国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENOXAPARIN SODIUM
MEDISPEC (M) SDN.BHD
ENOXAPARIN SODIUM
2 Pre-Filled Syringes; 2 Pre-Filled Syringes; 10 Pre-Filled Syringes; 10 Pre-Filled Syringes
Shenzhen Techdow Pharmaceutical Co., Ltd.
INHIXA 2,000 IU (20 MG)/0.2 ML INHIXA 4,000 IU (40 MG)/0.4 ML INHIXA 6,000 IU (60 MG)/0.6 ML enoxaparin sodium SOLUTION FOR INJECTION IN PREFILLED SYRINGE The package insert is continually updated: please read carefully before using a new pack. In case of any question, please contact your physician or pharmacist. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: enoxaparin sodium Solvent: water for injections. Each ml of the solution contains 10000 IU anti-Xa activity equivalent to 100 mg enoxaparin sodium. One mg (0.01 ml) of enoxaparin sodium corresponds approximately to 100 IU anti-Xa activity. Inhixa 2000 IU anti-Xa activity is equivalent to 20 mg, Inhixa 4000 IU anti-Xa activity is equivalent to 40 mg, Inhixa 6000 IU anti-Xa activity is equivalent to 60 mg. PRODUCT DESCRIPTION A clear, colourless or pale yellow solution IN READY-TO-USE PRE-FILLED SYRINGE • Inhixa is a biosimilar medicine to the reference product Clexane (Enoxaparin Sodium). • Inhixa is not interchangeable or automatically substitutable with Clexane. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Inhixa is indicated in adults for: _ _ • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. • Prevention of thrombus formation in extra corporeal circulation during haemodialysis. • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid. - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including 完全なドキュメントを読む