NEURACEQ

A PET scan with florbetaben (18F) 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 (18F).

4). Posology The recommended activity for an adult is 300 MBq florbetaben (18F). The maximum dose should not exceed 360 MBq and not fall below 240 MBq at time of administration. 5 to 10 mL in order to provide the target activity of 300 MBq at the time of intravenous administration.

Special populations Elderly No dose adjustment is recommended based on age. 4). Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. The pharmacokinetics of florbetaben (18F) in patients with renal or hepatic impairment has not been characterised.

Paediatric population There is no relevant use of Neuraceq in the paediatric population. Method of administration Neuraceq is for intravenous use and for multidose use. The activity of florbetaben (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.

Neuraceq should not be diluted. 9%) solution for injection to ensure full delivery of the dose. 5 and 1 mL, only syringes of an appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride solution (see section 12).

The injection of florbetaben (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. Image acquisition A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of florbetaben (18F).

Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view. Reducing head movement with tape or other flexible head restraints may be employed. 0 mm.

Summary of the safety profile The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle. Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing.

Tabulated list of adverse reactions The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 3:

List of adverse reactions System Organ Class Common Uncommon Nervous system disorders Neuralgia Headache Burning sensation Tremor Vascular disorders Hypotension Flushing Haematoma Gastrointestinal disorders Diarrhoea Nausea Hepatobiliary disorders Hepatic function abnormal Skin and subcutaneous tissue disorders Toxic skin eruption Rash Hyperhidrosis Musculoskeletal and connective tissue disorders Pain in extremity Limb discomfort General disorders and administration site conditions Injection site pain Injection/application site erythema Pyrexia Fatigue Feeling hot Vessel puncture site pain Catheter site pain Injection site haematoma Injection site irritation Puncture site reaction Injection site discomfort Injection site warmth Investigations Blood creatinine increased Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Individual benefit/risk justification For each patient, the radiation exposure must be justified by the likely benefit. The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.

Renal impairment and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. 2). 1. Interpretation of Neuraceq images Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F).

A negative scan indicates sparse or no density of cortical β-amyloid plaques. A positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.

PET images are read in a transaxial orientation using a grey scale. The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity. The images should be viewed in a systematic manner (Figure 1) starting at the level of cerebellum and scrolling up through the lateral temporal and frontal lobes, then to the area of the posterior cingulate cortex and precuneus, and finally to the parietal lobe.

Interpretation of the images is made visually comparing the activity in cortical grey matter with activity in adjacent cortical white matter. Each of these brain regions, the lateral temporal, frontal, posterior cingulate, precuneus, and parietal lobes should be systematically visually assessed and scored according to the regional cortical tracer uptake (RCTU) score (Table 1).

, signal intensity) in grey matter in the region is lower than in white matter. 2 (Moderate tracer uptake) Smaller area(s) of tracer uptake equal to or higher than that present in white matter: extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within the respective region.

1.