APO-DABIGATRAN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-07-2022
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
Available from:
APOTEX INC
ATC code:
B01AE07
INN (International Name):
DABIGATRAN ETEXILATE
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
DIRECT THROMBIN INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152467003; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-02-19
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
APO-DABIGATRAN
DABIGATRAN ETEXILATE CAPSULES
75 MG, 110 MG AND 150 MG
DABIGATRAN ETEXILATE (AS DABIGATRAN ETEXILATE MESYLATE)
ANTICOAGULANT
APOTEX INC DATE OF REVISION:
150 SIGNET DRIVE
July 18, 2022
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 258873
_ _
_ _
_ PAGE 2 OF 81 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT
INFORMATION.................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS..........................................................................................4
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
......................................................................................
31
OVERDOSAGE
......................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
37
STORAGE AND STABILITY
.................................................................................................
43
SPECIAL HANDLING
INSTRUCTIONS................................................................................
43
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 43
PART II: SCIENTIFIC
INFORMATION...............................................................................45
PHARMACEUTICAL INFORMATION
..................................................................................
4
Read the complete document
