AMMONIA N 13 injection

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NukeMed, Inc. dba SpectronRx

INN (Alþjóðlegt nafn):

AMMONIA N-13

Samsetning:

AMMONIA N-13 37.5 mCi in 1 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

1 INDICATIONS AND USAGE 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. 4 CONTRAINDICATIONS None 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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. 8.3 Nursing Mothers 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.

Vörulýsing:

16 HOW SUPPLIED Ammonia N 13 Injection is packaged in a multiple dose glass vial (10, 25, 30, or 50 mL) 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 8 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 30 minutes of the End of Synthesis (EOS) calibration.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

AMMONIA N 13- AMMONIA N 13 INJECTION
NUKEMED, INC. DBA SPECTRONRX
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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). (1)
DOSAGE AND ADMINISTRATION
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. (2)
DOSAGE FORMS AND STRENGTHS
DOSAGE