Vizamyl
flutemetamol (18F)
flutemetamol (18F)
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 VIZAMYL is and what it is used for
What you need to know before VIZAMYL is used
How VIZAMYL is used
Possible side effects
How VIZAMYL is stored
Contents of the pack and other information
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.
If you are allergic to flutemetamol (18F) or any of the other ingredients of this medicine (listed in section 6).
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
VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.
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.
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.
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). 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.
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.
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.
The usual amount recommended for an adult is 185 MBq. Megabecquerel (MBq) is the unit used to measure radioactivity.
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.
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.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
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.
looking flushed
increased blood pressure
headache
feeling dizzy
feeling anxious
feeling sick (nausea)
chest discomfort
low blood sugar (symptoms: hunger, headache)
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).
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.
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.
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.
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.
GE Healthcare AS Nycoveien 1
NO-0485 Oslo
Norway
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
Curium PET France
Parc scientifique Georges Besse 180 allee Von Neumann
30000 Nimes France
Advanced Accelerator Applications Iberica S.L.U Josep Anselm Clavé 100
Esplugues de Llobregat Barcelona, 08950 Spain
Via Ripamonti 435 | |
20141 Milano (MI) | |
Italy | |
.
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
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}.