MYLAN-WARFARIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

WARFARIN SODIUM

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

B01AA03

DCI (Dénomination commune internationale):

WARFARIN

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

WARFARIN SODIUM 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

COUMARIN DERIVATIVES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-01-09

Résumé des caractéristiques du produit

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