BIVALIRUDIN FOR INJECTION POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-04-2019
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Active ingredient:
BIVALIRUDIN
Available from:
FRESENIUS KABI CANADA LTD
ATC code:
B01AE06
INN (International Name):
BIVALIRUDIN
Dosage:
250MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
BIVALIRUDIN 250MG
Administration route:
INTRAVENOUS
Units in package:
5ML
Prescription type:
Prescription
Therapeutic area:
DIRECT THROMBIN INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0148342001; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-10-09
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
BIVALIRUDIN FOR INJECTION
Powder for Solution
250 mg / vial
Direct Thrombin Inhibitor
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Preparation:
April 18, 2019
Submission Control No: 217224
Bivalirudin for Injection-Annotated _ _Page 2 of 42 _ _
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMACOLOGY
...................................................
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