Clexane pre-filled syringes Ref.[2796] Active ingredients: Enoxaparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Sanofi-aventis One Onslow Street Guildford Surrey, GU1 4YS UK

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

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

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

Marketing authorization dates and numbers

PL 04425/0187

Date of first authorisation: 22 October 1990

Date of latest renewal: 8 August 2002

Drugs

Drug Countries
CLEXANE Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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