Ceretec 500 micrograms kit for radiopharmaceutical preparation

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Exametazime

Verfügbar ab:

GE Healthcare AS

ATC-Code:

V09AA; V09AA01

INN (Internationale Bezeichnung):

Exametazime

Dosierung:

500 microgram(s)

Darreichungsform:

Kit for radiopharmaceutical preparation

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Technetium (99mTc) compounds; technetium (99mTc) exametazime

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1988-04-19

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CERETEC 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
Exametazime
(called Ceretec in this leaflet)
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.
•
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 Ceretec is and what it is used for
2.
What you need to know before Ceretec is used
3.
How Ceretec is used
4.
Possible side effects
5.
How Ceretec is stored
6.
Contents of the pack and other information
1. WHAT CERETEC IS AND WHAT IT IS USED FOR
Ceretec is a radiopharmaceutical product for diagnostic use only. It
is used only to help identify illness.
Ceretec is given before a scan and helps a special camera see inside a
part of your body.
•
It contains an active ingredient called ‘exametazime’. This is
mixed with another ingredient
called technetium’ before it is used.
•
Once injected it can be seen from outside your body by a special
camera used in the scan.
•
The scan can help your doctor see how much blood is flowing through
the brain. This may be
important to know after a stroke, if you have fits or epilepsy,
Alzheimer's disease or a similar type of
dementia. It may also be used in people who have migraine (headaches)
or a brain tumour.
•
The scan can help your doctor investigate fever when the reason for
the fever is not known.
•
The scan can also help your doctor investigate sites of infection,
such as in your abdomen (the
area around your stomach).
•
Some other people are given this medicine to see swelling
(inflammation) in the bowel.
Your nuclear medicine doctor will explain which part of your body will
be scanned. The use of Ceretec
does involve exposure to small amounts of radioactivity. Your doctor
and the

Fachinformation

Health Products Regulatory Authority
23 December 2022
CRN00D7N4
Page 1 of 11
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 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 a 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 reconstitution with Sodium Pertechnetate (
99m
Tc) Injection, the solution of technetium (
99m
Tc) exametazime is indicated
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
Infectious or inflammatory diseases
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 evaluatio