MYLAN-WARFARIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

WARFARIN SODIUM

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

B01AA03

INN (Διεθνής Όνομα):

WARFARIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

WARFARIN SODIUM 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

COUMARIN DERIVATIVES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-01-09

Αρχείο Π.Χ.Π.

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