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NOXAFIL
®
ORAL
SUSPENSION
_Posaconazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOXAFIL. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NOXAFIL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING NOXAFIL, ASK YOUR DOCTOR
OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
TAKING NOXAFIL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOXAFIL IS
USED FOR
NOXAFIL contains the active
ingredient, posaconazole.
Posaconazole is a medicine that
belongs to the triazole group of
antifungal medicines.
NOXAFIL works by killing or
stopping the growth of the fungi
causing these infections.
NOXAFIL is used for:
•
The treatment of invasive
aspergillosis, a fungal infection
caused by a fungus called
aspergillus
•
The treatment of other serious
fungal infections called
fusariosis, zygomycosis,
chromoblastomycosis and
mycetoma.
•
The treatment of superficial
fungal infections of the mouth
and throat called oropharyngeal
candidiasis.
These types of fungal infections
usually occur in some patients who
may have lowered resistance to
infection due to poor immunity.
Treatment of these serious fungal
infections with NOXAFIL is usually
reserved for patients who do not
respond to or cannot tolerate other
medicines used to treat these types of
fungal infections.
NOXAFIL is also used to treat
coccidioidomycosis, a rare and
serious fungal infection.
NOXAFIL is also used to prevent
fungal infections, such as yeasts and
moulds, from occurring in patients
who are at high-risk of developing
these infections.
Your doctor may have prescribed
NOXAFIL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NOXAFIL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAK
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产品特点
Ref:LRN#056592-POS-SUo-CCDS-7 Version 12
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NOXAFIL
ORAL SUSPENSION
PRODUCT INFORMATION
NAME OF THE MEDICINE
Posaconazole.
Posaconazole is a broad spectrum triazole antifungal compound with a molecular
formula of C
37
H
42
F
2
N
8
O
4
yielding a molecular weight of 700.8.
The chemical structure, which possesses four chiral centres, two R and two S, and
chemical name are illustrated below:
F
F
N
N
N
O
O
N
N
N
N
ME
O
N
ME
OH
_S_
_R_
_S_
SCH 56592 (POSACONAZOLE)
_R_
CAS INDEX NAME: D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-
difluorophenyl)-4-[[4-[4-[4-[1-[(1S,2S)-1-ethyl-2-hydropropyl]-1,5-dihydro-5-oxo-4H-
1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]methyl]-1-(1H-1,2,4-triazol-1-yl)
CAS RN 171228-49-2.
IUPAC NAME: 4-4-[4-(4-{(3R, 5R)-5-(2,4-difluorophenyl)-5-(1H-1,2,4-triazol-1-
ylmethyl)tetrahydro-3-furanyl]methoxyphenyl)piperazino]phenyl-1-[(1S,2S)-1-ethyl-2-
hydroxypropyl]-4,5-dihydro-1H-1,2,4-triazol-5-one.
DESCRIPTION
Posaconazole is a white to off-white
crystalline powder. It has a melting range of 164
o
C
– 165
o
C and is insoluble in water.
NOXAFIL ORAL SUSPENSION is a white, cherry flavoured immediate-release oral
suspension containing 40 mg of posaconazole per mL and the following inactive
ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate,
citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide,
artificial cherry flavouring, and purified water.
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES _
Antiinfective for systemic use, triazole derivative, J02AC04
MECHANISM OF ACTION:
Posaconazole is a triazole antifungal agent. It is an inhibitor of the enzyme lanosterol
14
-demethylase, which catalyses an essential step
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