Vizamyl

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



 

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1. NAME OF THE MEDICINAL PRODUCT 
 

VIZAMYL 400 MBq/mL solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 

Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time. 

 

The activity per vial may range from 400 MBq to 4000 MBq or from 400 MBq to 6000 MBq at the 

reference date and time. 

 

Fluorine (18F) decays to stable oxygen (18O) 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 mL of solution contains 55.2 mg of ethanol and 4.1 mg of sodium. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Solution for injection. 

Clear, colourless to slightly yellow solution.  

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

This medicinal product is for diagnostic use only. 

 

VIZAMYL is a radiopharmaceutical medicinal product 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. VIZAMYL 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 flutemetamol (18F) should be requested by clinicians experienced in the clinical 

management of neurodegenerative disorders. 

 

VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images 

with flutemetamol (18F). A recent co-registered Computed Tomography (CT) scan or Magnetic 

Resonance (MR) scan of the patient to obtain 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 (see section 4.4 Interpretation of VIZAMYL images). 

 

Posology 

 

Adults 



 

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The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously 

(as a bolus within approximately 40 seconds). The volume of the injection should be not less than 

1 mL and not more than 10 mL. 

 

Special populations 

Extensive dose-range and adjustment studies with the medicinal product in normal and special 

populations have not been performed.  

 

Elderly patients 

No dose adjustment is recommended based on age. 

 

Renal and hepatic impairment  

VIZAMYL has not been studied in patients with significant renal or hepatic impairment. Careful 

consideration of the activity to be administered is required since an increased radiation exposure is 

possible in these patients (see section 4.4). The pharmacokinetics of flutemetamol (18F) in patients 

with renal or hepatic impairment has not been characterised. 

 

Paediatric population  

There is no relevant use of VIZAMYL in the paediatric population. 

 

Method of administration  

VIZAMYL is for intravenous use. 

 

The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to 

injection. 

 

Injection of VIZAMYL through a short intravenous catheter (approximately 12.5 cm or less) 

minimises the potential for adsorption of the active substance to the catheter. 

 

VIZAMYL is for multidose use. It must not be diluted. 

 

The dose is administered by intravenous bolus injection within approximately 40 seconds. If using an 

intravenous line, follow the injection with an intravenous flush of 5 mL to 15 mL of sterile sodium 

chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose. 

 

The injection of flutemetamol (18F) must be intravenous in order to avoid irradiation as a result of local 

extravasation, as well as imaging artefacts. 

 

Image acquisition  

VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D 

mode with appropriate data corrections. Position the patient supine with the patient’s brain (including 

the cerebellum) within a single field of view. The patient’s head should be tilted so that the anterior 

commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner 

with the head positioned in a suitable head support. Reducing head movement with tape or other 

flexible head restraints may be employed. 

 

Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 

4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a post-

smoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the 

filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of 

the reconstructed image. The scan duration should typically be 20 minutes. 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 



 

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4.4  Special warnings and precautions for use 
 

Potential for hypersensitivity or anaphylactic reactions 

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be 

discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate 

action in emergencies the necessary medicinal products and equipment such as endotracheal tube and 

ventilator must be readily available. 

 

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 /Hepatic impairment  

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation 

exposure is possible. Flutemetamol (18F) is excreted largely through the hepatobiliary system and 

patients with hepatic impairment have the potential of increased radiation exposure. See section 4.2. 

 

Paediatric population 

For information on the use in the paediatric population, see sections 4.2 or 5.1. 

 

Interpretation of VIZAMYL images 

VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images 

with flutemetamol (18F). A negative scan indicates none or a sparse density of cortical β-amyloid 

neuritic plaques. A positive scan indicates a 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 should be read using a Sokoloff, Rainbow or Spectrum colour 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 pons (p) and 

scrolling up through 

- The frontal lobes and anterior cingulate (f, ac, axial review) 
- Posterior cingulate and precuneus (pc, sagittal review) 
- Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) 
- Lateral temporal lobes (lt, axial review) 
- Striatal region (s, axial review) 
 

Interpretation of the images is performed visually by comparing the activity in cortical grey matter 

with activity in adjacent cortical white matter.  

 

- A region is considered as having a negative (normal) pattern if the tracer signal in cortical 
regions is low (i.e. distinctly lower signal intensity compared with adjacent white matter and 

similar in intensity to the grey matter-rich regions of the cerebellum). Signal will not be 

completely absent in grey matter regions of the images, as white matter binding in adjacent 

regions will bleed into the grey matter regions due to PET partial volume resolution effects. 

- A region is considered positive (abnormal) if the tracer signal in cortical regions appears high 
(i.e., approximately at the same or higher signal intensity as adjacent white matter and greater 

than the grey matter-rich regions of the cerebellum). 

- If any one of these regions is clearly positive (abnormal) then the image should be classified as 
positive (abnormal). Otherwise it should be classified as negative (normal). 

 

Atrophy may be present in many areas of the brain and may render image interpretation more difficult 

as loss of grey matter will result in reduced tracer uptake making a positive scan more difficult to 

recognise. It is strongly recommended to review MR or CT images when available to aid interpretation 

of the VIZAMYL image, especially when atrophy is suspected.  

 



 

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Figure 1 

VIZAMYL PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive 

scan (right). Axial view (first row), sagittal view (second row) and coronal view (third row) are 

displayed. 

 

 
 

Figure 1. Axial (a), Sagittal (b) and coronal (c) views of a negative and positive flutemetamol (18F) 

scans (left and right respectively). The negative images show a sulcal/gyral white matter pattern. The 

sulcal and gyral pattern is not discernible in the positive images on the right. Note that the intensity is 

higher (> 60% of max) in the grey matter regions of the positive images compared to the negative 

images and that the intensity radiates to a sharply defined convex edge in the lateral aspects. The 

negative images show a tapered intensity to the periphery of the tissue. Note also the medial regions 

where higher levels of intensity in the grey matter are seen in the positive images on the right.  



