Myoview

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Tetrofosmin; Stannous chloride dihydrate

Dostupno od:

GE Healthcare Australia Pty Ltd

Razred:

Medicine Registered

Uputa o lijeku

 
MYOVIEW™ 

_For preparation of Technetium [_
_99m_
_Tc] Tetrofosmin Injection _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

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

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

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

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

WHAT MYOVIEW IS USED 
FOR 

MYOVIEW is used in the preparation 
of Technetium [
99m
Tc] Tetrofosmin 
Injection, a radioactive medicinal 
product. Such substances are also 
known as  radiopharmaceuticals.   

Such radiopharmaceuticals are given in 
small amounts to find or rule out a 
disease.  When used in this way 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, especially the heart muscle 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. 

MYOVIEW is used to help detect 
areas in the heart that may not be 
getting enough blood to work properly. 

MYOVIEW is used as an aid in 
diagnosis only.  It is not used to treat or 
cure the condition. 

BEFORE YOU ARE GIVEN 
MYOVIEW 

_WHEN YOU MUST NOT BE GIVEN _
_IT _
_ _
MYOVIEW is not recommended for 
adolescents or children under 12 years 
of age. 

You must not be given MYOVIEW if 
you are allergic to it or any of the 
ingredients listed at the end of this 
leaflet or have had an allergic reaction 
in a diagn

Svojstava lijeka

 
PAGE 1 OF 12 
PRODUCT INFORMATION 

MYOVIEW
®

KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] TETROFOSMIN INJECTION 

DESCRIPTION 

MYOVIEW
®
 consists of a freeze-dried formulation contained within a 10mL,
neutral 
glass vial and sealed with a chlorobutyl closure and an
aluminium overseal. 

Each vial contains: 

Tetrofosmin (active ingredient) 

0.23mg 
 Stannous 
chloride 
dihydrate 
  0.03mg 
 Disodium 
sulphosalicylate 
  0.32mg 
 Sodium 
D-gluconate 
   1.0mg 
 Sodium 
bicarbonate 
   1.8mg 
 Nitrogen 
gas 
    to 
80% 
atmospheric 
pressure 

The structural formula of tetrofosmin is: 

OET 
OET 
P 
ETO 
P 
ETO 

tetrofosmin 

When sodium pertechnetate [
99m
Tc] is added to tetrofosmin in the presence of stannous 
tin, a lipophilic, cationic complex of 
99m
Tc-labelled tetrofosmin is formed.  The 
structure of the labelled complex is as follows: 

ETO ETO 
+ 
ETO ETO 
OET 
OET 
OET 
OET 
P 
P 
P 
P 
TC 
O 
O 

[
99m
TcO
2
(tetrofosmin)
2
]
+

MYOVIEW® PRODUCT INFORMATION 

PAGE 2 OF 12 
PHYSICAL CHARACTERISTICS 

NUCLEAR DATA FOR TECHNETIUM-99M 

Sodium Pertechnetate [
99m
Tc] Injection Ph.Eur is produced by a [
99
Mo/
99
Tc] generator.  
Technetium-99m disintegrates with the emission of gamma radiation
(energy 141keV, 
88.5%; 43keV, 0.03%) and a half life of 6.02 hours). 

To correct for the physical decay of this radionuclide, the fractions
that remain at 
selected intervals relative to the time of calibration are shown in
the following Table: 

TABLE 1 

PHYSICAL DECAY CHART FOR 
99M
TC 

         HOURS 
        FRACTION 
       REMAINING

          HOURS 
       FRACTION 
     REMAINING 

              0
*
          1.000 
              7 
         0.447 
              1 
          0.891 
              8  
         0