VFEND 200 MG POWDER FOR SOLUTION FOR INFUSION

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

VORICONAZOLE

Доступно од:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

АТЦ код:

J02AC03

Фармацеутски облик:

POWDER FOR SOLUTION FOR INFUSION

Састав:

VORICONAZOLE 200 MG/VIAL

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

FAREVA AMBOISE, FRANCE

Терапеутска група:

VORICONAZOLE

Терапеутска област:

VORICONAZOLE

Терапеутске индикације:

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.

Датум одобрења:

2012-10-31

Карактеристике производа

VFEND IV, POS & Film-Coated Tablets LPD CC 07 January 2024
2022-0080286; 2023-0084030
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 07 January 2024
2022-0080286; 2023-0084030
2
4. CLINICAL PART