 

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Key: Grey matter – f frontal and ac anterior cingulate, pc posterior cingulate and precuneus, lt lateral 

temporal, tp temporo-parietal and in insula and and s striatum. White matter – p pons and cc corpus 

callosum.  

 

 

Quantitative assessment of cortical radioactive signal intensity using validated and CE marked 

computer software may be used to assist in the visual estimate of radioactive signal distribution. Such 

software provides a calculation of brain amyloid load by dividing the mean image intensity in the 

cortical regions associated with amyloid deposition (raised in AD subjects) with the mean image 

intensity in a reference region such as the pons. The measure is referred to as Standard Uptake Value 

ratio or SUVR.  Dichotomous visual reads for flutemetamol (18F) scans were validated against the 

boundary between sparse and moderate neuritic plaque densities. An SUVR threshold value of 0.59 to 

0.61 derived from CE marked software using the pons as a reference has been determined to give very 

high concordance with visual reads (see section 5.1) and may be used as an adjunct to visual reading.   

 

Users should be trained in the use of CE marked software by the manufacturer and should have 

completed the reader training for the visual interpretation of Vizamyl images.  

 

In case of discordance of visual read and quantitation result, the following steps should be carefully 

considered to come to a final assessment. 

 

Readers should interpret the scan visually and then perform quantitation analysis according to 

manufacturer’s instructions including quality checks for the quantitation process. The results of 

quantitation should be compared to the visual interpretation, paying attention to the expected ranges 

for a negative or positive scan. If the quantitation values are inconsistent with the visual interpretation, 

the reviewer should:  

 
1. Check the placement of the regions of interest (ROIs) on the brain image. The regions should 

be placed on the grey matter regions of the brain such that the ROIs do not include CSF or 

significant areas of white matter.  

2. Examine the placement of the reference region ROI(s) to ensure that these are well fitted to 
the region. Secondly, examine the appearance of the reference region looking for any 

structural abnormalities or areas of reduced perfusion.  

3. Specifics of opposing visual and quantitative results 
i) In the case of an amyloid positive visual read and an amyloid negative or borderline 

quantitative result, a comparison should be made between the regions showing visual 

positivity and the equivalent area sampled by a ROI. In the case where tracer uptake is highly 

focal, it may be that the ROI samples a larger area and the average of the ROI returns a 

negative result. Further, a visual read may be conducted in such a way as to avoid atrophied 

regions, while quantitation may include these areas. 

ii) In the case of an amyloid negative visual read and a positive quantitative result, the 

reference region should be inspected and where any concerns on ROI placement accuracy or 

reduced uptake are evident, an alternative region should be used (the software may allow for a 

number of different reference regions). Further, the placement of the cortical ROIs should be 

checked to determine if white matter is sampled, which may increase quantitation values. 

 

4. A final interpretation of the PET image should be made on the basis of the visual read having 
conducted the review outlined in steps 1 to 3.    

 

 

 

 

 



 

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Limitations of use 

A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since 

neuritic plaque deposition in grey matter may be present in asymptomatic elderly patients and some 

neurodegenerative dementias (Alzheimer’s disease, but also Lewy body dementia and Parkinson’s 

disease dementia). 

 

For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1. 

 

The efficacy of flutemetamol (18F) for predicting development of AD or monitoring response to 

therapy has not been established (see section 5.1). 

 

Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon or 

image blur, which could lead to interpretation errors. For cases in which there is uncertainty about the 

location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent 

CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to 

clarify the relationship of the PET radioactivity and the grey matter anatomy. 

 

After the procedure  

Close contact with infants and pregnant women should be restricted during the initial 24 hours 

following the injection. 

 

Specific warnings  

This medicinal product contains (7 vol %) of ethanol (alcohol), i.e. up to 552 mg (approximately 

0.7 mL) per dose. This amount may be harmful for those suffering from alcoholism. To be taken into 

account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease 

or epilepsy. 

 

This medicinal product contains up to 41 mg (or 1.8 mmol) sodium per dose,equivalent to 2 % of the 

WHO recommended maximum daily intake of 2 g sodium for an adult. This may need to be taken into 

consideration by patients on a controlled sodium diet.  

 

For precautions with respect to environmental hazard see section 6.6. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the 

extent, if any, to which concomitant medicinal products may alter VIZAMYL image results. 

 

No in vivo interaction studies have been performed. 

 

In vitro binding studies have not shown interference of flutemetamol (18F) binding to β-amyloid 

plaques in the presence of other common medicinal products taken by AD patients. 

 

4.6 Fertility, pregnancy and lactation 
 

Women of childbearing potential 

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is 

important to determine whether or not she is pregnant. Any woman who has missed a period should be 

assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the 

woman has missed a period, if the period is irregular, etc.), alternative techniques not using ionising 

radiation (if there are any) should be offered to the patient. 

 



 

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Pregnancy 

No studies have been conducted in pregnant women. No animal studies have been conducted to 

investigate the reproductive effects of flutemetamol (18F) (see section 5.3). 

Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. 

Only essential investigations should therefore be carried out during pregnancy, when the likely benefit 

far exceeds the risk incurred by the mother and foetus. 

 

Breast-feeding 

It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding. Before 

administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given 

to the possibility of delaying the administration of radionuclide until the mother has ceased breast-

feeding, and to the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of 

activity in breast milk. If the administration is considered necessary, breast-feeding should be 

interrupted for 24 hours and the expressed feeds discarded. 

