DATSCAN 74 MBQML

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

IOFLUPANE

Dostupné z:

ELDAN ELECTRONIC INSTRUMENTS CO LTD

ATC kód:

V09AB03

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

IOFLUPANE 74 MBQ/ML

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

GE HEALTHCARE B.V., THE NETHERLAND

Terapeutické skupiny:

OTHER DOPAMINERGIC AGENTS

Terapeutické oblasti:

IODINE IOFLUPANE (123I)

Terapeutické indikácie:

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

Dátum Autorizácia:

2014-11-30

Príbalový leták

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
) :ךיראת
01.07.13
םש
רישכת
תילגנאב
רפסמו :םושירה
DATSCAN 74 MBQ/ML
םש
לעב
םושירה :
ELDAN ELECTRONIC INSTRUMENT
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.1
THERAPEUTIC
INDICATIONS
Therapoitic group; other dopaminergic agents
This medicinal product is for diagnostic use
only.
DaTSCAN is indicated for detecting loss of
functional dopaminergic neuron terminals in the
striatum:

In patients with clinically uncertain
Parkinsonian Syndromes, 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.

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.
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 de

Súhrn charakteristických

1
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.
_ _
Posology
Clinical efficacy has been demonstrated across the range 1