AMMONIA N 13- ammonia n-13 injection, solution

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:

Mayo Clinic

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 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 use of the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Ammonia N 13 Injection USP has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults [see Dosage and Administration (2.4) ].

Product summary:

Ammonia N 13 Injection USP is packaged in 30 mL single 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), in 0.9% sodium chloride injection solution in approximately 6 mL volume. The recommended dose of radioactivity (0.368-0.736 GBq, 10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMMONIA N 13- AMMONIA N-13 INJECTION, SOLUTION
MAYO CLINIC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMMONIA N 13 INJECTION
USPSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FORAMMONIA
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 N13 Injection from its container and
administer 0.368-0.736 GBq (10-20
mCi) 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 N 13 Injection USP 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 0.368-0.736 GBq
(10-20 mCi) 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 0.138-1.387 GBq/mL (3.75-37.5 mCi/mL) of Ammonia
N 13 Injection USP in aqueous
0.9%