CERETEC

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

EXAMETAZIME

Disponible depuis:

ELDAN ELECTRONIC INSTRUMENTS CO LTD

forme pharmaceutique:

POWDER FOR SOLUTION FOR INJECTION

Composition:

EXAMETAZIME 0.5 MG/VIAL

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

GE HEALTHCARE AS, NORWAY

indications thérapeutiques:

Regional cerebral blood flow scintigraphy- leucocytes labelling.

Date de l'autorisation:

2020-03-31

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceretec 500 micrograms kit for radiopharmaceutical preparation
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 effects: The product before reconstitution
contains:
Sodium: 1.77mg/vial. This needs to be taken into consideration for
patients on a
controlled sodium diet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
A white granular powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (99mTc) Injection, the
product is indicated
in adults for
regional cerebral blood flow scintigraphy- leucocytes labelling
:
Technetium (
99m
Tc) Exametazime Injection is indicated for brain scintigraphy. The
product is to be used for the diagnosis of abnormalities of regional
cerebral blood flow,
such as those occurring following stroke and other cerebrovascular
disease, epilepsy,
Alzheimer’s Disease and other forms of dementia, transient ischaemic
attack, migraine and
tumours of the brain.
Technetium (
99m
Tc) Exametazime Injection is also indicated for
_in vitro_
technetium-99m
leucocyte labelling, the labelled leucocytes subsequently being
re-injected and scintigraphy
carried out to image the sites of localisation. This procedure may be
used in the detection
of sites of focal infection (e.g. abdominal abscess), in the
investigation of pyrexia of
unknown origin and in the evaluation of inflammatory conditions not
associated with
infection such as inflammatory bowel disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is direct intravenous injection for brain
scintigraphy studies
and intravenous injection of labelled leucocytes post labelling in
vitro.
POSOLO