VORCON voriconazole 200 mg powder for injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

voriconazole, Quantity: 200 mg

Dostopno od:

Southern Cross Pharma Pty Ltd

INN (mednarodno ime):

Voriconazole

Farmacevtska oblika:

Injection, powder for

Sestava:

Excipient Ingredients: hydroxypropylbetadex; sodium chloride; hydrochloric acid

Pot uporabe:

Intravenous

Enote v paketu:

1 vial

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

Visual Identification: White to off white powder; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-07-27

Navodilo za uporabo

cmi-vorcon-v1
1
VORCON
_Voriconazole _
_ _
_TABLETS AND IV INJECTION_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VORCON.
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 VORCON
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 VORCON AND KEEP THIS
LEAFLET.
You may need to read it
again.
WHAT VORCON 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 with
a doctor's pre

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
VORCON
TM
, (VORICONAZOLE), TABLETS & IV POWDER FOR INJECTION
_ _
1. NAME OF THE MEDICINE
Voriconazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VORCON 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.
VORCON IV contains the active ingredient Voriconazole.
200 mg IV powder for injection: contains 200 mg of voriconazole.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
VORCON 50 mg tablets are white to off-white round biconvex film-coated
tablets with code V50 on one side.
VORCON 200 mg tablets are white to off-white oval biconvex film-coated
tablets with code V200 on one
side.
VORCON IV powder for injection is a white to off-white lyophilised
powder.
VORCON IV is intended for administration by intravenous infusion. It
is a single dose, unpreserved product.
The lyophilised powder contents of the VORCON 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 11.28 mg/ml sodium chloride. The resulting
solution is further diluted prior to
administration as an intravenous infusion, see section 4.2 DOSE AND
METHOD OF ADMINISTRATION.
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 haem