Vizamyl

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

flutemetamol (18F)

Saatavilla:

GE Healthcare AS

ATC-koodi:

V09AX04

INN (Kansainvälinen yleisnimi):

flutemetamol (18F)

Terapeuttinen ryhmä:

Diagnostic radiopharmaceuticals

Terapeuttinen alue:

Radionuclide Imaging; Alzheimer Disease

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-08-22

Pakkausseloste

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIZAMYL 400 MBQ/ML SOLUTION FOR INJECTION
flutemetamol (
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 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 (
18
F) 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 (
18
F) or any of the other ingr

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 (
18
F) 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 (
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 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 (
18
F) 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 (
18
F). 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