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florbetaben F 18

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Overview

What is Neuraceq?

Neuraceq contains florbetaben F18, a molecular imaging agent that binds to β-amyloid plaques in the brain, and is intended for use with PET imaging. Chemically, florbetaben F18 is described as 4-[(E)-2-(4-{2-[2-(2-[F] fluoroethoxy) ethoxy] ethoxy}phenyl)vinyl]-N-methylaniline. The molecular weight is 358.45 and the structural formula is:

Neuraceq is a sterile, non-pyrogenic radioactive diagnostic agent for intravenous injection. The clear solution is supplied ready to use. Each mL contains up to 3 micrograms and 50-5000 MBq (1.4 – 135 mCi) florbetaben F18 EOS, 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol 400, 28.8 mg sodium ascorbate. The pH of the solution is between 4.5 and 7.



What does Neuraceq look like?



What are the available doses of Neuraceq?

30 mL multi-dose vials containing a clear injectable solution at a strength of 50 to 5000 MBq/mL (1.4 to135 mCi/mL) florbetaben F18 at End Of Synthesis (EOS). At time of administration 300 MBq (8.1 mCi) are contained in up to 10 mL solution for injection.

What should I talk to my health care provider before I take Neuraceq?

How should I use Neuraceq?

Neuraceq 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 Neuraceq scan indicates sparse to no amyloid 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 Neuraceq 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. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations of Use

    • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder.

    • Safety and effectiveness of Neuraceq have not been established for:

       • Predicting development of dementia or other neurologic conditions;

       • Monitoring responses to therapies.

Neuraceq is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [] . Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Neuraceq. Radiopharmaceuticals, including Neuraceq, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.


What interacts with Neuraceq?

Sorry No Records found


What are the warnings of Neuraceq?

Sorry No Records found


What are the precautions of Neuraceq?

Sorry No Records found


What are the side effects of Neuraceq?

Sorry No records found


What should I look out for while using Neuraceq?

None

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What might happen if I take too much Neuraceq?

A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes.

In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition.


How should I store and handle Neuraceq?

Store Neuraceq at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F).The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq 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.Store Neuraceq at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F).The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq 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.Store Neuraceq at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F).The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq 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.Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC Metoprolol Tartrate Tablets, USP are available as follows:  Tablets 25 mg                Bottles of 1000       NDC 57237-100-99 (Non Child Resistant Closure)                Bottles of 100         NDC 57237-101-01 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-101-99 (Non Child Resistant Closure)                Bottles of 1000       NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense Citron Pharma LLC


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Florbetaben F18 is a F18-labeled stilbene derivative, which binds to β-amyloid plaques in the brain. The F 18 isotope produces a positron signal that is detected by a PET scanner. H-florbetaben binding experiments reveal two binding sites (Kd of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F18 to β-amyloid plaques in post-mortem brain sections from patients with AD using autoradiography correlates with both immunohistochemical and Bielschowsky silver stains. Florbetaben F 18 does not bind to tau or α-synuclein in tissue from patients with AD. Neither Neuraceq nor non-radioactive florbetaben F 19 bind to AT8 positive tau deposits in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively.

Non-Clinical Toxicology
None

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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