Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
florbetapir (18F)
Eli Lilly Nederland B.V.
V09AX05
florbetapir (18F)
Diagnostic radiopharmaceuticals
Radionuclide Imaging
This medicinal product is for diagnostic use only.Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.
Revision: 14
Authorised
2013-01-14
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMYVID 1,900 MBQ/ML SOLUTION FOR INJECTION AMYVID 800 MBQ/ML SOLUTION FOR INJECTION florbetapir ( 18 F) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure. - If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Amyvid is and what it is used for 2. What you need to know before Amyvid is used 3. How Amyvid will be used 4. Possible side effects 5 How Amyvid is stored 6. Contents of the pack and other information 1. WHAT AMYVID IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. Amyvid contains the active substance florbetapir ( 18 F). Amyvid is given to adults with memory problems so that doctors can perform a type of brain scan, called a PET scan. Amyvid, along with other brain function tests, may help your doctor find the reason for your memory problems. An Amyvid PET scan can help your doctor determine whether or not you may have β-amyloid plaques in your brain. β-amyloid plaques are deposits present in the brains of people with Alzheimer’s disease, but may also be present in the brain of people with other dementias. You should discuss the results of the test with the doctor that requested the scan. The use of Amyvid does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation. 2. WHAT YOU NEED TO KNOW BEFORE AMYVID IS USED AMYVID MUST NOT BE USED - if you are allergic to florbetapir ( 18 F) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECA Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amyvid 800 MBq/mL solution for injection Amyvid 1,900 MBq/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amyvid 800 MBq/mL solution for injection Each mL of solution for injection contains 800 MBq of florbetapir ( 18 F) at the date and time of calibration (ToC). The activity per vial ranges from 800 MBq to 12,000 MBq at the ToC. Amyvid 1,900 MBq/mL solution for injection Each mL of solution for injection contains 1,900 MBq of florbetapir ( 18 F) at the ToC. The activity per vial ranges from 1,900 MBq to 28,500 MBq at the ToC. Fluorine ( 18 F) decays to stable oxygen ( 18 O) with a half-life of approximately 110 minutes by emitting a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV. Excipients with known effect Each dose contains up to 790 mg of ethanol and 37 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A PET scan with florbetapir ( 18 F) should be requested by physicians skilled in the clinical management of neurodegenerative disorders. Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir ( 18 F). A recent co-registered computed tomography (CT) scan or magnetic Lestu allt skjalið