VORICONAZOLE WOCKHARDT voriconazole 200 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

voriconazole, Quantity: 200 mg

Available from:

Wockhardt Bio Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium chloride; hydroxypropylbetadex

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VORICONAZOLE WOCKHARDT is indicated for treatment of the following fungal infections:,Invasive aspergillosis.,Serious Candida infections (including C. krusei), including systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,Serious fungal infections caused by Scedosporium spp and Fusarium spp.,Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Product summary:

Visual Identification: White to off white lyophilized powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-03-21

Patient Information leaflet

CMI -
VORICONAZOLE WOCKHARDT
v 2.1
VORICONAZOLE WOCKHARDT
1
VORICONAZOLE WOCKHARDT
(VORICONAZOLE)
_VORICONAZOLE 200MG POWDER FOR INJECTION _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
VORICONAZOLE
WOCKHARDT.
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
WOCKHARDT
against
the
benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
READ
THIS
LEAFLET
CAREFULLY
BEFORE
TAKING
VORICONAZOLE
WOCKHARDT AND KEEP THIS LEAFLET.
You may need to read it again.
WHAT VORICONAZOLE
WOCKHARDT IS USED
FOR
Voriconazole 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
(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,
those that have spread into the blood
stream.
•
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 WOCKHARDT 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 docto

Summary of Product characteristics

VORICONAZOLE WOCKHARDT (VORICONAZOLE 200 mg powder for injection)
Version 2.1
1
AUSTRALIAN PRODUCT INFORMATION – VORICONAZOLE
WOCKHARDT (VORICONAZOLE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VORICONAZOLE WOCKHARDT is a white lyophilised powder containing
nominally
200
mg
voriconazole
in
a
25
mL
Type
I
clear
glass
vial.
VORICONAZOLE
WOCKHARDT is intended for administration by intravenous infusion. It
is a single dose,
unpreserved product.
It contains following excipients: hydroxypropylbetadex (HP-β-CD),
sodium chloride,
hydrochloric acid q.s. for pH adjustment and water for injection.
The lyophilised powder contents of the VORICONAZOLE WOCKHARDT 200 mg
vials
are intended for reconstitution with Water for Injections or (0.9%)
Sodium Chloride for
Infusion to produce a solution containing 10 mg/mL voriconazole. The
resulting solution
is further diluted prior to administration as an intravenous infusion
(see Section 4.2 DOSE
AND METHOD OF ADMINISTRATION).
3
PHARMACEUTICAL FORM
White, sterile lyophilised 200 mg powder for injection in single use
clear glass vials.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Voriconazole Injection is indicated for treatment of the following
fungal infections:
Invasive aspergillosis.
Serious Candida infections (including C. krusei), including systemic
Candida infections
(hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
Serious fungal infections caused by Scedosporium spp and Fusarium spp.
Other serious fungal infections, in patients intolerant of, or
refractory to, other therapy.
Prophylaxis in patients who are at high risk of developing invasive
fungal infections. The
indication is based on studies including patients undergoing
haematopoietic stem cell
transplantation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
VORICONAZOLE WOCKHARDT (VORICONAZOLE 200 mg powder for injection)
Version 2.1
2
*_Voriconazole _
_powder _
_for _
_oral _
_suspension _
_and _
_tablet _
_are _
_unavailable _
_in _
_VORICONAZOLE