Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
enoxaparin sodium
Sanofi-Aventis Australia Pty Ltd
Enoxaparin sodium
Registered
ENOXAPARIN WINTHROP AND ENOXAPARIN WINTHROP FORTE* _enoxaparin sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Enoxaparin Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Enoxaparin Winthrop against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT ENOXAPARIN WINTHROP IS USED FOR Enoxaparin Winthrop is used in a number of medical conditions. It is used to: • treat blood clots • treat certain types of heart disease (eg. angina and heart attacks), when used with aspirin • prevent blood clots forming after an operation, during hospitalisation or extended bed rest or during purification of the blood by an artificial kidney (haemodialysis). Enoxaparin Winthrop is one of a group of medicines called low molecular weight heparins (LMWH). These medicines work by reducing blood clotting activity. Your doctor may have prescribed Enoxaparin Winthrop for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ENOXAPARIN WINTHROP HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Enoxaparin Winthrop is addictive. This medicine is only available with a doctor's prescription. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT USE IT_ DO NOT USE ENOXAPARIN WINTHROP IF YOU HAVE AN ALLERGY TO ENOXAPARIN WINTHROP (ENOXAPARIN SODIUM), HEPARIN OR ITS DERIVATIVES INCLUDING OTHER LMWHS. SOME SIGNS AND SYMPTOMS OF AN ALLERGIC REACTION CAN INCLUDE SWELLING OF THE FACE, LIPS OR TONGUE, WHEEZING OR TROUBLED BREATHING, SKIN RASH, ITCHING HIVES, BLISTERS OR PEELING SKIN. DO NOT USE ENOXAPARIN WINTHROP IF YOU HAVE, OR HAVE EVER HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • major blood disorders • certain types of stroke • stomach or bowel problems Կարդացեք ամբողջական փաստաթուղթը
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 Կարդացեք ամբողջական փաստաթուղթը