VFEND 200MG TABLET

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

VORICONAZOLE

から入手可能:

PFIZER (MALAYSIA) SDN. BHD.

INN（国際名）:

VORICONAZOLE

パッケージ内のユニット:

10 Tablets; 20 Tablets

製:

Pfizer Italia S.r.l.

情報リーフレット

Not Applicable.

製品の特徴

1
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 of 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:_
Voriconazole oral suspension is a white to off-white powder providing
a white to off-white
orange-flavored suspension when constituted.
4.
CLINICAL PARTICULARS
4.1
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 fluconazole-resistant serious invasive _Candida_
infections (including _C. krusei_);
Treatment of serious _Candida_ infections including esophageal
candidiasis;
Treatment of candidemia in non-neutropenic patients and the following
_ Candida_ infections:
disseminated infection in skin and infections in abdomen, kidney,
bladder wall and wounds;
Treatment of serious fungal infections caused by _Scedosporium_ spp.
and _Fusarium_ spp.;
2
Prevention of breakthrough of fungal infections in febrile high-risk
neutropenic patients.
Prophylaxis in patients ≥12 years old who are at high risk of
developing invasive fungal
infections. The indication is based on a s