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Clexane pre-filled syringes (2012)

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

Chemical substance
Description
Enoxaparin

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