AMMONIA N 13 N 13- ammonia n-13 injection

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

AMMONIA N-13 (UNII: 9OQO0E343Z) (AMMONIA N-13 - UNII:9OQO0E343Z)

可用日期:

NCM USA Bronx LLC

INN（国际名称）:

AMMONIA N-13

组成:

AMMONIA N-13 260 mCi in 1 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

Abbreviated New Drug Application

产品特点

AMMONIA N 13 N 13- AMMONIA N-13 INJECTION
NCM USA BRONX LLC
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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