AMYVID- florbetapir f 18 injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

FLORBETAPIR F-18 (UNII: 6W15Z5R0RU) (FLORBETAPIR F-18 - UNII:6W15Z5R0RU)

Disponibil de la:

Eli Lilly and Company

INN (nume internaţional):

FLORBETAPIR F-18

Compoziție:

FLORBETAPIR F-18 51 mCi in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations. Limitations of Use: - A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. - Safety and effectivenes

Rezumat produs:

Amyvid is supplied in 50 mL or 100 mL vials containing 10-50 mL or 10-100 mL respectively, of a clear, colorless solution at a strength of 500 - 1900 MBq/mL (13.5 - 51 mCi/mL) florbetapir F 18 at EOS. Each vial contains multiple doses and is enclosed in a shielded container to minimize external radiation exposure. Store Amyvid at 25ºC (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F) [see USP Controlled Room Temperature]. The product does not contain a preservative. Store Amyvid within the original container or equivalent radiation shielding. Amyvid must not be diluted. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

AMYVID- FLORBETAPIR F 18 INJECTION, SOLUTION
ELI LILLY AND COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMYVID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMYVID.
AMYVID (FLORBETAPIR F 18 INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
Amyvid is a radioactive diagnostic agent for Positron Emission
Tomography (PET) imaging of the brain to
estimate β-amyloid neuritic plaque density in adult patients with
cognitive impairment who are being
evaluated for Alzheimer's Disease (AD) and other causes of cognitive
decline. A negative Amyvid scan
indicates sparse to no neuritic plaques, and is inconsistent with a
neuropathological diagnosis of AD at the
time of image acquisition; a negative scan result reduces the
likelihood that a patient's cognitive
impairment is due to AD. A positive Amyvid scan indicates moderate to
frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of amyloid
neuritic plaque is present in patients
with AD, but may also be present in patients with other types of
neurologic conditions as well as older
people with normal cognition. Amyvid is an adjunct to other diagnostic
evaluations (1).
Limitations of Use
A positive Amyvid scan does not establish a diagnosis of AD or other
cognitive disorder (1).
Safety and effectiveness of Amyvid have not been established for:
Predicting development of dementia or other neurologic condition;
Monitoring responses to therapies (1).
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety handling measures (2.1).
Administer 370 MBq (10 mCi) as a single intravenous bolus in a total
volume of 10 mL or less (2.2).
Obtain 10-minute PET images starting approximately 30 to 50 minutes
after intravenous injection (2.3).
Image interpretation: Refer to full prescribing information (2.4).
The radiation absorbed dose from a 370 MBq (10 mCi) dose of Amyvid is
7 mSv in an adult (2.5).
DOSAGE FORMS AND STRENGTHS
50 mL or 1