MYLAN-WARFARIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

WARFARIN SODIUM

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

B01AA03

INN (International Name):

WARFARIN

복용량:

10MG

약제 형태:

TABLET

구성:

WARFARIN SODIUM 10MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

COUMARIN DERIVATIVES

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-01-09

제품 특성 요약

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..........................................................................