VORICONAZOLE MYX voriconazole 200 mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

voriconazole

זמין מ:

Mayne Pharma International Pty Ltd

INN (שם בינלאומי):

Voriconazole

מצב אישור:

Registered

עלון מידע

VORICONAZOLE MYX
®
1
VORICONAZOLE MYX
®
_Voriconazole (vori-con-a-zole), IV injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Voriconazole MYX.
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 Voriconazole
MYX against the benefits they
expect it will have for you.
ASK THE DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT YOU OR YOUR CHILD
TAKING THIS MEDICINE.
KEEP THIS LEAFLET EVEN AFTER YOUR
TREATMENT
You may need to read it again.
WHAT VORICONAZOLE
MYX IS USED FOR
Voriconazole MYX is used to treat
fungal and yeast infections such as:
•
invasive aspergillosis (as-pur-
jilosis), a fungal infection caused
by a fungus called Aspergillus
(as-pur-jilus), which usually
begins in the respiratory tract (in
the nose, sinuses or lungs).
Aspergillus is harmless in most
healthy people; however, in
people with poor immune
systems (such as people who have
had organ transplants and people
with cancer or HIV/AIDS)
invasive aspergillosis can be
serious and spread to other tissues
and organs.
•
serious Candida (can-did-da)
infections, including Candida
infections that have spread into
the blood stream or to other parts
of the body.
•
serious fungal infections caused
by Scedosporium (ski-doe-
sporerium) species and Fusarium
(fewsaa-rium) species.
•
other serious fungal infections in
patients who do not respond to, or
cannot tolerate, other antifungal
medicines.
Voriconazole MYX is also used to
prevent invasive fungal infections in
patients who are at risk of developing
such infections.
This medicine belongs to a group of
medicines called triazole antifungals.
This medicine works by preventing
the growth of fungal and yeast
organisms causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medic

מאפייני מוצר

Product Information
v 1.0
1
VORICONAZOLE MYX
® POWDER FOR INJECTION
NAME OF THE MEDICINE
Voriconazole
The structural formula is:
CAS number 137234-62-9
Voriconazole is designated chemically as (2R,
3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-
4-
pyrimidinyl)-1-(1
_H _
-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of
C
16
H
14
F
3
N
5
O
and a molecular weight of 349.3.
DESCRIPTION
Voriconazole, a broad-spectrum, triazole antifungal agent, is
available as a lyophilised
powder for solution for intravenous infusion.
Voriconazole drug substance is a white to off white powder. Its
aqueous solubility is very
low at 0.7 mg/mL at 25ºC.
Voriconazole MYX is a white lyophilised powder containing nominally
200 mg
voriconazole in a 30 mL Type I clear glass vial. Voriconazole MYX is
intended for
administration by intravenous infusion. It is a single dose,
unpreserved product.
The lyophilised powder contents of the Voriconazole MYX 200 mg vials
are intended
for reconstitution with 19 mL Water for Injections to produce a
solution containing 10
mg/mL voriconazole, 120 mg/mL of hydroxypropylbetadex and 40 mg/mL
lactose
monohydrate. The resulting solution is further diluted prior to
administration as an
intravenous infusion (see
DOSAGE AND ADMINISTRATION
).
Product Information
v 1.0
2
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
MECHANISM OF ACTION
Voriconazole is a triazole antifungal agent. Voriconazole’s primary
mode of action is
the inhibition of fungal cytochrome P450-mediated 14α-sterol
demethylation, an
essential step in ergosterol biosynthesis. Voriconazole is more
selective than some
other azole drugs for fungal as opposed to various mammalian
cytochrome P450
enzyme systems. The subsequent loss of normal sterols correlates with
the
accumulation of 14α-methyl sterols in fungi and may be responsible
for its
fungistatic/fungicidal activity.
_In vitro_
, voriconazole displays broad-spectrum antifungal activity with high
antifungal
potency against
_Candida _
species (including fluconazole resistant
_C. krusei _
and resist