Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
VFEND 200 mg powder for solution for infusion.
VFEND 200 mg powder and solvent for solution for infusion.
| Pharmaceutical Form |
|---|
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VFEND 200 mg powder for solution for infusion: Powder for solution for infusion: White lyophilised powder. VFEND 200 mg powder and solvent for solution for infusion: Powder for solution for infusion: White lyophilised powder. Solvent for solution for infusion: Clear diluent solution. |
VFEND 200 mg 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.
VFEND 200 mg powder and 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.
| Active Ingredient | Description | |
|---|---|---|
| Voriconazole |
Voriconazole is a triazole antifungal agent. The primary mode of action of voriconazole is the inhibition of fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. |
| List of Excipients |
|---|
|
Powder for solution for infusion: Sulfobutylether beta cyclodextrin sodium (SBECD) Solvent for solution for infusion: Sodium chloride 0.9% in Water for Injections |
VFEND 200 mg powder for solution for infusion: 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal.
VFEND 200 mg powder and solvent for solution for infusion: VFEND powder and solvent for solution for infusion is available in a box containing: 1 single use 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal of VFEND 200 mg, powder for solution.
1 sterile, single use, foil overwrapped, polypropylene bag containing VFEND solvent for solution for infusion in one compartment (50 ml).
1 sterile, single use vial adapter.
1 sterile, single use syringe.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
VFEND 200 mg powder for solution for infusion: EU/1/02/212/025
VFEND 200 mg powder and solvent for solution for infusion: EU/1/02/212/027
Date of first authorisation: 19 March 2002
Date of latest renewal: 21 February 2012
| Drug | Countries | |
|---|---|---|
| VFEND | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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