 

Close contact with infants should be restricted during the initial 24 hours following injection. 

 

Fertility 

No studies on fertility have been performed. 

 

4.7 Effects on ability to drive and use machines 
 

VIZAMYL has no or negligible influence on the ability to drive and use machines. 

 

However, VIZAMYL may cause transient dizziness and vertigo. Therefore, following the 

administration of VIZAMYL, patients are advised not to drive, operate complex machinery or engage 

in other potentially hazardous activities until these effects have completely disappeared.  

 

4.8 Undesirable effects 

 

Summary of the safety profile  

The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects.  

 

Tabulated list of adverse reactions 

The frequencies of adverse reactions are defined as follows: 

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) and not known (cannot be estimated from the available data). 

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

 

The following adverse reactions are listed in the Table 1 below: 

 



 

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Table 1  List of adverse reactions 

System Organ Class Common  Uncommon 

Immune system disorders   Anaphylactoid reaction 

Psychiatric disorders   Anxiety 

Nervous system disorders 

 

  Dizziness 

 Headache 

 Hypoaesthesia 

 Hypotonia 

 Dysgeusia 

 Tremor 

Eye disorders   Eye swelling 

Ear and labyrinth disorders   Vertigo 

Cardiac disorders   Palpitations 

Vascular disorders Flushing  Pallor 

Respiratory, thoracic and 

mediastinal disorders 

  Dyspnoea 

 Hyperventilation 

 Throat irritation 

Gastrointestinal disorders   Nausea  

 Vomiting 

 Dyspepsia 

 Abdominal discomfort 

 Oral discomfort  

Skin and subcutaneous tissue 

disorders 

  Facial hypoaesthesia 

 Pruritus 

 Rash 

 Skin tightness 

 Swelling face 

Musculoskeletal and 

connective tissue disorders 

  Back pain 

 Muscle tightness 

 Musculoskeletal pain 

Reproductive system and 

breast disorders 

  Erectile dysfunction 

General disorders and 

administration site conditions 

  Chest discomfort 

 Feeling hot 

 Asthenia 

 Fatigue 

 Feeling abnormal 

 Feeling cold 

 Infusion site pain 

 Oedema 

 Pyrexia 

Investigations Increased blood 

pressure 

 Blood glucose decreased 

 Blood lactate dehydrogenase increased 

 Neutrophil count increased 

 Respiratory rate increased 

 

Exposure to ionising radiation is linked with cancer induction and a potential for development of 

hereditary defects. The effective dose is approximately 5.9 mSv when the maximal recommended 

activity of 185 MBq of flutemetamol (18F) is administered. These adverse events are expected to occur 

with low probability. 

 

Description of selected adverse reactions 

The following adverse reactions may occur as symptoms and signs of a hypersensitivity reaction to 

VIZAMYL or any of its excipients (see section 6.1): eye/face swelling, pallor, dyspnoea, throat 

irritation, vomiting, rash, pruritus, skin tightness, chest tightness (see also section 4.4). 

 



 

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Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Due to the small quantity of flutemetamol (18F) in each dose, overdose is not expected to result in 

pharmacological effects. In the event of administration of a radiation overdose, the absorbed dose to 

the patient should be reduced where possible by increasing the elimination of the radionuclide from 

the body by frequent micturition and defecation. It might be helpful to estimate the effective dose that 

was applied. 

 

 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1  Pharmacodynamic properties 
 

Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, 

ATC code: V09AX04  

 

Mechanism of action 

Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.  

In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to 

neurofibrillary tangles. Data suggest that flutemetamol (18F) is able to label cored and diffuse amyloid 

β deposits and neuritic plaques. There is no evidence of flutemetamol (18F) binding to soluble forms of 

Abeta. 

 

In vivo, quantitative correlation was assessed in end-of-life patients between flutemetamol (18F) uptake 

in cortical grey matter and the total β-amyloid burden in autopsied samples using 4G8 anti-amyloid 

antibody that stains β-amyloid found in both neuritic and diffuse plaques. In vivo, flutemetamol (18F) 

can detect β-amyloid diffuse plaques when they are frequent. The in vivo binding of flutemetamol 

(18F) to other β-amyloid structures or other brain structures or receptors remains unknown. 

 

Pharmacodynamic effects 

At the low concentrations present in VIZAMYL, flutemetamol (18F) has no detectable 

pharmacodynamic activity. 

 

Brain uptake and distribution of flutemetamol (18F) were not evaluated in a specific study aimed to 

evaluate pharmacodynamics. In two similar studies of biodistribution and a phase II clinical study, 

mean quantitative uptake values in PET images differed between pAD and HV subjects in most 

examined areas of the brain. 

 

Clinical efficacy 

A pivotal study in 68 end-of-life patients was aimed at establishing the diagnostic performance of 

flutemetamol (18F) to detect the cortical neuritic plaque density. The PET results were compared with 

the neuritic plaque density measured on sections of eight predefined brain regions at the patient’s 

autopsy. The histopathology regions included, but were not restricted to the CERAD regions. The 

cognitive status of the patients was not determined. In the 68 patients, a blinded visual patient-level 

PET read by 5 blinded readers resulted in a majority read sensitivity of 86% (95% CI: 72% to 95%) 

and specificity 92% (95% CI: 74% to 99%).  

 

Sensitivity and specificity to estimate β-amyloid deposition of flutemetamol (18F) was further 

investigated in one additional study, in which a different set of 5 electronically-trained blinded readers 

interpreted images from the same 68 patients followed to autopsy in the pivotal study. Histopathology 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

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from the pivotal study was used. The majority read sensitivity and specificity were 93% 

(95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.  

