MYLAN-WARFARIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
17-10-2011

有效成分:

WARFARIN SODIUM

可用日期:

MYLAN PHARMACEUTICALS ULC

ATC代码:

B01AA03

INN(国际名称):

WARFARIN

剂量:

10MG

药物剂型:

TABLET

组成:

WARFARIN SODIUM 10MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

COUMARIN DERIVATIVES

產品總結:

Active ingredient group (AIG) number: 0104597004; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2017-01-09

产品特点

                                PRODUCT MONOGRAPH
Pr
MYLAN-WARFARIN
Warfarin Sodium Tablets, USP
1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg and 10 mg Warfarin
Sodium (crystalline clathrate)
ANTICOAGULANT
Mylan Pharmaceuticals ULC
85 Advance Rd
Toronto, ON
M8Z 2S6
Control #: 149434
Date of Revision:
September 22, 2011
IMPORTANT: PLEASE READ
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND
STABILITY.........................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL
INFORMATION.........................................................................
27
CLINICAL
TRIALS..........................................................................
                                
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