Fuzeon 90 mg/ml powder and solvent for solution for injection.
Powder and solvent for solution for injection.
White to off-white lyophilised powder.
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.
Powder:
Sodium carbonate
Mannitol
Sodium hydroxide
Hydrochloric Acid
Solvent:
Water for Injections
Vial: 3 ml vial, colourless glass type 1
Closure: lyophilisate stopper, rubber (latex free)
Seal: aluminum seal with flip-off cap
Vial: 2 ml vial, colourless glass type 1
Closure: rubber stopper (latex free)
Seal: aluminum seal with flip-off cap
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
EU/1/03/252/001-002
Date of first authorisation: 27 May 2003
Date of last renewal: 27 May 2008