Definity

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Perflutren 1.1 mg/mL

Disponível em:

Global Medical Solutions (NZ) Limited

DCI (Denominação Comum Internacional):

Perflutren 1.1 mg/mL

Dosagem:

1.1 mg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Perflutren 1.1 mg/mL Excipient: Colfosceril palmitate Dibasic sodium phosphate monohydrate Glycerol Sodium dipalmitoylphosphatidate N-(Methoxy-PEG-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium Monobasic sodium phosphate monohydrate Propylene glycol Sodium chloride Water for injection

Unidades em pacote:

Vial, glass, clear, 4 dose units

Classe:

General sale

Tipo de prescrição:

General sale

Fabricado por:

Fluoromed LP

Resumo do produto:

Package - Contents - Shelf Life: Vial, glass, clear - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorização:

2007-05-31

Características técnicas

NEW ZEALAND DATA SHEET
_New Zealand Data Sheet - 30_
_ _
_June 2019 _
_ _
_Page 1 of 10 _
1 PRODUCT NAME
DEFINITY® (perflutren lipid microsphere) dispersion for injection.
Octafluoropropane and perfluoropropane
are synonyms for 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),
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:
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
sodium phosphate monobasic
monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87
mg sodium chloride in Water for
Injection. The pH is 6.2-6.8.
F
F
F
F
F
F
F
F
NEW ZEALAND DATA SHEET
_New Zealand Data Sheet - 30_
_ _
_June 2019 _
_ _
_Page 2 of 10 _
After activating the contents of the vial in a Vialmix
TM
, each mL of the milky white suspension contains a
maximu