 

In a re-reading study that increased the patient population of the pivotal study to include 38 additional 

autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent β-

amyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% 

(95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached 

by at least 3 of the 5 readers after electronic training). In a secondary analysis that used a standard of 

truth based on the region of maximum neuritic plaque involvement in the 3 neocortical regions 

originally recommended by CERAD, sensitivity was 92% (95% CI: 83% to 97%), and specificity was 

88% (95% CI: 71% to 97%). 

 

In a longitudinal study, 232 patients clinically diagnosed with amnestic mild cognitive impairment 

(aMCI), underwent baseline flutemetamol (18F) PET scans, and were followed for 36 months to 

evaluate the relationship between flutemetamol (18F) imaging and changes in diagnostic status. 

98 (42%) of the 232 patients had abnormal (positive) flutemetamol (18F) scans. Of the 232 patients 

enrolled, 224 had at least one post-scan review by the independent committee and were included in the 

analysis. At the 36-month follow-up, 81 (35%) converted to clinical AD. Of the 97 aMCI patients who 

had a positive PET scan and at least one committee assessment, 52 (54%) were classified clinically as 

converted to clinical AD after 36 months compared to 29 (23%) of 127 who had a negative scan and at 

least one committee assessment. At 36 months, sensitivity of flutemetamol (18F) scans for predicting 

conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 

non-converters was 69% (95% CI: 60% to 76 %). Based on the majority read, the positive and 

negative likelihood ratios were 2.04 and 0.52 respectively. The design of this study does not allow 

estimating the risk of MCI progression to clinical AD.  

 

 

Clinical Studies demonstrating adjunctive use of quantitative information for image interpretation 

 

The reliability of using quantitative information as an adjunct to visual inspection was analysed in two 

clinical studies where the concordance between the two methods of image interpretation were 

compared. In both studies (total n=379) CE marked amyloid quantitation software was used and the % 

agreement between visual reads and quantitation was 98.8% to 99%. In study one, the thresholds for 

amyloid quantitation were calculated against post-mortem confirmation of brain amyloid status as the 

standard of truth (from pivotal clinical autopsy cohort n=68) and a healthy cohort of n=105 volunteers 

used to define the reference range for normal quantitative measures. The derived thresholds were used 

to categorise a test cohort of 172 scans (33 probable AD, 80 amnestic MCI and 59 healthy volunteers) 

as negative or positive and compared to categorisation by visual read. Agreement was 98.8% (170/172 

scans).  

In the second study, to investigate the impact of amyloid PET with flutemetamol (18F) on diagnosis 

and treatment management in a cohort of patients attending a tertiary memory clinic, 207 patients had 

images interpreted by visual inspection or CE marked software with an agreement of 99% (205/207 

scans) between the two methods.. 

 

Paediatric population 

The European Medicines Agency has waived the obligation to submit the results of studies with 

flutemetamol (18F) in all subsets of the paediatric population as the disease or condition for which the 

specific medicinal product is intended only occurs in adults (see section 4.2 for information on 

paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Distribution 

Flutemetamol (18F) is distributed throughout the body within several minutes of injection. After 

20 minutes approximately 20 % of the active compound flutemetamol (18F) remains in the circulation, 

falling to 10 % at 180 minutes. 

 



 

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Organ uptake 

Maximal flutemetamol (18F) brain uptake of approximately 7% of an injected dose occurs within two 

minutes of administration. This is followed by rapid clearance from the brain in the first 90 minutes 

(the recommended time to start scanning), followed by more gradual clearance. The five 

organs/tissues with the highest cumulated activities were the wall of the small intestines, liver, urinary 

bladder wall, wall of the upper large intestine and the wall of the gallbladder. 

 

Healthy controls show low levels of flutemetamol (18F) retention in cerebral cortex. The highest level 

of uptake is in pons and other white matter regions. In AD patients, cortical regions and striatal 

regions show significantly greater uptake compared to cortical regions in controls. In AD patients, as 

in controls, there is high retention in pons and other white matter areas. 

 

The biophysical basis of the white matter retention of flutemetamol (18F) in the living human brain has 

not been definitively explained. It is hypothesized that solubility of the radiopharmaceutical in the 

lipid content of brain tissues may contribute to white matter retention. 

 

 

 

Elimination and half-Life 

Flutemetamol (18F) is rapidly cleared from circulation (through the intestinal and urinary tracts). At 

20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites. At 

180 minutes, 90% of the radioactivity was present in plasma in the form of polar metabolites. 

Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary. The apparent 

elimination half-life is 4.5 hours whereas the radioactive half-life of flutemetamol (18F) is 110 minutes. 

 

Renal/hepatic impairment  

The pharmacokinetics in patients with renal or hepatic impairment have not been characterised. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology and repeated dose toxicity. 

 

Flutemetamol (18F) was positive in in vitro genotoxicity tests in bacteria and mammalian cells but 

negative in three different in vivo studies with sufficiently high doses. Any clinically relevant 

mutagenic potential is therefore considered highly unlikely. 

 

No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F). 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Sodium chloride 

Ethanol, anhydrous 

Polysorbate 80 

Sodium dihydrogen phosphate dihydrate 

Disodium hydrogen phosphate dodecahydrate 

Water for injections 

 

6.2 Incompatibilities 
 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products. 

 

6.3 Shelf life 



 

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Eight hours from the reference date and time.  

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive 

materials. 

 

6.5 Nature and contents of container 

 

VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and 

aluminium seals. 

As a result of the manufacturing process some vials are distributed with punctured rubber stoppers. 

