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:

Decatur Memorial Hospital

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. 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, taking

產品總結:

Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 10 mL volume. The recommended dose of radioactivity (10 mCi – 20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles of Ammonia. NDC 73410-001-01 Storage 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- AMMONIA N 13 INJECTION
DECATUR MEMORIAL HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMMONIA N13 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N13
INJECTION.
AMMONIA N13 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):
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STRESS IMAGING STUDY (2.2):
•
•
•
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PATIENT PREPARATION (2.3):
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DOSAGE FORMS AND STRENGTHS
Glass vial containing 0.138 GBq-1.387 GBq (3.75 mCi/mL-37.5 mCi/mL) of
Ammonia N 13 Injection in aqueous 0.9%
sodium chloride solution (approximately 10mL volume) (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Ammonia N 13 Injection may increase the risk of cancer. Use the
smallest dose necessary for imaging and ensure safe
handling to protect the patient and health care worker (5.1).
ADVERSE REACTIONS
No adverse reactions have been reported for Ammonia N 13 Injection
based on a review of the published literature,
publicly available reference sources, and adverse drug reaction
reporting system (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DECATUR MEMORIAL
HOSPITAL AT 800-826-2827 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2019
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 10-20 minute
If a rest imaging study is performed, begin the stress imaging study
40