XIGRIS Powder for solution for infusion Ref.[9395] Active ingredients: Drotrecogin alfa

Source: European Medicines Agency (EU)  Revision Year: 2012  Publisher: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands

Product name and form

Xigris 20 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

Xigris is supplied as a lyophilised, white to off-white powder.

Qualitative and quantitative composition

Each vial contains 20 mg of Drotrecogin alfa (activated).

After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).

Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.

Excipient: Each vial contains approximately 68 mg sodium.

For a full list of excipients, see 6.1.

Active Ingredient Description
Drotrecogin alfa

Drotrecogin alfa is a recombinant version of the natural plasma-derived activated Protein C, from which it differs only by unique oligosaccharides in the carbohydrate portion of the molecule. Activated Protein C is a crucial coagulation regulator. Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties. Drotrecogin alfa has similar properties to those of endogenous human Activated Protein C.
List of Excipients

Sucrose
Sodium chloride
Sodium citrate
Citric acid
Hydrochloric acid
Sodium hydroxide

Pack sizes and marketing

Powder in Type I glass vial. Pack of 1 vial.

Marketing authorization holder

Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands

Marketing authorization dates and numbers

EU/1/02/225/002

Date of first authorisation: 22 August 2002

Drugs

Drug Countries
XIGRIS South Africa
 
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