Celsunax

Šalis: Europos Sąjunga

kalba: anglų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

ioflupane (123i)

Prieinama:

Pinax Pharma GmbH

ATC kodas:

V09AB03

INN (Tarptautinis Pavadinimas):

ioflupane (123I)

Farmakoterapinė grupė:

Diagnostic radiopharmaceuticals

Gydymo sritis:

Radionuclide Imaging; Dementia; Movement Disorders

Terapinės indikacijos:

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

Autorizacija statusas:

Authorised

Leidimo data:

2021-06-17

Pakuotės lapelis

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CELSUNAX 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 Celsunax is and what it is used for
2.
What you need to know before Celsunax is used
3.
How Celsunax is used
4.
Possible side effects
5.
How Celsunax is stored
6.
Contents of the pack and other information
1.
WHAT CELSUNAX IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only. It is used only to identify
illness.
Celsunax 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 Celsunax 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 yo

Prekės savybės

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Celsunax 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.
Excipient with known effect
This medicinal product contains 39.5 g/L ethanol, resulting in a
maximum of 197 mg of ethanol in
5 mL solution.
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.
Celsunax 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.
Celsunax 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.
Celsunax 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.
Celsunax should only be used in adult patients referred by physicians
experienced in the management of
movement disorders and/or dementi