AMMONIA N 13- ammonia n-13 injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Biomedical Research Foundation of Northwest Louisiana

INN（国際名）:

Ammonia N-13

構図:

Ammonia N-13 37.5 mCi in 1 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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, ta

製品概要:

Ammonia N 13 Injection, USP is packaged in 30 mL multiple dose glass vial containing between 1.80 GBq to 18.0 GBq (48.75 mCi to 487.5 mCi) of [13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately 13 mL volume. The recommended dose of radioactivity (10 mCi-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of Ammonia. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature]. Use the solution within 60 minutes of the End of Synthesis (EOS) calibration.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

AMMONIA N 13- AMMONIA N-13 INJECTION, SOLUTION
BIOMEDICAL RESEARCH FOUNDATION OF NORTHWEST LOUISIANA
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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):
Aseptically withdraw Ammonia N 13 Injection from its container and
administer 10 mCi-20 mCi
(0.368GBq – 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 mCi-20 mCi
(0.368GBq – 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 0.138GBq-1.387 GBq (3.75mCi/m