AMMONIA N-13 injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cardinal Health 414, LLC

INN (International Name):

AMMONIA N-13

Sammensetning:

AMMONIA N-13 37.5 mCi in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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

Produkt oppsummering:

Ammonia N-13 Injection, USP is packaged in 10 mL multiple dose glass vial containing between 1.11–11.1 GBq (30–300 mCi/mL) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 8 mL to 10 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles of Ammonia. NDC 65857-200-10 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMMONIA N-13- AMMONIA N-13 INJECTION
CARDINAL HEALTH 414, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMMONIA N-13 INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA 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):
•
•
Stress Imaging Study (2.2):
•
•
•
•
Patient Preparation (2.3):
•
DOSAGE FORMS AND STRENGTHS
Glass vial containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia
N-13 Injection, USP in aqueous 0.9 % sodium
chloride solution (approximately 8 mL to 10 mL volume) (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Ammonia N-13 Injection, USP 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).
ADVERSE REACTIONS
No adverse reactions have been reported for Ammonia N-13 Injection,
USP 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 CARDINAL HEALTH AT
1-800-618-2768 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2018
Aseptically withdraw Ammonia N-13 Injection, USP 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.
If a rest imaging study is performed, begin the stress imag