Active ingredients: Bivalirudin
Angiox 250 mg powder for concentrate for solution for injection or infusion.
Powder for concentrate for solution for injection or infusion.
White to off-white lyophilised powder.
Each vial contains 250 mg bivalirudin.
After reconstitution 1 ml contains 50 mg bivalirudin.
After dilution 1 ml contains 5 mg bivalirudin.
For a full list of excipients see section 6.1.
Bivalirudin is a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.
Mannitol
Sodium hydroxide solution (for pH adjustment)
Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.
Angiox is available in packs of 10 vials.
The Medicines Company UK Ltd
115L Milton Park
Abingdon
Oxfordshire
OX14 4SA
UNITED KINGDOM
EU/1/04/289/001
20.09.2004/20.09.2009