 

Pack size 

One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 

4000 MBq at reference date and time. 

One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 

6000 MBq at reference date and time. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 

 

Withdrawals should be performed under aseptic conditions. The vials must not be opened before 

disinfecting the stopper. The solution should then be withdrawn via the stopper, using either a  

single-dose syringe fitted with suitable protective shielding and a disposable sterile needle, or an 

authorised automated application system. If the integrity of the vial is compromised, the medicinal 

product should not be used. 

 

General warning 

Radiopharmaceuticals should be received, used and administered only by authorised persons in 

designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the 

regulations and/or appropriate licences of the competent official organisation. 

 

Radiopharmaceuticals should be prepared in a manner that satisfies both radiation safety and 

pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. 

 

VIZAMYL is a radioactive medicinal product that emits positrons, which annihilate with electrons to 

produce gamma rays, and must be handled with safety measures to minimise radiation exposure to 

clinical personnel and patients. VIZAMYL should be used by, or under the control of, physicians who 

are qualified by specific training and experienced in the safe use and handling of radionuclides, and 

whose experience and training have been approved by the appropriate government agency authorised 

to license the use of radiopharmaceuticals. To minimise radiation dose to the bladder, hydration before 

and after VIZAMYL administration should be encouraged in order to permit frequent voiding. The 

patient should be encouraged to void prior to and following imaging with VIZAMYL, and frequently 

thereafter for the next 24 hours. 

 

If at any time in the preparation of this product the integrity of the vial is compromised, it should not 

be used. 

 

Administration procedures should be carried out in a way to minimise risk of contamination of the 

medicinal product and irradiation of the operators. Adequate shielding is mandatory. 

 



 

14 

The administration of radiopharmaceuticals creates risks for other persons from external radiation or 

contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with 

national regulations must be taken. 

 

Disposal 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

7. MARKETING AUTHORISATION HOLDER 
 

GE Healthcare AS 

Nycoveien 1  

NO-0485 Oslo  

Norway 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/941/001 

EU/1/14/941/002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 22 August 2014 

Date of latest renewal: 25 July 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

11. DOSIMETRY  

 

Table 2 below shows the dosimetry as calculated using the OLINDA/EXM (Organ Level INternal 

Dose Assessment/Exponential Modeling) software. The estimated absorbed radiation doses for adults 

following intravenous injection of VIZAMYL are shown in Table 2. Values were calculated assuming 

emptying of the urinary bladder at 3.5-hour intervals and human biodistribution data using 

OLINDA/EXM software. 

 

Table 2 Estimated radiation absorbed doses from intravenous injection of VIZAMYL 

(adults) 

 

Organ/Tissue Dose absorbed per activity administered [mGy/MBq] 

Adrenal 0.013 

Brain 0.011 

Breasts 0.005 

Gallbladder  0.287 

Heart  0.014 

Kidneys 0.031 

Liver  0.057 

Lower large intestine wall 0.042 

Lungs 0.016 

Muscles 0.009 

Osteogenic cells 0.011 

Ovaries 0.025 

Pancreas 0.015 



 

15 

Red marrow 0.013 

Skin 0.005 

Small intestine  0.102 

Spleen 0.015 

Stomach  0.012 

Testes 0.008 

Thymus 0.006 

Thyroid 0.006 

Upper large intestine  0.117 

Bladder 0.145 

Uterus 0.025 

Remaining organs 0.012 

Effective dose (mSv/MBq) 0.032 

 

The adult effective dose resulting from the administration of a maximal recommended activity of 

185 MBq dose for an adult weighing 70 kg is approximately 5.9 mSv. For an administered activity of 

185 MBq the typical radiation dose to the target organ (brain) is 2.0 mGy. If a CT scan is 

simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in 

an amount dependent on the settings used in the CT acquisition.  

 

For an administered activity of 185 MBq the typical radiation doses delivered to the critical organs, 

gallbladder, urinary bladder wall, upper large intestine wall, lower large intestine wall, small intestine 

and liver are 53.1 mGy, 26.8 mGy, 21.6 mGy, 7.8 mGy, 18.9 mGy and 10.5 mGy, respectively. 

 

 

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 

 

Method of preparation  

The package must be checked before use and the activity measured using a dose calibrator. 

 

See special handling precautions in section 6.6. 

 

Flutemetamol (18F) must not be diluted. 

 

Quality control  

The solution should be inspected visually prior to use. Only clear solutions, free of visible particles 

should be used. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements (see section 6.6).  

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


 

16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



 

17 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

AAA, Troyes 

Advanced Accelerator Applications 

Technopole de l’Aube 

14 rue Gustave Eiffel 

10430 Rosières près Troyes 

France 

 

AAA, Forli 

Advanced Accelerator Applications S.r.l 

Via Piero Maroncelli 40 

47014 Meldola (FC) 

Italy 

 

Curium Pharma Spain, S.A.,  

C/Manuel Bartolome Cossio 10 

28040 Madrid 

Spain 

 

Seibersdorf Laboratories, Seibersdorf 

Seibersdorf Labor GmbH 

Grundstuck Nr. 482/2 EZ98 KG 

2444 Seibersdorf 

Austria  

 

AAA, Zaragoza  

Advanced Accelerator Applications Ibérica S.L. 

Polígono Industrial la Cuesta  3, Parcelas 1 y 2 

50100 La Almunia de Doña Godina  

Zaragoza 

Spain 

 

 

Catalana De Dispensación Sau 

Josep Anselm Clavé 100 

Esplugues de Llobregat 

Barcelona, 08950 

Spain 

 

Nucleis SA 

Allée du Six-Août, 8 

4000 Liège  

Belgium 

 

MAP, Helsinki 

MAP Medical Technologies Oy 

Saukonpaadenranta 2 

Helsinki, FI-00180 

Finland 

 

ITEL, Ruvo di Puglia 
ITEL Telecomunicazioni S.r.l. 

