AMMONIA N 13- ammonia n-13 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Kreitchman PET Center

INN (International Name):

AMMONIA N-13

Composition:

AMMONIA N-13 37.5 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ammonia N 13 Injection 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

Product summary:

Ammonia N 13 Injection is packaged in 20 mL multiple dose glass vial containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 8 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.05-0.1 picomoles (8.4716.94 picograms) of Ammonia. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Use the solution within 30 minutes of the End of Synthesis (EOS) calibration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

Kreitchman PET Center
KREITCHMAN PET CENTER
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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
LABELER -
Kreitchman PET Center (010861487)
REGISTRANT -
Kreitchman PET Center (010861487)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Kreitchman PET Center
010861487
positron emission tomography drug production(62072-456)
Revised: 1/2024