AMMONIA N 13 n-13 injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

The University of Texas MD Anderson Cancer Center

INN (국제 이름):

AMMONIA N-13

구성:

AMMONIA N-13 37.5 mCi in 1 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AMMONIA N 13- AMMONIA N-13 INJECTION
THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
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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