Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
VORICONAZOLE
PFIZER PRIVATE LIMITED
J02AC03
50 mg
TABLET, FILM COATED
VORICONAZOLE 50 mg
ORAL
Prescription Only
R-Pharm Germany GmbH
ACTIVE
2003-08-05
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 Lees het volledige document
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 Lees het volledige document