Velcade 3.5 mg powder for solution for injection (2012)
Active ingredients: Bortezomib
Product Name and Form
VELCADE 3.5 mg powder for solution for injection.
Powder for solution for injection.
White to off-white cake or powder.
Qualitative and Quantitative Composition
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.
Bortezomib is a proteasome inhibitor. It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells. Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Mannitol (E 421)
Nitrogen
Pack sizes and Marketing
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
Turnhoutseweg 30
B-2340 Beerse
Belgium
Date of first authorization: 26 Apr 2004
Date of latest renewal: 26 Apr 2009
EU/1/04/274/001