Via Antonio Labriola Zona Industriale SNC,  

70037, Ruvo di Puglia (BA)  

Italy 

 



 

18 

Helmholtz-Zentrum Dresden-Rossendorf e.V.  

Zentrum für Radiopharmazeutische Tumorforschung  

Bautzner Landstraβe 400  

01328 Dresden 

Germany 
 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription.  

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 

 Periodic safety update reports  
 

The marketing authorisation holder shall submit the first periodic safety update report for this 

product within six months following authorisation. Subsequently, the marketing authorisation holder 

shall submit periodic safety update reports for this product in accordance with the requirements set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency;  

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 

same time. 

 

 Additional risk minimisation measures  
 

Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final 

educational programme with the National Competent Authority. 

The MAH shall ensure that, following discussions and agreement with the National Competent 

Authorities in each Member State where VIZAMYL is marketed, at launch and after launch, all 

physicians who are expected to use VIZAMYL have access to a training course in order to ensure 

accurate and reliable interpretation of the PET images. 

 

The training course for healthcare professionals should contain the following key elements: 

 Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as 
an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations 

of VIZAMYL use, interpretation errors, safety information and the results of clinical trials 

informing on the diagnostic use of VIZAMYL. 



 

19 

 Review of the PET reading criteria, including method of image review, criteria for 
interpretation, and images demonstrating the binary read methodology. 

 The material should include VIZAMYL PET demonstration cases with correct PET scan 
interpretation by an experienced reader; VIZAMYL-PET scans for self-assessment; and a self-

qualification procedure to be offered to each trainee. Training should include a sufficient 

number of clearly positive and negative cases as well as intermediate level cases. Cases should 

be histopathologically confirmed, if possible. 

 

Expertise and qualification of trainers in both electronic and in-person training should be ensured. 

 



 

20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



 

21 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
 

 



 

22 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

SHIELD LABEL / 10 mL 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIZAMYL 400 MBq/mL solution for injection 

flutemetamol (18F) 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time. 

 

3. LIST OF EXCIPIENTS 

 

Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate 

dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections. 

See leaflet for further information.  

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

Volume: xx.x mL 

Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} 

Activity: YYYY MBq at hh:mm {Time Zone} dd-mm-yyyy  

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use. 

Multidose vial 

Read the package leaflet before use. 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Radioactive medicine 

 
 

8. EXPIRY DATE 

 

EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy} 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Storage in accordance with national regulation on radiopharmaceuticals.  

 

 



 

23 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GE Healthcare AS 

Nycoveien 1  

NO-0485 Oslo  

Norway 

 

Manufacturers: 

 

Advanced Accelerator Applications, 47014 Meldola (FC), Italy 

 

Advanced Accelerator Applications, Technopole de l’Aube,10430 Rosières près Troyes, France 

 

Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria 

 

Curium Pharma Spain, S.A., 28040 Madrid, Spain 

 

Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain 

 

Catalana De Dispensación Sau, Josep Anselm Clavé 100, 08950 Barcelona, Spain 

 

Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgium 

 

MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland  

 

ITEL Telecomunicazioni, Via Antonio Labriola Zona Industriale SNC, 70037, Ruvo di Puglia, Italy  

 

Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 

Bautzner Landstraβe 400, 01328 Dresden, Germany 
 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/941/001 

 

13. BATCH NUMBER 

 

Lot: 

Vial No: xxx 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

 



 

24 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted 

 

17.     UNIQUE IDENTIFIER – 2D BARCODE 

 

 

 

18.     UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 



 

25 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

SHIELD LABEL / 15 mL 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIZAMYL 400 MBq/mL solution for injection 

flutemetamol (18F)  

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time. 

 

3. LIST OF EXCIPIENTS 

 

Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate 

dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections. 

See leaflet for further information. 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

Volume: xx.x mL 

Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} 

Activity: YYYY MBq {at hh:mm} {Time Zone} on {dd-mm-yyyy}  

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use.  

Multidose vial 

Read the package leaflet before use. 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Radioactive medicine 

 
 

 

8. EXPIRY DATE 

 

EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy} 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Storage in accordance with national regulation on radiopharmaceuticals.  

 



 

26 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GE Healthcare AS 

Nycoveien 1  

NO-0485 Oslo  

Norway 

 

Manufacturers: 

 

Advanced Accelerator Applications, 47014 Meldola (FC), Italy 

 

Advanced Accelerator Applications, Technopole de l’Aube,10430 Rosières près Troyes, France 

 

Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria 

 

Curium Pharma Spain, S.A.,  28040 Madrid, Spain 

 

Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain 

 

Catalana De Dispensación Sau, Josep Anselm Clavé 100, 08950 Barcelona, Spain 

 

Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgium 

 

MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland  

 

ITEL Telecomunicazioni, Via Antonio Labriola Zona Industriale SNC , 70037, Ruvo di Puglia, Italy  

 

Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 

Bautzner Landstraβe 400, 01328 Dresden, Germany 
 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/941/002 

 

 

13. BATCH NUMBER 

 

Lot: 

Vial No: xxx 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

 



 

27 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted 

 

17.      UNIQUE IDENTIFIER – 2D BARCODE 

 

 

 

18.     UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 



 

28 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL / 10 mL 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

VIZAMYL 400 MBq/mL solution for injection 

flutemetamol (18F)  

IV 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP: reference time +8 h  

 

 

4. BATCH NUMBER 

 

Lot: 

Vial No: xxx 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

xx.x mL       YYYY MBq at reference time  

 

 

6. OTHER 

 

Radioactive material. 

