ARIXTRA Solution for injection Ref.[7951] Active ingredients: Fondaparinux

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive Citywest Business Campus, Dublin 24, Ireland

Product name and form

Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.

Pharmaceutical Form

Solution for injection.

The solution is a clear and colourless liquid.

Qualitative and quantitative composition

Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.

Excipient(s) with known effect: Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fondaparinux

Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
List of Excipients

Sodium chloride
Water for injections
Hydrochloric acid
Sodium hydroxide

Pack sizes and marketing

Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.

Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes. There are two types of syringes:

  • syringe with a yellow plunger and an automatic safety system
  • syringe with yellow plunger and a manual safety system.

Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/02/206/005-008
EU/1/02/206/024
EU/1/02/206/025
EU/1/02/206/026

Date of first authorisation: 21 March 2002
Date of latest renewal: 21 March 2007

Drugs

Drug Countries
ARIXTRA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States
 
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