Florbetaben (18F)
Image for illustration purposes only.
Radiopharmaceutical for brain imaging to investigate Alzheimer’s disease. Produced in Brazil in partnership with Life Molecular Imaging (LMI), Florbetabene (18 F) is a radiopharmaceutical indicated for PET-CT brain imaging to estimate the density of the β-amyloid plaque present in the brains of adults with cognitive impairment, to investigate Alzheimer’s disease as a cause of this decline.
Manufactured and distributed by:
Duque de Caxias/RJ (Official Letter No. 1147785257)
- Presentation: Shielded packaging containing 1 multidose vial.
- Pharmaceutical form: Solution for injection.
- Route of administration: Intravenous.
- Composition: Each vial contains from 296 to 9,957 MBq of Florbetabene (18F) at the reference time, in a maximum volume of 10 mL per vial.
- Excipients: Each mL of solution contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose.
- Physical half-life: Approximately 110 minutes.
- Indication: This radiopharmaceutical is intended exclusively for diagnostic purposes. Florbetaben (18F) is indicated for the visualization of β-amyloid neuritic plaque density, by means of Positron Emission Tomography (PET), in the brains of adult patients with cognitive impairment being evaluated for Alzheimer's disease (AD) or other causes of cognitive impairment.
- Negative image: indicates sparse or absent β-amyloid neuritic plaques and is not consistent with a neuropathological diagnosis of AD at the time of image acquisition. A negative result reduces the likelihood of cognitive impairment being associated with AD.
- Positive image: indicates the presence of moderate to frequent neuritic β-amyloid plaques. Neuropathological findings show that this amount of plaques is present in AD patients, but can also occur in other neurological conditions and in elderly people with preserved cognition.
Florbetabene (18F) should be used as a complement to other diagnostic assessments.
Porto Alegre/RS location, in partnership with InsCer – PUCRS, (Official letter No. 7100563213)
- Presentation: Shielded packaging containing 1 multidose vial.
- Pharmaceutical form: Sterile solution.
- Route of administration: Intravenous.
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Ingredients: Each vial may contain up to 12 mL of:
600 MBq (16,2 mCi) of Florbetaben (18F) at the date and time of calibration;
900 MBq (24,3 mCi) of Florbetaben (18F) at the date and time of calibration;
1200 MBq (32,4 mCi) of Florbetaben (18F) at the date and time of calibration;
1500 MBq (40,5 mCi) of Florbetaben (18F) at the date and time of calibration;
1800 MBq (48,6 mCi) of Florbetaben (18F) at the date and time of calibration;
2100 MBq (56,7 mCi) of Florbetaben (18F) at the date and time of calibration;
2400 MBq (64,8 mCi) of Florbetaben (18F) at the date and time of calibration;
2700 MBq (72,9 mCi) of Florbetaben (18F) at the date and time of calibration;
3000 MBq (81,0 mCi) of Florbetaben (18F) at the date and time of calibration;
3300 MBq (89,1 mCi) of Florbetaben (18F) at the date and time of calibration; - Excipients: Ascorbic acid, ethanol, macrogol 400, and sodium ascorbate (for pH adjustment).
- Physical half-life: 109.8 minutes.
- Indication: Florbetaben (18F) is indicated for brain imaging using positron emission tomography (PET) to estimate the density of the neuritic β-amyloid plaques in adult patients with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline.
R2Pharma products are available only by means of medical prescription from a licensed physician.
IF SYMPTOMS PERSIST, A DOCTOR SHOULD BE CONSULTED.
Contraindications, warnings, adverse reactions, drug interactions, precautions and posology: refer to package leaflet.
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