DaTSCAN
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-02-2022
Charakterystyka produktu
(SPC)
10-02-2022
Sprawozdanie z oceny publicznego
(PAR)
08-06-2011
Składnik aktywny:
ioflupane (123l)
Dostępny od:
GE Healthcare B.V.
Kod ATC:
V09AB03
INN (International Nazwa):
ioflupane (123l)
Grupa terapeutyczna:
Diagnostic radiopharmaceuticals
Dziedzina terapeutyczna:
Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease
Wskazania:
This medicinal product is for diagnostic use only.DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:In adult patients with clinically uncertain Parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. DaTSCAN is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.
Podsumowanie produktu:
Revision: 23
Status autoryzacji:
Authorised
Data autoryzacji:
2000-07-27
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
DATSCAN 74 MBQ/ML SOLUTION FOR INJECTION
Ioflupane (
123
I)
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 DaTSCAN is and what it is used for
2.
What you need to know before DaTSCAN is used
3.
How DaTSCAN is used
4.
Possible side effects
5.
How DaTSCAN is stored
6.
Contents of the pack and other information
1.
WHAT DATSCAN IS AND WHAT IT IS USED FOR
DaTSCAN contains the active substance ioflupane (
123
I) which is used to help identify (diagnose)
conditions in the brain. It belongs to a group of medicines called
“radiopharmaceuticals”, which contain
a small amount of radioactivity.
•
When a radiopharmaceutical is injected, it collects in a specific
organ or area of the body for a
short time.
•
Because it contains a small amount of radioactivity it can be detected
from outside the body using
special cameras.
•
A picture, known as a scan, can be taken. This scan will show exactly
where the radioactivity is
inside the organ and the body. This can give the doctor valuable
information about how that organ
is working.
When DaTSCAN is injected into an adult, it is carried around the body
in the blood. It collects in a small
area of your brain. Changes in this area of the brain occur in:
•
Parkinsonism (including Parkinson’s disease) and
•
dementia with Lewy bodies.
A scan will give your doctor information about any changes in this
area of your brain. Your doctor may
feel that the scan would help in finding out more about your condition
and deciding on possible
treatment.
When DaTSCAN is used, you are exposed to small am
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
DaTSCAN 74 MBq/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains ioflupane (
123
I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).
Each 2.5
ml single dose vial contains 185 MBq ioflupane (
123
I) (specific activity range 2.5 to
4.5 x 10
14
Bq/mmol) at reference time.
Each 5 ml single dose vial contains 370 MBq ioflupane (
123
I) (specific activity range 2.5 to
4.5 x 10
14
Bq/mmol) at reference time.
_ _
Excipient(s) with known effect
This medicinal product contains 39.5 g/l ethanol.
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.
DaTSCAN is indicated for detecting loss of functional dopaminergic
neuron terminals in the striatum:
•
In adult patients with clinically uncertain Parkinsonian Syndromes,
for example those with early
symptoms, in order to help differentiate Essential Tremor from
Parkinsonian Syndromes related
to idiopathic Parkinson’s Disease, Multiple System Atrophy and
Progressive Supranuclear Palsy.
DaTSCAN is unable to discriminate between Parkinson's Disease,
Multiple System Atrophy and
Progressive Supranuclear Palsy.
•
In adult patients, to help differentiate probable dementia with Lewy
bodies from Alzheimer’s
disease.
DaTSCAN is unable to discriminate between dementia with Lewy bodies
and Parkinson’s disease
dementia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to administration appropriate resuscitation equipment should be
available.
DaTSCAN should only be used in adult patients referred by physicians
experienced in the management
of movement disorders and/or dementia. DaTSCAN should only be used by
qualified personnel with the
appropriate government authorisation for the use and manipulation of
radionuclides within a designated
clinical setting.
3
Posology
Clinic
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