VFEND 200 MG FILM-COATED TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VORICONAZOLE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

J02AC03

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

VORICONAZOLE 200 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER ITALIA S.R.L, ITALY

المجال العلاجي:

VORICONAZOLE

الخصائص العلاجية:

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.

تاريخ الترخيص:

2022-10-31

نشرة المعلومات

Vfend POS; Film-Coated Tablets PIL CC 17 August 2023 English
2023-0084997
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
VFEND
® 50 MG FILM-COATED TABLETS
VFEND
® 200 MG FILM-COATED TABLETS
VFEND
® 40 MG/ML POWDER FOR ORAL SUSPENSION
FILM-COATED TABLETS: VORICONAZOLE 50 MG, 200 MG
EACH ML OF RECONSTITUTED SUSPENSION CONTAINS: VORICONAZOLE 40 MG
Inactive ingredients and allergens: see section 2 under “Important
information
about some of this medicine’s ingredients” and section 6
“Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
VFEND is a broad-spectrum antifungal preparation intended for the
treatment
of:
•
invasive aspergillosis (a fungal infection caused by _Aspergillus
sp._)
•
_Candida_ infections in the blood system (candidemia) in
non-neutropenic
patients
•
invasive infections of _Candida_ that are resistant to fluconazole
(another
antifungal medicine), including _C. krusei_
•
severe fungal infections caused by _Scedosporium _and _Fusarium_ type
of
fungi.
VFEND is intended for patients with severe, possibly life-threatening,
fungal
infections.
VFEND is intended for the prevention of invasive fungal infections in
high-risk
bone marrow transplant recipients.
THERAPEUTIC GROUP:
Antifungal from the triazole group. It works by killing or stopping
the growth of
different fungi that cause infections.
2. BEFORE USING THIS MEDICINE
Vfend POS; Film-Coated Tablets PIL CC 17 August 2023 English
2023-0084997
2
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients

خصائص المنتج

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