ENOXAPARIN WINTHROP FORTE enoxaparin sodium 150 mg/1 mL injection syringe with automatic safety lock system

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

enoxaparin sodium

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Enoxaparin sodium

Authorization status:

Registered

Summary of Product characteristics

enoxaparin-winthrop-ccdsv13-piv3-13jul18
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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
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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