Definity

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

Perflutren

Доступна с:

Lantheus MI Australia Pty Ltd

класс:

Medicine Registered

тонкая брошюра

DEFINITY


Perflutren 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

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

All medicines have risks and benefits.  Your doctor has weighed
the risks of you 
receiving Definity 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 DEFINITY 

Definity contains the active ingredient perflutren.  Perflutren
is a gas.  Definity 
consists of perflutren-containing lipid microspheres dispersed in a
solution that is 
given intravenously by infusion (drip) or injection. 

Perflutren containing lipid micospheres enhance the images
seen with ultrasound and 
give your doctor a clearer picture of your liver, kidneys or
heart. 

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

This medicine is for diagnostic use and is only available with
a doctor’s prescription. 

BEFORE YOU ARE GIVEN DEFINITY 

Before you are given Definity your doctor will explain to you the
procedure you are 
about to undergo.  You must discuss any concerns you
have with your doctor. 

_WHEN YOU MUST NOT BE GIVEN DEFINITY_ 
You must not be given Definity if you have an allergy to  

  Perflutren or  

  any of the other ingredients listed at the end of this
leaflet. 
You must not be given Definity if you have a cardiac shunt. 

_BEFORE YOU ARE GIVEN DEFINITY _
YOU MUST TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO: 

  any other medicines 
�

Характеристики продукта

 
1 
515752-0613   

NAME OF THE MEDICINE 

DEFINITY
®
 (PERFLUTREN LIPID MICROSPHERE) DISPERSION FOR INJECTION 

Octafluoropropane and perfluoropropane are synonyms
for perflutren. 

DESCRIPTION 

DEFINITY
®
 contains a clear, colourless, sterile, nonpyrogenic,
hypertonic liquid, which upon 
activation with the aid of a Vialmix
TM
, provides a homogeneous, opaque, milky white injectable 
suspension of perflutren lipid microspheres.  

The perflutren lipid microspheres are composed of perflutren
encapsulated in an outer lipid shell 
consisting of (R) - hexadecanoic acid,
1 –[(phosphonoxy)methyl]-1,2-ethanediyl ester, 
monosodium salt (abbreviated DPPA);
(R) - 4-hydroxy-N,N,N-trimethyl-l0-oxo-7-[(l-
oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-l-aminium, 4-oxide,
inner salt 
(abbreviated DPPC); and
(R) ά-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]5,7,11-trioxa-2-
aza-6-phosphahexacos-1-yl]-ω-methoxypoly(ox-l,2-ethanediyl),
monosodium salt (abbreviated 
MPEG5000 DPPE). 

The CAS number of DEFINITY
® 
is [76-19-7].  The physical and chemical characteristics of 
perflutren gas are provided in Table 1. 

Table 1 
Physical and Chemical Characteristics of Perflutren 

Physical/Chemical Property 
Characteristic 
Appearance 
Colorless gas 
Boiling point (1 atmosphere) 
-36.7°C 
Freezing Point (1 atmosphere) 
-183°C 
Density, Liquid (20°C) 
1.350 g/mL 

Perflutren is chemically characterized as
1,1,1,2,2,3,3,3-octafluoropropane.  It has a molecular 
weight of 188, empirical formula of C
3
F
8
 and has the following structural formula: 

F
F
F
F
F
F
F
F

2 
Prior to Vialmix
TM
 activation, the DEFINITY
®
 vial contains 6.52_ _mg/mL perflutren in the 
headspace. Each mL of the clear liquid contains 0.75 mg lipid blend
(consisting of 0.045 mg 
DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE), 103.5
mg propylene glycol, 126.2 
mg