Ceretec

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Exametazime

Boleh didapati daripada:

GE Healthcare Australia Pty Ltd

Kelas:

Medicine Registered

Risalah maklumat

 
1-020605

CERETEC™ 

_FOR PREPARATION OF TECHNETIUM [_
_99M_
_TC] EXAMETAZIME INJECTION _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET? 

This leaflet answers some common 
questions about CERETEC.  It does 
not contain all the available 
information, nor does it take the place 
of talking to your doctor or treatment 
provider. 

All medicines and diagnostic 
preparations have risks and benefits.  
Your doctor has weighed the risks of 
you being treated with CERETEC 
against the expected benefits. 

IF YOU HAVE ANY CONCERNS ABOUT 
BEING GIVEN THIS PREPARATION, ASK 
YOUR DOCTOR,  OR TREATMENT PROVIDER. 

KEEP THIS LEAFLET.   You may need to 
read it again. 

WHAT CERETEC IS USED 
FOR 

CERETEC is used in the preparation of 
a radiopharmaceutical which is a 
medicinal product containing a small 
amount of radioactivity. 

Such radiopharmaceuticals are given in 
small amounts to find or rule out a 
disease. The radiation your body 
receives is very low and is considered 
safe.  After the radioactive liquid is 
given to you, it is taken up by the  
organs of interest or just passes 
through your body.  The radiation is 
taken up by a special camera and 
pictures are prepared. These pictures 
allow the nuclear medicine doctor to 
detect any problems. 

In particular, CERETEC is used to 
produce images of the brain of patients 
who have fits or seizures.  They occur 
when the brain's electrical currents 
become disordered from time to time in 
some people. This disease is called 
epilepsy  There is a number of different 
types of epilepsy.  CERETEC is used 
particularly for the imaging of patients 
with  epilepsy  which originates in the 
parts of the brain just centre and 
slightly behind the ears. 

CERETEC is used to help find or rule 
out a diagnosis only.  It is not used to 
treat or cure epilepsy. 

Your doctor may have prescr

Ciri produk

 
PAGE 1 OF 12 
PRODUCT INFORMATION 

CERETEC
®

FOR THE PREPARATION OF TECHNETIUM [
99M
TC] EXAMETAZIME INJECTION 

DIAGNOSTIC RADIOPHARMACEUTICAL 
FOR INTRAVENOUS SINGLE USE ONLY 

DESCRIPTION 

The Ceretec® kit is supplied as packs of two or five single dose
vial units for use in the 
preparation of a technetium [
99m
Tc]-exametazime intravenous injection.  Each single dose 
vial unit contains a pre-dispensed sterile, non-pyrogenic, lyophilized
mixture of 0.5 mg 
exametazime [(RR,SS)-4,8-diaza-3,6,6,9-tetramethylundecane-2,10-dione
bisoxime], 7.6 µg 
stannous chloride dihydrate (minimum stannous tin 0.6 µg;
maximum total stannous and 
stannic tin 4.4 µg per vial) and 4.5 mg sodium chloride, sealed
under nitrogen atmosphere at 
a pressure just below atmospheric, with a rubber closure.  The
product contains no 
antimicrobial preservative. 

Exametazime was formerly known as hexamethylpropylene amine
oxime (HM-PAO).  (The 
name HM-PAO appears in many publications). 

The structural formula of exametazime is: 

When sterile pyrogen-free sodium pertechnetate [
99m
Tc] in isotonic saline is added to the vial, 
CERETEC® PRODUCT INFORMATION 

PAGE 2 OF 12 
a [
99m
Tc]-complex of exametazime is formed. 

Administration is by intravenous injection for diagnostic use. 

PHYSICAL CHARACTERISTICS 

Technetium-99m decays by isomeric transition with a physical
half-life of 6 hours.  Photons 
associated with this transition which are useful for detection and
imaging studies are listed 
below: 

TABLE 1: PRINCIPAL RADIATION EMISSION DATA 

          Principal 

   Mean Percent per 

    Mean Energy 
          Radiation 

      Disintegration 

          (keV) 

          Gamma-2               

87.2 

140.5 

Reference: 
Brown, E, Firestone, R B and Shirley, V S (Ed):  Table of  

Radioactive Isotopes, 1986, J Wiley 

TABLE 2: PHYSIC