NOXAFIL ORAL SUSPENSION

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

POSACONAZOLE, MICRONIZED

Mevcut itibaren:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Adı):

POSACONAZOLE, MICRONIZED

Paketteki üniteler:

0105ml1Units mL

Tarafından üretildi:

PATHEON INC

Bilgilendirme broşürü

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NOXAFIL
® ORAL SUSPENSION
_Posaconazole_
(40mg/mL)
_ _
_ _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
_NOXAFIL ORAL_
_SUSPENSION_
is used for
2.
How
_NOXAFIL ORAL SUSPENSION_
works
_3._
_ _
Before you take
_NOXAFIL ORAL _
_SUSPENSION _
_4._
_ _
How to take
_NOXAFIL ORAL _
_SUSPENSION _
_5._
_ _
While you are taking
_NOXAFIL _
_ORAL SUSPENSION _
6.
Side effects
_7._
_ _
Storage and Disposal of
_NOXAFIL _
_ORAL SUSPENSION _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _NOXAFIL ORAL SUSPENSION_
IS USED FOR
_NOXAFIL ORAL SUSPENSION_
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 ORAL _
_SUSPENSION_
is usually reserved for
patients who do not respond to or cannot
tolerate other medicines used to treat
these types of fungal infections.
_NOXAFIL ORAL SUSPENSION_
is also
used to treat coccidioidomycosis, a rare
and serious fungal infection.
_NOXAFIL ORAL SUSPENSION_
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 ORAL SUSPENSION_
for
another reason.
Ask your doctor if you have any
questions about why
_NOXAFIL ORAL _
_SUSPENSION _
has been prescribed for
you.
This medicine is available only with a
doctor's prescription.
HOW _NOXAFIL ORAL SUSPENSION_
WORKS
_NOXAFIL ORAL SUSPENSION_
contains
the active ingredient,
_posaconazole_
.
_Posaconazole_
is a medicine that belongs
to the
_triazole_
group of an

Ürün özellikleri

Noxafil 40mg/ml Oral Suspension
LPC-MK5592-OS-042021b
NOXAFIL
®
40 MG/ML 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:
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
– 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
PHARMACOTHERAPEUTIC
GROUP
Antiinfective for Systemic Use, Triazole derivative,
J02AC04
MECHANISM OF
ACTION:
Posaconazole is a triazole antifungal agent. It is an inhibitor of the
enzyme
lanosterol
14α-demethylase,
which catalyses
an essential
step in ergosterol
biosynthesis.
Ergosterol depletion, coupled with the accumulation of methylated
sterol
precursors,
is thought
to impair
membrane
integrity
and the function
of some
membrane-
associated proteins. This results in the inhibition of cell growth
and/or cell
death.
Consequently,
posaconazole
exhibits broad-spectrum
antifungal activity against
a
vari