Fuzeon 90 mg/ml powder and solvent for solution for injection (2010)
Active ingredients: Enfuvirtide
Product Name and Form
Fuzeon 90 mg/ml powder and solvent for solution for injection.
Powder and solvent for solution for injection.
White to off-white lyophilised powder.
Qualitative and Quantitative Composition
Each vial contains 108 mg enfuvirtide.
Each ml of reconstituted solution contains 90 mg enfuvirtide.
For a full list of excipients, see section 6.1.
Enfuvirtide is a member of the therapeutic class called fusion inhibitors. It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.
Powder:
Sodium carbonate
Mannitol
Sodium hydroxide
Hydrochloric Acid
Solvent:
Water for Injections
Pack sizes and Marketing
Powder
Vial: 3 ml vial, colourless glass type 1
Closure: lyophilisate stopper, rubber (latex free)
Seal: aluminum seal with flip-off cap
Solvent
Vial: 2 ml vial, colourless glass type 1
Closure: rubber stopper (latex free)
Seal: aluminum seal with flip-off cap
Pack sizes
Pack 1:
60 vials powder for solution for injection
60 vials solvent
60 3 ml syringes
60 1 ml syringes
180 alcohol swabs
Pack 2:
60 vials powder for solution for injection
60 vials solvent
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Date of first authorisation: 27 May 2003
Date of last renewal: 27 May 2008
EU/1/03/252/001-002