Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Flutemetamol F-18 (UNII: L49M066S0O) (Flutemetamol F-18 - UNII:L49M066S0O)
Medi-Physics, Inc. dba GE Healthcare
Flutemetamol F-18
Flutemetamol F-18 4.05 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
New Drug Application
VIZAMYL- FLUTEMETAMOL F-18 SOLUTION MEDI-PHYSICS, INC. DBA GE HEALTHCARE ---------- 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 Прочетете целия документ