MYLAN-WARFARIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-10-2011
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Active ingredient:
WARFARIN SODIUM
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
B01AA03
INN (International Name):
WARFARIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
WARFARIN SODIUM 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
COUMARIN DERIVATIVES
Product summary:
Active ingredient group (AIG) number: 0104597004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-01-09
Summary of Product characteristics
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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