REGADENOSON injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

REGADENOSON (UNII: 2XLN4Y044H) (REGADENOSON ANHYDROUS - UNII:7AXV542LZ4)

Доступно од:

Gland Pharma Limited

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Regadenoson injection  is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Do not administer Regadenoson injection to patients with: ·       Second- or third- degree AV block, or ·       Sinus node dysfunction  unless these patients have a functioning artificial pacemaker [see Warnings and Precautions (5.2) ]. Risk Summary There are no available data on Regadenoson injection use in pregnant women to inform a drug-associated risk. In animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Reproductive studies in rats showed that regadenoson dos

Резиме производа:

Regadenoson injection is supplied as a sterile, preservative-free solution containing 0.08 mg/mL regadenoson in the following package: Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ See USP Controlled Room Temperature.]

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

REGADENOSON - REGADENOSON INJECTION, SOLUTION
GLAND PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REGADENOSON INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
REGADENOSON INJECTION.
REGADENOSON INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2) 5/2018
Warnings and Precautions, Myocardial Ischemia (5.1) 5/2018
INDICATIONS AND USAGE
Regadenoson injection is a pharmacologic stress agent indicated for
radionuclide myocardial perfusion
imaging (MPI) in patients unable to undergo adequate exercise stress
(1).
DOSAGE AND ADMINISTRATION
The recommended dose of Regadenoson Injection is 5 mL (0.4 mg
regadenoson) administered as an
intravenous injection within 10 seconds; followed immediately by
saline flush and radiopharmaceutical (2)
DOSAGE FORMS AND STRENGTHS
Single-dose vial: Injection solution containing regadenoson 0.4 mg/5
mL (0.08 mg/mL) (3)
CONTRAINDICATIONS
Do not administer Regadenoson injection to patients with:
· Second- or third- degree AV block, or
· sinus node dysfunction
unless the patients have a functioning artificial pacemaker (4).
WARNINGS AND PRECAUTIONS
• Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use
in patients with symptoms or signs
of acute myocardial ischemia, for example unstable angina or
cardiovascular instability, who may be at
greater risk. Cardiac resuscitation equipment and trained staff should
be available before administration
(5.1)
• Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine
receptor agonists, including
Regadenoson Injection, can depress the SA and AV nodes and may cause
first-second- or third-degree AV
block, or sinus bradycardia (5.2)
• Atrial Fibrillation/Atrial Flutter. New-onset or recurrent atrial
fibrillation with rapid ventricular response and
atrial flutter have been reported (5.3)
• Hypersensitivity, including anaphylaxis, angioedema, cardiac or
respiratory arres