 
Advanced Accelerator Applications, 47014 Meldola (FC), Italy 

 

Advanced Accelerator Applications, Technopole de l’Aube,10430 Rosières près Troyes, France 

 

Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria 

 

Curium Pharma Spain, S.A., 28040 Madrid, Spain 

 

Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain 

 

Catalana De Dispensación Sau, Josep Anselm Clavé 100, 08950 Barcelona, Spain 

 

Nucleis SA, 4000 Liège, Belgium 

 

MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland  

 

ITEL Telecomunicazioni, Via Antonio Labriola Zona Industriale SNC,  70037, Ruvo di Puglia, Italy  

 

Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 

01328 Dresden, Germany 
 



 

29 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL LABEL / 15 mL 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

VIZAMYL 400 MBq/mL solution for injection 

flutemetamol (18F) 

IV 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP: reference time + 8h 

 

 

4. BATCH NUMBER 

 

Lot: 

Vial No: xxx 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 xx.x m L       YYYY MBq at reference time. 

 

 

6. OTHER 

 

Radioactive material. 

 
Advanced Accelerator Applications, 47014 Meldola (FC), Italy 

 

Advanced Accelerator Applications, Technopole de l’Aube,10430 Rosières près Troyes, France 

 

Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria 

 

Curium Pharma Spain, S.A.,  28040 Madrid, Spain 

 

Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain 

 

Catalana De Dispensación Sau, Josep Anselm Clavé 100, 08950 Barcelona, Spain 

 

Nucleis SA, 4000 Liège, Belgium 

 

MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland  

 

ITEL Telecomunicazioni, Via Antonio Labriola Zona Industriale SNC,  70037, Ruvo di Puglia, Italy  

 

Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 

01328 Dresden, Germany 
 



 

30 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

31 

Package leaflet: Information for the patient 
 

VIZAMYL 400 MBq/mL solution for injection 

flutemetamol (18F) 

 

 

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 your 

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 VIZAMYL is and what it is used for 

2. What you need to know before VIZAMYL is used 

3. How VIZAMYL is used 

4. Possible side effects 

5. How VIZAMYL is stored 

6. Contents of the pack and other information  

 

 

1. What VIZAMYL is and what it is used for 
 

VIZAMYL contains the active substance flutemetamol (18F) )and is used to help diagnose Alzheimer’s 

disease and other causes of memory loss.  

This medicine is a radiopharmaceutical product for diagnostic use only. 

 

VIZAMYL is used to help diagnose Alzheimer’s disease and other causes of memory loss. It is given 

to adults with memory problems before they undergo a type of brain scan called a positron-emission 

tomography (PET) scan. This scan, along with other brain function tests, can help your doctor 

determine whether or not you may have β-amyloid plaques in your brain. β-Amyloid plaques are 

deposits sometimes present in the brains of people with dementias (such as Alzheimer’s disease).  

 

You should discuss the results of the test with the doctor that requested the scan. 

 

The use of VIZAMYL involves 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 these small amounts of radiation. 

 

 

2. What you need to know before VIZAMYL is used 

 

VIZAMYL must not be used: 
- If you are allergic to flutemetamol (18F) 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 VIZAMYL if you: 

- have kidney problems 
- have liver problems 
- are pregnant or think you may be pregnant 
- are breast-feeding 
 



 

32 

Children and adolescents 

VIZAMYL is not intended for use in children and adolescents below the age of 18 years old. 

 

Other medicines and VIZAMYL 
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other 

medicines since they may interfere with the images obtained from the brain scan. 

 

Pregnancy and breast-feeding 

You must inform the nuclear medicine doctor before you are given VIZAMYL if there is a possibility 

you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it 

is important to consult the nuclear medicine doctor who will supervise the procedure.  

 

If you are pregnant 

The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected 

which would outweigh the risks.  

 

If you are breast-feeding 

You must stop breast-feeding for 24 hours after the injection. Express the breast milk during this 

period and discard any breast milk you have expressed. Resuming breast-feeding should be in 

agreement with the nuclear medicine doctor who will supervise the procedure.  

 

You should avoid any close contact with young children for 24 hours following the injection. 

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your nuclear medicine doctor for advice before you are given this medicine. 

 

Driving and using machines 
VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or use 

machines. You should not drive, use machines or engage in other potentially hazardous activities until 

these effects have completely disappeared. 

 

VIZAMYL contains alcohol (ethanol) and sodium 

VIZAMYL contains alcohol (ethanol). Each dose contains up to 552 mg alcohol. This is about the 

same as 14 mL of beer or 6 mL of wine. This could be harmful for people with alcoholism and needs 

to be taken into account in pregnant or breast-feeding women and people with liver problems or 

epilepsy. 

 

VIZAMYL contains a maximum of 41 mg of sodium (main component of cooking/table salt) in each 

dose. This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake 

for sodium  These amounts may need to be considered for people on a low sodium diet. 

 

 

3. How VIZAMYL will be used 

 

There are strict laws on the use, handling and disposal of radiopharmaceutical products. 

VIZAMYL will only be used in special controlled areas. This product will only be handled and given 

to you by professionals who are trained and qualified to use it safely. They will provide you with the 

necessary information on the procedure. 

 

Your nuclear medicine doctor may ask you to drink plenty of water before the start of the examination 

and the 24 hours after the study in order to urinate as often as possible to help remove it from your 

body faster.  
 

Dose 
The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be 

used in your case. The doctor will choose the smallest amount necessary.  

 



 

33 

The usual amount recommended for an adult is 185 MBq. Megabecquerel (MBq) is the unit used to 

measure radioactivity. 

 

Administration of VIZAMYL and conduct of the procedure 

VIZAMYL is given as an injection into your vein (intravenous injection) followed by a flush of 

sodium chloride solution to ensure full delivery of the dose. 

