REGADENOSON injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hospira, Inc.

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: 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 doses 10 and 20 times the maximum recommended human dose (MRHD) based on body surface area caused reduce

Резиме производа:

Regadenoson Injection is supplied as a sterile, preservative-free, clear and colorless solution containing 0.08 mg/mL regadenoson in the following package: NDC 0409-1401-01 0.4 mg/5 mL NDC 0409-1401-05 Bundle containing 10 Ansyr® syringes (0.08 mg/mL) 5 mL single‑dose pre-filled plastic Ansyr® syringe with luer-lock fitting Discard unused portion. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

REGADENOSON- REGADENOSON INJECTION, SOLUTION
HOSPIRA, INC.
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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
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
•
CONTRAINDICATIONS
Do not administer regadenoson injection to patients with:
•
•
unless the patients have a functioning artificial pacemaker (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common (incidence ≥ 5%) adverse reactions to regadenoson
injection are dyspnea, headache,
Injection: Single-dose pre-filled syringe: 0.4 mg/5 mL (0.08 mg/mL)
(3).
Second- or third-degree AV block, or
sinus node dysfunction
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
respira