Clexane pre-filled syringes

Active ingredients: Enoxaparin

Product name and form

Clexane Syringes.

Pharmaceutical Form

Solution for injection.

Clear, colourless to pale yellow solution.

Qualitative and quantitative composition

Pre-filled syringes

20 mg Injection: Enoxaparin sodium 20 mg (equivalent to 2,000 IU anti-Xa activity) in 0.2 mL Water for Injections

40 mg Injection: Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa activity) in 0.4 mL Water for Injections

60 mg Injection: Enoxaparin sodium 60 mg (equivalent to 6,000 IU anti-Xa activity) in 0.6 mL Water for Injections

80 mg Injection: Enoxaparin sodium 80 mg (equivalent to 8,000 IU anti-Xa activity) in 0.8 mL Water for Injections

100 mg Injection: Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0 mL Water for Injections

For full list of excipients, see section 6.1

Active Ingredient
Description

Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is the sodium salt and has a high anti-Xa activity.

List of Excipients

Water for Injections

Pack sizes and marketing

Solution for injection in Type I glass pre-filled syringes fitted with injection needle and an automatic safety device in packs of 10.

Marketing Authorization Holder
Authorization Dates

Sanofi-aventis
One Onslow Street
Guildford
Surrey, GU1 4YS
UK

Date of first authorisation: 22 October 1990

Date of latest renewal: 8 August 2002

Marketing authorization number:

PL 04425/0187

Drugs

Drug
Countries
Australia, Cyprus, Spain, Hong Kong, Lithuania, Netherlands, Singapore, United Kingdom