 

One injection is sufficient to carry out the scan that your doctor needs. 

 

Duration of the procedure 

A brain scan is usually taken 90 minutes after VIZAMYL is given. Your nuclear medicine doctor will 

inform you about the usual duration of the procedure.  

 

After administration of VIZAMYL 
You should avoid any close contact with young children and pregnant women for 24 hours following 

the injection. 

 

The nuclear medicine doctor will inform you if you need to take any special precautions after 

receiving this medicine. Contact your nuclear medicine doctor if you have any questions. 

 

If you have received more VIZAMYL than you should 
An overdose is unlikely since you will only receive a single dose of VIZAMYL from the nuclear 

medicine doctor under controlled conditions. 

 

However, in the case of an overdose, you would receive the appropriate treatment. Treatment consists 

of increasing the passing of urine and stools in order to help remove radioactivity from your body. 

 

If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor 

who supervises the procedure. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

The following side effects may happen with this medicine: 

 

Serious side effects 

Tell your doctor straight away, if you notice any of the following, as you may need urgent medical 

treatment: 

- Allergic reactions - the signs may include swelling of your face or eyes, having pale, itchy or 
tight skin or having a rash, feeling short of breath, tightness in the chest, irritation in your throat 

or being sick. These are uncommon side effects and may affect up to 1 in 100 people. 

 

Tell your doctor straight away if you notice any of the signs above. 

 

Other side effects include 

Common - may affect up to 1 in 10 people 

- looking flushed 
- increased blood pressure 
Uncommon - may affect up to 1 in 100 people. You may experience the following uncommon side 

effects: 

- headache 
- feeling dizzy 
- feeling anxious 
- feeling sick (nausea) 
- chest discomfort 
- low blood sugar (symptoms: hunger, headache) 



 

34 

- back pain 
- feeling hot or cold 
- increased breathing rate 
- pain at the injection site 
- heart pounding (palpitations) 
- pain in muscles or bones 
- shaking movements (tremor) 
- puffy and swollen skin  
- fever 
- over breathing (hyperventilation) 
- change in the way you taste things 
- a spinning feeling (vertigo) 
- reduced sense of touch or sensation 
- feeling tired or weak 
- inability to get or maintain an erection 
- indigestion, stomach ache or sore mouth 
- vomiting 
- decreased feeling or sensitivity especially in your skin or your face 
- increase in “blood lactate dehydrogenase” or “neutrophils” in blood tests 
- skin tightness 
 

This radiopharmaceutical will deliver low amounts of ionising radiation, which is associated with very 

low risk of cancer and hereditary abnormalities (passing on faulty genes). 

 

Reporting of side effects 

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How VIZAMYL is stored 

 

You will not have to store this medicine. This medicine is stored under the responsibility of the 

specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national 

regulation on radioactive materials. 

 

The following information is intended for the specialist only. 

 

Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP’. 

 

Do not use this medicine if you notice that the vial is damaged or the solution contains particulate 

matter or appears discoloured. 

 

 

6. Contents of the pack and other information 

 

What VIZAMYL contains 

- The active substance is flutemetamol (18F). Each mL of solution contains flutemetamol (18F) 
400 MBq at reference time. 

- The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium 
dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for 

injections, see section 2.  

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

35 

What VIZAMYL looks like and contents of the pack 

- VIZAMYL is a clear, colourless to slightly yellow solution for injection. 
- VIZAMYL is supplied in a 10-mL or 15-mL glass vial. Each vial is stored in a container. 
- Not all pack sizes may be marketed. 
 

Marketing Authorisation Holder 

 

GE Healthcare AS 

Nycoveien 1  

NO-0485 Oslo  

Norway 

 

Manufacturers 

Advanced Accelerator Applications S.r.l 

Via Piero Maroncelli 40 

47014 Meldola (FC) 

Italy 

 

Advanced Accelerator Applications 

Technopole de l’Aube 

14 rue Gustave Eiffel 

10430 Rosières près Troyes 

France 

 

Seibersdorf Labor GmbH 

Grundstuck. Nr. 482/2 EZ98 KG 

2444 Seibersdorf 

Austria 

 

Curium Pharma Spain, S.A.  

C/Manuel Bartolome Cossio 10 

28040 Madrid 

Spain 

 

 

Catalana De Dispensación Sau 

Josep Anselm Clavé 100 

Esplugues de Llobregat 

Barcelona, 08950 

Spain 

 

 

Advanced Accelerator Applications Ibérica S.L. 

Polígono Industrial la Cuesta 3, Parcelas 1 y 2 

50100 La Almunia de Doña Godina 

Zaragoza 

Spain 

 

MAP Medical Technologies Oy 

Saukonpaadenranta 2 

Helsinki, FI-00180 

Finland 

 

Nucleis SA 

Allée du Six-Août, 8 

4000 Liège  

Belgium 

 

Helmholtz-Zentrum Dresden-Rossendorf e.V. 

Zentrum für Radiopharmazeutische 

Tumorforschung 

Bautzner Landstraβe 400 

01328 Dresden 

Germany 

 

ITEL Telecomunicazioni S.r.l. 

Via Antonio Labriola Zona Industriale SNC  

70037, Ruvo di Puglia (BA)  

Italy 

 

This leaflet was last revised in {month YYYY}. 
 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

The following information is intended for medical or healthcare professionals only: 

 

The complete SmPC of VIZAMYL is provided as a separate document in the product package, with 

the objective to provide healthcare professionals with other additional scientific and practical 

information about the administration and use of this radiopharmaceutical. 

 

Please refer to the SmPC {SmPC should be included in the box}. 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET