Land: Taívan
Tungumál: kínverska
Heimild: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
WARFARIN SODIUM CRYSTALLINE
臺灣必治妥施貴寶股份有限公司 台北市松山區健康路156號4樓、5樓 (11922609)
B01AA03
錠劑
WARFARIN SODIUM CRYSTALLINE (2012401021) 1MG
瓶裝;;鋁箔盒裝
製 劑
須由醫師處方使用
BRISTOL-MYERS SQUIBB COMPANY 4601 HIGHWAY 62 EAST, MOUNT VERNON, INDIANA 47620 USA US
warfarin
1.預防及/或治療靜脈栓塞症及其相關疾病,以及肺栓塞。2.預防或治療因心房纖維顫動及/或更換心臟瓣膜引起之血栓性栓塞症。
註銷日期: 2020/04/16; 註銷理由: 許可證已逾有效期; 有效日期: 2019/03/10; 英文品名: COUMADIN TABLETS 1MG
已註銷
1994-03-10
COUMADIN ® TABLETS (WARFARIN SODIUM TABLETS, USP) CRYSTALLINE WARNING: BLEEDING RISK • COUMADIN can cause major or fatal bleeding [see _Warnings and Precautions_]. • Perform regular monitoring of INR in all treated patients [see _Dosage _ _and _ _Administration _]. • Drugs, dietary changes, and other factors affect INR levels achieved with COUMADIN therapy [see _Drug Interactions_]. • Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see _Patient Counseling Information_ ]. 1 INDICATIONS AND USAGE COUMADIN is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. COUMADIN is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. 2 DOSAGE AND ADMINISTRATION The dosage and administration must be adjusted based upon the patient’s PT/INR. THE BEST AVAILABLE INFORMATION SUPPORTS THE FOLLOWING RECOMMENDATIONS FOR DOSING OF COUMADIN. VENOUS THROMBOEMBOLISM (INCLUDING DEEP VENOUS THROMBOSIS [DVT] AND PULMONARY EMBOLISM [PE]) For patients with a first episode of DVT or PE secondary to a transient (reversible) risk factor, treatment with warfarin for 3 months is recommended. For patients with a first episode of idiopathic DVT or PE, warfarin is recommended for at least 6 to 12 months. For patients with two or more episodes of documented DVT or PE, indefinite treatment with warfarin is suggested. For patients with a first episode of DVT or PE who have documented antiphospholipid antibodies or who have two or more thrombophilic conditions, treatment for 12 months is recommended and indefinite therapy is suggested. For patients with a first episode of DVT or PE who have documented deficiency of antithrombin, deficiency of Protein C or Protein S, or the Factor V Leiden or prothrombin 20210 gene mutation, homocystinemia, or high Factor VIII levels (>90th percentile of normal), treatment for 6 to 12 Lestu allt skjalið