DEFINITY perflutren lipid microsphere injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perflutren, Quantity: 1.1 mg/mL

Available from:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

INN (International Name):

Perflutren

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium chloride; propylene glycol; water for injections; dipalmitoylphosphatidylcholine; N-(methoxy-PEG-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium; sodium dipalmitoylphosphatidate; glycerol; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate

Administration route:

Intravenous

Units in package:

4 vials, each containing at least 1.5 mL liquid

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This medicinal product is for diagnostic use only. DEFINITY is indicated for use in patients in contrast-enhanced diagnostic ultrasound imaging to improve the characterization of focal lesions of the liver and kidney. DEFINITY is indicated for use in patients with suboptimal echocardiograms to provide opacification of cardiac chambers, improvement of left ventricular endocardial border delineation and assessment of regional wall at both rest and stress.

Product summary:

Visual Identification: A clear, colourless, sterile, nonpyrogenic, hypertonic liquid, which upon activation with the aid of a VialmixTM, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-01-30

Patient Information leaflet

DEFINITY

1
DEFINITY

PERFLUTREN LIPID MICROSPHERE
INJECTION VIAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING [MEDICINE NAME]?
DEFINITY

contains the active ingredient perflutren. DEFINITY

is used in patients on contrast-enhanced diagnostic ultrasound
imaging to improve characterisation of focal lesions of the liver and
kidney. It is also used in patients with suboptimal
echocardiograms to provide opacification of cardiac chambers,
improvement of left ventricular endocardial border delineation
and assessment of regional wall motion at both rest and stress.
For more information, see Section 1. Why am I using [medicine name]?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEFINITY

?
Do not use if you have ever had an allergic reaction to DEFINITY

, Polyethylene glycol or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
[medicine name]?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DEFINITY

and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE DEFINITY

?
•
Your doctor will decide how much you will be given DEFINITY

. This depends on which organ (liver, kidney or heart) is
being examined and other factors such as weight.
•
DEFINITY

is given as an injection or infusion (drip) into a vein.
More instructions can be found in Section 4. How do I use [medicine
name]?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DEFINITY

?
THINGS YOU
SHOULD DO
•
Remind any docto

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – DEFINITY PERFLUTREN LIPID
MICROSPHERE INJECTION VIAL (PERFLUTREN) DISPERSION FOR
INTRAVENOUS INJECTION
1
NAME OF THE MEDICINE
perflutren
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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),
commonly called N-(MethoxyPolyEthylene Glycol 5000
carbamoyl)-1,2-DiPalmitoyl-sn-glycero-3-
PhosphatidylEthanolamine, monosodium salt (abbreviated MPEG5000 DPPE).
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
glycerin, 2.34 mg monobasic
sodium phosphate monohydrate, 2.16 mg dibasic sodium phosphate
heptahydrate, and 4.87 mg
sodium chloride in Water for Injection. The pH is 6.2-6.8.
After activating the contents of the vial in a VIALMIX
TM
, each mL of the milky white suspension contains
a maximum of 1.2 x 10
10
perflutren lipid microspheres, and about 1.1 mg/mL perflutren. The
microsphere particle size parameters are listed in Table 1 below:
Table 1 Microsphere Size Distribution
Microsphere particle size parameters
Mean diameter range
1.1 μm — 3.3 μm
Percent less than 10 μm
98%
Maximum diameter
20 μm
Octafluoropropane and perfluoropropane are synonyms for perflutren.
3
PHARMACEUTICAL FORM
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 suspen