Country: Canada
Language: English
Source: Health Canada
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
TEVA CANADA LIMITED
B01AE07
DABIGATRAN ETEXILATE
75MG
CAPSULE
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75MG
ORAL
30
Prescription
DIRECT THROMBIN INHIBITORS
Active ingredient group (AIG) number: 0152467001; AHFS:
APPROVED
2018-02-19
1 PRODUCT MONOGRAPH PR TEVA-DABIGATRAN Dabigatran Etexilate Capsule s Capsules 75 mg and 150 mg Dabigatran Etexilate, (as Dabigatran Etexilate Me silate) Anticoagulant Teva Canada Limited. 30 Novopharm Court, Toronto, Ontario M1B 2K9 Date of Preparation APRIL 26, 2017 Control Number: 184807 2 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS ...................................................................................................... 3 WARNINGS AND PRECAUTIONS .................................................................................... 4 ADVERSE REACTIONS ..................................................................................................... 11 DRUG INTERACTIONS..................................................................................................... 21 DOSAGE AND ADMINISTRATION ................................................................................ 27 OVERDOSAGE .................................................................................................................... 32 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 34 STORAGE AND STABILITY ............................................................................................ 38 DOSAGE FORMS, COMPOSITION AND PACKAGING.............................................. 38 PART II: SCIENTIFIC INFORMATION .................................................................................... 40 PHARMACEUTICAL INFORMATION ........................................................................... 40 CLINICAL TRIALS............................................................................................................. 42 DETAILED PHARMACOLOGY ............ Read the complete document