VIZAMYL- flutemetamol f-18 solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Flutemetamol F-18 (UNII: L49M066S0O) (Flutemetamol F-18 - UNII:L49M066S0O)

זמין מ:

Medi-Physics, Inc. dba GE Healthcare

INN (שם בינלאומי):

Flutemetamol F-18

הרכב:

Flutemetamol F-18 4.05 mCi in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Vizamyl 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 Vizamyl 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 Vizamyl 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 in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations of Use: - A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. - Safety and effe

leaflet_short:

Vizamyl is supplied in a 30-mL multi-dose glass vial with 1-30 mL fill volume. Each vial is enclosed in an appropriate radiation shield. The total concentration is 150 MBq/mL (4.05 mCi/mL) of flutemetamol F 18 at reference date and time. 30-mL sterile multi-dose vial with variable fill volume: NDC 17156-067-30 Store Vizamyl at 2° to 30°C (36° to 86°F). The product does not contain a preservative. Store Vizamyl within radiation shielding. Do not use Vizamyl after the expiry date and time stated on the label. Vizamyl must not be diluted. This preparation is for use by persons licensed by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

מצב אישור:

New Drug Application

מאפייני מוצר

VIZAMYL- FLUTEMETAMOL F-18 SOLUTION
MEDI-PHYSICS, INC. DBA GE HEALTHCARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIZAMYL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIZAMYL.
VIZAMYL (FLUTEMETAMOL F 18 INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Vizamyl is a radioactive diagnostic agent 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) or other causes of
cognitive decline. A negative Vizamyl 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 Vizamyl scan indicates moderate to
frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of 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. Vizamyl is an adjunct to other diagnostic
evaluations (1).
Limitations of Use:
A positive Vizamyl scan does not establish a diagnosis of AD or other
cognitive disorder (1)
Safety and effectiveness of Vizamyl have not been established for:
Predicting development of dementia or other neurological condition (1)
Monitoring responses to therapies (1)
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety handling measures (2.1)
Administer 185 megabecquerels (MBq) [5 millicuries (mCi)] within 40
seconds as a single intravenous
bolus in a total volume of 10 mL or less (2.2)
Follow injection with an intravenous flush of 5 to 15 mL of 0.9%
sterile sodium chloride injection (2.2)
Obtain 10 to 20-minute PET images starting approximately 60 to 120
minutes after intravenous
injection (2.3)
Image interpretation