Cardiolite

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate

Available from:

Lantheus MI Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CARDIOLITE


Technetium Tc-99m Sestamibi 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some of the common questions about Cardiolite.
 It does not 
contain all of the available information about Cardiolite.  It does
not replace talking to 
your doctor. 

All medicines have risks and benefits.  Your doctor has weighed
the risks of you or 
your child receiving Cardiolite against the benefits he or
she expects it will have. 

IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE,
ASK YOUR DOCTOR. 

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

WHAT IS CARDIOLITE 

Cardiolite contains the active ingredient called _Technetium
Tc-99m_ _Sestamibi_ and 
belongs to a group of medicines called radiopharmaceutical agents,
which are all 
radioactive. 

Cardiolite comes in a kit, containing ingredients that are mixed
with a radioactive 
solution before being given to you as an injection. 

WHAT CARDIOLITE IS USED FOR 

Cardiolite is used to show the blood flow inside your heart
during exercise and rest. 

Cardiolite can be used to show the presence and size of
any breast cancer. 

Your doctor may have prescribed Cardiolite for another purpose.
 Ask your doctor if 
you have any questions about why Cardiolite has been
prescribed for you.  If you 
have any concerns, you should discuss these with your doctor. 

This medicine is only available with a doctor’s prescription. 

BEFORE YOU ARE GIVEN CARDIOLITE 

Before you are given Cardiolite your doctor will explain to you
the procedure you are 
about to undergo, and the radioactive medicine you will be given.
 You must discuss 
any concerns you have with your doctor. 

Cardiolite is not recommended for patients less than 18 years of
age.  If your doctor 
believes it is necessary to give Cardiolite to a patient under 18,
he or she will discuss 
the

Summary of Product characteristics

512358-0811 
AUGUST 2011 

CARDIOLITE® 
KIT FOR THE PREPARATION OF TECHNETIUM [99MTC] SESTAMIBI FOR
INJECTION 

DESCRIPTION:  Each vial contains a sterile, non-pyrogenic,
lyophilized mixture of: 

Tetrakis (2-methoxy isobutyl isonitrile) Copper (I)
Tetrafluoroborate - 
1.0mg 

Tin (II) Chloride - 0.075mg 

Sodium Citrate - 2.6mg 

Cysteine Hydrochloride - 1.0mg 

Mannitol - 20mg

The product contains no preservatives. 

Prior to lyophilization the pH is
5.3 to 5.9.  The contents of the vial are lyophilized and 
stored under nitrogen. 

This drug is administered by intravenous injection for diagnostic
use after reconstitution 
with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate 
99m
Tc Injection. 

The precise structure of the technetium complex is 
99m
Tc[MIBI]
6
+ where MIBI is  
2-methoxy isobutyl isonitrile. 

PHYSICAL CHARACTERISTICS 

Technetium 
99m
Tc 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% / 
Mean 

Radiation 
Disintegration 
Energy (keV) 

Gamma-2 

87.2 
  140.5 
Reference:  Browne E., Firestone R.B., and Shirley V.S., (Ed.)
Table of Radioactive 
Isotopes, 1986, J. Wiley 

TABLE 2.  PHYSICAL DECAY CHART; 
99M
TC HALF-LIFE 6 HOURS 

Fraction 

Fraction 

Hours 
Remaining 
Hours 
Remaining 

0*  
1.000 
    8 

.397 

1  
.891 
    9 

.354 

2  
.794 
    10 

.315 

3   
.707 
    11 

.281 

4  
.630 
    12 

.250 

5   
.561 

6  
.500 

7  
.445 
*Calibration Time 
EXTERNAL RADIATION 

The specific gamma ray constant for 
99m
Tc is 0.19 mGy pe