Vfend

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

voriconazole

Available from:

Pfizer Europe MA EEIG

ATC code:

J02AC03

INN (International Name):

voriconazole

Therapeutic group:

Antimycotics for systemic use

Therapeutic area:

Candidiasis; Mycoses; Aspergillosis

Therapeutic indications:

Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of in candidaemianon-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Product summary:

Revision: 55

Authorization status:

Authorised

Authorization date:

2002-03-19

Patient Information leaflet

116
B. PACKAGE LEAFLET
117
PACKAGE LEAFLET: INFORMATION FOR THE USER
VFEND 50 MG FILM-COATED TABLETS
VFEND 200 MG FILM-COATED TABLETS
voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VFEND is and what it is used for
2.
What you need to know before you take VFEND
3.
How to take VFEND
4.
Possible side effects
5.
How to store VFEND
6.
Content of the pack and other information
1.
WHAT VFEND IS AND WHAT IT IS USED FOR
VFEND contains the active substance voriconazole. VFEND is an
antifungal medicine. It works by killing or
stopping the growth of the fungi that cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:
•
invasive aspergillosis (a type of fungal infection due to
_Aspergillus sp_
),
•
candidaemia (another type of fungal infection due to
_Candida sp_
) in non-neutropenic patients
(patients without abnormally low white blood cells count),
•
serious invasive
_Candida sp._
infections when the fungus is resistant to fluconazole (another
antifungal medicine),
•
serious fungal infections caused by
_Scedosporium sp._
or
_Fusarium sp_
. (two different species of
fungi).
VFEND is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be taken under the supervision of a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VFEND
DO NOT TAKE VFEND
If you are allergic to voriconazole or

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VFEND 50 mg film-coated tablets
VFEND 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 or 200 mg voriconazole.
Excipient with known effect
VFEND 50 mg film-coated tablets
Each tablet contains 63.42 mg lactose monohydrate.
VFEND 200 mg film-coated tablets
Each tablet contains 253.675 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
VFEND 50 mg film-coated tablets
White to off-white, round tablet, debossed “Pfizer” on one side
and “VOR50” on the reverse (tablets).
VFEND 200 mg film-coated tablets
White to off-white, capsule-shaped tablet, debossed “Pfizer” on
one side and “VOR200” on the reverse
(tablets).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VFEND, is a broad-spectrum, triazole antifungal agent and is indicated
in adults and children aged 2 years
and above as follows:
Treatment of invasive aspergillosis.
Treatment of candidaemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive
_Candida_
infections (including
_C. krusei_
).
Treatment of serious fungal infections caused by
_Scedosporium_
spp. and
_Fusarium_
spp.
VFEND should be administered primarily to patients with progressive,
possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell transplant (HSCT)
recipients.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be monitored
and corrected, if necessary, prior to initiation and during
voriconazole therapy (see section 4.4).
VFEND is also available as 200 mg powder for solution for infusion and
40 mg/ml powder for oral
suspension.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral VFEND to
achieve plasma concentrations on Day 1 that are close to steady state.
O