Voriconazole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Voriconazole 200mg

Available from:

Neo Health (NZ) Limited

INN (International Name):

Voriconazole 200 mg

Dosage:

200 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Voriconazole 200mg Excipient: Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Dishman Pharmaceuticals & Chemicals Ltd

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.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I sealed with rubber stopper and aluminium cap with plastic flip-off seal - 1 dose units - 30 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2016-09-07

Patient Information leaflet

Voriconazole CMI New Zealand
1
VORICONAZOLE
IV INJECTION
_Voriconazole (vori-con-a-zole) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about voriconazole.
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
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 AND KEEP THIS
LEAFLET.
You may need to read it again.
WHAT VORICONAZOLE IS
USED FOR
Voriconazole is used to treat fungal
and yeast infections such as:
•
invasive aspergillosis
(as-pur-ji-losis), a fungal infection
caused by a fungus called
_Aspergillus _
(as-pur-jilus), which
usually begins in the
respiratorytract (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 of the food pipe and
those 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.
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 medicine is not addictive.
This medicine is available only with a
doctor’s p

Summary of Product characteristics

Page 1 of 32
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Voriconazole (Neo Health) 200mg powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IV powder for injection
Each vial contains 200mg of voriconazole
The lyophilised powder contents of the Voriconazole 200 mg vials are
intended for reconstitution with
19 mL Water for Injections to produce a solution containing 10 mg/mL
voriconazole and 120mg/ml
hydroxypropyl beta cyclodextrine (HP-β-CD) and 11.87mg/ml of sodium
chloride. The resulting solution
is further diluted
prior to administration as an intravenous infusion (see
SECTION 6.6
)
For full list of excipients, see
SECTION 6.1
3.
PHARMACEUTICAL FORM
Powder for Injection
White to off white lyophilized powder containing nominally 200mg
voriconazole in a 30ml Type 1 clear
glass vial. Voriconazole is intended for administration by intravenous
infusion. It is a single dose,
unpreserved product.
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_USE IN ADULTS_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
Voriconazole to achieve plasma concentrations on Day 1 that are close
to steady state. On the
basis of
the high oral bioavailability (96%; see section 5.2), switching
between
intravenous and oral
administration is appropriate when clinically indicated.
Page 2 of 32
Intravenous administration is not recommended for the treatment of
oesophageal candidiasis;
dosage
recommendations for oesophageal candidiasis are provided in the
following table.
DETAILED INFORMATION ON DOSAG