Amyvid

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

florbetapir (18F)

Saatavilla:

Eli Lilly Nederland B.V.

ATC-koodi:

V09AX05

INN (Kansainvälinen yleisnimi):

florbetapir (18F)

Terapeuttinen ryhmä:

Diagnostic radiopharmaceuticals

Terapeuttinen alue:

Radionuclide Imaging

Käyttöaiheet:

This medicinal product is for diagnostic use only.Amyvid 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. Amyvid 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: 14

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-01-14

Pakkausseloste

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMYVID 1,900 MBQ/ML SOLUTION FOR INJECTION
AMYVID 800 MBQ/ML SOLUTION FOR INJECTION
florbetapir (
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 Amyvid is and what it is used for
2.
What you need to know before Amyvid is used
3.
How Amyvid will be used
4.
Possible side effects
5
How Amyvid is stored
6.
Contents of the pack and other information
1.
WHAT AMYVID IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Amyvid contains the active substance florbetapir (
18
F).
Amyvid is given to adults with memory problems so that doctors can
perform a type of brain scan,
called a PET scan. Amyvid, along with other brain function tests, may
help your doctor find the reason
for your memory problems. An Amyvid PET scan can help your doctor
determine whether or not you
may have β-amyloid plaques in your brain. β-amyloid plaques are
deposits present in the brains of
people with Alzheimer’s disease, but may also be present in the
brain of people with other dementias.
You should discuss the results of the test with the doctor that
requested the scan.
The use of Amyvid does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the benefit of this
procedure with the
radiopharmaceutical outweighs the risk of being exposed to radiation.
2.
WHAT YOU NEED TO KNOW BEFORE AMYVID IS USED
AMYVID MUST NOT BE USED
-
if you are allergic to florbetapir (
18
F) or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECA

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amyvid
800 MBq/mL solution for injection
Amyvid
1,900 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amyvid
800 MBq/mL solution for injection
Each mL of solution for injection contains 800 MBq of florbetapir (
18
F) at the date and time of
calibration (ToC).
The activity per vial ranges from 800 MBq to 12,000 MBq at the ToC.
Amyvid
1,900 MBq/mL solution for injection
Each mL of solution for injection contains 1,900 MBq of florbetapir (
18
F) at the ToC.
The activity per vial ranges from 1,900 MBq to 28,500 MBq at the ToC.
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 dose contains up to 790 mg of ethanol and 37 mg of sodium.
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.
Amyvid 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. Amyvid
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 florbetapir (
18
F) should be requested by physicians skilled in the clinical
management of neurodegenerative disorders.
Amyvid images should only be interpreted by readers trained in the
interpretation of PET images with
florbetapir (
18
F). A recent co-registered computed tomography (CT) scan or magnetic