VELCADE 3.5 mg powder for solution for injection.
Powder for solution for injection.
White to off-white cake or powder.
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
For the full list of excipients, see section 6.1.
Mannitol (E 421)
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial.
JANSSEN-CILAG INTERNATIONAL NV
Date of first authorization: 26 Apr 2004
Date of latest renewal: 26 Apr 2009