VFEND 50 MG FILM-COATED TABLETS

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

VORICONAZOLE

Dostępny od:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Kod ATC:

J02AC03

Forma farmaceutyczna:

FILM COATED TABLETS

Skład:

VORICONAZOLE 50 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

R - PHARM GERMANY GMBH

Grupa terapeutyczna:

VORICONAZOLE

Dziedzina terapeutyczna:

VORICONAZOLE

Wskazania:

Treatment of:- invasive aspergillosis, - fluconazole-resistant serious invasive Candida infections (including C. krusei)- serious fungal infections caused by scedosporium spp. and fusarium spp.- Vfend should be administered primarily to immunocompromised patients with progressive possibly life-threatening infections. - Treatment of candidemia in non neutropenic patients.- Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Data autoryzacji:

2013-11-11

Ulotka dla pacjenta

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Charakterystyka produktu

VFEND IV, POS & Film-Coated Tablets LPD CC 10 Novmber 2021
2020-0065736; 2020-0065737 2021-0067528
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VFEND
®
200 mg Powder for Solution for Infusion
VFEND
®
50 mg Film-Coated Tablets
VFEND
®
200 mg Film-Coated Tablets
VFEND
®
40 mg/mL Powder for Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_VFEND Powder for solution for infusion: _
Each vial contains 200 mg of voriconazole.
After reconstitution, each ml contains 10 mg of voriconazole. Once
reconstituted further dilution is
required before administration.
Excipients with known effect
Each vial contains 221 mg sodium.
Each vial contains 3,200 mg cyclodextrin.
_VFEND Film-coated tablets: _
Each tablet contains 50 mg or 200 mg voriconazole.
Excipient with known effect
Each 50 or 200 mg tablet contains 62.5 or 250.0 mg lactose monohydrate
respectively.
_VFEND Powder for oral suspension: _
Each ml of oral suspension contains 40 mg of voriconazole when
reconstituted with water. Each bottle
contains 3 g of voriconazole.
Excipient with known effect:
Each ml of suspension contains 0.54 g sucrose.
Each ml of suspension contains 2.40 mg sodium benzoate.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3. PHARMACEUTICAL FORM
_VFEND Powder for solution for infusion: _
Powder for solution for infusion is a white lyophilised powder
containing nominally 200 mg
voriconazole presented in a 30 ml clear glass vial.
_VFEND Film-coated tablets: _
VFEND 50 mg film-coated tablets are white to off-white, round tablets,
debossed “Pfizer” on one side
and “VOR50” on the reverse.
VFEND 200 mg film-coated tablets are white to off-white,
capsule-shaped tablets, debossed “Pfizer” on
one side and “VOR200” on the reverse.
_VFEND Powder for oral suspension: _
Powder for oral suspension is a white to off-white powder providing a
white to off-white opaque fluid
containing undissolved solids when constituted.
VFEND IV, POS & Film-Coated Tablets LPD CC 10 Novmber 2021
2020-0065736; 2020-0065737 2021-