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:

Houston Cyclotron Partners LP dba Cyclotope

INN (International Name):

AMMONIA N-13

Composition:

AMMONIA N-13 260 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 into

Product summary:

Ammonia N 13 Injection is packaged in 30 mL multiple dose glass vial containing between 0.14-9.62 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 in approximately 5 mL volume. The recommended dose of radioactivity (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 60 minutes of the End of Synthesis (EOS) calibration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMMONIA N 13- AMMONIA N-13 INJECTION
HOUSTON CYCLOTRON PARTNERS LP DBA CYCLOTOPE
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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
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).
DOSAGE AND ADMINISTRATION
Rest Imaging Study ( 2.1):
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.
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 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.
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 (30 mL) containing 0.14-9.62 GBq (3.75-260 mCi/mL) of
Ammonia N 13 Injection in aqueous 0.9 % s