AMMONIA N 13- ammonia n 13 injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Global Isotopes, LLC d/b/a Zevacor Molecular

INN (Medzinárodný Name):

AMMONIA N-13

Zloženie:

AMMONIA N-13 37.5 mCi in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

AMMONIA N 13- AMMONIA N 13 INJECTION
GLOBAL ISOTOPES, LLC D/B/A ZEVACOR MOLECULAR
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMMONIA N13 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMMONIA N13
INJECTION.
AMMONIA N13 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 (0.368 GBq—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 minute
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 to allow for 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 (0.368 GBq—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 containing 0.138 GBq-1.387 GBq (3.75 mCi/mL-37.5 mCi/mL) of
Ammonia