Exembol 100 mg/ml concentrate for solution for infusion (2012)
Product Name and Form
Exembol 100 mg/ml concentrate for solution for infusion.
Concentrate for Solution for Infusion.
Clear colourless to pale yellow solution.
Qualitative and Quantitative Composition
1 ml concentrate for solution for infusion contains argatroban as 100 mg argatroban monohydrate.
1 Vial with 2.5 ml concentrate for solution for infusion contains argatroban as 250 mg argatroban monohydrate. Final concentration after dilution as recommended is 1 mg/ml (see section 6.6).
Excipients: 1 ml solution contains 400 mg ethanol (50% by volume) and 300 mg sorbitol.
For a full list of excipients, see section 6.1.
Sorbitol (E 420i)
Water for injections
Pack sizes and Marketing
Clear 5 mL type I glass vial sealed with a teflon-coated chlorobutylrubber stopper and an aluminium crimp-seal with a polypropylene flip-off cap. Each vial contains 2.5 ml of concentrate for solution for infusion.
Vials are supplied in cardboard cartons of 1 or 6 vials. Not all pack-sizes may be marketed.
Mitsubishi Pharma Europe Ltd
6 th Floor Dashwood House
69 Old Broad Street
London EC2M 1QS