可邁丁錠1毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

WARFARIN SODIUM CRYSTALLINE

可用日期:

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)

ATC代码:

B01AA03

药物剂型:

錠劑

组成:

WARFARIN SODIUM CRYSTALLINE (2012401021) 1MG

每包单位数:

瓶裝;;鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

BRISTOL-MYERS SQUIBB COMPANY 4601 HIGHWAY 62 EAST, MOUNT VERNON, INDIANA 47620 USA US

治疗领域:

warfarin

疗效迹象:

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。

產品總結:

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

授权状态:

已註銷

授权日期:

1994-03-10

资料单张

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