DATSCAN SOLUTION FOR INJECTION 74 MBQML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ioflupane (123I)

Available from:

GE HEALTHCARE PTE. LTD.

ATC code:

V09AB03

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Ioflupane (123I) 74 MBq/mL at reference time

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

GE Healthcare B.V.

Authorization status:

ACTIVE

Authorization date:

2017-09-04

Summary of Product characteristics

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
DaTSCAN is a radiopharmaceutical indicated for striatal dopamine
transporter visualisation using
single photon emission computed tomography (SPECT) brain imaging to
assist evaluation:
•
In adult patients with clinically uncertain Parkinsonian Syndromes,
for example those with
early symptoms, in order to help differentiate Essential Tremor from
tremor due to
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.
DaTSCAN is an adjunct to other diagnostic evaluations.
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 withi