Stabilised Ceretec -

Maa: Norja

Kieli: norja

Lähde: Statens legemiddelverk

Aktiivinen ainesosa:

Kobolt(II)kloridheksahydrat / Eksametazim

Saatavilla:

GE HEALTHCARE AS

ATC-koodi:

V09AA01

INN (Kansainvälinen yleisnimi):

Kobolt(II)kloridheksahydrat / Eksametazim

Lääkemuoto:

Preparasjonssett til radioaktive legemidler

Kpl paketissa:

5 sett

Prescription tyyppi:

C

Valtuutuksen tilan:

Markedsført

Valtuutus päivämäärä:

2001-06-01

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
FOR
STABILISED CERETEC, KIT FOR RADIOPHARMACEUTICAL PREPARATION
1.
NAME OF THE MEDICINAL PRODUCT
Stabilised Ceretec
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains exametazime 500 micrograms.
Stabilised Ceretec is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection Ph.Eur.
(not included in this kit) to prepare stabilised Technetium (
99m
Tc) Exametazime Injection.
Excipients:
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
White powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabeling with Sodium Pertechnetate (
99m
Tc) Injection, the solution of technetium
(
99m
Tc) exametazime is indicated in adults 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 disease and
frontotemporal dementia);
-
Adjuvant technique in the diagnosis of brain death
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_Page 2 of 11 _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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_Adults_555-1110 MBq by direct intravenous injection
Normally a once-only diagnostic procedure
_ Paediatric population _
Technetium-99m exametazime with the cobalt chloride solution is not
recommended for
administration to children. Safety and effectiveness of the cobalt
solution has not been
established in the paediatric population.
Method of administration
This me