VFEND FILM-COATED TABLET 50 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

VORICONAZOLE

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J02AC03

Dosage:

50 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

VORICONAZOLE 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

R-Pharm Germany GmbH

Authorization status:

ACTIVE

Authorization date:

2003-08-05

Patient Information leaflet

VFEND

VORICONAZOLE
1.
NAME OF THE MEDICINAL PRODUCT
_ _
VFEND
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Film-coated tablets: _
Each tablet contains 50 mg or 200 mg voriconazole.
_Powder for solution for infusion:_
Vials contain 200 mg voriconazole, equivalent to a 10 mg/mL solution
following reconstitution (see
Section 6.6).
_Powder for oral suspension: _
Each bottle contains 45 g powder for oral suspension providing 40
mg/mL voriconazole when
constituted with water (see Section 6.6).
3.
PHARMACEUTICAL FORM
_ _
_Film-coated tablets: _
Voriconazole 50 mg film-coated tablets are white, round tablets,
debossed “Pfizer” on one side and
“VOR50”on the reverse.
Voriconazole 200 mg film-coated tablets are white, capsule-shaped
tablets, debossed “Pfizer” on one
side and “VOR200”on the reverse.
_Powder for solution for infusion: _
Voriconazole powder for solution for infusion is a white lyophilized
powder containing nominally
200 mg voriconazole presented in a 30 mL clear glass vial.
_ _
_Powder for oral suspension: _
White to off-white powder for oral suspension providing a white to
off-white, orange-flavoured
suspension when constituted.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole is a broad spectrum, triazole antifungal agent and is
indicated as follows:
Treatment of invasive aspergillosis;
Treatment of candidemia 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.;
Prophylaxis in patients ≥12 years old who are at high risk of
developing invasive fungal infections.
The indication is based on a study which includes patients ≥12 years
old undergoing allogeneic
haematopoietic stem cell transplantation (see Section on 'Clinical
Experience').
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1
_Film-coated tablets: _
Voriconazole film-coated tablets are to be taken at least one hour
before, or one hour following a
mea

Summary of Product characteristics

VFEND
®
VORICONAZOLE
1.
NAME OF THE MEDICINAL PRODUCT
VFEND
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Film-coated tablets: _
Each tablet contains 50 mg or 200 mg voriconazole.
_Powder for solution for infusion:_
Vials contain 200 mg voriconazole, equivalent to a 10 mg/mL solution
following reconstitution (see
Section 6.6).
_Powder for oral suspension: _
Each bottle contains 45 g powder for oral suspension providing 40
mg/mL voriconazole when
constituted with water (see Section 6.6).
3.
PHARMACEUTICAL FORM
_Film-coated tablets: _
Voriconazole 50 mg film-coated tablets are white, round tablets,
debossed “Pfizer” on one side and
“VOR50” on the reverse.
Voriconazole 200 mg film-coated tablets are white, capsule-shaped
tablets, debossed “Pfizer” on one
side and “VOR200” on the reverse.
_Powder for solution for infusion: _
Voriconazole powder for solution for infusion is a white lyophilised
powder containing nominally
200 mg voriconazole presented in a 30 mL clear glass vial.
_Powder for oral suspension: _
White to off-white powder for oral suspension providing a white to
off-white, orange-flavoured
suspension when constituted.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole is a broad spectrum, triazole antifungal agent and is
indicated as follows:
Treatment of invasive aspergillosis;
Treatment of candidemia 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.;
Prophylaxis in patients ≥12 years old who are at high risk of
developing invasive fungal infections.
The indication is based on a study which includes patients ≥12 years
old undergoing allogeneic
haematopoietic stem cell transplantation (see Section on 'Clinical
experience').
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Film-coated tablets: _
Voriconazole film-coated tablets are to be taken at least one hour
before, or one hour following a
meal.
_Powder for or