Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
enoxaparin sodium
Sanofi-Aventis Australia Pty Ltd
Enoxaparin sodium
Registered
enoxaparin-winthrop-ccdsv13-piv3-13jul18 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION – ENOXAPARIN WINTHROP AND ENOXAPARIN WINTHROP FORTE (ENOXAPARIN SODIUM) 1 NAME OF THE MEDICINE Enoxaparin sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ENOXAPARIN WINTHROP Ready-to-use, prefilled syringes: 20 mg injection: enoxaparin sodium 20 mg/0.2 mL (anti-Xa: 2,000 IU) 40 mg injection: enoxaparin sodium 40 mg/0.4 mL (anti-Xa: 4,000 IU) Ready-to-use, prefilled syringes with graduated markings: 60 mg injection: enoxaparin sodium 60 mg/0.6 mL (anti-Xa: 6,000 IU) 80 mg injection: enoxaparin sodium 80 mg/0.8 mL (anti-Xa: 8,000 IU) 100 mg injection: enoxaparin sodium 100 mg/1 mL (anti-Xa: 10,000 IU) ENOXAPARIN WINTHROP (WITH AUTOMATIC SAFETY LOCK SYSTEM) Ready-to-use, prefilled syringes: 20 mg injection: enoxaparin sodium 20 mg/0.2 mL (anti-Xa: 2,000 IU) 40 mg injection: enoxaparin sodium 40 mg/0.4 mL (anti-Xa: 4,000 IU) Ready-to-use, prefilled syringes with graduated markings 60 mg injection: enoxaparin sodium 60 mg/0.6 mL (anti-Xa: 6,000 IU) 80 mg injection: enoxaparin sodium 80 mg/0.8 mL (anti-Xa: 8,000 IU) 100 mg injection: enoxaparin sodium 100 mg/1 mL (anti-Xa: 10,000 IU) ENOXAPARIN WINTHROP FORTE Ready-to-use, prefilled syringes with double graduated markings: 120 mg injection: 120 mg/0.8 mL (anti-Xa: 12,000 IU) 150 mg injection: 150 mg/1 mL (anti-Xa: 15,000 IU) enoxaparin-winthrop-ccdsv13-piv3-13jul18 Page 2 of 27 ENOXAPARIN WINTHROP FORTE (WITH AUTOMATIC SAFETY LOCK SYSTEM) Ready-to-use, prefilled syringes with double graduated markings: 120 mg injection: 120 mg/0.8 mL (anti-Xa: 12,000 IU) 150 mg injection: 150 mg/1 mL (anti-Xa: 15,000 IU) For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Injection, solution Clear, colourless to pale yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery. • Prophylaxis of venous thromboembolism in medical patients be Read the complete document