Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
florbetaben (18F)
Life Molecular Imaging GmbH
V09AX06
florbetaben (18F)
Diagnostic radiopharmaceuticals
Radionuclide Imaging; Alzheimer Disease
This medicinal product is for diagnostic use only.Neuraceq 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. Neuraceq 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: 20
Authorised
2014-02-20
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEURACEQ 300 MBQ/ML SOLUTION FOR INJECTION florbetaben ( 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 Neuraceq is and what it is used for 2. What you need to know before Neuraceq is used 3. How Neuraceq will be used 4. Possible side effects 5. How Neuraceq is stored 6. Contents of the pack and other information 1. WHAT NEURACEQ IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. Neuraceq contains the active substance florbetaben ( 18 F). Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, called a PET scan. A Neuraceq PET scan, along with other brain function tests, can help your doctor 32 determine whether or not you may have β-amyloid plaques in your brain. This medicine is intended for adults only. You should discuss the results of the test with the doctor that requested the scan. The use of Neuraceq does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation. 2. WHAT YOU NEED TO KNOW BEFORE NEURACEQ IS USED NEURACEQ MUST NOT BE USED: - if you are allergic to florbetaben ( 18 F) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your nuclear medicine doctor before you are given Neuraceq if you: - have kidney problems - have liver problems - are pregnant or think you may be pregnant - are breast-feeding CH Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Neuraceq 300 MBq/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 300 MBq of florbetaben ( 18 F) at the date and time of calibration. The activity per vial ranges from 300 MBq to 3000 MBq at the date and time of calibration. 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. Excipient(s) with known effect This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see section 4.4). 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. Neuraceq 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. Neuraceq 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 florbetaben ( 18 F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders. Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben ( 18 F). A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) imaging of the patient to get a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan ( Baca dokumen lengkapnya