Ceretec -

Country: Norway

Bahasa: Norway

Sumber: Statens legemiddelverk

Bahan aktif:

Eksametazim

Boleh didapati daripada:

GE HEALTHCARE AS

Kod ATC:

V09AA01

INN (Nama Antarabangsa):

Eksametazim

Borang farmaseutikal:

Preparasjonssett til radioaktive legemidler

Unit dalam pakej:

Hetteglass 2x0.5 mg

Jenis preskripsi:

C

Status kebenaran:

Markedsført

Tarikh kebenaran:

2000-03-03

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS
FOR
CERETEC, KIT FOR RADIOPHARMACEUTICAL PREPARATION
1.
NAME OF THE MEDICINAL PRODUCT
Ceretec
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains exametazime 500 micrograms
Ceretec is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection (not included in
this kit) to prepare Technetium (
99m
Tc) Exametazime Injection.
Excipients with known effect
The product before reconstitution contains sodium: 1.77 mg/vial. This
needs to be
taken into consideration for patients on a controlled sodium diet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
A white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with Sodium Pertechnetate (
99m
Tc) Injection, the solution of
technetium (
99m
Tc) exametazime is indicated in adults, children and adolescents for:
Neurology
Technetium (
99m
Tc) Exametazime Injection is indicated for use with single photon
emission tomography (SPECT). In brain perfusion SPECT, the diagnostic
target is
detection of abnormalities of regional cerebral blood flow, including:
-
Evaluation of patients with cerebrovascular disease (specifically
acute stroke,
chronic ischaemia and transient ischaemic attack);
-
Presurgical lateralisation and localisation of epileptogenic foci;
-
Evaluation of patients with suspected dementia (specifically
Alzheimer’s
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Page 2 of 16
disease and frontotemporal dementia);
-
Adjuvant technique in the diagnosis of brain death
Infectious or inflammatory diseases
Technetium (
99m
Tc) Exametazime Injection is also indicated for
_in vitro_
technetium-
99m leukocyte labelling, the labelled leukocytes subsequently being
re-injected and
scintigraphy carried out to image the sites of localisation. This
procedure may be
used in the d