VFEND 200mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Voriconazole

Available from:

Pfizer Ltd

ATC code:

J02AC03

INN (International Name):

Voriconazole

Dosage:

200mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100; GTIN: 5013457010541

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
VFEND
 200 MG POWDER FOR SOLUTION FOR INFUSION
Voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What VFEND is and what it is used for
2.
What you need to know before you take VFEND
3.
How to use VFEND
4.
Possible side effects
5.
How to store VFEND
6.
Content of the pack and other information
1. WHAT VFEND IS AND WHAT IT IS USED FOR
VFEND contains the active substance voriconazole. VFEND is an
antifungal medicine. It
works by killing or stopping the growth of the fungi that cause
infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:

invasive aspergillosis (a type of fungal infection due to _Aspergillus
sp_),

candidaemia (another type of fungal infection due to _Candida sp_) in
non-neutropenic
patients (patients without abnormally low white blood cells count),

serious invasive _Candida sp._ infections when the fungus is resistant
to fluconazole
(another antifungal medicine),

serious fungal infections caused by _Scedosporium sp._ or _Fusarium
sp_. (two different
species of fungi).
VFEND is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be used under the supervision of a doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VFEND
DO NOT TAKE VFEND:
-
If you are allergic to the active ingredient voriconazole, or to
sulfo

Summary of Product characteristics

OBJECT 1
VFEND 40 MG/ML POWDER FOR ORAL SUSPENSION
Summary of Product Characteristics Updated 01-May-2018 | Pfizer
Limited
1. Name of the medicinal product
VFEND 50 mg and 200 mg film-coated tablets.
VFEND 200 mg powder for solution for infusion.
VFEND 200 mg powder and solvent for solution for infusion.
VFEND 40 mg/ml powder for oral suspension.
2. Qualitative and quantitative composition
FILM-COATED TABLETS :
Each tablet contains 50 mg or 200 mg voriconazole.
Excipient with known effect
Each tablet contains 63.42 mg or 253.675 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
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.
Excipient with known effect
Each vial contains 217.6 mg sodium.
For the full list of excipients, see section 6.1.
SOLVENT FOR SOLUTION FOR INFUSION :
Each 50 ml polypropylene bag contains sodium chloride 0.9% in Water
for Injections.
Excipient with known effect
Each bag contains 177.02 mg sodium.
For the full list of excipients, see section 6.1.
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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
FILM-COATED TABLETS:
White to off-white, round tablet, debossed “Pfizer” on one side
and “VOR50” on the reverse.
White to off-white, capsule-shaped tablet, debossed “Pfizer” on
one side and “VOR200” on the reverse.
POWDER FOR SOLUTION FOR INFUSION:
White lyophilised powder
POWDER AND SOLVENT FOR SOLUTION FOR INFUSION:
Powder for solution for infusion:
White lyophilised powder
Solvent for solution for infusion:
Clear diluent solution
POWDER FOR ORAL SUSPENSION:
White to off-white powder
4. Clinical particulars
4.1 Therapeutic indications
VFEND is a broad