MYLAN-WARFARIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

WARFARIN SODIUM

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

B01AA03

INN (nume internaţional):

WARFARIN

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

WARFARIN SODIUM 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

COUMARIN DERIVATIVES

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-01-09

Caracteristicilor produsului

                                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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