VORICONAZOLE APO voriconazole 50 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

voriconazole

זמין מ:

Southern Cross Pharma Pty Ltd

מצב אישור:

Registered

עלון מידע

1
VORICONAZOLE APO
_Voriconazole _
_ _
_TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VORICONAZOLE
APO.
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 APO 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 APO
AND KEEP THIS LEAFLET.
You may need to read it again.
WHAT
VORICONAZOLE
APO IS USED FOR
This medicine is used to treat
fungal and yeast infections such
as:
•
invasive aspergillosis, a fungal
infection caused by a fungus
called Aspergillus, 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 infections,
including Candida infections of
the oesophagus (food pipe or
gullet) and those that have spread
into the blood stream or to other
parts of the body.
•
serious fungal infections caused
by Scedosporium species and
Fusarium species.
•
other serious fungal infections in
patients who do not respond to, or
cannot tolerate, other antifungal
medicines.
This medicine is also used to prevent
invasive fungal infections in patients
who are at risk of developing such
infections.
Voriconazole belongs to a group of
medicines called triazole antifungals.
It 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 medicine is not addictive.
This medicine is available only

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
VORICONAZOLE APO, VORICONAZOLE
_ _
1. NAME OF THE MEDICINE
Voriconazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VORICONAZOLE APO tablets contain the active ingredient Voriconazole.
50 mg tablets: each contains 50 mg of voriconazole.
200 mg tablets: each contains 200 mg of voriconazole.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
VORICONAZOLE APO 50 mg tablets are white to off-white round biconvex
film-coated tablets with code V50
on one side.
VORICONAZOLE APO 200 mg tablets are white to off-white oval biconvex
film-coated tablets with code
V200 on one side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Voriconazole is indicated for treatment of the following fungal
infections:
Invasive aspergillosis.
Serious _Candida_ infections (including C. _krusei_), including
oesophageal and 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. DOSE AND METHOD OF ADMINISTRATION
_Voriconazole powder for oral suspension and powder for injection are
unavailable in the VORICONAZOLE APO _
_brand. _
_Information _
_obtained _
_using _
_voriconazole _
_powder _
_for _
_oral _
_suspension _
_and _
_powder _
_for _
_injection _
_formulations _
_have _
_been _
_retained _
_throughout _
_the _
_PI, _
_where _
_appropriate, _
_for _
_continuity _
_and _
_prescriber _
_information. _
VORICONAZOLE APO tablets are to be taken at least one hour before, or
one hour following, a meal.
APO VORICONAZOLE – AUSTRALIAN PRODUCT INFORMATION
2
USE IN ADULTS
Therapy must be initiated with the specified loadin