AMMONIA N-13 injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Precision Nuclear LLC

INN (International namn):

AMMONIA N-13

Sammansättning:

AMMONIA N-13 260 mCi in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Ammonia N 13 Injection is packaged in 30 or 50 mL multiple dose glass vial, or in a single-dose 3 mL or 5 mL syringe containing between 1.11 GBq to 48.1 GBq (30 mCi to 1300 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 1 to 5 mL volume. The recommended dose of radioactivity (10 to 20 mCi) is associated with a theoretical mass dose of 0.5 to 1.0 picomoles (8.47 to 16.94 picograms) of Ammonia. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature ]. Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMMONIA N-13- AMMONIA N-13 INJECTION, SOLUTION
PRECISION NUCLEAR LLC
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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 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 N 13 Injection from its container (if
applicable) and administer 10 to 20
mCi (0.368 to 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 to 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 (if
applicable) and administer 10 to 20
mCi (0.368 to 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 to 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 or syringe containing 0.138 to 9.62 GBq (3.75 to 260
mCi/mL)