EXEMBOL Solution for infusion

Active ingredients: Argatroban

Product name and form

Exembol 1 mg/ml Solution for Infusion.

Pharmaceutical Form

Solution for Infusion.

Clear colourless to pale yellow solution.

The pH of the intravenous solution is 5.0–8.0.

Qualitative and quantitative composition

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.

Active Ingredient
Description

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.

List of Excipients

Sorbitol (E420i)
Sodium chloride
Anhydrous ethanol
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House, 69 Old Broad Street, London EC2M 1QS, United Kingdom

Marketing authorization dates and numbers

PL 20012/0011

2015-12-31

Drugs

Drug
Countries
United Kingdom