Active ingredients: Argatroban
Exembol 1 mg/ml Solution for Infusion.
Solution for Infusion.
Clear colourless to pale yellow solution.
The pH of the intravenous solution is 5.0–8.0.
One ml solution for infusion contains 1 mg argatroban monohydrate.
One vial with 50 ml solution for infusion contains 50 mg argatroban monohydrate.
Excipients: 1 ml of solution for infusion contains 4 mg ethanol (0.5% by volume), 3 mg sorbitol (E420 i) and 9 mg sodium chloride.
For a full list of excipients, see section 6.1.
Argatroban, a synthetic L-arginine derivative, is a direct thrombin inhibitor (molecular weight 526.65) that binds reversibly to thrombin. Argatroban exerts its anticoagulant effect independently of antithrombin III and inhibits fibrin formation; activation of coagulation factors V, VIII and XIII; activation of protein C; and platelet aggregation.
Water for injections
Clear 50 ml glass vial sealed with an ethylene tetrafluorethylene (ETFE)-coated chlorobutyl rubber stopper and aluminium crimp-seal with a polypropylene flip-off cap. Each vial contains 50 ml of solution for infusion.
Vials are supplied in cardboard cartons of 4 or 12 vials. Not all pack-sizes may be marketed.
Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old Broad Street, London EC2M 1QS, United Kingdom