commission, for distribution to entities licensed pursuant to 10 CFR 35.200 or under the equivalent licenses of an Agreement State or Licensing State. Storage Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). Use the solution within 70 minutes of the End of Synthesis (EOS) calibration.
Abbreviated New Drug Application
AMMONIA N 13- AMMONIA N-13 INJECTION SHERTECH LABORATORIES, 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: 2007 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 from its container and administer 10 mCi – 20 mCi (0.368 GBq – 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 minutes – 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 mCi – 20 mCi (0.368 GBq – 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 minutes - 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 GBq/mL – 9.620 GBq/mL (3.75 mC Les hele dokumentet