Striascan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ioflupane (123l)

Available from:

CIS bio international

ATC code:

V09AB03

INN (International Name):

ioflupane (123l)

Therapeutic group:

Diagnostic radiopharmaceuticals

Therapeutic area:

Radionuclide Imaging; Dementia; Movement Disorders

Therapeutic indications:

This medicinal product is for diagnostic use only.Striascan 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. Striascan 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. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-06-25

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STRIASCAN 74
MBQ/ML SOLUTION FOR INJECTION
ioflupane (
123
I)
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 Striascan is and what it is used for
2.
What you need to know before Striascan is used
3.
How Striascan is used
4.
Possible side effects
5.
How Striascan is stored
6.
Contents of the pack and other information
1.
WHAT STRIASCAN IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Striascan 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.
Striascan is used only to identify illness. When this medicine is
injected into a patient, it is carried around
the body in the blood and 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Striascan 74 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 74 MBq of ioflupane (
123
I) 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.
Iodine-123 has a physical half-life of 13.2 hours. It decays emitting
gamma radiation with a predominant
energy of 159 keV and X-rays of 27 keV.
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.
Striascan 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.
Striascan 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
d i s e a s e . Striascan is unable to discriminate between dementia
with Lewy bodies and
Parkinson’s disease dementia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Striascan should only be used in adult patients referred by physicians
experienced in the management of
movement disorders and/or dementia.
This medical product is for use in hospitals or in designated nuclear
medicine facilities only.
3
Posology
Clinical efficacy has been demonstrated across the range 110 to 185
MBq. Do not exceed 185 MBq a