CLEXANE MULTI DOSE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ENOXAPARIN SODIUM
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
300/3 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2009-06-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clexane Multi Dose 300 mg/3 ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
3 ml
Enoxaparin Sodium Ph. Eur.
300.0 mg
(EQUIVALENT TO 30,000 IU ANTI-XA ACTIVITY)
Every 1 ml contains 100 mg Enoxaparin Sodium Ph. Eur. (equivalent to 10,000 IU anti-Xa activity).
EXCIPIENTS
Benzyl alcohol Ph. Eur.
45.0 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection
Sterile, colourless to slightly yellow solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with
orthapaedic or general surgery
The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illnesses including
cardiac insufficiency, respiratory failure or severe infections.
The treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or
both.
The treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with asprin.
Treatment of acute ST-segment Elevation Myocardial Infraction (STEMI) including patients to be managed
medically or with subsequent Percutaneous Coronary Intervention (PCI).
The prevention of thrombus formation in the extracorporeal circulation during haemodialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Prophylaxis of venous thromboembolism in surgical patients
In patients with a moderate risk of venous thromboembolism, the recommended dosage of enoxaparin sodium is 20mg
(2,000 IU) once daily by subcutaneous injection. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively.
In patients with a higher risk of thromboem
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